SYRINGE NEEDLE REMOVER (S.N.R.) by POST MEDICAL, INC.

This looks like a 510k clearance letter for a medical device (Syringe Needle Remover (S.N.R.)) from 1997. The document primarily focuses on the regulatory approval and does not contain details about acceptance criteria or a study proving device performance in the way modern AI/ML device submissions do. Such detailed performance studies were not typically required or documented in this format for 510(k) submissions in 1997 for this type of device.

Therefore, most of the requested information cannot be found in the provided text.

Here's what can be extracted and a clear indication of what's missing:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in this document. For a Syringe Needle Remover, acceptance criteria would typically relate to its effectiveness in removing needles, preventing accidental sticks, and safe containment.
- Reported Device Performance: Not reported in this document.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. This document is a regulatory clearance letter, not a study report.
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/Not provided. This document does not describe a study involving expert-established ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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 a mechanical device, not an AI/ML diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an AI/ML algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided.
The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI/ML model that undergoes training.
How the ground truth for the training set was established:
- Not applicable.

Summary based on the provided document:

The provided document is a 510(k) clearance letter from the FDA for a non-AI/ML medical device, the "Syringe Needle Remover (S.N.R.)". The letter confirms that the device is "substantially equivalent" to predicate devices already on the market. It does not contain information about specific performance acceptance criteria or detailed study results that would typically be associated with modern AI/ML device submissions. The "study that proves the device meets the acceptance criteria" is not described in this regulatory clearance letter.

Summary

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David R. Thead Vice President Operations Post Medical, Incorporated P.O. Box-29863 30359 Atlanta, Georgia

AUG 1 5 1997

K972536 Re : Syringe Needle Remover (S.N.R.) Trade Name: Regulatory Class: II Product Code: FMI May 22, 1997 Dated: June 8, 1997 Received:

Dear Mr. Thead:

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, good 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

{1}------------------------------------------------

Page 2 - Mr. Thead

through 542 of the Act for devices under the Electronic enrough Siz of the noorol provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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
premarket notification" (21 CFR 807.97). 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,

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

Enclosure

{2}------------------------------------------------

400 JUL

rua cuku ude

Page ol

510(k) Number (if known): __ K972536

Device Name:_ (S.N.R.) Syringe Needle Remover

Indications For Use:

For the disposal of medical sharps in health care facilities and home use.

(PI.EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Formal 1-2-96)

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).