The Injex 30 Injector System is designed to deliver various medicines and vaccines by means of a narrow, high velocity jet of fluid which penetrates the surface of the skin and delivers the medicine or vaccine to the body.

Device Description

Equidyne Systems Injex 30 Injector System is a means of administering subcutaneous medications without the use of needles. The needle free injector utilizes a high velocity focused jet of liquid to penetrate the skin and deposit the medication in the subcutaneous tissue. The process takes place in a fraction of a second. Needle free injection is useful in a wide range of drug therapy including immunization vaccines, hormones and local anesthetics, as well as the administration of insulin to the diabetic population, where individuals may need a number of injections per day.

The Injex 30 Injector system consists of four main components;

Injector A small re-usable hand held Injector,
Reset Box A compact re-usable Reset Box used to reset and store the Injex 30 Injector,
Ampule A disposable, sterile 0.3 ml Ampule that functions like a needle syringe to draw the medication from the medicine bottle or vial using a hand draw with a plunger. Once the Ampule is loaded into the Iniex 30 Iniector, the dose is injected into the individual by releasing the Safety and pressing the trigger.
Vial Adapter A disposable, sterile Vial Adapter facilitates the transfer of the medication from the medicine bottle or vial to the Ampule.

The Injex 30 Injector can deliver variable doses of fluid medication from 0.05 ml to 0.30 ml.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Injex 30 Needle Free Injection System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative manner for the Injex 30's primary function of medication delivery compared to a predicate. Instead, it describes a comparative study aiming for "substantial equivalence." The "acceptance criteria" are implied by the conclusion of this equivalency testing.

Acceptance Criteria (Implied)	Reported Device Performance & Conclusion
Biocompatibility: Device materials are non-toxic.	Cytotoxicity: Non-toxic (Agarose Overlay test).
Biocompatibility: Device materials are non-irritating.	Irritation/Sensitization: Non-irritating (Primary Skin Irritation test in rabbits).
Equivalency (Injection Performance): Flow and dispersion of injected fluid is substantially equivalent to the predicate device (Hypex Jet Injector).	Equivalency Tests: "The results of testing showed that the flow and dispersion of the injected fluid from the Injex 30 Injector System was substantially equivalent to that of the predicate device." (Performed using colored water in a chicken breast model at various volumes: 0.05, 0.10, 0.15, 0.20, 0.25, and 0.30 ml).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Description: The "equivalency tests" involved injecting colored water into chicken breasts. The term "chicken breast" was used as a human subcutaneous tissue model.
Sample Size: The document does not specify the number of chicken breasts used, or how many injections were performed at each volume.
Data Provenance: The study was conducted by Equidyne Systems Inc. It is a prospective study, specifically designed to demonstrate equivalence for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

No external experts are mentioned for establishing ground truth regarding the injection performance.
The comparison was performed internally by Equidyne Systems Inc., with "The injection sites were then dissected and the flow and dispersion of the colored water was examined and compared" to the predicate device. The qualifications of the individuals performing this comparison are not stated.

4. Adjudication Method for the Test Set

None described. The comparison appears to have been a direct observation and qualitative assessment by the company, not involving a formal adjudication process or multiple independent reviewers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This study solely focused on the physical characteristics of the injection performed by the device, not on human reader interpretation or clinical outcomes with and without AI assistance. The device is a physical delivery system, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Yes, a standalone study was done. The "equivalency tests" were conducted on the device itself (Injex 30 Injector System) in a model (chicken breast) to assess its performance in delivering fluid compared to a predicate device, independent of human interaction beyond the operation of the device during the test. There is no AI involved, so the concept of "human-in-the-loop" is not applicable here.

7. Type of Ground Truth Used

For Biocompatibility: Laboratory test results (non-toxic, non-irritating) are the ground truth.
For Equivalency (Injection Performance): The "ground truth" was a direct comparison to the predicate device's performance in the same chicken breast model. The predicate's fluid flow and dispersion characteristics served as the benchmark for "substantial equivalence." This is a comparative engineering/performance assessment, not a clinical ground truth like pathology or patient outcomes.

8. Sample Size for the Training Set

Not applicable. The Injex 30 is a mechanical device, not an AI/machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI model, this question is irrelevant to the Injex 30.

