(118 days)
This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.
This device consists of the two predicate devices preattached, packaged and sterilized. This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks. The device features a "one-piece" design of needle hub and protective sheath with a living hinge. The needle cannula is permanently affixed into the hub. The sheath has an "arrow" indicating the bevel orientation. i.e. when the sheath is oriented to the right, the bevel is in the "up position". After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the needle is engaged under the hook and contained within the sheath. The device is then discarded into a sharps container.
The provided document describes a premarket notification (510(k)) for a medical device, the Portex® Needle-Pro® EDGE™ Safety Device with Syringe. This submission focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data for a new, complex device requiring such rigorous testing.
Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details is not applicable or available within this 510(k) submission.
Here's an breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to ISO 594-1:1986(E) (Conical fittings with a 6% taper for syringes, needles and certain other medical equipment-Part 1: General requirements) | Declared conformance to this standard. |
| Conformance to ISO 594-2:1998(E) (Conical fittings with a 6% taper for syringes, needles and certain other medical equipment-Part 2: Lock Fittings) | Declared conformance to this standard. |
| Conformance to ISO 7864:1993(E) (Sterile hypodermic needles for single use) | Declared conformance to this standard. |
| Conformance to ISO 7886-1:1993 (Sterile hypodermic syringes for single use) | Declared conformance to this standard. |
| Substantial Equivalence to Predicate Devices (K041399: Hypodermic Needle-Pro® EDGE™ Needle Protection Device; K030683: Nipro Disposable Syringes) | The FDA determined the devices are substantially equivalent to legally marketed predicate devices. |
Explanation: The "acceptance criteria" here are primarily based on conformance to established international standards for syringes and needles, and the demonstration of substantial equivalence to already approved predicate devices. The "reported device performance" is the declaration of conformance to these standards and the FDA's agreement on substantial equivalence. No specific quantitative performance metrics beyond these were required or provided in this type of submission.
2. Sample size used for the test set and the data provenance:
- Not Applicable/Not Provided. This 510(k) submission did not involve a clinical study with a "test set" in the context of AI or diagnostic device performance evaluation. The review was based on device description, materials, and conformance to standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided. No external experts were used to establish ground truth for a test set in this context. The "ground truth" for this submission was based on existing standards and predicate devices.
4. Adjudication method for the test set:
- Not Applicable/Not Provided. No adjudication method for a test set was necessary as per the nature of this 510(k) submission.
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:
- No, this was not done. This device is a manual medical syringe with a safety mechanism, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this was not done. This device does not involve an algorithm.
7. The type of ground truth used:
- The "ground truth" in this context is the established performance and safety of the predicate devices and conformance to recognized international standards for medical syringes and needles. The submission posits that because the new device is substantially similar in materials, design, and intended use, and meets the same relevant standards as already-approved devices, it is safe and effective.
8. The sample size for the training set:
- Not Applicable/Not Provided. There was no "training set" in the context of an AI/machine learning algorithm for this device.
9. How the ground truth for the training set was established:
- Not Applicable/Not Provided. No training set was used.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).