(22 days)
The AV Fistula Needle Protector (AVFNP) is intended for use in the prevention of accidental needle stick injuries upon completion of hemodialysis and apheresis procedures.
The AV Fistula Needle Protector (AVFNP) is a disposable, single-use, non-sterile needle protector, which is used as an aid in preventing accidental needle stick injuries upon completion of hemodialysis and apheresis procedures. The design of the AVFNP is compatible with currently marketed AV Fistula needle sets produced by most major manufacturers.
The hinged assembly allows the AVFNP to be included on AV Fistula needle sets at the time of manufacture or during a hemodialysis or apheresis procedure (i.e., before needle insertion or just prior to withdrawal). Once the AVFNP is clipped over the tubing, it can be engaged at any time by moving the AVFNP down the tubing to rest behind the butterfly wings of the AV Fistula needle. Prior to withdrawal of the needle, the AVFNP should be held securely between the index finger and thumb while the other hand pulls the tubing and needle assembly into the AVFNP. This position shields the point of the needle. A lock, an additional safety feature, can be activated once the needle has been shielded by pressing the top and bottom of the AVFNP together. This lock restricts further access to the needlepoint and contains any blood that may drop from the needle. An audible click can be heard when the lock is activated.
The AVFNP can be operated with either hand and leaves the other hand free to apply pressure to the puncture point and/or stabilize the AVFNP while withdrawing the needle. The AVFNP can be stabilized by holding, between the index finger and thumb, either the ribbed area on the front (e.g., when health care professional applies pressure to the puncture site during withdrawal of the needle) or the thumb rest on the back (e.g., when patient applies pressure to the puncture site during withdrawal of the needle).
The provided document is a 510(k) summary for a medical device called the "AV Fistula Needle Protector (AVFNP)". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria and detailed study designs as might be found for a novel, higher-risk device.
Therefore, the information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance, is not typically included or required in a 510(k) submission like this. The regulatory pathway for this device (Class II) allows for substantial equivalence based on comparison to predicate devices, focusing on technological characteristics, intended use, and materials.
Here's a breakdown of why many of your excellent questions cannot be answered by this document:
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A table of acceptance criteria and the reported device performance: This document does not establish new, quantitative acceptance criteria for performance beyond demonstrating that its specifications (e.g., dimensions allowing complete encapsulation and preventing finger access) are "adequate" and "same" as the predicate. It relies on the predicate devices already having met such criteria.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No dedicated "test set" or clinical study with human or simulated data is described for the AVFNP in this summary. The comparison is primarily based on design and materials.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable, as there is no test set requiring expert ground truth for specific medical outcomes.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the same reasons as above.
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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: Not applicable. This device is a physical needle protector, not an AI or imaging diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices.
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The sample size for the training set: Not applicable, as there is no "training set" for an algorithm.
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How the ground truth for the training set was established: Not applicable.
However, I can extract the relevant information regarding the basis for acceptance for the AV Fistula Needle Protector (AVFNP) within the context of a 510(k) submission:
Basis for Acceptance (Substantial Equivalence):
The device gained acceptance based on its substantial equivalence to existing legally marketed predicate devices, specifically the Bloodpack Needle Protector (BNP) (BK980008) and the Medisystems Apheresis Needle with Guard (K932074).
1. Table of Acceptance Criteria and Reported Device Performance (as demonstrated through substantial equivalence):
| Characteristic | Predicate Devices (BNP and ANNG) | AVFNP Device | Comment |
|---|---|---|---|
| Intended Use | For use in preventing accidental needle stick injuries upon completion of hemodialysis and apheresis procedures. | For use in preventing accidental needle stick injuries upon completion of hemodialysis and apheresis procedures. | Same |
| Technological Features | The protector fits over the needle and tubing. The tubing is pulled with one hand until the assembly is locked into place. | The protector fits over the needle and tubing. The tubing is pulled with one hand until the assembly is locked into place. (Additional AVFNP features described: hinged assembly, engagement mechanism, lock with audible click, one-handed operation, stabilization methods - implying functionally equivalent or enhanced without new risks) | Same (core function) |
| Specifications | Samples of various needle sizes, commonly used for the intended purpose, were tested to verify that dimensions allowed complete encapsulation of the needle and prevented finger access. Specifications were determined adequate. | Samples of various needle sizes, commonly used for the intended purpose, were tested to verify that dimensions allowed complete encapsulation of the needle and prevented finger access. Specifications were determined adequate. | Same |
| Materials | Polypropylene grades: GYM 28, GYM 45, and HD810P. | Polypropylene grades: GYM 28, GYM 45, and HD810P. | Same |
| Sterilization | Not sterile. | Not sterile. | Same |
Reported Device Performance (based on comparison):
The document states, "The intended use, design, materials of fabrication, and performance are the same as the predicate devices..." This implies that the AVFNP performs equivalently to the predicates in preventing needle stick injuries because its fundamental characteristics match those of previously cleared devices for the same purpose. The details about its operation (hinged assembly, locking mechanism, one-handed operation) further describe its designed functionality.
Summary of Study Information (or lack thereof, due to 510(k) pathway):
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific test set or clinical data is detailed for the AVFNP in this summary. The "testing" mentioned under 'Specifications' refers to internal verification that the device dimensions adequately covered various needle sizes, implied to be laboratory-based rather than a clinical study.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable (this is not an AI/imaging device).
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for the substantial equivalence determination is the existing regulatory clearance and presumed safety/effectiveness of the predicate devices based on their own prior reviews.
- 8. The sample size for the training set: Not applicable (no algorithm).
- 9. How the ground truth for the training set was established: Not applicable.
§ 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).