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Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers (Text Only)

This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.

March 1993

        GUIDANCE ON THE CONTENT OF PREMARKET NOTIFICATION [510(K)] 
            SUBMISSIONS FOR CLINICAL ELECTRONIC THERMOMETERS

I.  INTRODUCTORY INFORMATION

A.  Scope

    This document establishes the 510(k) review requirements for clinical 
electronic thermometers.  Examples of devices within this generic type 
include devices which measure oral, axillary, rectal, or tympanic 
temperature utilizing a number of methods.  The thermometer may or may not 
include separate disposable probe covers. 

    EXCLUSIONS

    This guidance does not address submissions for clinical mercury 
thermometers or clinical color change thermometers (as described in 21 CFR 
880.2900 and 880.2920, respectively)
    
B.  Purpose

    This guidance is intended to:

    1.  assist persons (manufacturers, distributors, or
        importers) in organizing premarket notifications for
        clinical electronic thermometers; 

    2.  achieve consistency in meeting of requirements and in
        the presentation of information; and

    3.  guide FDA review staff in conducting and documenting the
        review of premarket notifications for clinical
        electronic thermometers.

C.  Definitions

    1.  Clinical Electronic Thermometer:  described in FDA
        regulation,  880.2910, as "a device used to measure the
        body temperature of a patient by means of a transducer
        coupled with an electronic signal amplification,
        conditioning, and display unit.  The transducer may be
        in a detachable probe with or without a disposable
        cover."

    2.  Accuracy:  the degree to which the measurements from the
        device agree with the "true" values as would be measured
        by some other standard device, such as a thermocouple
        device calibrated against NIST Standards or other
        accepted national standards.
 
    3.  Probe:  an assembly, including the transducer, used to
        position the transducer in the specific location at
        which the temperature is to be determined.

    4.  Radiation Thermometer:  a device used to measure the
        temperature of a target body part based upon radiation
        emitted from the target part (e.g., an infrared tympanic
        thermometer).

    5.  Transducer:  a component that provides a measurable
        output (e.g., resistance) as a function of temperature.

    6.  Precision:  the degree to which the temperature is
        measured and represented.  

    7.  Intended Use:  the objective intent of the persons
        legally responsible for the labeling of the device.  The
        intent is determined by their expressions or may be
        shown by the circumstances surrounding the distribution
        of the device.  The objective intent may, for example,
        be shown by labeling claims, advertising matter, or oral
        or written statements by such representatives.  It may
        be shown by the offering or the using of the device,
        with the knowledge of such persons or their
        representatives, for a purpose for which it is neither
        labeled nor advertised ( 801.4).  Some use conditions
        for thermometers may include reusable, oral, axillary,
        rectal and typmanic measurements, and home use.

    8.  Abbreviations:
        ANSI - American National Standards Institute
        ASTM - American Society for Testing and Materials
        CDRH - Center for Devices and Radiological Health
        CFR - Code of Federal Regulations
        DSMA - Division of Small Manufacturers Assistance
        FDA - Food and Drug Administration
        FR - Federal Register
        IEC - International Electrotechnical Commission
        HIMA - Health Industry Manufacturers Association
        NIST - National Institute of Standards and Technology 
        ISO - International Organization for Standardization
        OCS - Office of Compliance and Surveillance
        ODE - Office of Device Evaluation
        SMDA - Safe Medical Devices Act of 1990
        UL - Underwriters Laboratory

D.  General Principles Regarding Presentation of Data

    1.  Editorial Considerations:  The 510(k) should be
        carefully edited, as well as scientifically reviewed
        before it is submitted to FDA.  It should be proofread
        to assure that all pages/sections are included and are
        properly indicated, consecutive, distinctly copied, and
        legible.

    2.  Abbreviations:  Standard abbreviations acceptable to a
        significant peer reviewed journal should be used
        wherever possible.  All other abbreviations should be
        identified at the beginning of each section in which
        they are used or in footnotes to tables and graphs.

    3.  Data Availability:  This document outlines typical
        circumstances of data review.  It is not possible to
        anticipate all situations that may require FDA review. 
        Thus, those submitting applications should be aware that
        they may be asked to submit additional data, to present
        data in another format or to provide more detailed
        explanations of the information submitted, if required
        to establish equivalence.

        Applicants should keep data used for the 510(k)
        submission on file in a controlled and well-organized
        format.  This will allow the applicant to expeditiously
        supply FDA with additional information or analysis if
        required.  Errors in data that are identified by the
        applicant after submission to FDA should be brought to
        FDA's attention immediately.

    4.  Tables and Graphs:  Well-constructed tables are
        fundamental to the reporting and evaluation of data. 
        All tables should be clearly identified and captioned
        with symbols keyed to a footnote or accessible reference
        page that adequately indicates the nature of the data.

        Graphs should supplement, not replace, data tables. 
        They should be of a high quality.

    5.  Published Literature:  Published methods or data
        referenced in study reports should be made available to
        FDA upon request.  Reprints of other referenced
        published reports or data should also be made available
        to FDA upon request.  All referenced reports and data
        should be summarized including an explanation how it
        relates to the current submission.  Reference citations
        should be complete (e.g., title, author, volume, year).

    6.  Protocols and Data Analysis:  

        Test reports must include the protocol (objectives,
        precise description of materials, experimental methods,
        controls), observations, statistical methods and
        analyses, conclusions and comments.  Do not submit raw
        data.  Additional specific directions on protocols are
        included in sections that follow.
        
    7.  Reference to Submitted Data:

        In support of the 510(k), the applicant may reference
        any information previously submitted to FDA.  If the
        applicant did not submit the referenced data he must
        provide, or have the submitter provide to FDA, a letter
        of authorization.  Often, if the data are not extensive,
        resubmitting data in the 510(k) will facilitate the
        review of the document.

E.  Document Availability

    The following documents are available from DSMA [(800)638-
    2041 or (301)443-6597]:   
      Tripartite Biocompatibility Guidance for Medical Devices
      ODE Blue Book Memorandum #K90-1:  510(k) Sterility Review  
        Guidance    

II. CONTENT AND ORGANIZATION OF INFORMATION IN A 510(K) FOR A
    CLINICAL ELECTRONIC THERMOMETER 
   
A.  Cover Letter

    The submission shall have a signed cover letter providing
    the following information described in  807.87 (Information
    required in a premarket notification submission):
    
    1.  The thermometer's trade or proprietary name.
                         
    2.  Common Name:  Oral Thermometer, Tympanic Thermometer,
        etc.
            
    3.  Classification name:  Clinical Electronic Thermometer

    4.  The establishment registration number, if applicable, or
        the sponsor, owner or operator submitting the premarket
        notification

    5.  Class:  II
        Panel:  80
        Procode:  FLL - clinical electronic thermometer
                         
    6.  A statement explaining the purpose of the submission
        (e.g., new device, significant modification of device
        previously found equivalent (new intended use, material,
        or manufacturing process, etc.)).  Refer to  807.87(g)
        for additional information regarding changes to devices. 
        The change may require some or all of the information
        needed for a new device.  Please supply the previous
        510(k) number(s), if applicable.      

    7.  A brief statement indicating the device is similar to
        and/or different from other products of comparable type
        in commercial distribution.

    8.  Name, address, and phone number of a U.S. contact
        person, if available.

B.  Labels and Labeling

    1.  The submission shall contain proposed labels, labeling,
        and advertisements sufficient to describe the device,
        its intended use, and the directions for use.  Labels
        include the information affixed directly to the device
        or its container or packaging.  Labeling also includes
        professional or patient package inserts, and any other
        information that accompanies the device.  

    2.  The labeling must meet the requirements of 21 CFR Part
        801 as it relates to a determination of intended use. 
        ODE will concentrate on the following portions of Part
        801:

            Subpart A,   801.4 and 801.5, related to intended
            uses and adequate directions for use; and

            Subpart B,   801.109 and 801.116, related to
            prescription devices and commonly known directions. 
            

        Other provisions of Part 801 are deferred for review to
        CDRH/OCS Device Labeling Compliance Branch.
    
    3.  Labeling for the clinical electronic thermometer should
        include, if applicable: 

        a.  the type(s) of temperature measurements (e.g., oral,
            axillary, tympanic, etc.) which can be made by the
            thermometer as indicated in the statement of
            intended use (see D.2); 

        b.  a list of device specifications including, but not
            limited to:  temperature range, accuracy, and
            precision;  

        c.  the ambient temperature environment (range) in which
            the device may be used;

        d.  adequate directions for use for all possible
            functions of the device;

        e.  identification of compatible probe covers and
            instructions on their use and/or instructions on how
            to clean and disinfect or sterilize the device
            between uses; 

        f.  instructions for proper maintenance of the device
            including a recalibration schedule and recalibration
            instructions;

        g.  instructions for interpreting the device output with
            regard to core body temperature; and

        h.  the time required to obtain a steady state reading.

C.  Standards

    Listed are some, but not all, of the standards related to
    clinical electronic thermometers:

    1.  ASTM E1112-86 Standard Specification for Electronic
        Thermometer for Intermittent Determination of Patient
        Temperature.

