K Number
K032976
Device Name
BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001
Date Cleared
2004-04-16

(205 days)

Product Code
Regulation Number
880.5430
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

Not Found

No
The summary describes a mechanical, non-electrically powered needle-free injection system. There is no mention of AI, ML, image processing, or any data-driven decision-making components.

No.
The device is described as an injection system to deliver fluid subcutaneously, which is a method of administration, not a treatment itself. It facilitates the delivery of therapeutic substances but is not inherently therapeutic.

No
Explanation: The device is described as a needle-free injection system designed to deliver fluid, not to diagnose or detect a condition.

No

The device description clearly states it is a physical, sterile, single-use medical device with an injector, luer adapter, and a proprietary charge system. It is a hardware device for delivering fluid.

Based on the provided information, the Mini-Ject device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is designed to "deliver fluid subcutaneously" and "deliver an injection of fluid." This describes a device used on the body for therapeutic purposes (delivering medication), not a device used with samples taken from the body for diagnostic purposes.
  • Device Description: The description focuses on the mechanism of delivering fluid into the body.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Mini-Ject device does not fit this description.

N/A

Intended Use / 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 subcutaneous area 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.

Product codes (comma separated list FDA assigned to the subject device)

KZE

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

subcutaneous area of the body

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K960373, K920631

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 880.5430 Nonelectrically powered fluid injector.

(a)
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.(b)
Classification. Class II (performance standards).

0

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:(508) 421-9500 X222
Fax Number:(508) 421-4848
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,
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
2000) K960373, K920631 | Proposed Device: Mini-Ject
Needlefree Injection System |
|---------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Intended Use | Needlefrec subcutaneous and
intramuscular injection system | Needlefree subcutaneous
injection system |
| System Configuration | Three Part System

  • Reusable Handle
  • Disposable injector head
  • Vial Fill Adapter | Three Part System
  • Disposable Injector
  • Syringe Fill Adapter
  • Syringe with needle (not
    supplied) |
    | Materials - Fluid Contact | Polycarbonate, Silicone,
    Polystyrene | Polycarbonate, Silicone. ABS,
    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.

1

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.

2

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.

3

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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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

4

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

Page 1 of _

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