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.

Device Description

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).

AI/ML Overview

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:

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.
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.
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.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the same reasons as above.
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.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
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.
The sample size for the training set: Not applicable, as there is no "training set" for an algorithm.
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.

Summary

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MAY 14 Hay

K991404

Summary of Safety and Effectiveness for AV Fistula Needle Protector (AVFNP)

Submitter

ITL Corporation 22 Molonglo Mall Fyshwick, 2609 Canberra, Australia

Date summary was prepared

June 16, 1998

Name(s) of the device

AV Fistula Needle Protector (AVFNP)

Identification of predicate device(s)

Bloodpack Needle Protector (BNP) Manufactured by ITL Corporation, PTY Ltd. BK980008

Medisystems Apheresis Needle with Guard Manufactured by Medisystems Corporation K932074

Description of the device

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Intended Use

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.

Comparison of device characteristics to predicate

The table below provides a side-by-side comparison of the technological characteristics of the AVFNP and the following predicate devices: Bloodpack Needle Protector (BNP), BK980008, and Apheresis Needle with Needle Guard (ANNG), K932074.

Technological Characteristics
Characteristic	Predicate Devices:BNP and ANNG	Device:AVFNP	Comment:
Intended Use	For use in preventing accidentalneedle stick injuries uponcompletion of hemodialysis andapheresis procedures. (ANNG)	For use in preventing accidentalneedle stick injuries uponcompletion of hemodialysis andapheresis procedures.	Same
TechnologicalFeatures	The protector fits over the needleand tubing. The tubing is pulledwith one hand until the assemblyis locked into place. (BNP andANNG)	The protector fits over theneedle and tubing. The tubingis pulled with one hand until theassembly is locked into place.	Same
Specifications	Samples of various needle sizes,commonly used for the intendedpurpose of the device, wereselected and tested to verify thatthe dimensions of the deviceallowed complete encapsulationof the needle and preventedfinger access. It was determinedthat the specifications wereadequate. (BNP and ANNG)	Samples of various needle sizes,commonly used for the intendedpurpose of the device, wereselected and tested to verify thatthe dimensions of the deviceallowed complete encapsulationof the needle and preventedfinger access. It wasdetermined that thespecifications were adequate.	Same
Materials	Polypropylene grades: GYM 28,GYM 45, and HD810P. (BNP)	Polypropylene grades: GYM28, GYM 45, and HD810P.	Same
Sterilization	Not sterile. (BNP)	Not sterile.	Same

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Conclusion

The intended use, design, materials of fabrication, and performance are the same as the predicate devices, the Bloodpack Needle Protector (BNP), BK980008, and Apheresis Needle with Needle Guard, K932074. Therefore, the AVFNP is substantially equivalent to the Bloodpack Needle Protector (BK980008), the Apheresis Needle with Needle Guard (K932074), and devices marketed in interstate commerce prior to May 28, 1976.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 1999

ITL Corporation C/O Kenneth A. Palmer, Ph.D. Senior Technical Advisor Quintiles, Incorporated 15825 Shady Grove Road, Suite 130 Rockville, Maryland 20850-4008

Re : K991404 Platypus AV Fistula Needle Protector (AVFNP) Trade Name: Regulatory Class: II Product Code: FMI Dated: April 22, 1999 April 22, 1999 Received:

Dear Dr. Palmer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Dr. Palmer

This letter will allow you to beqin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 991404
CONFIDENTIAL

510(k) Number None assigned as of this time

Device Name AV Fistula Needle Protector (AVFNP)

Indications for Use

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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use (per 21 CFR 801.109)

Over-the Counter Use

here Reveau for ABC 7/14/99

Division Sign-Off) (Division Sign-on)
Division of Dental, Infection Control, Division of Dospital Devices 510(k) Number

PRESCRIPTION
use

Regulation Number and Section

§ 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).