• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles (Text Only)

April 1993

        GUIDANCE ON THE CONTENT OF PREMARKET NOTIFICATION [510(K)]
             SUBMISSIONS FOR HYPODERMIC SINGLE LUMEN NEEDLES

I.   INTRODUCTORY INFORMATION

A.   Scope

     This document establishes the 510(k) review requirements for 
hypodermic single lumen needles.

B.   Purpose

     This guidance is intended to:

     1.   assist persons (manufacturers, distributors, or
          importers) in organizing premarket notifications for
          hypodermic single lumen needles; 

     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 hypodermic
          single lumen needles.

C.   Definitions

     1.   Hypodermic Single Lumen Needle:  described in FDA
          regulation,  880.5570, as "a device intended to inject
          fluids into, or withdraw fluids from, parts of the body
          below the surface of the skin.  The device consists of
          a metal tube that is sharpened at one end and at the
          other end joined to a female connector (hub) designed
          to mate with a male connector (nozzle) of a piston
          syringe or an intravascular administration set."

     2.   Nozzle:  the portion of the barrel of the syringe to
          which a needle is attached.  The types are as follows:

               Luer-lock:  secures the needle onto the syringe by
               locking the needle hub onto the nozzle.  The luer-
               lock makes a stable connection between the syringe
               and needle.  

               Slip Tip:  secures the needle with only a
               compression fitting of the needle hub to the
               syringe nozzle.    

               Eccentric:  provides a connection that is almost
               flush with the side of the barrel.

     3.   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 needles may include single use only, disposable,
          and home use.

     4.   Abbreviations:
          AAMI - Association for the Advancement of Medical       
                 Instrumentation
          ASTM - American Society for Testing and Materials
          CBER - Center for Biologics Evaluation and Research
          CDER - Center for Drug Evaluation and Research
          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
          ISO - International Organization for Standardization
          OCS - Office of Compliance and Surveillance
          ODE - Office of Device Evaluation
          SMDA - Safe Medical Devices Act of 1990

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
     HYPODERMIC SINGLE LUMEN NEEDLE
   
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 needle's trade or proprietary name.
                              
     2.   Common Name:  Hypodermic Needle, etc.
            
     3.   Classification name:  Hypodermic Single Lumen Needle

     4.   The establishment registration number, if applicable,
          of the sponsor, owner or operator submitting the
          premarket notification
               
     5.   Class: II
          Panel: 80
          Procode:   FMI - Hypodermic Single Lumen Needle
                              
     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 needle should include, if applicable: 

          a.   the identity of the device (gauge and length) and
               quantity; 

          b.   the statements "sterile, single use only,
               nonpyrogenic, nontoxic";

          c.   the prescription statement under  801.109(b)(1); 

C.   Standards 

     Listed are some, but not all, of the standards relating to needles:

     1.   ISO 7864, Sterile Hypodermic Needles for Single Use;

     2.   ISO 594, Conical Fittings with a 6% (Luer) Taper for
          Syringes, Needles, and Certain Other Medical Equipment;

     3.   ISO 9626, Stainless Steel Needle Tubing for Manufacture
          of Medical Devices;

     4.   ISO 6009, Hypodermic Needles for Single Use - Colour
          Coding for Identification;

     5.   ASTM for stainless steel tubing testing. 

     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, please refer to the labeling.
     
     2.   Provide a clear description of the intended use(s) of
          the device. 
          
     3.   Provide the specifications for the device.  The
          applicant may refer to relevant standards.

          a.  Physical Specifications

          (1)  Needle:  length, gauge, and configuration of the
               tip.  

          (2)  Cover:  dimensions and color.

          b.   Mechanical Specifications

          (1)  Needle Cover:  strength.

          (2)  Hub/needle:  bond strength.

          c.   Biological Specifications

               According to the draft ISO 194 Biocompatibility
               Standard, needles are categorized as Externally
               Communicating, Circulating Blood, Limited
               Exposure.  The Tripartite Biocompatibility
               Guidance has a related categorization.    

     4.   Provide a complete listing of all materials (chemical
          formulations), particularly those with fluid or body
          contact, used in fabricating the needle, hub, and
          needle cover.

