The intended use for these Semi-Rigid ureteroscopes is for examination/operation of the urinary tract and, using additional accessories, to perform various diagnostic and therapeutic procedures.

ACMI Circon's Semi-Rigid Ureteroscopes are intended for use by qualified physicians to provide access to the urinary tract to perform various diagnostic and therapeutic procedures.

Device Description

ACMI Circon's Semi-Rigid Ureteroscopes are substantially equivalent to other currently marketed ureteroscopes, referenced above. The Semi-Rigid Ureteroscopes and their predicate device(s) are all telescopes that incorporate fiber optical lenses and working channels within a semirigid shaft. The working channels of the Semi-Rigid Ureteroscopes and predicate device(s) allow the insertion of accessory instrumentation during urinary tract procedures. Both the Semi-Rigid Ureteroscopes and the predicate device(s) may be connected to an external light source to permit better illumination of the bladder surfaces.

AI/ML Overview

The provided text is a 510(k) summary for the ACMI Circon Semi-Rigid Ureteroscopes. This document is a premarket notification to the FDA for a medical device and does not contain a study or data proving the device meets acceptance criteria in the way a clinical trial or performance study would for an AI/ML device.

Instead, the submission focuses on substantial equivalence to a predicate device. This means the manufacturer is asserting their new device is as safe and effective as a device already legally marketed. Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not available in this type of document because it is not a performance study report for an AI/ML device.

Here's an assessment based on the available information:

Table of acceptance criteria and reported device performance:
- Not applicable / Not provided. For a 510(k) based on substantial equivalence for a physical medical device like a ureteroscope, "acceptance criteria" are generally related to demonstrating similar technological characteristics, materials, and intended use as the predicate device, rather than performance metrics from a study against specific clinical endpoints. The document explicitly states the device "raise no new issues of safety or effectiveness," which serves as the primary "acceptance criterion" for this type of submission.
Sample size used for the test set and data provenance:
- Not applicable / Not provided. No test set or data provenance is mentioned as this is not a study reporting on a specific performance measurement.
Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable / Not provided. No ground truth establishment for a test set is discussed. The device's safety and effectiveness are established by comparison to a predicate device, which itself would have been approved based on similar principles or pre-amendment status.
Adjudication method for the test set:
- Not applicable / Not provided. No test set or adjudication method is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical medical device (a ureteroscope), not an AI/ML device. Therefore, no MRMC study or AI-related effectiveness is relevant or discussed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used:
- Not applicable / Not provided. Ground truth, in the context of AI/ML device performance, is not relevant here. The "ground truth" for this submission is the legally marketed status and established safety/effectiveness of the predicate device (an ACMI Circon preamendment ureteroscope from circa 1971).
The sample size for the training set:
- Not applicable / Not provided. This is not an AI/ML device developed using training data.
How the ground truth for the training set was established:
- Not applicable / Not provided. No training set or ground truth establishment for it is mentioned.

Summary of Device and Approval:

Device Name: ACMI Circon Semi-Rigid Ureteroscopes
Intended Use: For use by qualified physicians to provide access to the urinary tract for diagnostic and therapeutic procedures.
Predicate Device: ACMI Circon preamendment ureteroscope (circa 1971).
Basis for Approval: Substantial equivalence to the predicate device. The submission asserts that the new ureteroscopes have similar technological characteristics (fiber optical lenses, working channels, semi-rigid shaft, connection to external light source) and intended use, and "raise no new issues of safety or effectiveness" compared to the predicate.
Regulatory Status: Cleared by the FDA on April 9, 2002 via a 510(k) premarket notification as a Class II device (Endoscope and accessories, 21 CFR §876.1500).

Summary

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APR - 9 2002

Pg 1 of r

11 012758

510(k) SUMMARY

ACMI Circon' SEMI-RIGID URETEROSCOPES

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

ACMI Circon Corporation 6500 Hollister Avenue Santa Barbara, CA 93117

Phone: 805-961-3290 Fax: 805-968-7385

Mr. Wayne B. Sterner Contact Person: Corporate Director Regulatory Affairs

Date Prepared: February 8, 2002

Name of Device and Name/Address of Sponsor:

ACMI Circon's Semi-Rigid Ureteroscopes

ACMI Circon Corporation 6500 Hollister Avenue Santa Barbara, CA 93117

Common or Usual Name:

Ureteroscopes

Classification Name and Classification Number:

Endoscope and accessories, 21 CFR Section 876.1500

Predicate Device(s):

The predicate device is an ACMI Circon preamendment ureteroscope (circa, 1971).

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K012758

pg 2 of 2

Intended Use:

ACMI Circon's Semi-Rigid Ureteroscopes are intended for use by qualified physicians to provide access to the urinary tract to perform various diagnostic and therapeutic procedures.

Technological Characteristics and Substantial Equivalence:

The ACMI Circon's Semi-Rigid Ureteroscopes raise no new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administra 200 Cornorate Boulevard Rockville MD 20850

Mr. Wayne B. Sterner Director, Regulatory Affairs ACMI Circon Corporation 6500 Hollister Avenue SANTA BARBARA CA 93117-3019

Re: K012758

Trade/Device Name: Semi-Rigid Ureteroscopes and Accessories Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FGB Dated: February 8, 2002 Received: February 11, 2002

Dear Mr. Sterner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovious your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abounding 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(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 premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy Cbrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CIRCON CORPORATION CONFIDENTIAL

K012758

CIRCON CORPORATION Semi-Rigid Ureteroscopes and Accessories FDA Premarket Notification 510(k)

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Semi-Rigid Ureteroscopes and Accessories Device Name:

The intended use for these Semi-Rigid ureteroscopes is for examination/operation of the urinary tract and, using additional accessories, to perform various diagnostic and therapeutic procedures.

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

Concurrence of CRDH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

David A. Bergerson

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.