(55 days)
The PharmaJet® Stratis Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet® Needle-free Injection System. It may be used for adults and children. It can also be used by patients authorized by their physicians to self-inject, or to have other individuals administer injections of prescribed medication.
The PharmaJet® Stratis 0.5 mL Needle-free Injection System is a compact, spring-loaded needle-free hypodermic injection system. The PharmaJet® System consists of an injector, a reset station, a single use, sterile disposable filling adapter, and a single use, sterile, disposable needle-free syringe. The components of the system may be sold separately for replacements as they are used. The components of the PharmaJet® System are unique and cannot be used with any other needle-free system.
The provided document describes a Special 510(k) Premarket Notification for the PharmaJet® Stratis 0.5 mL Needle-free Injection System. This submission focuses on demonstrating substantial equivalence to a predicate device (PharmaJet® 0.5 mL Needle-free Injection System, K081532) rather than establishing novel safety and effectiveness criteria through extensive clinical trials. Therefore, the information typically available for AI/ML device studies (such as MRMC studies, detailed expertise of adjudicators, specific ground truth methods beyond bench and animal testing, and large training/test sets for algorithm performance) is not directly applicable or available in this type of submission.
The "acceptance criteria" here largely refer to meeting the requirements of the Product and Engineering Specifications, essential requirements of ISO21649:2006, and demonstrating substantial equivalence to the predicate device through various non-clinical and animal studies.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document emphasizes substantial equivalence to a predicate device. Acceptance criteria are primarily regulatory and standard-based, rather than performance metrics of an AI model. "Reported Device Performance" for this submission focuses on demonstrating these equivalences and compliance.
| Acceptance Criteria Category | Specific Acceptance Criteria (from ISO 21649:2006 & other tests) | Reported Device Performance (Summary) |
|---|---|---|
| Robustness | Product and Engineering Specifications | System meets requirements |
| ISO 21649:2006 Compliance | Requirements and test methods for Needle-free injectors for medical use | Yes (compliant) |
| Environmental Stress | Temperature, storage temperature, free-fall, vibration, shock (per ISO 21649:2006) | Successfully completed |
| Dose Accuracy | Per ISO 21649:2006 | Successfully completed |
| Life Cycle | Per ISO 21649:2006 (for spring life cycle: 20,000) | Successfully completed (20,000 spring life cycle) |
| Performance Profile | Upper and lower acceptance limits (per ISO 21649:2006) | Successfully completed |
| Emitted Noise | Per ISO 21649:2006 | Successfully completed |
| Syringe Robustness | Needle-free Syringe Irradiated Dose Test | Successfully completed |
| Biocompatibility | ISO 10993 standard | Meets requirements for safe short-term exposure |
| Design Controls | In accordance with PharmaJet® SOPs, ISO 13485, ISO 14971, 21 CFR 820.30 | Conducted and prepared |
| Depth of Penetration (IM) | Substantially equivalent or greater than predicate | Greater depth of penetration than predicate (for IM) |
| Depth of Penetration (SC) | Substantially equivalent to predicate | Substantially equivalent to predicate (for SC) |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Tests: No specific sample sizes (n-numbers) are provided for each individual bench test (e.g., how many devices were tested for dose accuracy or life cycle). The document states "The following tests have been successfully completed" without quantification of samples per test.
- Animal Test: The document states "Animal testing was performed... in an animal (pig) model." No specific number of animals (sample size) or injections is specified.
- Data Provenance:
- Bench tests are assumed to be conducted in-house or by a contract lab.
- Animal test data is from an "animal (pig) model," implying a laboratory setting.
- The document does not mention country of origin for the data, but the applicant (PharmaJet®, Inc.) is based in Golden, CO, USA.
- All data described appears to be prospective testing specifically conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable (N/A) for this type of submission. This submission is for a physical medical device (needle-free injection system), not an AI/ML diagnostic or prognostic device that relies on expert interpretation of medical images or data for ground truth. Ground truth for this device is based on objective measurements from bench tests, animal studies, and compliance with recognized standards.
4. Adjudication Method for the Test Set
- Not Applicable (N/A) for this type of submission. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in radiological reads). This device relies on objective physical measurements and functional performance, not subjective expert judgment that requires adjudication.
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 (N/A) for this type of submission. MRMC studies are specific to evaluating the clinical performance of AI/ML algorithms, particularly in diagnostic imaging, by comparing human readers' performance with and without AI assistance. This document describes a physical medical device and its equivalence to a predicate, not an AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A) for this type of submission. This question pertains to AI/ML software performance. The PharmaJet® Stratis Needle-free Injection System is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance and safety is established through:
- Objective Measurements: Results from bench tests such as dose accuracy, life cycle, temperature, free-fall, vibration, shock, performance profile, and noise testing, using calibrated equipment and defined protocols based on ISO 21649:2006.
- Animal Study Observations: Data from the pig model for intramuscular and subcutaneous penetration depth. This serves as a proxy for in-vivo performance compared to the predicate.
- Material Science & Biocompatibility Testing: Compliance with ISO 10993 for material safety.
- Compliance with Standards: Meeting the requirements of ISO 21649:2006.
8. The Sample Size for the Training Set
- Not Applicable (N/A) for this type of submission. The concept of a "training set" applies to machine learning algorithms. This document describes the development and testing of a physical medical device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable (N/A) for this type of submission. As there is no AI training set, there is no ground truth established for it.
§ 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).