(269 days)
The PharmaJet 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 have other individuals administer injections of prescribed medication.
The PharmaJet, Inc. PharmaJet Needle-free Injector System (PharmaJet System) is a compact, spring-loaded needle-free hypodermic injector system. The PharmaJet System consists of two (2) injectors (One is the light injector suitable for infants up to two years old, geriatric adults or locations with thin skin and minimal adipose tissue and one is the heavy injector suitable for adults and children two years and older, or locations with thicker skin and more adipose tissue.), a cocking device, a single use, sterile, disposable filling adapter, and a single use, sterile, disposable needle-free syringe.
The PharmaJet Needle-free Injection System was evaluated through pre-clinical animal testing and bench testing to demonstrate its performance and substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Essential Requirements of ISO21649:2006) | Reported Device Performance (PharmaJet Needle-free Injection System) |
|---|---|
| Variability in depth of penetration (compared to predicate Bioject B2000) | Equal to or less than the variability of the Bioject B2000 injector. |
| Dose accuracy | Meets ± 5% expelled volume tolerance. |
| Operating temperature performance | Meets requirements. |
| Storage temperature performance | Meets requirements. |
| Free-fall protection | Meets requirements. |
| Vibration resilience | Meets requirements. |
| Shock resilience | Meets requirements. |
| Life cycle (spring) | 20,000 cycles (compared to predicate Genesis Medical Technologies PharmaJet Injector at 600 cycles). |
| Performance profile upper and lower acceptance limits | Meets requirements. |
| Emitted noise | Meets requirements. |
| Material robustness (needle-free syringe after maximum irradiated sterility dose test) | Demonstrates material robustness. |
| Microbial ingress (filling adapter) | Demonstrates that the Filling Adapter can be disinfected using common disinfection techniques. |
| Biocompatibility (needle-free syringe and filling adapter) | Meets requirements for safe short-term exposure. |
| Performance and damage after Glutaraldehyde-based disinfection | No degradation of performance or damage to Injectors or Cocking Devices. |
| Performance and damage after peroxide-based high level disinfection | No degradation of performance or damage to Injectors or Cocking Devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Preclinical Animal Testing: The specific number of animals (pigs and lambs) used for each test is not explicitly stated.
- Pigs: Used as predictive models for healthy adults and children two years and older, or locations with thicker skin and more adipose tissue (for deltoid, lateral thigh, or buttocks injections).
- Lambs: Used as predictive models for infants up to two years old, geriatric adults, or locations with thin skin and minimal adipose tissue.
- Provenance: Retrospective, as these are established animal models for such studies.
- Bench Testing: The sample sizes for each specific bench test (e.g., free-fall, vibration, shock, dose accuracy) are not explicitly stated in the provided text, but the tests were performed to establish that the system meets the essential requirements of ISO21649:2006.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The reported studies are focused on objective device performance criteria (e.g., depth of penetration, dose accuracy, durability) and material resistance, rather than diagnostic interpretation requiring human expert ground truth.
4. Adjudication Method for the Test Set:
Not applicable. The studies involved objective measurements of device performance rather than subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The study focused on the performance of the device itself and its equivalence to predicate devices, not on human readers improvement with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone performance evaluation of the device was done. All tests described (preclinical animal testing and bench testing) assessed the device's functional and material performance independently.
7. The Type of Ground Truth Used:
- Preclinical Animal Testing: The ground truth for depth of penetration in animal models was established through direct measurement in the animal tissues. This is a form of direct biophysical measurement.
- Bench Testing: The ground truth for various performance criteria (e.g., dose accuracy, life cycle, temperature resistance, sterilization effectiveness) was based on established engineering and medical device standards (specifically ISO21649:2006) and physical measurements.
8. The Sample Size for the Training Set:
Not applicable. This device is a mechanical medical injector, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a mechanical 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).