SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE

K042314 · Biogen · FMF · Nov 22, 2004 · General Hospital

Device Facts

• Record ID: K042314
• Device Name: SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE
• Applicant: Biogen
• Product Code: FMF · General Hospital
• Decision Date: Nov 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The Syringe Grip for the AVONEX pre-filled syringe is a single use device intended to be used by the patient to assist with the self-administered injection of a fixed dose of AVONEX from a pre-filled syringe through a single lumen hypodermic needle. The devices are intended to be used in any setting including the home and are reusable.

Device Story

Reusable plastic grip/handle; designed to securely snap onto AVONEX pre-filled syringe; provides increased surface area and leverage for manual intramuscular injections. Used by patients in home or clinical settings to improve ergonomics and comfort during self-administration. Device does not automate injection; purely mechanical assist for holding syringe. Benefits patient by facilitating easier manual control of injection process.

Clinical Evidence

No clinical data; bench testing only. Device has no functional requirements beyond secure syringe capture.

Technological Characteristics

One-piece plastic grip/handle; manual operation; reusable; non-powered; dimensions/form factor designed for AVONEX pre-filled syringe compatibility.

Indications for Use

Indicated for self-administered injection of a fixed dose of AVONEX via pre-filled syringe and single lumen hypodermic needle by patients in any setting, including the home.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Invisiject reusable auto-injector (K032425)
• Carpuject syringe holder (K820164)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(K) SUMMARY August 25, 2004

## 8.0 Summary of Safety and Effectiveness

| 8.1 Submitter's Name and Address: | Biogen Idec Inc. 14 Cambridge Center Cambridge, MA 02142 |
|-----------------------------------|----------------------------------------------------------------------------------|
| Contact Person: | Victor J. Gangi Tel: [phone] Fax: [phone] |
| 8.2 Trade/Proprietary Name: | Syringe Grip for the AVONEX pre-filled syringe |
| 8.3 Common/Usual Name: | Injection Assist Device |
| 8.4 Classification Name: | Syringe, Piston (Accessory) |

- 8.5 Substantial Equivalence: Substantial Equivalence: The Syringe Grip for the AVONEX pre-filled syringe is substantially equivalent to the Invisiject reusable auto-injector (K032425) and the Carpuject syringe holder (K820164).
- 8.6 Description: The Syringe Grip for the AVONEX pre-filled syringe is a reusable, grip/handle that is designed to assist the user with the Intramuscular injection of 0.5 mL of AVONEX from a prefilled syringe and single lumen hypodermic needle. The syringe is securely snapped into the one-piece plastic grip/handle for the primary purpose of providing patients more surface area, hence leverage, with which to hold the syringe while performing manual injections. Using the Syringe Grip for the AVONEX pre-filled syringe instead of direct injection with the re-filled syringe offers the patient a more comfortable and ergonomic handle to more easily only and inject the drug. The AVONEX pre-filled syringes and commercially available single humen hypodermic needles are provided separately.
- 8.5 Intended Use: The Syringe Grip for the AVONEX pre-filled syringe is a single use device intended to be used by the patient to assist with the self-administered injection of a fixed dose of AVONEX from a pre-filled syringe through a single lumen hypodermic needle. The devices are intended to be used in any setting including the home and are reusable.
- 8.6 Technological Characteristics: The technological characteristics of the Syringe Grip for the AVONEX pre-filled syringe differ from the predicate device in as much as it is a manual versus spring assist device.
- 8.7 Performance Data: The device has no functional requirements so performance data is not applicable. The device is designed to securely capture the syringe.
- 8.8 Conclusion: Biogen Idec concludes based on the information presented that the Syringe Grip for the AVONEX pre-filled syringe is substantially equivalent to products currently legally marketed in the USA.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with three stylized lines representing the bird's wings or feathers. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2004

Ms. Nadine D. Cohen, Ph.D. Senior Vice President, Regulatory Affairs Biogen Idec Incorporated 14 Cambridge Center Cambridge, Massachusetts 02142

Re: K042314

Trade/Device Name: Syringe Grip for the AVONEX Pre-filled Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: October 22, 2004 Received: October 28, 2004

Dear Dr. Cohen:

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.

{2}------------------------------------------------

Page 2 - Dr. Cohen

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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

hiu 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

{3}------------------------------------------------

## Indications for Use

510(k) Number : K042314

Device Name: Syringe Grip for the AVONEX Pre-filled Syringe

Indications For Use:

The Syringe Grip for the AVONEX prefilled syringe is a reusable device indicated for rne Synngo Cinp for the self-administered injection of a fixed dose of ase by the pation. to work to work a single lumen hypodermic needle. The devices are intended to be used in any setting including the home.

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

Over-The-Counter Use X________________________________________________________________________________________________________________________________________________________ (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)

Anton D. m=

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

510(k) Number_ KP42314

Page 1 of __ 1________________________________________________________________________________________________________________________________________________________________