The NovoFine® 32G Tip needle is designed for single use in conjunction with insulin injection delivery devices. Prior to giving an injection, the protective tab is removed from the plastic needle cap of the single-use disposable needle. With the disposable needle remaining in the needle cap, it is then carefully screwed onto the delivery injection device until tight and then the needle outer and inner caps are removed. Prepare for injection by following the procedure described in the instruction leaflet provided with the pen injection device and instructions from your health care professional. After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent injection, another disposable needle must be used. Delivery device function checks can be performed with the NovoFine® 32G Tip by using the needle cap as described in the instruction leaflet provided with the pen injection device.

AI/ML Overview

The provided 510(k) Premarket Notification for the NovoFine® 32G Tip Disposable Needle does not contain detailed acceptance criteria or a study that specifically "proves the device meets the acceptance criteria" in terms of performance metrics based on detailed statistical analysis. Instead, it relies on substantial equivalence to a predicate device and non-clinical testing.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding device performance results in a quantitative manner (e.g., minimum tensile strength: X, device measurement: Y).

Instead, the submission states:

Claimed Performance: "NovoFine® 32G Tip needles meet all applicable product and quality standards for hypodermic single lumen needle products."
Study Type: "Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards."

Without the specific standards referenced and the detailed results of those tests, a precise table cannot be constructed. The "acceptance criteria" are implied to be compliance with these "existing domestic and international standards" for hypodermic needles.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the performance tests.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given it's a medical device, it's highly likely the testing was prospective, but this is not confirmed in the text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the device is a sterile disposable hypodermic needle and the evaluation is based on engineering and biocompatibility standards, not on interpretations by medical experts for diagnostic accuracy. Ground truth, in this context, would be established by validated test methods and reference materials, not expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used for expert review in clinical studies, typically for diagnostic devices or algorithms.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI systems where human readers interpret data, and the device aims to assist or replace that interpretation. This device is a physical sterile needle.

6. If a Standalone Study Was Done

Yes, in essence. The submission indicates "Biocompatibility and performance tests have been performed." These tests would be conducted on the NovoFine® 32G Tip needles themselves, in a "standalone" fashion, to confirm they meet relevant physical, chemical, and biological safety standards specified for hypodermic needles. The performance is assessed against these established standards, which serve as the implicit acceptance criteria.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be established by:

Validated test methods: e.g., sterility tests, needle strength tests, material composition analysis.
Reference standards: Established specifications for materials, dimensions, and performance of hypodermic needles as outlined in "existing domestic and international standards" (e.g., ISO, ASTM standards relevant to medical devices and needles).
Biocompatibility guidelines: Meeting established criteria for biological safety as per international standards (e.g., ISO 10993 series).

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical device, not an AI algorithm, so there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

Summary of what is known from the document regarding compliance:

The primary method used to demonstrate safety and effectiveness for the NovoFine® 32G Tip Disposable Needle is substantial equivalence to a previously cleared predicate device (NovoFine® 31G x 6 mm needle, K002403) and compliance with relevant non-clinical performance and biocompatibility standards. The document states: "Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards." This statement serves as the general proof that the device meets the implicit acceptance criteria defined by those standards. However, the specific details of these tests (e.g., sample sizes, specific criteria, detailed results) are not provided in this 510(k) summary.

Summary

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K053470

DEC 2 1 2005

NovoFine® 32G Tip Disposable Needle

510(k) Premarket Notification

Date: Version: Status:

10 Oct 2005 Novo Nordisk ﺴﻤ Final

Novo Nordisk Inc.

807.87(h) 510(k) Summary 10

As required by Section 807.92(a)

(1) DATE OF PREPARATION: December 2, 2005

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. NovoFine® 32G Tip needles meet all applicable product and quality standards for hypodermic single lumen needle products.

SUBMITTER'S NAME AND ADDRESS:

Novo Nordisk Inc.100 College Road WestPrinceton, New Jersey 08540	Contact Person: John SignorinTel: 609-987-5967Fax: 609-987-3910
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(2) NAME OF DEVICE:

Proprietary Name:	NovoFine ® 32G Tip needles
Common or usual name:	Sterile disposable hypodermic needle
Classification:	Hypodermic single lumen needle
Class:	Class II

(3) SUBSTANTIAL EQUIVALENCE:

The NovoFine® 32G Tip x 6 mm needle is substantially equivalent to the Novo Nordisk NovoFine * 31G x 6 mm needle (K002403) which was cleared by FDA in December 2000.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug, and Cosmetic Act, as amended and as supplied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the

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NovoFine 32G TipDisposable Needle	510(k) Premarket Notification	Date: 10 Oct 2005Version: 1Status: Final Novo Nordisk
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Novo Nordisk Inc.

807.87(h) 510(k) Summary (continued)

resolution of patent infringement suits or any other patent matters. No statement related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent laws or their application by the court.

(4) DEVICE DESCRIPTION:

After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent injection, another disposable needle must be used. Delivery device function checks can be performed with the NovoFine® 32G Tip by using the needle cap as described in the instruction leaflet provided with the pen injection device.

(5) INTENDED USE:

The intended use for the modified device remains the same as the predicate device (NovoFine 31G):

For use in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products.

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NovoFine® 32G TipDisposable Needle	510(k) Premarket Notification	Date:Version:Status:	Final	10 Oct 2005 Novo Nordisk
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Novo Nordisk Inc.

807.87(h) 510(k) Summary (continued)

(6) TECHNOLOGICAL CHARACTERISTICS:

The NovoFine® 32G Tip needle is substantially equivalent to the NovoFine® 31G needle in intended use, technology/principle of operation, materials and performance. Differences between the devices do not raise any significant issues of safety and effectiveness.

Section 807.92(b)

(1) NON-CLINICAL TESTS PERFORMED:

The NovoFine® 32G Tip needles will be manufactured in accordance with current Good Manufacturing Practices for Medical Devices. Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards.

(2) CLINICAL TESTS SUBMITTED:

No clinical tests are required.

(3) CONCLUSIONS DRAWN FROM THE NON-CLINICAL AND CLINICAL TESTS:

Based on the design equivalency and the functional testing, Novo Nordisk had determined that the NovoFine® 32G Tip needles are substantially equivalent to a device currently marketed in the United States. Differences between the devices do not raise any significant issues of safety and effectiveness.

Mell Me Elligson

Mary Ann McElligott, Associate Vice President, Regulatory Affairs Novo Nordisk Inc.

12/13/05
Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2005

Mr. John Signorin Manager, Regulatory Affairs Novo Nordisk, Incorporated 100 College Road West Princeton, New Jersey 08540

Re: K053470

Trade/Device Name: NovoFine® 32G Tip ¼" (6mm) Disposable Needle Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 13, 2005 Received: December 14, 2005

Dear Mr. Signorin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls pro farman al registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr.), it may of backed to back of Federal Regulations, Title 21, Parts 800 to 898. In your device tax roublish further announcements concerning your device in the Lederal Register.

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Page 2 - Mr. Signorin

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements moan that I Drima made a detes and regulations administered by other Federal agencies. or the For any I vith all the Act's requirements, including, but not limited to: registration r od into compry with and 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 CF RT rar 007), acclity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I remarket notification. The FDA finding of substantial equivalence of your device to a premainer notification. For the results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you don't the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overnit our gamer gaternational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sydtte y. Michael Omd.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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NovoFinc® 32G Tip Disposable Needle

510(k) Premarket Notification

Date: Version Status:

administration of sterile parenteral insulin products.

10 Oct 2005 Novo Nordisk Final

Novo Nordisk Inc.

Indication for Use Statement 2

K053470 Not available 510(k) Number (if known) NovoFine® 32G Tip Device Name: ¼" (6 mm) Disposable needle NovoFine® 32G Tip needles are used in conjunction Indications For Use: with insulin injection delivery devices for subcutaneous

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 :: :: : : : : : : : : ... ku 53470 . . . . . . . .

Novo Nordisk Inc.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is 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.(b)
Classification. Class II (performance standards).