The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This nonelectrically 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 patient authorized by their physicians to self inject at home.

Device Description

AI/ML Overview

This submission (K051985) is for a "label-only" modification to an already marketed device, the BioValve Mini-Ject Needlefree Injection System. As such, the submission explicitly states that no performance data was required or provided to demonstrate the device meets acceptance criteria because the technological characteristics and the device itself remained unchanged.

Therefore, most of the requested information regarding acceptance criteria and performance studies is not applicable to this specific 510(k) submission.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not applicable. This submission focuses on updating the Instructions for Use (labeling) for an already marketed device. The text explicitly states: "No change was made to the Mini-Ject device and therefore no physical testing was required to confirm the injectors meet their specifications." This indicates that previous acceptance criteria were met by the device itself, but those criteria and performance data are not part of this submission.

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 new performance testing was conducted for this label-only modification.

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. No new performance testing was conducted for this label-only modification, so no ground truth establishment for a test set was required.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new performance testing was conducted for this label-only modification.

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 device is a needle-free injection system, not an AI-assisted diagnostic or therapeutic device that would typically involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical injection system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No new performance testing was conducted for this label-only modification.

8. The sample size for the training set

Not applicable. This device is a mechanical injection system, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is a mechanical injection system, not a machine learning model.

Summary of the 510(k) Submission (K051985):

This 510(k) submission sought to update the Instructions for Use (IFU) for the BioValve Mini-Ject Needlefree Injection System. The device itself (including its technological characteristics) remained unchanged from the previously cleared version (K021969). Therefore, the manufacturer stated, and the FDA determined, that no new performance data or testing was required to demonstrate substantial equivalence for this specific submission, as it was solely a labeling modification. The substantial equivalence was based on the device being identical to the legally marketed predicate device, with only the instructions for use being updated to clarify and simplify warnings, precautions, and contraindications.

Summary

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K051985

5. Summary of Safety and Effectiveness

Scott Huie Submitted By: Vice President of Operations Biovalve Technologies, Inc

21 July, 2005 Date Prepared:

5.1. Trade/Proprietary Name:	Biovalve Mini-Ject Needlefree Injection Systems
5.2. Common/Usual Name:	Needlefree Injector; Jet Injector

Non-Electrically Powered Fluid Injector 5.3. Classification Name:

5.4. Classification:

FDA has classified Non-Electrically Powered Fluid Injector Jet Injectors in Class II. Final Order was published in the Federal Register on October 21, 1980 after review by the General Hospital and Personal Use Devices Classification Panel

KZE- Non-Electrically Powered Fluid Injector Jet Panel: 80 Procode: Injectors

5.5. Purpose of Submission
To update the Instructions for Use for the currently marketed Needlefree Iniector in order to clarify and simplify the warnings, precautions and contraindications sections.
5.6. Substantial Equivalence
The product with the modified Instructions for Use is substantially equivalent to the currently marketed product.
5.7. Technological Characteristics
This is a label only modification and as a result it does not change the technological characteristics of the current product.
5.8. Performance Data
No change was made to the Mini-Ject device and therefore no physical testing was required to confirm the injectors meet their specifications.
5.9. Conclusion
BioValve, Inc. concludes based on the information presented that the modified product (i.e. modified Instruction for Use) is substantially equivalent to the current product legally marketed in the USA.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 17 2005

Mr. Scott Huie Vice President of Operations BioValve Technologies, Incorporated 155 Flanders Road Westborough, Massachusetts 01581

Re: K051985

K021969
Trade/Device Name: BioValve Mini-Ject Needlefree Injection System Regulation Number: 21 CFR 880.5430 Regulation Name: Nonelectrically powered fluid injector Regulatory Class: II Product Code: KZE Dated: July 21, 2005 Received: July 25, 2005

Dear Mr. Huie:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars annent date of the Medical Device Amendments, or to commerce provided 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). and Cosmetic Act (71ct) that do nov sequent to the general controls provisions of the Act. The You may, therefore, market the devices, octorements for annual registration, listing of general controls provisions of wactice, 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 If your device is classified (soc aborb) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations ED may be subject to such additional controlier and one of the 21, Parts 800 to 898. In addition, FDA may be found in the Outs of concerning 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 Please be advised that FDA s issuated of a builter complies with other requirements of the Act
that FDA has made a determination that your device complies with on your must that FDA has made a decemmation administered by other Federal agencies. You must or any Federal Statures and regulations daministered of registration and listing (21)
comply with all the Act's requirements, including, but not limited to: ret comply with an the Act s requirements, merading, and manufacturing practice requirements as set CFR Part 807), labening (21 CFR Part 800), good if applicable, the electronic forth in the quality systems (QD) regardens (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decreens over device as described in your Section 510(k) I his letter will anow you to begin marketing your artial equivalence of your device to a legally premarket notification. The PDF mailing of basistication 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 If you desire specific advice ion your ac not the same and the regulation entitled, and contact the Office of Complanes at (210) = i C = a rt 807.97). You may obtain "Misbranding by reference to promanto notified in the Act from the Division of Small
other general information on your responsibilities under the Act from the 2000 C28.00 other general information on your responsive Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consultation of Consultant Constitutions try/support/index.html.

Sincerely yours,

signature

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

510(k) Number: K051985

MINI-JECT NEEDLEFREE INJECTIO BIOVALVE Device Name: SYSTEM

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

✓

Over-the-Counter Use:

(Per 21 CFR 801.109)

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510(k) No.	K945195
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Regulation Number and Section

§ 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).