FLEXPEN NEEDLE

K062500 · Novo Nordisk, Inc. · FMI · Nov 21, 2006 · General Hospital

Device Facts

• Record ID: K062500
• Device Name: FLEXPEN NEEDLE
• Applicant: Novo Nordisk, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Nov 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

FlexPen® needle is a sterile, single-use disposable hypodermic needle designed for attachment to Novo Nordisk pen injection devices. Operation involves removing a protective tab, screwing the needle onto the pen injector, and removing protective caps. After subcutaneous injection of insulin or somatropin, the needle is detached and disposed of per local regulations. Used in clinical or home settings by patients or healthcare professionals. The device facilitates medication delivery; it does not contain electronic components or software.

Clinical Evidence

No clinical tests were required or submitted. Substantial equivalence is based on non-clinical bench testing, including biocompatibility and performance testing, which demonstrated compliance with applicable standards.

Technological Characteristics

Sterile, single-lumen, disposable hypodermic needle. Materials and performance characteristics are equivalent to predicate pen needles. No energy source, software, or electronic components. Manufactured per current Good Manufacturing Practices.

Indications for Use

Indicated for subcutaneous injection of insulin and somatropin using pen injector devices.

Regulatory Classification

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.

Predicate Devices

• NovoFine® 32G Tip (0.23/ 0.25 mm) x 6 mm disposable needle (K053470)
• NovoFine® Autocover® 30G x 8 mm (K050106)
• Becton Dickinson BD Pen Needle (29G, 30G, 31G) x (5 mm, 8 mm, 12.7 mm) (K051899)

Submission Summary (Full Text)

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K062500 page 1 of 3

FlexPen® needle Disposable Needle Novo Nordisk Inc.

510(k) Premarket Notification

Date Version Status Page

18 August 2006 Novo Nordisk 0.1 Final l of 3

## 807.87(h) 510(k) Summary

## As required by Section 807.92(a)

## (1) DATE OF PREPARATION: August 18, 2006

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 for hypodermic single lumen needle products.

#### SUBMITTER'S NAME AND ADDRESS:

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

Contact Person: Rick Spring Tel: [phone] Fax: [phone]

## (2) NAME OF DEVICE:

| Proprietary Name: | FlexPen® needle |
|-----------------------|--------------------------------------------------|
| Common or usual name: | Sterile disposable hypodermic needle |
| Classification: | Hypodermic single lumen needle (21 CFR 880.5570) |
| Class: | Class II |

## (3) SUBSTANTIAL EQUIVALENCE:

FlexPen® needle is a disposable needle which is substantially equivalent to Novo Nordisk's 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.

NOV 2 1 2006

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FlexPen® needle Disposable Needle Novo Nordisk Inc.

510(k) Premarket Notification

Datc: Version: Status: Pagc:

18 August 2006 Novo Nordisk (). I Final 2 of 3

## 807.87(h) 510(k) Summary (Continued)

## (4) DEVICE DESCRIPTION:

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 can 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.

### (5) INTENDED USE:

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

### (6) TECHNOLOGICAL CHARACTERISTICS:

The FlexPen® needle is considered substantially equivalent to the 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 and somatropin), technology/principle of operation, materials and performance. Differences between the devices do not raise any significant issues of safety and effectiveness. See Table 1 for comparison to a legally marketed device.

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KUC2500 Page 3 of 3

FlexPen® needic Disposable Needle Novo Nordisk Inc.

510(k) Premarket Notification

Date: Version: Status: Page:

18 August 2006 Novo Nordisk 0.1 Final 3 of 3

# 807.87(h) 510(k) Summary (Continued)

As required by Section 807.92(b)

(1) NON-CLINICAL TESTS PERFORMED:

The 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 the 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.

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

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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the department's name, which is written in a circular pattern around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rick Spring Manager, Regulatory Affairs Novo Nordisk. Incorporated 100 College Road West Princeton, New Jersey 08540-7810

NOV 2 1 2006

Re: K062500

Trade/Device Name: FlexPen® Needle 32G Tip x 6mm (1/4") Disposable Needle Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 24, 2006 Received: August 25, 2006

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.

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 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of Compliance at [phone]. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Aury Sarlion for

Chiu Lin, Ph. 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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K062500

FlexPen® necdlc Disposable Needle Novo Nordisk Inc.

510(k) Premarket Notification

K062500

Date: Version: Status: Page:

August 2006 Novo Nordisk 1.0 Final l of l

# Indications for Use Statement

510(k) Number (if known)

Device Name:

Indications For Use:

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

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

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rhd C. Azyh Apu 11/21/06

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on Control, Dental Devices

K062500