INVISIJECT RESUSABLE AUTO-INJECTOR

K032425 · Biogen · KZH · Nov 5, 2003 · General Hospital

Device Facts

• Record ID: K032425
• Device Name: INVISIJECT RESUSABLE AUTO-INJECTOR
• Applicant: Biogen
• Product Code: KZH · General Hospital
• Decision Date: Nov 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6920
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Invisiject™ Reusable Auto-Injector is a reusable 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 auto-injectors are intended to be used in any setting including the home.

Device Story

Invisiject™ is a reusable, spring-loaded mechanical auto-injector designed to deliver 0.5 mL of AVONEX® from a pre-filled syringe. Device components include a syringe adapter, syringe holder, base unit, and power pack, housed in a case that functions as a handling console for assembly and charging. Operated by the patient in home or clinical settings, the device conceals the syringe and needle during the injection process to mitigate needle phobia and injection anxiety. The device facilitates the delivery of the medication through a standard single lumen hypodermic needle. It provides a consistent, assisted method for self-injection, potentially improving patient compliance and comfort.

Clinical Evidence

Bench testing only. Performance assessed per ISO 11608-1 standards, including penetration depth, activation force, loading force, and injection time. The device met all specifications.

Technological Characteristics

Reusable, spring-loaded mechanical auto-injector. Components: syringe adapter, syringe holder, base unit, power pack. Materials: plastic case. Standards: ISO 11608-1 (Pen-injectors for Medical Use). No electronic or software components.

Indications for Use

Indicated for patients requiring self-administration of a fixed dose of AVONEX® via pre-filled syringe and single lumen hypodermic needle. Intended for use in any setting, including the home, to assist with injection and address needle phobia/anxiety.

Regulatory Classification

Identification

A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.

Predicate Devices

• B-D Auto-Injector (K974678)
• Owen Mumford Autoject 2 (K013362)
• Standard Piston Syringe
• Meridian's EpiPen® (NDA 19-430)

Submission Summary (Full Text)

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K032425

NOV - 5 2003

# 510(K) SUMMARY June 30, 2003

### Summary of Safety and Effectiveness 8.0

| 8.1 | Submitter's Name and Address: | Biogen<br>14 Cambridge Center<br>Cambridge, MA 02142 |
|-----|-------------------------------|---------------------------------------------------------------|
| | Contact Person: | Michael Poirier<br>Tel: [phone]<br>Fax: [phone] |
| 8.2 | Trade/Proprietary Name: | Invisiject™ Reusable Auto-Injector |
| 8.3 | Common/Usual Name: | Auto-injector |
| 8.4 | Classification Name: | Introducer, Syringe Needle |

### 8:5 Substantial Equivalence:

The Invisiject " Reusable Auto-Injector is substantially equivalent to the B-D Auto-Iniector (K974678), the Owen Mumford Autoject 2 (K013362), the standard Piston Syringe (Numerous Devices) and Meridian's EpiPen® (NDA -19-430). The attached documentation supports the equivalence.

### 8.6 Description:

The Invisiject" Reusable Auto-Injector is a reusable, spring-loaded injection device that is designed to deliver 0.5 mL of AVONEX® from a pre-filled syringe. Using the Auto-Injector instead of direct injection with the pre-filled syringe provides an alternative method of injection to address needle phobia and injection anxiety by covering the svringe and needle during the injection process. The product consists of four separate components that are used to prepare and inject the drug from the pre-filled syringe through the single lumen hypodermic needle. The components, a Syringe Adapter, Syringe Holder, Base Unit, and Power Pack are packaged together in a plastic case, which doubles as the Handling Console used for assembly and charging the Power Pack. The AVONEX® pre-filled syringes and commercially available single lumen hypodermic needles are provided separately.

### 8.7 Intended Use:

The Invisiject" Reusable Auto-Injector is a reusable 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 auto-injectors are intended to be used in any setting including the home.

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### 8.8 Technological Characteristics:

The technological characteristics of the AVONEX® Reusable Auto-Injector are the same as products currently legally marketed in the USA

#### 8.9 Performance Data:

Performance of the Invisiject™ Reusable Auto-Injector was assessed using applicable sections and methods specified in the ISO standard, ISO 11608-1, "Pen-injectors for Medical Use - Part 1: Requirements and Test Methods". Penetration depth, activation force for injection, loading force and Injection time were also assessed. The device met all requirements and specifications.

#### 8.10 Conclusion:

Biogen concludes based on the information presented that the Invisiject™ Reusable Auto-Injector is substantially equivalent to products currently legally marketed in the USA.

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Public Health Service

NOV - 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biogen Mr. Michael Poirier Associate Director Regulatory Affairs 14 Cambridge Center Cambridge, Massachusetts 02142

Re: K032425

Trade/Device Name: Invisiject ™ Reusable Auto-Injector Regulation Number: 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: August 5, 2003 Received: August 7, 2003

Dear Mr. Poirier:

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. Poirier

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/dsma/dsmamain.html

Sincerely vours.

Susan Runno

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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## INDICATIONS FOR USE STATEMENT

510(k) File Number: K032425

Device Name:

Invisiject™Reusable Auto-Injector

Indications For Use:The Invisiject™ Reusable Auto-Injector is a reusable device indicated for use 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 auto-injectors are intended to be used in any setting including the home.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cuccente

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

510(k) Number: K032425