The Rusch DD Ureter Stent Set is an over the wire, coaxial, sterile, single use, radiopaque ureter stent that consists of a graduated open or cylindrical tip ureter stent with DD connector, optional hydrogel coating to aid in insertion, an introducer sheath with connector, a PTFE/Hydrogel coated guidewire with flexible core and marking, fixing clamp and an inner pouch that separates the stent from the guidewire during shipping and storage. These items are packaged in a paper and film pouch and sterilized with Ethylene Oxide.

The Rusch Integral Ureter Stent Set consists of a ureter stent that is completely radiopaque, coiled cylindrical or open tip with drainage holes at intervals of 5-20 mm, centimeter graduations, optional hydrogel coating, continuous black positioning line to indicate the direction in which the catheter tip coils, and black marking at the catheter end. The introducer sheath is approximately 45 cm long. The spiral stylet is made of stainless steel with optional PTFE/Hydrogel coating and a flexible safety tip and a marked rigid tip and is approximately 100 cm long. There are also plastic clips in the set.

For Ureterorenoscope applications the same features exist but the introducer sheath is approximately 90 cm long and the flexible stylet is approximately 150 cm long. One product configuration allows drainage of the renal system to external collection equipment (not supplied).

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Rüsch Ureter Stent), not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML is not applicable.

The document provided describes a traditional medical device and its substantial equivalence to legally marketed predicate devices, a common pathway for medical device clearance in the US, which does not involve performance studies of the sort relevant to AI/ML.

Here's why the requested information cannot be provided:

No AI/ML Component: The device described, the Rüsch Ureter Stent, is a physical medical device (a stent and associated components) used for drainage. There is no mention of any artificial intelligence or machine learning component, software, or algorithm in its design, function, or intended use.
Substantial Equivalence (510(k) Pathway): The 510(k) pathway for device clearance focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device (a device already legally on the market). This typically involves comparing design, materials, technological characteristics, and intended use to established devices, rather than conducting novel performance studies as would be required for an AI/ML diagnostic or assistive tool.
No "Acceptance Criteria" for AI Performance: Since there's no AI/ML, there are no acceptance criteria related to metrics like sensitivity, specificity, AUC, or other performance characteristics typically associated with AI algorithms.
No "Study Proving Device Meets Acceptance Criteria" (in the AI/ML sense): The "review" mentioned by the FDA is a regulatory review of the substantial equivalence claim, not a clinical trial or performance study designed to assess AI diagnostic accuracy or human performance with AI assistance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor information on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details as these are specific to AI/ML device evaluations and are not present in this document.

Summary

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2 1999 JUL -

K982974

Image /page/0/Picture/2 description: The image shows the logo for RUSCH International Group Regulatory Affairs, a subsidiary of Teleflex Incorporated (USA). The word "RUSCH" is in large, bold, black letters at the top of the image. Below that, in smaller letters, is the text "INTERNATIONAL Group Regulatory Affairs A Subsidiary of Teleflex Incorporated (USA)".

Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108

510 (k) Summary

Submitter Name, Address, and Date of Submission. ਜ

Miss Karenann J. Brozowski Group Regulatory Affairs Director Rüsch International Tall Pines Park Jaffrey, New Hampshire 03452

(603) 532-7706 Telephone: Facsimile: (603) 532-8211

Contact : Same as above

2 -Name of the Device, Common, Proprietary (if Known), and Classification.

Classification Name: Ureteral Stent

Common Name: Ureteral Stent

Proprietary Name: Rüsch Ureter Stent Integral Set and Rüsch Ureter DD Stent Sets

3 . Identification of the legally marketed device to which the submitter claims equivalence.

The Rüsch Ureter Stent, is substantially equivalent in design, use, and materials to the:

Microvasive® Boston Scientific Corporation, Mardis Stent Set with guidewire.
. Surgitek®, Cabot Medical Corporation, available with and without guidewire.
Mentor filiform ureteral double pigtail silicone stent .

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Cook Double Pigtail Standard and AQ Stent Sets .
American Catheter Amcath Uroglide™ Stent ●
. Microvasive Hydro-Plus™ Coated Marquis Stent

Description of the Device. 4 .

The pouch is printed with company name and address, "Sterile", "Contents sterile provided package is not damaged or open", and the USA caution statement "Caution: Federal law (USA and Canada) restricts this device to sale by or on the order of a physician." The pouches are packed in a paperboard box which bears the manufacturer's name and address and a description of the product within. The box label contains the company name and address, product name, quantity, size, lot number, sterilization date, method of sterilization, expiration date, catalog number, single use statement, Sterile, and length of product.

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5. Intended Use of the Device.

The Rüsch Ureter Stent is intended for use in temporary internal drainage from the kidney to the bladder or other external collecting location.

6. Summary of Technological Characteristics.

The technological characteristics are the same as or equivalent to predicate devices, which have been listed in section 3.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1999 اللا

Ms. Karenann J. Brozowski Group Requlatory Affairs Director Rüsch International Talls Pines Park Jaffrev, NH 03452

Re: K982974

Rüsch DD Ureteral Stent Set, Rüsch Integral Ureteral Stent Set Dated: April 16, 1999 Received: April 19, 1999 Requiatory Class: II 21 CFR §876.4620/Procode: 78 FAD

Dear Ms. Brozowski:

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 legally marketed predicate 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 (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 Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 the Electronic Product 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiiance 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 requiation 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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 1 of 1

K982972 510(k) Number (if known): _

Device Name: _ Rüsch Ureter Stent

Indications for Use:

Rusch ureter stents are intended for use in temporary internal drainage from the kidney to the bladder or other external collecting location.

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

Concurrence of CDRH/ Office of Device Evaluation (ODE)

David h. Segmen
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number

Prescription Use X

Over-The-Counter Use

(Per 21 CFR 801.109)

Regulation Number and Section

§ 876.4620 Ureteral stent.

(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).