(205 days)
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.
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.
The provide submission does not include information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a typical diagnostic or AI/ML device submission would. This 510(k) submission is for a physical medical device—a needle-free injection system—and its approval is based on demonstrating substantial equivalence to a predicate device rather than performance against a set of predefined acceptance metrics for accuracy, sensitivity, or specificity.
Instead, the submission focuses on:
- Device Description: Detailing the components and function of the "Mini-Ject Needlefree Injection System."
- Substantial Equivalence: Comparing the proposed device to a legally marketed predicate device (Biojector 2000) based on intended use, system configuration, materials, packaging, sterility, shelf life, and fill adapter. The goal is to show that the new device is as safe and effective as the predicate.
- Intended Use Statement: Clearly defining the purpose and user population for the device.
Based on the information provided, here's how to address your questions in the context of this device type:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or performance metrics (like accuracy, sensitivity, specificity) are provided for this needle-free injection system in the document. The regulatory pathway here is demonstrating "substantial equivalence," not meeting quantitative performance targets in the same sense as an AI/ML or diagnostic device.
The "performance" is implicitly demonstrated through the comparison table, showing that:
| Feature | Predicate Device (Biojector 2000) Performance | Proposed Device: Mini-Ject Performance | Acceptance Criteria (Implicit) |
|---|---|---|---|
| Intended Use | Needlefree subcutaneous and intramuscular injection system | Needlefree subcutaneous injection system (0.5ml only) | Safe and effective delivery of medication subcutaneously. |
| Materials - Fluid Contact | Polycarbonate, Silicone, Polystyrene | Polycarbonate, Silicone, ABS, UHMWPE | Biocompatible and suitable for fluid contact. |
| Packaging | Tyvek/Film Pouch | Same | Maintains sterility and device integrity. |
| Sterility | Ethylene Oxide (ETO) Sterilized | Same | Sterile. |
| Shelf Life | 3 years | 3 years | Stable efficacy and sterility over the declared shelf life. |
| Fluid Delivery | Multiple orifices for achieving subcutaneous or intramuscular injections in various injection volumes | Set orifice size and energy source designed to achieve 0.5 ml subcutaneous injections only (fully disposable) | Delivers specified 0.5 ml subcutaneously with appropriate force for skin penetration and drug dispersion. |
The main "study" proving the device meets the (implicit) acceptance criteria is the comparison to the predicate device, asserting that its fundamental technology, materials, and intended function are comparable, and any differences (like being fully disposable and fixed volume/route) do not raise new questions of safety or effectiveness.
Regarding your other questions, they are largely not applicable to this type of 510(k) submission for a physical, non-AI medical device:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No "test set" in the context of diagnostic performance or AI model evaluation is mentioned. Device testing would have been conducted for aspects like sterility, material compatibility, dose delivery accuracy, and shelf life, but details on sample sizes for such engineering/bench tests are not provided in this summary document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical injection device, not an AI or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this device, "ground truth" would relate to successful fluid delivery, sterility, and material safety, which are confirmed through engineering tests and material specifications, not clinical outcomes or expert consensus on a diagnostic interpretation.
8. The sample size for the training set
Not applicable. This device does not have a "training set" as it's not an AI/ML product.
9. How the ground truth for the training set was established
Not applicable.
{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 (Biojector2000) K960373, K920631 | Proposed Device: Mini-JectNeedlefree Injection System |
|---|---|---|
| Intended Use | Needlefrec subcutaneous andintramuscular injection system | Needlefree subcutaneousinjection 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 (notsupplied) |
| 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
§ 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).