(121 days)
Push-On Needle is intended for hypodermic injection of fluids into the body when attached to a compatible auto injector.
The Push-On Needle is a sterile, non-pyrogenic, single-use, pen needle designed for use with a compatible auto-injector. The Push-On Needle consists of a 30GX 8 mm stainless steel cannula, plastic hub, plastic shield and a protective sealing paper. The assembled Push-On Needle has a circular hub design that clicks and attaches to a cartridge retainer ridge of an auto-injector. Push-On Needle is used by peeling the sealing paper, thus exposing the non-patient end of the needle and pushing this end up against the auto-injector nozzle, and then attaching the needle hub to the auto injector nozzle. The needle shield can be pulled off making the Push-On Needle ready to use.
The provided text describes the Push-On Needle, a sterile, single-use hypodermic needle intended for use with a compatible auto-injector for fluid injections.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Device Performance/Standard Met |
|---|---|
| Performance: | Meets requirements outlined in ISO 7864 and ISO 9626. Additional tests included (paper seal) peel resistance (ASTM F2824) and (needle) cover (i.e., shield) pull-off force (internal standard). |
| Biocompatibility: | Materials successfully passed testing as outlined in ISO 10993-1 for devices categorized as External Communicating Devices, Circulating Blood, Limited Exposure. |
| Sterilization: | Assured by a validated sterilization method qualified in accordance with AAMI TIR 33:2005. Needles are sterilized by gamma irradiation and have a Sterility Assurance Level (SAL) of 10⁻⁶. |
| Shelf-life: | Performed in accordance with ISO 11607-1:2006. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for the individual performance, biocompatibility, sterilization, or shelf-life tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, although regulatory submissions for new devices typically involve prospective testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
This information is not provided in the document. The device's substantial equivalence is primarily based on meeting established international and internal performance standards, not on expert-adjudicated ground truth in a clinical context.
4. Adjudication Method for the Test Set:
This information is not provided. The testing described is largely objective measurement against specified standards, rather than subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted and is not relevant for this type of device. This device is a hypodermic needle, and its effectiveness is determined by its physical and material properties meeting safety and performance standards, not by human reader interpretation of images or data. Therefore, an effect size of human readers improving with or without AI assistance is not applicable.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
A standalone performance study was not explicitly mentioned in the context of an algorithm. However, the performance and safety data presented (e.g., ISO 7864, ISO 9626, ASTM F2824, ISO 10993-1, AAMI TIR 33:2005, ISO 11607-1:2006) describe the "algorithm only" or device-only performance without human interaction during the actual functioning of the device for its intended purpose.
7. Type of Ground Truth Used:
The "ground truth" for the device's performance is based on established international and industry standards. For example:
- Performance: ISO 7864 (Sterile hypodermic needles for single use), ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices -- Requirements and test methods), ASTM F2824 (Standard Test Method for Determining Peel Resistance of Medical and Surgical Adhesive Tapes and Dressings to Skin), and an internal standard for shield pull-off force.
- Biocompatibility: ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).
- Sterilization: AAMI TIR 33:2005 (Sterilization of health care products — Radiation — Guidance on the method for validating a sterility assurance level of 10⁻⁶).
- Shelf-life: ISO 11607-1:2006 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems).
These standards define the objective and measurable criteria that the device must meet.
8. Sample Size for the Training Set:
This information is not applicable as the Push-On Needle is a physical medical device (hypodermic needle), not an AI algorithm or software that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as point 8; there is no training set for a physical hypodermic needle.
§ 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).