The Avant Guardian™ 101 is designed to deliver various liquid medications and vaccines by penetrating the skin with a high-speed fluid jet and delivering the medication or vaccine to the underlying subcutaneous tissue.

Device Description

The Avant Guardian™ 101 allows a medication or vaccine to be injected subcutaneously without the use of a needle. The system is designed to mimic the best clinical practices for iniecting medications, namely, a slow injection of medication into tissue that is not compressed.

The product consists of a single-use medication reservoir (syringe) and a reusable injector. The operator employs an offthe-shelf vial adapter to fill the single-use medication reservoir with medication. The injector device is reset by compressing the spring-loaded push-rod. The medication reservoir is then placed in the Avant injector, which has an integral, batteryoperated vacuum source. The patient places the reservoir against his skin and activates the vacuum by depressing the safety switch. To prevent an accidental discharge, the safety switch must be depressed and held until the injection is initiated by the operator depressing the inject button. As the vacuum is formed, skin is drawn up to and securely held in contact with the reservoir tip. Suction generated by the injector stabilizes the reservoir against the patient's skin to create a subcutaneous pocket (thereby avoiding muscle), eliminating the need to force the injector against the skin and compress the underlying tissue. The suction creates a seal around the tip that allows slow delivery of the medication, and stabilizes the device to prevent lacerations and movement of the orifice.

The medication is delivered in two stages. The patient depresses the inject button, causing a mechanism in the device to impact the medication reservoir plunger. Initially a high pressure, high speed jet of medication exits the reservoir orifice, puncturing the skin and the underlying tissue. The injection force quickly falls to a low level as the spring-loaded mechanism forces the medication into the subcutaneous tissue. The injector automatically stops the vacuum pump at the end of the injection, thereby indicating when the injector can be removed from the skin.

AI/ML Overview

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

It's important to note that the provided document is a 510(k) summary for a medical device (Avant Guardian™ 101 Needle-Free Injection System), not a detailed study report. Therefore, some of the requested information, particularly regarding specific test results, sample sizes for detailed performance tests, and ground truth establishment methods for those tests, is not fully explicit or available in this summary.

Device Name: Avant Guardian™ 101 Needle-Free Injection System

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria with specific numerical targets. Instead, it describes general categories of testing and states that the device successfully completed them to demonstrate its safety and effectiveness. The reported performance is summarized qualitatively.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Successful completion per ISO 10993 requirements. (This implies the device materials are safe for biological contact.)
Design Verification	Successful completion to confirm product integrity. (This implies the device met its design specifications and is structurally sound and functions as intended.)
Performance (Delivery Similar to Predicates)	Successful completion of side-by-side performance testing using a tissue model and simulated skin test chamber. The system is designed to mimic the best clinical practices for injecting medications, namely, a slow injection of medication into tissue that is not compressed. The device is designed to: - penetrate the skin with a high-speed fluid jet. - deliver medication to underlying subcutaneous tissue. - create a subcutaneous pocket (to avoid muscle). - form a vacuum seal around the tip for slow delivery and device stabilization. - deliver medication in two stages: high-pressure jet for puncture, then low-pressure for subcutaneous delivery. (The statement implies the device achieved these functional requirements comparably to predicate devices.)
Risk Analysis	Successful completion. (Implies potential risks were identified and mitigated, and the device presents "no new issues of safety when compared to the predicate devices.")
Overall Safety and Effectiveness	The data submitted constitutes valid scientific evidence to support safety and effectiveness. The device is considered "safe and effective when used according to the device labeling." (This is the overarching conclusion related to the regulatory submission.)

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

The document does not specify exact sample sizes for each test mentioned (Biocompatibility, Design Verification, Performance Testing, Risk Analysis). It generically refers to "extensive design verification, functional and performance testing."

Test Set Sample Size: Not explicitly stated for specific performance tests.
Data Provenance: Not explicitly stated (e.g., country of origin). The testing would have been conducted by or for Avant Medical Corporation. Based on the contact information, the company is located in San Diego, CA, USA, suggesting the testing was likely conducted in the US or by US-based entities. The text does not specify if the studies were retrospective or prospective, but given they are pre-market verification tests, they would inherently be prospective in nature, performed specifically for regulatory submission.

