(67 days)
This needle-free fluid injector system is indicated for the delivery of vaccines or medications to the subcutaneous tissue by penetrating the skin under high pressure. This device is to be used by a health care professional only.
The Bi-3M Needle-Free Injector System consists of a hand-held injector unit to which a multiple-dose vial of vaccine or medication can be attached. The unit is spring-powered and is connected to its hydraulic fluid power source, which is operated by a foot pump.
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Acceptance Criteria and Study for the Bi-3M Needle-Free Injector System
The provided document describes performance and safety tests conducted to demonstrate substantial equivalence of the Bi-3M Needle-Free Injector System to predicate devices, particularly the Ped-O-Jet. The primary focus of the studies was on dosage accuracy and prevention of cross-contamination.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state pre-defined "acceptance criteria" as pass/fail thresholds for the performance tests. Instead, it compares the Bi-3M's performance directly to the predicate device (Ped-O-Jet) to demonstrate substantial equivalence. For the cross-contamination study, it reports a specific clean sample rate.
| Performance Parameter | Acceptance Criteria (Implied by comparison) | Reported Bi-3M Performance |
|---|---|---|
| Dosage Accuracy | No significant difference compared to Ped-O-Jet | No significant difference between Bi-3M and Ped-O-Jet |
| Penetration | Similar to Ped-O-Jet | Similar to Ped-O-Jet |
| Focus | Similar to Ped-O-Jet | Similar to Ped-O-Jet |
| Force | Similar to Ped-O-Jet | Similar to Ped-O-Jet |
| Stream Quality | Similar to Ped-O-Jet | Similar to Ped-O-Jet |
| Environmental Stability | Consistent functionality at temperature extremes and after free fall | Indicated consistent functionality |
| Noise Level | Below OSHA exposure limits | Below OSHA exposure limits |
| Cross-Contamination Prevention | Designed to significantly reduce cross-contamination | 99.8% clean sample rate (vs. 54% for Ped-O-Jet in high-contamination model) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for performance tests (Dosage Accuracy, Penetration, Focus, Force, Stream Quality): The document does not specify the exact sample sizes used for these tests. It generally states a "battery of performance testing was done."
- Sample Size for Cross-Contamination Safety Test: The document does not explicitly state the number of injections or replicates performed in the cross-contamination study, but it refers to "the one Bi-3M sample for which fluorescein was reported in the downstream collection," implying multiple samples were tested.
- Data Provenance: The document does not explicitly state the country of origin. The organization (Felton International, Inc.) is based in Lenexa, Kansas, USA, so it's likely the testing was conducted in the USA or supervised by this entity. The study appears to be prospective as it was designed to test the Bi-3M device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- The document does not mention the use of experts to establish ground truth for any of the reported tests. The performance and safety tests appear to be laboratory-based, objective measurements (e.g., measuring fluorescein, mechanical properties).
4. Adjudication Method for the Test Set
- None. Since expert-defined ground truth or human interpretation is not indicated, an adjudication method is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance is evaluated. This device is a physical medical device (injector), not an AI diagnostic tool.
6. Standalone Performance
- Yes. The document details standalone performance tests for the Bi-3M device. These tests evaluate the device's inherent mechanical function (dosage accuracy, penetration, etc.) and its ability to prevent cross-contamination, independent of human interaction in the outcome assessment (beyond operating the device). The results for dosage accuracy, penetration, focus, force, stream quality, environmental testing, noise level, and the 99.8% clean sample rate in the cross-contamination study represent its standalone performance.
7. Type of Ground Truth Used
- Objective Laboratory Measurements: The ground truth for the performance tests (dosage accuracy, penetration, focus, force, stream quality, environmental, noise) was established through direct, quantifiable physical or mechanical measurements comparing the Bi-3M to the Ped-O-Jet.
- Fluorescein Detection: For the cross-contamination study, the ground truth was the presence or absence of fluorescein (a chemical marker) in the downstream collection vessel, indicating contamination. This is an objective, laboratory-based detection method.
8. Sample Size for the Training Set
- Not applicable. This document describes the testing and 510(k) submission for a physical medical device. It does not involve a machine learning algorithm or an "AI" device that would typically have a training set in the computational sense. The "training" of the device would refer to its engineering and design, not an ML model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As noted above, there is no "training set" in the context of machine learning for this physical device. The device's design and manufacturing are based on engineering principles and previous iterations (e.g., the Bi-3 injector).
§ 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).