(44 days)
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.
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.
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.
§ 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).