          Identify all colors (ink, dyes, markings, radiopaque
          materials, etc.) used in manufacturing the device.  
  
E.   Descriptive Comparison to a Legally Marketed Device

     Identify a legally marketed needle to which substantial equivalence is 
claimed.  If possible, identify the 510(k) number(s).  More than one needle 
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 1).  This information may be 
identical to that provided under Part C and the applicant may wish to 
combine some or all of Parts C and D information.  Indicate how any 
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 for the new
          device to the predicate device(s).  

     3.   Compare all materials used to fabricate the devices. 
          The precise materials of the new device, and if
          possible, the predicate device(s) should be identified
          to the extent possible.

     4.   Compare physical, mechanical, and biological
          specifications.

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.   Biocompatibility 

          Certify that the identical materials have been used in
          other legally marketed devices used under the same use
          conditions, or provide data documenting 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).  The test category
          of needles in the ISO standard are specified in Section
          D.3.(c) above.  With regard to metals, if the applicant
          certifies that a component metal meets an ASTM standard
          where biocompatibility is indicated, e.g., ASTM 316
          stainless steel, the certification will suffice for
          documentation purposes.   

          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.
     
     2.   Comparative Claims

          Additional data may be needed to support comparative
          claims.  

     3.   Unique Designs

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

G.   Sterilization Information

     See Attachment 2

H.   SMDA Information

     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 a statement that 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 on a separate 
page 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.

I.   Sample

     Provide a sample, if possible.

J.   Anti-needlestick Requirements 

     If the hypodermic single lumen needle incorporates an anti-needlestick 
mechanism, the applicant must completely describe the mechanism, 
demonstrate the equivalence of the mechanism, and substantiate all labeling 
claims associated with the anti-needlestick feature.  

     CDRH is currently writing a guidance document on the content of 
510(k)s for devices incorporating antistick features and for stand-alone 
antistick devices.  This document will be available from DSMA when 
finalized.


III. PREMARKET NOTIFICATIONS FOR KITS

     1.   See Attachment 3 for required information.

     2.   The following kit components require further evaluation
          by FDA and/or require language in an equivalence letter
          noting special requirements or limitations for these
          components:
          
               Sutures
               Dressings
               Medical Gloves
               Drugs
               Biologics

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
EXAMPLE OF SIDE BY SIDE COMPARISON TABLE

 

ELEMENT OF COMPARISON SUBJECT
DEVICE
CLAIMED
SE DEVICE #1
(CLAIMED
SE DEVICE #2)
intended use(s)      
length      
gauge      
tip configuration      
cover dimensions      
cover color      
cover strength      
hub/needle bond strength      
biocompatibility      
materials      
labeling      
other      