    2.  ASTM E1104-86 Standard Specification for Clinical
        Thermometers Probe Covers and Sheaths

    3.  UL 544 Standards for safety, medical and dental
        equipment 

    4.  IEC 601-1/ANSI ES1-1985 Safe Current Limits for
        Electromedical Apparatus

    The applicant may certify that the device meets a standard. 
    The applicant then is obliged to comply with the standard
    and maintain documentation of tests showing that the device
    meets the standard.  Certification of meeting a specific
    standard and reference to standards in the 510(k) may reduce
    the documentation needed in the 510(k) submission.  This is
    noted in pertinent sections.   
    
D.  Device Description
    
    The applicant must submit a complete description of the
    device, including all models and variations.  

    1.  Provide a labeled representation of the device in
        sufficient detail to facilitate the evaluation of the
        nature and operation of the device (e.g., photographs,
        detailed drawings, or engineering drawings).  If the
        labeling already includes sufficient illustrations of
        the device, refer to the labeling.
    
    2.  Provide a clear statement of the intended use(s) of the
        thermometer. 
        
        a.  Specify the type(s) of temperature measurements
            (e.g., oral, axillary, tympanic) which can be made
            by the thermometer.

        b.  Describe any specific use of this device other than
            for the type(s) of temperature measurements as
            indicated in 2.a. above. 

    3.  Provide the following information for the device.  The
        applicant may refer to relevant standards.

        a.  Physical Specifications

        (1) Components:  Identify and describe all major
            components or component groups and give dimensions. 
            Each component/component group should be identified
            as reusable or disposable.  Identify any
            component/component group which contacts the patient
            tissue or fluid and the type of tissue/fluid
            contacted.

        (2) Sensor:  Describe the sensor/transducer which is
            used to measure temperature.  

        (3) Signal Processing and Display:  Provide a
            qualitative description of the signal processing and
            display components and their capabilities.
 
        (4) Power Requirements:  Describe the energy/power
            requirements and characteristics.  Indicate if the
            device meets UL 544.  If not, describe how.  

        (5) Materials:  Identify the basic materials of
            construction.  Provide the chemical formulation of
            all materials which contact patient tissue or
            fluids.  If probe covers are included in this
            submission, identify their materials of
            construction.  

        b.  Operational Specifications

        (1) Temperature Range:  Provide the temperature range of
            the device.   

        (2) Ambient Temperature Environment:  Provide the
            ambient temperature range in which the device may be
            operated.

        (3) Accuracy:  Provide the accuracy over the entire
            temperature range specified for the device.  The
            effects of air currents, over the entire useful
            temperature range specified, on accuracy should also
            be provided.

        (4) Precision and Repeatability:  Describe the precision
            and repeatability of measurements over the
            temperature range specified.  The effects of air
            currents, over the entire useful temperature range
            specified, on precision and repeatability should
            also be provided.

        (5) Algorithms:  If applicable, provide the model and
            algorithms used for the conversion of temperatures
            (e.g., tympanic to core). 

        (6) Time:  Indicate the time required for the device to
            obtain a steady state reading.

        (7) Other Capabilities:  Describe any other capabilities
            the device may possess.

        c.  Biological Specifications

            State the biocompatibility category for all patient
            tissue and fluid contacting components and materials
            per the draft ISO 194 Biocompatibility Standard or
            the Tripartite Biocompatibility Guidance.

E.  Descriptive Comparison to a Legally Marketed Device

    Identify a legally marketed electronic thermometer to which
    substantial equivalence is claimed.  (If possible, identify
    the 510(k) number(s).)  More than one thermometer can be
    listed, but the device(s) chosen should be as close in
    intended use and technology to the new device as possible. 
    Provide the information noted below to show how the new
    device is both similar to and different from the legally
    marketed device.  Side by side comparisons, whenever
    possible are desirable (see Attachment 2).  This information
    may be identical to that provided under Part D and the
    applicant may wish to combine some or all of Parts D and E
    information.  Indicate how the differences may affect safety
    and effectiveness.    

    1.  Provide labeling (labels, instructions for use,
        promotional material) for the legally marketed device(s)
        to which substantial equivalence is claimed.  To
        facilitate comparison, also include clear
        representations of the legally marketed device(s),
        unless the labeling has ample information.
    
    2.  Compare and contrast the intended use(s) for the new
        device to the predicate device(s).  

    3.  Compare materials used to fabricate tissue or fluid
        contacting components.  The precise materials of the
        tissue or fluid contacting components of the new device,
        and if possible, the predicate device(s) should be
        identified to the extent possible.

