The Stryker Flexible Ureteroscope is indicated for use during minimally invasive urological procedures accessed through natural body orifices and is intended for, but not limited to transurethral examination of the upper urinary tract including the ureter, and kidney and, utilizing additional accessories for various diagnostic and therapeutic procedures.

Device Description

The Stryker Flexible Ureteroscope is a newly marketed product for Stryker Endoscopy and is based upon technology used in endoscope production and clinical applications for over 30 years. All applicable materials are tested and validated for biocompatibility according to the voluntary standard ISO 10993 "Biological Evaluation of Medical Devices". The cleaning, disinfection, and sterilization methods will be equivalent to those for which the Karl Storz Uretero-Fiberscope is currently validated. The Stryker Flexible Ureteroscope will be electrically isolated from the patient and the physician, will meet safety standards for leakage current, will not present a thermal hazard to the physician, and will meet all applicable safety standards established by EN 60601-2-18: Particular Requirements for the Safety of Endoscopic Equipment.

AI/ML Overview

The provided text describes a 510(k) summary for the Stryker Flexible Ureteroscope. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study with specific acceptance criteria and detailed performance metrics as would be found for a novel AI/software device.

Therefore, the requested information elements related to AI device performance, such as sample size for test sets, expert ground truth adjudication, MRMC studies, standalone performance, and training set details, are not applicable to this submission.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Demonstration of Equivalence)	Reported Device Performance (Claimed Equivalence)
Material Biocompatibility: Conformance to ISO 10993 "Biological Evaluation of Medical Devices".	"All applicable materials are tested and validated for biocompatibility according to the voluntary standard ISO 10993."
Cleaning, Disinfection, and Sterilization: Equivalent methods to the predicate device.	"The cleaning, disinfection, and sterilization methods will be equivalent to those for which the Karl Storz Uretero-Fiberscope is currently validated."
Electrical Safety: Electrical isolation, meeting leakage current standards, no thermal hazard.	"The Stryker Flexible Ureteroscope will be electrically isolated from the patient and the physician, will meet safety standards for leakage current, will not present a thermal hazard to the physician, and will meet all applicable safety standards established by EN 60601-2-18: Particular Requirements for the Safety of Endoscopic Equipment."
Sterilization Standard Conformance: Conformance to EN 550 Ethylene Oxide Sterilization.	"The Stryker Flexible Ureteroscope will conform to the following voluntary standards: EN 550 Ethylene Oxide Sterilization."
Overall Safety and Effectiveness: No significant technological differences that raise new issues of safety and effectiveness compared to the predicate.	"There are no significant technological differences between the Stryker Flexible Ureteroscope and the predicate Karl Storz Uretero-Fiberscope. Clinical data and laboratory testing demonstrate that the differences do not raise new issues of safety and effectiveness of the proposed device."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The submission relies on "clinical data and laboratory testing" in a general statement to support substantial equivalence, but it does not detail a specific test set, its size, or provenance for performance evaluation in the context of an AI device.

3. 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. This information is relevant for AI performance evaluation, which is not the focus of this 510(k) for a physical medical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This information is relevant for AI performance evaluation, which is not the focus of this 510(k) for a physical medical device.

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

No. An MRMC study is not mentioned or implied because this is a physical medical device, not an AI diagnostic/assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This information is relevant for AI performance evaluation, which is not the focus of this 510(k) for a physical medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. For a physical device like an endoscope, "ground truth" typically refers to established engineering standards, biocompatibility testing results, and clinical observations for safety and functionality, rather than diagnostic outcomes from a test set. The document refers to "clinical data and laboratory testing" but does not elaborate on the specific nature or "ground truth" definition within that context.

8. The sample size for the training set

Not applicable. This information is relevant for AI performance evaluation, which is not the focus of this 510(k) for a physical medical device.

9. How the ground truth for the training set was established

Not applicable. This information is relevant for AI performance evaluation, which is not the focus of this 510(k) for a physical medical device.

Summary

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OCT 1 6 2003

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Device Name

Classification Name:	Endoscopes and Accessories
Common and Usual Name:	Endoscope, Ureteroscope
Proprietary Name:	Stryker Flexible Ureteroscope

This 510(k) summary and effectiveness is being submitted in accordance with requirements of SMDA 1990.

The Stryker Flexible Ureteroscope is substantially equivalent in safety and efficacy to the currently marketed Karl Storz Uretero Fiberscope (KSEA11273) as cleared under 510(k) #K970427.

The Stryker Flexible Ureteroscope will conform to the following voluntary standards: EN 550 Ethylene Oxide Sterilization; ISO 10993: Biological Evaluation of Medical Devices.

There are no significant technological differences between the Stryker Flexible Ureteroscope and the predicate Karl Storz Uretero-Fiberscope. Clinical data and laboratory testing demonstrate that the differences do not raise new issues of safety and effectiveness of the proposed device. Therefore, the Stryker Flexible Ureteroscope is substantially equivalent to the currently marketed Karl Storz Uretero-Fiberscope.

Contact:

CTK

Christopher L. Cook Quality Engineer Stryker Endoscopy

4/17/03
Date

Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2003

Mr. Christopher L. Cook Quality Engineer Stryker® Endoscopy 5900 Optical Court SAN JOSE CA 95138

Re: K031278

Trade/Device Name: Stryker Flexible Ureteroscope Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FGB Dated: August 20, 2003 Received: August 21, 2003

Dear Mr. Cook:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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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l'age 2

This letter will allow you to begin marketing your device as described in your Section 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 the 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" (21CFR Part 807.97) you may obtain. 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 C. Brogdon

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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Stryker Flexible Ureteroscope

K031270

Koz 12 78

Appendix H

Indications for use statement

18 April, 2003

510(k) Number: K031270

Device Name: Stryker Flexible Ureteroscope

INDICATION FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR Over

Nancy C Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devis 510(k) Number

Over-the-Counter Use

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.