NOVOFINE AUTOCOVER 30G X 8MM

K050106 · Novo Nordisk, Inc. · FMI · Mar 30, 2005 · General Hospital

Device Facts

• Record ID: K050106
• Device Name: NOVOFINE AUTOCOVER 30G X 8MM
• Applicant: Novo Nordisk, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Mar 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NovoFine® Autocover™ 30G x 8 mm needles are used in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products. Additionally, after withdrawal of the needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.

Device Story

Single-use disposable 30G x 8mm hypodermic needle for subcutaneous insulin delivery. Attaches to insulin pen injection devices. Features integrated safety shield mechanism; activates automatically upon withdrawal from skin to cover needle tip; prevents accidental needlesticks. Red indicator window confirms safety lock activation. Used by patients, diabetes nurse educators, and staff nurses in clinical or home settings. Device provides physical barrier post-injection; reduces risk of sharps injury to user.

Clinical Evidence

Handling tests conducted with diabetes nurse educators, patients, and staff nurses to evaluate efficacy and safety of the safety mechanism. No specific quantitative clinical metrics provided; bench testing performed for biocompatibility and performance.

Technological Characteristics

30G x 8mm hypodermic single lumen needle. Features integrated automatic safety shield mechanism. Materials and performance comply with domestic and international standards. Manufactured per GMP. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring subcutaneous administration of sterile parenteral insulin using insulin injection delivery devices. No specific age or gender contraindications noted.

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® 31G x 6 mm needle (K002403)
• BD SafetyGlide™ 25G x 16mm needle (K951254)

Submission Summary (Full Text)

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K050106

Page 1 of 3

# MAR 3 0 2005

NovoFine Autocover™ 30G Disposable Safety Needle

510(k) Premarket Notification

Date Version:

Status:

17 Jan 2005 Novo Nordist

Final

Novo Nordisk Inc

#### 10 807.87(h) 510(k) Summary

## As required by Section 807.92(a)

## (1) DATE OF PREPARATION: January 15, 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® Autocover™ 30 G x 8 mm needles meet all applicable product and quality standards for hypodermic single lumen needle products.

## SUBMITTER'S NAME AND ADDRESS:

| Novo Nordisk Inc. | Contact Person: John Signorini |
|-----------------------------|--------------------------------|
| 100 College Road West | Tel: [phone] |
| Princeton, New Jersey 08540 | Fax: [phone] |

## (2) NAME OF DEVICE:

| Proprietary Name: | NovoFine® Autocover™TM 30G x 8 mm needles |
|-----------------------|-------------------------------------------|
| Common or usual name: | Sterile disposable hypodermic needle |
| Classification: | Hypodermic single lumen needle |
| Class: | Class II |

## (3) SUBSTANTIAL EQUIVALENCE:

The NovoFine® Autocover™ 30G x 8 mm needle is substantially equivalent to the Novo Nordisk NovoFine® 31G x 6 mm needle (K002403) which was cleared by FDA in December 2000 and the Becton Dickenson BD SafetyGlide™ 25G x 16mm needle (K951254) which was cleared by FDA in October 1995.

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* Autocover™ 30G<br>Disposable Safety Needle<br><br>Novo Nordisk Inc | 510(k) Premarket Notification | Date:<br>Version:<br>Status | 17 Jan 2005<br>1<br>Final | Novo Nordisk |
|------------------------------------------------------------------------------|-------------------------------|-----------------------------|---------------------------|--------------|
|------------------------------------------------------------------------------|-------------------------------|-----------------------------|---------------------------|--------------|

### 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:

The NovoFine® Autocover™ 30G x 8mm 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 cap is 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. While pushing the needle into the skin, the shield and lock will be pushed into the house enabling the needle to penetrate the skin barrier and into the subcutaneous tissue.

After the injection, the needle is removed from the skin. The NovoFine® Autocover™ needle stick safety mechanism will activate automatically when the needle is withdrawn from the skin. Once NovoFine® Autocover™ is in the locked position, it can no longer be used. The needle is not exposed protecting against an unintentional needlestick. The red indicator windows tells the user that the safety lock has been activated. 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 Autocover by using the needle cap as described in the instruction leaflet

### (5) INTENDED USE:

The intended use for the modified device remains the same as the predicate devices (NovoFine® 31G x 6 mm and BD Safety Glide 25G x 16 mm):

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

Additionally, after withdrawal of the needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.

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| NovoFine Autocover™ 30G<br>Disposable Safety Needle | 510(k) Premarket Notification | Date: | 17 Jan. 2005 | Novo Nordisk |
|-----------------------------------------------------|-------------------------------|----------|--------------|--------------|
| | | Version: | 1 | |
| | | Status: | Final | |

Novo Nordisk Inc.

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

### (6) TECHNOLOGICAL CHARACTERISTICS:

The NovoFine® Autocover™ 30G needle is substantially equivalent to the NovoFine® 31G and BD SafetyGlide 25G 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® Autocover™ 30G 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:

Handling tests were conducted to investigate the efficacy and safety of the NovoFine® Autocover™ 30G disposable safety needles by diabetes nurse educators, diabetes patients and staff nurses. Differences between the devices tested do not raise any significant issues of safety and effectiveness.

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

Based on the design equivalency and the functional and safety testing, Novo Nordisk had determined that the NovoFine® Autocover™ 30G x 8 mm needles are substantially equivalent to the devices currently marketed in the United States. Differences between the devices do not raise any significant issues of safety and effectiveness.

M.U. McElroy, Ph.D., R.E.t.

Barry Reit, PhD Vice President, Regulatory Affairs & Quality Assurance Novo Nordisk Inc.

1/17/05

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Date

Date

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2005

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

Re: K050106

Trade/Device Name: NovoFine® Autocover™ 30G x 8 mm Disposable Safety Needle Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: January 17, 2005 Received: January 18, 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 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. 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 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 (OS) 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 yours.

Sylitte Michau Oms.

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

Enclosure

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| NovoFine® Autocover™ 30G<br>Disposable Safety Needle<br><br>Novo Nordisk Inc. | 510(k) Premarket Notification | Date:<br>Version:<br>Status: | 17 Jan 2005<br>1<br>Final | Novo Nordisk |
|-------------------------------------------------------------------------------|-------------------------------|------------------------------|---------------------------|--------------|
|-------------------------------------------------------------------------------|-------------------------------|------------------------------|---------------------------|--------------|

#### Indication for Use Statement 2

| 510(k) Number (if known) | Not available K050106 | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Device Name: | NovoFine® Autocover™ 30G x 8 mm Disposable Safety Needle | |
| Indications For Use: | NovoFine® Autocover™ 30G x 8 mm needles are used in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products. Additionally, after withdrawal of the needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick. | |
| 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)

C. Alan Brock

rsion Sim-Off) Chision of Anes hestology, General Hospital, Intection Control Dental Devices

Number. K050106

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