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