Summary

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JUL 2 3 2002

510(k) Summary (As required by 21 CFR 807.92(a))

A. Submitter Information
Equidyne Systems Inc. 11770 Bernardo Plaza Court, Suite 351 San Diego, CA 92128

858-451-7001 Phone Number: 858-451-7002 Fax Number: Contact: Jim Barley Regulatory Affairs June 21, 2002 Date:

B. Device Information

Trade/Proprietary Name:	Injex 30 Needle Free Injection System
Common name of device:	Jet Injector
Classification Name:	Injector, Fluid, Non-Electrically Powered
Predicate Device:	Hypex Jet Injector
Predicate 510(k) #:	K945873

D. Device Description:
C:

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Device Description: (cont.) D.

The Injex 30 Injector system consists of four main components;

Injector A small re-usable hand held Injector, 1.
Reset Box A compact re-usable Reset Box used to reset and store 2. the Injex 30 Injector,
Ampule A disposable, sterile 0.3 ml Ampule that functions like a 3. needle syringe to draw the medication from the medicine bottle or vial using a hand draw with a plunger. Once the Ampule is loaded into the Iniex 30 Iniector, the dose is injected into the individual by releasing the Safety and pressing the trigger.
Vial Adapter A disposable, sterile Vial Adapter facilitates the transfer 4. of the medication from the medicine bottle or vial to the Ampule.

The Injex 30 Injector can deliver variable doses of fluid medication from 0.05 ml to 0.30 ml.

E. Intended Use:
The Iniex 30 Injector System is designed to deliver various medicines and vaccines by means of a narrow, high velocity jet of fluid which penetrates the surface of the skin and delivers the medicine or vaccine to the body.
F. Comparison of Required Technological Characteristics:
The Injex 30 Injector System has the same technological characteristics as the Hypex Jet Injector. The key differences between the two devices is the spring force.
લ. Summary and Conclusion of Nonclinical Tests

Biocompatibility

The ISO-FDA Modified Matrix, FDA/ODE General Program Memorandum - # G95-1 was reviewed to determine applicable biocompatibility tests. In addition to the raw material testing by the supplier, Equidyne Systems conducted a Cytotoxicity Study using the ISO Agarose Overlay Method and ISO Skin Irritation Study in the rabbit on the sterilized Ampule material.

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Summary and Conclusion of Nonclinical Tests G.
Biocompatibility (cont.)

Following is a summary of all test results:

BIOCOMPATIBILITYTEST	TYPE	RESULT
Cytotoxicity	Agarose Overlay	Non toxic
Irritation andSensitization	Primary Skin Irritation	Non irritating

Equivalency Tests

The purpose of the equivalency testing was to show that the Injex 30 Injection System is safe and effective for its intended use and that an injection from the Injex 30 Injector is substantially equivalent to that of the predicate device.

The chicken breast was used as a human subcutaneous tissue model due to its similarity to human tissue. Chicken breasts were injected with 0.05, 0.10, 0.15, 0.20, 0.25 and 0.30 ml of colored water using the Injex 30 Injector. The injection sites were then dissected and the flow and dispersion of the colored water was examined and compared.

The results were compared to the predicate device.

Results and Conclusion

The objective of this study was to show that the Injex 30 Injector System is safe and effective for its intended use and is substantially equivalent to the predicate device.

The results of testing showed that the flow and dispersion of the injected fluid from the Injex 30 Injector System was substantially equivalent to that of the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2002

Mr. Jim Barley Regulatory Affairs Equidyne Systems, Incorporated 11770 Bernardo Plaza Court, Suite 351 San Diego, California 92128

Re: K022148

Trade/Device Name: Injex 30 Needle Free Injector System Regulation Number: 880.5430 Regulation Name: Nonelectrically Powdered Fluid Injector Regulatory Class: II Product Code: KZE Dated: June 21, 2002 Received: July 2, 2002

Dear Mr. Barley:

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.

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.

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Page 2 - Mr. Barley

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 " see 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and 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

Sincerely yours

Timothy A. Ulatowski

Tim 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) Number (if known): ____________________________________________________________________________________________________________________________________________________

. Device Name: . . Injex 30 Needle Free Injector System_

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) 4***************************************************************************************************************************************************************************

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Patrizia Cuciniello

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices and General Hospital 2022148

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).