    4.  Compare the operational principles including mode of
        action. 

    5.  Compare physical, operational, and biological
        specifications.

    6.  If applicable, compare results from bench testing (see
        F.).

F.  Performance Data Supporting Substantial Equivalence

    Provide the protocols and results of the tests indicated
    below.  If the stated test is taken from a standard that
    specifically addresses the performance criterion, then the
    applicant should reference the standard and certify that the
    device will meet the criterion.  Data need not be submitted
    in this instance.
  
    The studies should be well-designed to meet the stated
    objectives.  This will include rigorous attention to:
    statistical elements (hypotheses, test statistics, analyses,
    sample size and sampling, power, etc.), inclusion/exclusion
    criteria, controls, minimization of bias, test parameters
    (endpoints), follow-up, evaluation criteria, etc.  Some of
    the above points may overlap.  Ample reference material
    exists on study design and methods upon which the applicant
    may rely (e.g., biocompatibility). 
            
    1.  Bench Data
            
        a.  The accuracy of the device must be characterized. 
            Devices which utilize standard type electrical
            transducer designs (e.g., standard thermocouple or
            thermistor) may not require testing.  Devices which
            utilize other types of transducer designs (e.g.,
            optical) or unique designs should have data showing
            the accuracy of device over the entire temperature
            range specified for the device.  The effects of air
            currents, over the entire useful temperature range
            specified, on accuracy should also be provided.   

        b.  The precision and repeatability of the device over
            the temperature range specified for the device
            should be characterized as indicated above.  The
            effects of air currents, over the entire useful
            temperature range specified, on precision and
            repeatability should also be provided.    
        
    2.  Biocompatibility Data

            For all body tissue or fluid contacting materials
            certify that the identical materials have been used
            in other legally marketed devices under the same use
            conditions, or provide documentation attesting to
            the biocompatibility of the component materials in
            the finished product according to the 1987
            Tripartite Biocompatibility Guidance for Medical
            Devices and 1992 draft ISO 194 standard (Biological
            testing of medical and dental materials and
            devices).  With regard to metals, the applicant may
            simply identify device components made of an ASTM
            grade of metal that ASTM certifies is biocompatible,
            e.g., ASTM 316 stainless steel.   

            Biocompatibility test data may be required for
            colors that are not listed in FDA regulations or are
            not used in other legally marketed devices for a
            similar intended use.

    3.  Comparative Claims

            Additional data may be needed to support comparative
            claims.  

    4.  Unique Designs

            Additional data may be needed to support designs
            that are significantly different from typical
            designs.
    
G.  Software

    The sponsor must indicate the level of concern (see p.16 of
    the document indicated below) for electronic thermometers
    which are software controlled and provide appropriate
    software information according to the "Reviewer Guidance for
    Computer Controlled Medical Devices Undergoing 510(k)
    Review." 

H.  Sterilization Information

    See Attachment 1

I.  SMDA Information

    Summary or Statement of Safety and Effectiveness

    All persons submitting a 510(k) must include either a
    summary of safety and effectiveness information in the
    510(k) upon which an equivalence determination could be
    based OR the statement "safety and effectiveness information
    about the [device name] will be made available to any
    interested person upon request."  Safety and effectiveness
    information refers to adverse safety and effectiveness
    information, descriptive information about the new and
    predicate devices, and performance/clinical testing
    information.

    If the summary option is selected, it should be included as
    a separate attachment and identified as the Summary of
    Safety and Effectiveness for [device name].

    If the statement option is selected, do not include the word
    "summary" in the statement.

    The content and format of this information is specified in
    57FR No. 82, Tuesday, April 28, 1992, page 18062.

J.   Sample

     Provide a sample of the device, if possible.

IV.  COMMENTS

     Address any comments regarding this guidance to:


          Chief, General Hospital Devices Branch
          HFZ-412
          1390 Piccard Drive
          Rockville, MD  20850-4308

Attachments

                               ATTACHMENT 1
                           STERILITY INFORMATION


For a device sold sterile, provide the following information as
detailed in the ODE Blue Book Memorandum #K90-1.

     1.   Sterilization method that will be used.  

     2.   A description of the method that will be used to
          validate the sterilization cycle, but not the
          validation data itself.  Reference to a standard method
          (e.g., AAMI Radiation Standard) usually is sufficient.

     3.   The sterility assurance level (SAL) for the device
          which the firm intends to meet.  An SAL of 10-6 is
          required for devices which contact normally sterile
          areas of the body.

     4.   A description of the packaging to maintain the device's
          sterility (this is not to include packaging integrity
          testing data).