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

This information is not provided in the summary. For performance tests involving tissue models or simulated skin, the "ground truth" would be established by the physical and chemical properties of the models and the measurement instruments. For biocompatibility, established ISO standards serve as the "ground truth." For design verification, engineering specifications are the "ground truth." There is no indication of human expert panels establishing ground truth for these technical tests in the sense implied by clinical evaluation of AI.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the summary. The tests described (biocompatibility, design verification, side-by-side performance with models, risk analysis) are objective engineering and laboratory tests, not subjective interpretations requiring human expert adjudication methods like 2+1 or 3+1.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or described. This type of study is typically associated with diagnostic imaging or clinical decision support AI devices where human performance is part of the evaluation. The Avant Guardian™ 101 is a physical injection device. The "comparison" was against predicate jet injectors through "side-by-side performance testing" with models, not a human reader study.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Yes, in spirit. The testing described (biocompatibility, design verification, and side-by-side performance testing using a tissue model and simulated skin test chamber) evaluates the device's technical performance in a standalone manner, without requiring human intervention during the measurement of its core functions in these specific tests. However, it's a mechanical device, not an algorithm. The "human-in-the-loop" would be the operator using the device, but the verification tests assessed the device's intrinsic capabilities.

7. The Type of Ground Truth Used

The ground truth for the tests conducted includes:

Established International Standards: For biocompatibility (ISO 10993 requirements).
Engineering Specifications/Design Requirements: For design verification and confirming product integrity.
Physical Properties of Tissue Models and Simulated Skin: For performance testing related to penetration, subcutaneous delivery, vacuum seal, and fluid dynamics. Performance was also compared to predicate devices as a reference.
Risk Analysis Methodologies: For identifying and assessing potential hazards.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The Avant Guardian™ 101 is a mechanical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI.

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

This information is not applicable and therefore not provided. As mentioned above, there is no "training set" for this type of device.

Summary

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KO24616 Rage Lo& 3

JAN 1 7 2003

3914 Kendall Street San Diego, CA 92109 Phone: (858) 273-3674 Fax: (858) 274-6744 jslate@san.rr.com

Image /page/0/Picture/3 description: The image shows the logo for Avant Medical Corporation. The word "avant" is in large, bold, sans-serif font. Below it, in smaller font, are the words "MEDICAL CORPORATION". The logo is black and white.

SUMMARY OF SAFETY AND EFFECTIVENESS

AVANT MEDICAL CORPORATION

Avant Guardian™ 101

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Company:	Avant Medical Corporation3914 Kendall StreetSan Diego, CA 92109Tel: (858) 273-3674Fax: (858) 274-6744
Company Representative:	John B. Slate, Ph.D.Sr. Vice President, Operations
Date 510(k) Prepared:	3 December 2002
Device Name:	Avant Guardian TM 101
Common Name:	Needle-free injection system
Classification Panel:	General Hospital
Classification Name:	Nonelectrically Powered Fluid Injector
Product Code:	KZE
CFR Section:	880.5430
Classification:	Class II

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Devices to Which Substantial Equivalence is Claimed:

Avant Guardian™ 101 is substantially equivalent to the following currently marketed jet injectors:

Bioject Biojector 2000 (K960373, K920631) .
. Medi-Ject Vision (modification of the Medi-Ject Choice, K962956 and K994384)
Equidyne Injex 30 (K945873) .

Device Description:

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Intended Use:

The Avant Guardian™ 101 is designed to deliver various liquid medications and vaccines by penetrating the skin with a highspeed fluid jet and delivering the medication or vaccine to the underlying subcutaneous tissue.

Summary of Technological Characteristics Compared to Predicate Devices:

Extensive design verification, functional and performance testing have been conducted on the Avant Guardian™ 101 to demonstrate its ability to safely and effectively deliver injections similar to currently marketed jet injectors. The Avant Guardian™ 101 successfully completed the following tests:

Biocompatibility testing per ISO 10993 requirements .
Design verification tests to confirm product integrity .
Side-by-side performance testing using a tissue model ● and simulated skin test chamber
. Risk analysis

The results indicate that the Avant Guardian™ 101 presents no new issues of safety when compared to the predicate devices.

The sponsor believes that the data submitted for the Avant Guardian™ 101 constitutes valid scientific evidence to support safety and effectiveness. The sponsor believes that the Guardian is safe and effective when used according to the device labeling.

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping heads or faces, and a wing-like shape extending from the back of the head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

Dr. John B. Slate Avant Medical Corporation 3914 Kendall Street San Diego, California 92109

Re: K024018

Trade/Device Name: Avant Guardian™ 101 Needle Free Injection System Regulation Number: 880.5430 Regulation Name: Nonelectrically Powered Fluid Injector Regulatory Class: II Product Code: KZE Dated: December 3, 2002 Received: December 4, 2002

Dear Dr. Slate:

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.

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Page 2 - Dr. Slate

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 (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 vour 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. 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) you may obtain. 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. Uhlmann

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use __________

Patricia Ciccarelli

f Anesthesiology, General Hospital. Infection Control, Den

510(k) Number: K024418

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).