(148 days)
The MicronJet 600 is intended to be used for injecting fluids into parts of the body below the surface of the skin. The MicronJet 600 is indicated for use in intradermal injections of any substance or drug approved for intradermal delivery.
The MicronJet 600 Needle is a small plastic adapter (female luer) equipped with a chip having three microneedles designed to mate with any standard syringe (Luer Slip or Luer Lock). The MicronJet 600 is a sterile, single use device.
The NanoPass MicronJet 600 device is intended for injecting fluids into the body below the skin surface, specifically for intradermal injections of approved substances or drugs.
1. Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria in a table format. Instead, it describes performance testing as demonstrating that the "MicronJet 600 is as safe and effective as the predicate devices."
Therefore, the implicit acceptance criteria are that the MicronJet 600 performs comparably to the predicate devices in terms of safety and effectiveness for intradermal injections.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety comparable to predicate devices | Performance testing demonstrated safety equivalent to predicate devices. |
| Effectiveness comparable to predicate devices | Performance testing demonstrated effectiveness equivalent to predicate devices. |
2. Sample Size and Data Provenance
The provided document does not specify the sample sizes used for the test set in either bench, animal, or clinical testing. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts and Qualifications
The document does not mention the use of experts to establish a ground truth for a test set, as this is a medical device approval and not an AI/diagnostic algorithm.
4. Adjudication Method
Not applicable, as this is related to medical device approval, not AI/diagnostic algorithm testing.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic device, so an MRMC comparative effectiveness study is not relevant to its approval.
6. Standalone Performance
The "Performance Testing" section states that "Bench, animal and clinical testing was performed to assess the safety and effectiveness of the device for the stated indications for use." This indicates that the device undergoes standalone testing to demonstrate its performance independently.
7. Type of Ground Truth Used
The "ground truth" for this device would be established through:
- Bench Testing: Engineering measurements and physical properties (e.g., fluid delivery accuracy, needle integrity).
- Animal Testing: Physiological responses, tissue reactions, and successful delivery to the intended dermal layer.
- Clinical Testing: Human subject outcomes related to comfort, efficacy of fluid delivery, and absence of adverse events, demonstrating safe and effective intradermal injection.
8. Sample Size for the Training Set
Not applicable. This is a medical device, not an AI algorithm requiring a training set.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).