(295 days)
Sterile Piston Hypodermic Syringes (With/Without Needed 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 fennector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from the body.
The hypodermic 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.
The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip/Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas. And it is a Non-Pyrogenic and single use device. The mainly raw materials are PP, PE and rubber.
The Hypodermic Needle is a single lumen needle, designed for use with syringes and injection devices for general purpose fluid injection. The needle is sterilized by EtO gas. and it is a Non-Pyrogenic and single use device. The mainly raw materials are PP and stainless steel.
The provided text is a 510(k) summary for WUXI YUSHOU MEDICAL APPLICANCES CO., LTD's "Iston Syringe With/Without Needle." This document outlines the substantial equivalence of the new device to existing predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria through clinical or performance data.
The FDA 510(k) pathway is for devices that are "substantially equivalent" to predicate devices already on the market. It does not typically involve the kind of detailed clinical study data, ground truth establishment, or multi-reader multi-case (MRMC) studies that would be necessary to demonstrate performance against acceptance criteria in the way you've described for an AI/CADe device.
Therefore, many of the requested fields cannot be filled from the provided document. The acceptance criteria in this context are implicitly that the device performs equivalently to the predicate devices and meets relevant recognized standards (like ISO).
Here's a breakdown based on the information available:
1. Table of acceptance criteria and the reported device performance
For a traditional medical device like a syringe or needle, "acceptance criteria" are typically defined by recognized standards (e.g., ISO for sterility, performance, biocompatibility) and comparisons to predicate devices. The document states that the device conforms to these standards, implying it meets the criteria.
| Acceptance Criteria (Standard/Attribute) | Reported Device Performance (Claimed Conformance) |
|---|---|
| Conformance to ISO7886-1 (Syringes) | Conforms to ISO7886-1 |
| Conformance to ISO7864 (Needles) | Conforms to ISO7864 |
| Conformance to ISO10993 (Biocompatibility) | Conforms to ISO10993 |
| Labeling Requirements (21 CFR Part 801) | Meets the requirements of 21 CFR Part 801 |
| Intended Use | Same as predicate devices |
| Principle of Operation | Normal (Same as predicate devices) |
| Syringe Capacity/Needle Gauge & Length | Various Sizes |
| Lubricant | Silicone Oil |
| Materials (Barrel, Plunger, Piston, etc.) | PP, PE, Rubber, Stainless Steel (Same as predicate) |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly mentioned in terms of a "test set" for clinical performance. The document refers to conformance to standards, which would involve testing multiple units, but the specific sample size for these tests is not provided in this summary.
- Data provenance: Not explicitly mentioned. Testing would likely have been conducted by the manufacturer or a contracted lab in China to demonstrate conformance to ISO standards. The submission is from China.
- Retrospective or prospective: Not applicable in this context; these terms are used for clinical studies with patient data, which is not described here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. Ground truth, in the context of AI/CADe, refers to a definitive diagnosis or finding. For a syringe/needle, "ground truth" relates to its physical performance and material properties. Compliance with standards is typically assessed through engineering tests and material analysis by qualified technicians/engineers, not medical experts establishing a "ground truth" for a diagnostic outcome.
- Qualifications of experts: Not applicable for establishing diagnostic ground truth.
4. Adjudication method for the test set
- Adjudication method: Not applicable. Adjudication is used to resolve discrepancies in expert interpretations in diagnostic studies. For device performance, adherence to standards is demonstrated through validated test methods.
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
- MRMC study: No. This is not applicable to a hypodermic syringe or needle. MRMC studies are for diagnostic devices, especially those involving human interpretation of medical images with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone performance: No. This is not applicable to an entirely mechanical medical device like a syringe/needle.
7. The type of ground truth used
- Type of ground truth: The "ground truth" here is the adherence to established international standards (ISO7886-1 for syringes, ISO7864 for needles, ISO10993 for biocompatibility) and regulatory requirements (21 CFR Part 801 for labeling). This is affirmed through technical testing and documentation, rather than clinical outcomes or expert consensus on a diagnostic finding.
8. The sample size for the training set
- Training set sample size: Not applicable. This device is not an AI/ML product and does not have a "training set."
9. How the ground truth for the training set was established
- Ground truth establishment for training set: Not applicable.
§ 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).