     5.   If sterilization involves EtO, the maximum levels of
          residues of ethylene oxide, ethylene chlorohydrin, and
          ethylene glycol which remain on the device.  The levels
          should be consistent with the draft Federal Register
          Notice on EtO limits.1

     6.   Whether the product is "pyrogen free" and an
          identification of the method used to make that
          determination.2

     7.   The radiation dose, if radiation sterilization will be
          used, and if it has been determined.  Otherwise, amend
          the 510(k) file at FDA when the dose has been
          determined.

References

1.   FDA Proposed Rule, 43 FR 27482 (June 23, 1978), Maximum
     Residue Limits for Ethylene Oxide, Ethylene Chlorohydrin,
     and Ethylene Glycol.

2.   FDA Guidelines on Validation of the Limulus Amebocyte Lysate
     (LAL) Test as an End-Product Endotoxin Test for Human and
     Animal Parenteral Drugs, Biological Products, and Medical
     Devices.

  
ATTACHMENT 2
EXAMPLE OF SIDE BY SIDE COMPARISON TABLE

 

 ELEMENT OF COMPARISON    SUBJECT 
  DEVICE  
  CLAIMED  
 SE DEVICE  
  #1  
  (CLAIMED 
  SE DEVICE 
 (#2)  
thermometer type      
intended use(s)      
labeling      
components      
sensor      
signal processing and
display
     
power requirements      
materials      
temperature range      
ambient temperature
environment
     
accuracy      
precision and repeatability      
response time      
other capabilities      

SE=Substantially equivalent
The applicant may reference relevant standards in theTable .

 

 

ATTACHMENT 3 CLINICAL ELECTRONIC THERMOMETER REVIEW CHECKLIST 510(k)#:__________ Sponsor:__________ Date:____________ Reviewer:_________ ELEMENT ADEQUATE COMMENTS (e.g., N/A, page #, 30ml, YES NO 18g, PVC, EtO, 10-6, ¾ ") Cover Letter

  • trade name                                                                
    
    
  • common name                                                              
    
  • classification name                                                      
    
  • establishment reg. #                                                          
    
  • procode(s)                                                               
    
  • purpose of submission                                                         
    
  • previous files referenced                                                
    
  • statement that device is 
    similar to and/or different 
    from other products                                             
    
Labeling
specifications
	
  • temperature range                                                         
    
  • acccuracy                                                             
    
  • precision                                                            
    
  • ambient temperature
    environment    
    
  • instructions
    
    • type of temperature
      measurements                                                              
      
    • directions for use and 
      interpretation of
      devce output                                                               
      
    • directions for reuse
      (cleaning/disinfection)                                                
      
    • maintenance/recalibration
      instructions                                                               
      
    Description of Device
    
    • type                                                                
      
    • basic description                                                        
      
    • photograph/drawing                                                        
      
    Intended Use(s)
    
    • clear statement                                                               
      
    • type of measurement(s)                                                   
      
    • any other specific use                                              
      
    Physical Specifications
    
    • component/component groups                                               
      
    • sensor/transducer                                                      
      
    • signal processing
      and display                                                            
      
    • power requirements                                                       
      
    • materials                                                                
      
    Operational Specifications
    
    • temperature range                                                        
      
    • accuracy                                                                  
      
    • precision and repeatability                                            
      
    • ambient temperature
      environment                                                            
      
    • algorithms                                                               
      
    • response time                                                            
      
    • other capabilities                                                       
      
    Biological Specifications
    
    • biocompatibility require-
        ments for all fluid/tissue 
        contact components and 
        materials                                                                     
      
    Descriptive Comparison to Legally Marketed Device
    
  • identified appropriate     
      legally marketed device(s)                                               
    
  • labeling                                                                  
    
  • description                                                               
    
  • intended use(s)                                                                
    
  • materials                                                                 
    
  • mode of operation                                                         
    
  • physical specifications                                              
    
  • operational specifications                                                
    
  • biological specifications                                                 
    
  • side by side comparison                                              
    
  • discussion of how differences
      may affect safety and
      effectiveness                                                            
    
    Performance Data Supporting Equivalence
    
    • bench data      
                                                                
      accuracy     
                                                       
      precision and 
      repeatability                                                              
      
  • iocompatibility                                                          
    
  • comparative claims                                                       
    
  • unique designs                                                            
    
    
    Sterilization Information
    
    • method                                                                    
      
    • validation method                                                         
      
    • SAL                                                                       
      
    • packaging description                                                         
      
    • EtO residuals                                                             
      
    • pyrogen free method                                                       
      
    • radiation dose                                                            
      
    SMDA Information
    
    • summary                                                                   
      
    • statement                                                                 
      
    Sample
    
  • provided                                                                   
    
    
    ADDITIONAL REMARKS: