FlexPen® needle is designed for single use in conjunction with Novo Nordisk injection delivery devices. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Prepare for injection by following the procedure described in the user manual 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 national/local regulations. For each subsequent injection, another disposable needle must be used. Delivery device function checks can be performed with the FlexPen® needle by using the needle cap as described in the user manuals provided with the Novo Nordisk pen injection devices.

FlexPen® needle is used in exactly the same manner as the NovoFine® needles. The instructions for use are described in the user manuals for Novo Nordisk delivery devices for injection and are the same for all NovoFine® needles and FlexPen® needle.

AI/ML Overview

The provided document details a 510(k) summary for the FlexPen® needle. This is a medical device, and the submission focuses on demonstrating substantial equivalence to already marketed devices, rather than a novel AI or software-driven diagnostic tool. Therefore, many of the requested criteria (such as acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for AI models) do not apply directly to this type of submission.

Here's a breakdown of the relevant information provided and how it addresses the spirit of your request within the context of a medical device submission:

Acceptance Criteria and Study for FlexPen® Needle (K090111)

The FlexPen® needle is a sterile disposable hypodermic needle intended for use with pen injector devices for subcutaneous injection of insulin, liraglutide, and somatropin. The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices, meaning it performs as safely and effectively as these devices.

The study that proves the device meets the acceptance criteria is a non-clinical performance and biocompatibility study, along with a comparison of technological characteristics to predicate devices.

1. A table of acceptance criteria and the reported device performance

Criteria Category / Characteristic	Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported Device Performance (FlexPen® needle)
Intended Use	For use with pen injector devices for subcutaneous injection of insulin, liraglutide, and somatropin (matching predicate devices).	Confirmed: FlexPen® needle is intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, and somatropin. This matches the intended use of predicate devices (K062500, K053470, K050106, K051899).
Technological Characteristics	Similar principle of operation, materials, and overall performance/design to predicate devices (K062500, NovoFine® 32G Tip x 6 mm; NovoFine® Autocover® 30G x 8 mm; Becton Dickinson BD Pen Needle (29G, 30G, 31G) x (5 mm, 8 mm, 12.7 mm)). Differences should not raise significant safety/effectiveness concerns.	FlexPen® needle is considered substantially equivalent in technology/principle of operation, materials, and performance to the listed predicate devices. The document explicitly states: "Differences between the devices do not raise any significant issues of safety and effectiveness." It also states, "FlexPen® needle is used in exactly the same manner as the NovoFine® needles."
Biocompatibility	In compliance with existing domestic and international standards for patient contact.	Biocompatibility tests have been performed, and the results are in compliance with existing domestic and international standards.
Performance (Functional)	Device functions as intended without compromise to safety or efficacy (e.g., proper fit with pen injector, needle integrity, smooth injection, sterility).	Performance tests have been performed, and the results are in compliance with existing domestic and international standards. The submission highlights "functional testing" to support design equivalency and substantial equivalence. The device is designed for single use, and proper disposal is outlined, implying expected single-use functionality. Delivery device function checks can be performed using the needle cap as described in user manuals, indicating compatibility and proper function.
Manufacturing Standards	Manufactured in accordance with current Good Manufacturing Practices (GMP) for Medical Devices.	FlexPen® needle will be manufactured in accordance with current Good Manufacturing Practices for Medical Devices. Confirmed through the overall submission process and regulatory oversight.
Sterility	Sterile disposable device.	The device is described as "Sterile disposable hypodermic needle." Performance tests (likely including sterility assurance) confirmed compliance.

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify a distinct "test set" sample size in the way an AI/software study would. The data provenance is based on non-clinical performance and biocompatibility testing conducted by Novo Nordisk Inc. The submission is silent on the specific number of needles tested for these non-clinical evaluations.
Data Provenance: The studies were conducted by the manufacturer, Novo Nordisk Inc., based in Princeton, New Jersey, USA. The nature of the studies implies prospective testing of the new FlexPen® needle design against established standards and comparative analysis with predicate device specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept does not apply to this device submission. There is no "ground truth" established by experts for a test set in the context of an ordinary medical device like a hypodermic needle, unlike an AI diagnostic system. The "truth" is based on objective physical/chemical properties, functional performance, and biocompatibility standards.

4. Adjudication method for the test set

This concept does not apply. There was no need for expert adjudication as the assessment was based on objective non-clinical tests compared to established standards and the characteristics of predicate devices.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human interpretation plays a significant role, often in conjunction with AI. The FlexPen® needle is a physical medical device, not a diagnostic or AI-powered system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone algorithm performance study was not done. This is not an AI or software device.

7. The type of ground truth used

The "ground truth" for this device is based on:

Existing domestic and international standards for biocompatibility, sterility, and performance of hypodermic needles.
Functional testing demonstrating the device meets its intended mechanical and physical requirements.
Comparison to legally marketed predicate devices to establish substantial equivalence in design, materials, and intended use. The "truth" is that the new device behaves similarly to the established safe and effective devices.

8. The sample size for the training set

This concept does not apply. There is no "training set" as this is not an AI or machine learning device.

9. How the ground truth for the training set was established

This concept does not apply. There is no ground truth for a training set in this context.

Summary

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CONFIDENTIAL

Date: Version: Status: Page:

17 September 2009 -Final

P. lot

Steve Nordick

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807.87(h) 510(k) Summary

As required by Section 807.92(a)

FEB - 1 2010

(1) DATE OF PREPARATION: September 16, 2009

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. FlexPen® needle meets all applicable product and quality standards.

SUBMITTER'S NAME AND ADDRESS:

Novo Nordisk Inc. 100 College Road West Princeton, New Jersey 08540

Contact Person: Rick Spring Tel: 609-987-5046 Fax: 609-987-3916

(2) NAME OF DEVICE:

Proprietary Name: Common or usual name: Classification: Class:

FlexPen® needle Sterile disposable hypodermic needle Hypodermic single lumen needle (21 CFR 880.5570) Class II

(3) SUBSTANTIAL EQUIVALENCE:

FlexPen® needle is a disposable which is substantially equivalent to K062500 cleared on November 21, 2006, NovoFine® 32G Tip (0.23/ 0.25 mm) x 6 mm disposable needle, cleared under 510/k) K053470. NovoFine Autocover® 30G x 8 mm, cleared under 510(k) K050106, and to the Becton Dickinson BD Pen Needle (29G, 30G, 31G) x (5 mm, 8 mm, 12.7 mm), cleared under 510(k) K051899.

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 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.

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(4) DEVICE DESCRIPTION:

(5) INTENDED USE:

FlexPen® needle is intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, and somatropin.

(6) TECHNOLOGICAL CHARACTERISTICS:

FlexPen® needle is considered substantially equivalent to K062500, NovoFine® 32G Tip x 6 mm, NovoFine® Autocover® 30G x 8 mm, and to the Becton Dickinson BD Pen Needle (29G, 30G, 31G) in intended use (intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide and somatropin), technology/principle of operation, materials and performance. Differences between the devices do not raise any significant issues of safety and effectiveness.

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FlexPen needlc 510(k) - K090111 Novo Nordisk Inc.

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As required by Section 807.92(b)

(1) NON-CLINICAL TESTS PERFORMED: None

FlexPen® needle 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 FlexPen® needle is 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.

(1) me Ellingto

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

18 Sept 04
Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The image is in black and white.

Food and Drug Administration 10903 New Hampshire Avenne Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Rick Spring Senior Manager, Regulatory Affairs Novo Nordisk, Incorporated 100 College Road West Princeton, New Jersey 08540

FEB - 1 2010

Re: K090111

Trade/Device Name: FlexPen Needle 32G Tip x 6mm (1/4") Disposable Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: January 26, 2010 Received: January 27, 2010

Dear Mr. Spring:

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 Amendments, 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 controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Spring .

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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known)

K090111

Device Name:

FlexPen needle 32G Tip x 6mm (1/4") Disposable Needle

Indications For Use:

FlexPen® needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, and somatropin.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (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)

Charles G. Koch

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090111

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).