SE=substantially equivalent The applicant may reference relevant standards in the Table. ATTACHMENT 2 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 Chlorohydin, 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 3 KIT INFORMATION The applicant must provide the following for a kit, i.e., a package consisting of at least one medical device and additional devices, drugs, or biologics as other components. 1. Include a complete and specific listing of all components of the kit(s). 2. Certifications: (a) I certify that the medical device components of my kit listed on page(s) [SUBMITTER PROVIDE PAGE NUMBERS] are either (1) legally marketed preamendments devices, (2) exempt from premarket notification (consistent with the exemption criteria described in the classification regulations and the limitations of exemptions from Section 510(k) of the act (e.g., 21 CFR 862.9), or (3) have been found to be substantially equivalent through the premarket notification process for the use(s) for which the kit is intended (i.e., not claiming or causing a new use for the component(s)). (b) I further certify that I purchase the device components in finished form, i.e., they are packaged, labeled, etc., consistent with their preamendments, exemption, or premarket notification criteria and status. All purchased drug or biologic components are also packaged and labeled consistent with their approval or licensing. If you cannot make certification statement (a) for each device component of your kit, you must itemize the components without preamendments, exemption, or premarket notification status. You must also supply adequate information so that FDA can evaluate the equivalence of these components of your kit. This information may be the same information needed for a separate 510(k) for each component. If you cannot make certification statement (b), then identify the components purchased in unfinished form, e.g., packaged in bulk (not final packaged and labeled in separate units). 3. Clearly identify in the list of kit components any that are drugs and biologics. For example, state next to the item that it is a drug or a biologic. 4. Describe how the kit is assembled and processed into finished form for purchase (e.g., the components are taken out of the finished product or bulk packaging, component X is individually sterilized, all the components are then placed on a tray, the kit is wrapped, but not sterilized prior to shipment). If there is any repackaging or reprocessing of a separate component, then you must provide details on the repackaging or processing and an analysis of the effect on the component. This may require testing. For example, for (re)sterilized devices conduct a validation study and provide data in accordance with the ODE Sterility Blue Book Memorandum. The processing of the final kit is also important. You must evaluate whether the final processing for the kit as a whole affects the safety or effectiveness of any of the kit components. 5. The 510(k) should include all labels and labeling for the kit. A kit label alone may suffice for all components only if the label consolidates the required information typically found in labeling for each individual kit component when sold separately in final form. A component may require specific labeling, such as a package insert, when adequate directions for use (precautions, warnings, etc.) are required. It is important to examine the labeling for the individual components sold separately versus the labeling provided for the kit. Verify that the labeling is adequate or enclose additional labeling in the kit, as needed. 6. The items above identify labeling and processing issues which may affect the regulatory status, or safety and effectiveness of the kit. If you are aware of any other factor which may impact upon the status of your kit, then please bring it to our attention so that we may consider it in our evaluation. ATTACHMENT 4 HYPODERMIC SINGLE LUMEN NEEDLE REVIEW CHECKLIST 510(k)#: _______________ Sponsor: ___________________________________ Date: ___________________ Reviewer: __________________________________ ELEMENTADEQUATE 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                                                                  
    
  • purpose of submission                                                         
    
  • previous files referenced                                                
    
  • statement that device is
     
    similar to and/or different
     
    from other products            
    
Labeling  
  • identifies device                    
    
                                 
      gauge                                                                   
      length                                                                  
      quantity   
  • statements
    
      sterile                                                                  
      single use only                                                               
      nonpyrogenic                                                              
      nontoxic                                                                  
      Rx                                                                        
Description of Device
  • basic description                                                        
    
  • photograph/drawing                  
    
                     
Intended Use(s)
  • clear statement
    
                                                               
Physical Specifications
  • length                                                                   
    
  • gauge                                                                  
    
  • tip configuration                                                      
    
Mechanical Specifications
  • cover strength                                                           
    
  • hub/needle bond strength                         
    
                 
Biological Specifications
  • biocompatibility require-
    ments for all components
    and materials
    
                                                            
Materials Identification
  • needle                                                                    
    
  • cover                                                                     
    
  • hub                                                                      
    
  • any colors used in mfg.                             
    
Descriptive Comparison to Legally Marketed Device
  • identified appropriate      
    legally marketed device(s)                                               
    
  • labeling                                                                  
    
  • description                                                               
    
  • intended use(s)                                                                
    
  • materials                                                                 
    
  • physical specifications                                              
    
  • mechanical specifications                                                 
    
  • biological specifications                                                 
    
  • side by side comparison                                              
    
  • discussion of how differences
    may affect safety and
    effectiveness                         
    
                                  
Performance Data Supporting Equivalence
  • biocompatibility                                                          
    
  • comparative claim(s)                                                         
    
  • unique design                         
    
                                   
Sterilization Information
  • method                                                                    
    
  • validation method                                                         
    
  • SAL                                                                       
    
  • packaging description                                                         
    
  • EtO residuals                                                             
    
  • pyrogen free method                                                       
    
  • radiation dose                         
    
                                 
SMDA Information
  • summary                                                                   
    
  • statement                  
    
                                             
Sample
  • provided                     
    
                                             
Kit Information
  • list of components                                                        
    
  • certification statements                                             
    
  • any drugs and/or biologics                                                
    
  • any sutures, dressings, gloves                                                                  
    
  • description of assembly
    and processing                                                                
    
  • kit label/labeling                           
    
                             
Antistick Feature                         If yes, see additional review     


ADDITIONAL REMARKS: