GUIDANCE DOCUMENT
Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers March 1993
- Docket Number:
- FDA-2020-D-0957
- Issued by:
-
Guidance Issuing OfficeCenter for Devices and Radiological Health
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.
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:
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.