BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001

K032976 · Biovalve Technologies, Inc. · KZE · Apr 16, 2004 · General Hospital

Device Facts

• Record ID: K032976
• Device Name: BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001
• Applicant: Biovalve Technologies, Inc.
• Product Code: KZE · General Hospital
• Decision Date: Apr 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5430
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This non electrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body. The Mini-Ject device is intended for home and professional use. It may be used by physicians, nurses and other practitioners who routinely administer injections and by patients authorized by their physicians to self inject at home.

Device Story

Mini-Ject is a sterile, single-use, non-electrically powered needle-free injection system. Device utilizes a proprietary internal charge system to generate a high-velocity jet of fluid, enabling subcutaneous delivery of 0.5 ml of medication. System includes an injector and a luer adapter for filling via standard slip-lock syringe. Intended for use in clinical settings by physicians/nurses or at home by patients under physician authorization. Device replaces traditional needle-based delivery, potentially reducing needle-stick risks and improving patient comfort through needle-free administration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Polycarbonate, Silicone, ABS, UHMWPE. Energy source: Proprietary internal charge system (non-electrical). Form factor: Single-use, disposable, 0.5 ml capacity. Sterilization: Ethylene Oxide (ETO).

Indications for Use

Indicated for subcutaneous delivery of medications in patients requiring injections. Suitable for use by healthcare professionals and patients authorized for self-injection at home.

Regulatory Classification

Identification

A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.

Predicate Devices

• Bioject, Biojector 2000 (K960373)
• Bioject, Biojector 2000 (K920631)

Submission Summary (Full Text)

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i.032976

510(k) Premarket Notification -- Biovalve Technologies, Inc. - Mini-Ject Needlefree Injection System 0.5 ml S

# APR 1 6 2004

# 510(k) Summary of Safety and Effectiveness

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| Submitter's Name: | BioValve Technologies, Inc. |
|----------------------|------------------------------------------------------------------------------|
| Submitter's Address: | One Innovation Drive, 3 Biotech, Worcester, MA 01605 |
| Telephone Number: | [phone] X222 |
| Fax Number: | [phone] |
| Contact Person: | Scott Huie |
| Date: | September 19,2003 |
| Proprietary Name; | Mini-Ject Needlefree Injection System |
| Common Name: | Needle-free fluid injector |
| Classification Name: | 21CFR 880.5430, non-electrically powered fluid injector,<br>product code KZE |
| Classification: | Class II |
| Predicate Device: | Bioject, Biojector 2000. K960373 and K920631 |

Device Description: The Mini-Ject is a sterile, single use medical device. The Mini-Ject delivers 0.5ml subcutaneously. The device consists of an injector and a luer adapter to provide a means of filling the device using a standard slip lock syringe. The device is powered by a proprietary charge system wholly contained in the distal portion of the device.

Substantial Equivalence: The information provided in this premarket notification demonstrates that the proposed device is substantially equivalent to legally marketed devices. The proposed Mini-Ject device is substantially equivalent to the Bioject, Biojector 2000 (K960373 and K920631). Both devices have the same intended use to deliver medicinal to the subcutaneous tissue and both arc self-filled.

A comparison of features and principles of operation between the proposed device and predicate device is provided in the table below.

| Feature | Predicate Device (Biojector<br>2000) K960373, K920631 | Proposed Device: Mini-Ject<br>Needlefree Injection System |
|---------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Intended Use | Needlefrec subcutaneous and<br>intramuscular injection system | Needlefree subcutaneous<br>injection system |
| System Configuration | Three Part System<br>- Reusable Handle<br>- Disposable injector head<br>- Vial Fill Adapter | Three Part System<br>- Disposable Injector<br>- Syringe Fill Adapter<br>- Syringe with needle (not<br>supplied) |
| Materials - Fluid Contact | Polycarbonate, Silicone,<br>Polystyrene | Polycarbonate, Silicone. ABS,<br>UHMWPE |
| Packaging | Tyvek/Film Pouch | Same |
| Sterility | Ethylene Oxide (ETO) Sterilized | Same |
| Shelf Life | 3 years | 3 years |
| Fill Adapter Provided | Yes | Yes |

#### COMPARISON DATA

BioValve Technologies, Inc.

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#### 510(k) Premarket Notification - Biovalve Technologies, Inc. - Mini-Ject Needlefree Injection System 0.5 ml Self Fill

Summary of differences between predicate and proposed device: The predicate uses a disposable injector head and reusable handle with compressed gas source. This allows use of multiple orifices for achieving subcutaneous or intramuscular injections in various injection volumes.

The Mini-Ject has a set orifice size and energy source designed to achieve 0.5 ml subcutaneous injections only and is fully disposable.

Intended Use: The Mini-Ject is intended to be used to deliver medications approved for subcutancous injection.

BioValve Technologies, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads 'HEALTH & HUMAN SERVICES - USA' in a circular arrangement. The central symbol consists of three stylized, curved lines resembling a bird in flight or a flowing ribbon, oriented diagonally within the circle.

APR 1 6 2004

Food and Drug Administra 9200 Corporate Bouleva Rockville MD 20850

Mr. Scott Huie Vice President, Operations BioValve Technologies, Incorporated One Innovation Drive 3 Biotech Worcester, Massachusetts 01605

Re: K032976

Trade/Device Name: BioValve Mini-Ject, Needle-Free Injection System, 0.5 ml Self-fill, Model FG-01-001 Regulation Number: 21 CFR 880.5430 Regulation Name: Nonelectrically Powered Fluid Injector Regulatory Class: II Product Code: KZE Dated: January 21, 2004 Received: January 27,2004

Dear Mr. I-hie:

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, Down, 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 announcementsconcerning your device in the Federal Register.

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Page 2 - Mr. Huie

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 responsibilitiesunder the Act from the Division of Small Manufacturers, Internationaland Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincercly yours.

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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510(k) Premarket Notification -- Biovalve Technologies, Inc. - Mini-Ject Needlefree Injection System 0.5 ml Self F

## Indications for use Statement

Page __

510(k) Number (if known): K032976

Device Name:

BioValve MiniJect Device

Indications for Use:

The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This n electrically powered device is intended lo deliver an injection of fluid by means & a high velocity jet o fluid that penetrates the skin and delivers the fluid to the subcutaneousarea of the body. The Minibect device is intended for home and professionaluse. It may be used by physicians, nurses and other practitioners who routinely administer injections and by patients authorized by their physicians to self inject at home.

Prescription Use _ ﺎ (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)

Viole Hubbard for Anthony Watson / BC-GHDB

Rul

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(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K032926