URESIL GUIDEWIRE by URESIL CORP.

The provided document is a 510(k) clearance letter from the FDA for a medical device: the Uresil® Guidewire. This type of document is generally a regulatory approval based on demonstrating "substantial equivalence" to a predicate device already on the market, rather than a de novo approval based on extensive clinical trials proving safety and effectiveness through well-defined acceptance criteria and study results.

Therefore, the information requested regarding acceptance criteria and study details (such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is typically not found or relevant in a 510(k) clearance letter dated 1997 for a guidewire.

The 510(k) process focuses on comparing a new device to an existing predicate device, primarily to show that it is as safe and effective and raises no new questions of safety or effectiveness. It does not generally require the detailed performance studies or statistical analysis with specific acceptance criteria that would be expected for novel devices or AI/software as a medical device (SaMD) where such information would be central to demonstrating efficacy and safety.

However, I can extract the following information that is present:

Device Name: Uresil® Guidewire
Intended Use Statement: "This device is intended for use in percutaneous nephrostomy, biliary und abscess drainage and other gastrointestinal and genitourinary procedures."
Regulatory Class: Class II
Product Codes: 78 FGE, 78 EZB
Date of Clearance: November 21, 1997

Therefore, I cannot provide the requested table and study details as they are not part of a standard 510(k) clearance documentation for a guidewire from 1997. The document explicitly states that the device is determined to be "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This implies that its performance is expected to be similar to those existing devices, and detailed evidence of meeting specific numerical acceptance criteria (as for an AI algorithm) is not presented here.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1997

Mr. Lev Melinyshyn Director of Operations UreSil, L.P. 5418 W. Touhy Avenue Skokie, Illinois 60077

Re: K972582

NOV 21 Uresil® Guidewire Dated: September 3, 1997 Received: September 18, 1997 Regulatory Class: II 21 CFR §876.5010/Product code: 78 FGE 21 CFR §876.5130/Product code: 78 EZB

Dear Mr. Melinyshyn:

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 of the Act. The general controls provisions 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 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 Regulations, 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 action. In addition. FDA may publish further announcements 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 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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) 594-4613. 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 of the regulation of the "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.

W.Liau Yu
Lillian Yiu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

K972582 510(k) Number iif known):

Uresil Guidewire Device Name:_

Indications For Use:

This device is intended for use in percutaneous nephrostomy, biliary und abscess drainage and other gastrointestinal and genitourinary procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Rober R. Salling
	(Division Sign-Off)
	Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K972582

Prescription Use	✓	OR	Over-The-Counter Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.