The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.

Device Description

The components subject of this submission are: the Flexible HD Cysto-Urethroscope (Part Number: 11272VH(U)), the LUER ports (Part Number: 11014L(U)), the Suction Valve (Part Number: 11301CE1/20), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).

AI/ML Overview

The provided information is a 510(k) summary for the KARL STORZ Flexible HD Cysto-Urethroscope System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on AI performance or clinical efficacy. The changes submitted in this 510(k) are related to adding new sterilization methods (Sterilization V PRO-60 and High Level Disinfection).

Therefore, the document does not contain the kind of information requested regarding acceptance criteria and performance studies for an AI/ML driven device, specifically:

A table of acceptance criteria and the reported device performance: This document does not describe performance metrics for a diagnostic or AI-driven device, but rather refers to reprocessing validation and biocompatibility.
Sample size used for the test set and the data provenance: Not applicable as there's no mention of a test set for AI performance. The studies mentioned are non-clinical (biocompatibility and reprocessing validation).
Number of experts used to establish the ground truth...: Not applicable as there's no AI component or ground truth establishment for diagnostic performance.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: The document explicitly states "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This means no MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of Device Performance and Acceptance Criteria from the Provided Document:

The acceptance criteria and performance data in this 510(k) summary are related to the safety and functionality of the endoscope itself, particularly regarding its reprocessing and biocompatibility, as opposed to diagnostic performance of an AI component.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance/Conclusion
Biocompatibility	ISO 10993-5:2009/(R) 2014 Cytotoxicity	Performed according to ISO 10993-1 and FDA Guidance.
	ISO 10993-10:2010 Sensitization & Irritation	Performed according to ISO 10993-1 and FDA Guidance.
	ISO 10993-11:2006/(R) 2010 Systemic Toxicity	Performed according to ISO 10993-1 and FDA Guidance.
	Overall Conclusion	The biocompatibility evaluation for patient-contacting components was performed and deemed acceptable.
Reprocessing Validation	Cleaning Validation	Validation activities performed according to FDA Guidance. The device maintained functionality after reprocessing cycles.
	Sterilization Validation (V-PRO 60 and HLD)	Validation activities performed according to FDA Guidance and relevant standards (AAMI TIR 12, ISO 15883-5, AAMI TIR 30, AAMI/ANSI/ISO 11737-1, ASTM E1837-96). Confirmed effective sterilization for specified methods.
	Overall Conclusion	The reprocessing data submitted is in compliance with relevant standards, demonstrating the device can be effectively cleaned, sterilized, and high-level disinfected.
Functional Equivalence	Comparison to Predicate Device (K182723)	The nonclinical tests demonstrate that the subject device performs as well as or better than the legally marketed predicate device (KARL STORZ Flexible HD Cysto-Urethroscope K182723).

2. Sample size used for the test set and the data provenance:

The document does not specify sample sizes for the biocompatibility or reprocessing validation tests. These tests are typically performed on a limited number of device samples or representative materials.
Data provenance is not specified beyond being "non-clinical bench testing." There's no mention of country of origin or retrospective/prospective nature as this applies to clinical study data, which was explicitly not required.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth establishment by experts pertains to diagnostic or clinical performance evaluations, which were not part of this 510(k) submission.

4. Adjudication method for the test set:

Not applicable.

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 comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This device is an endoscope system, not an AI-driven diagnostic tool.

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

Not applicable. This is not an algorithm or AI-driven device.

7. The type of ground truth used:

Not applicable in the context of diagnostic performance. For biocompatibility and reprocessing, the "ground truth" is adherence to established international standards and FDA guidance for these types of non-clinical tests.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is not an AI/ML device.

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

Not applicable.

Summary

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September 18, 2019

KARL STORZ Endoscopy-America, Inc. Irina Fedorov Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245

Re: K191357

Trade/Device Name: Flexible HD Cysto-Urethroscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FAJ, FBO Dated: August 14, 2019 Received: August 19, 2019

Dear Irina Fedorov:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sharon M. Andrews Acting Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191357

Device Name Flexible HD Cysto-Urethroscope System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K191357 Page 1 of 3

KARL STORZ Premarket Notification Flexible HD Cysto-Urethroscope System 007 510(k) Summarv

7. 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

KARL-STORZ Endoscopy-America is submitting this 510(k) to seek clearance for a change to add Sterilization V PRO-60 and High Level Disinfection (HLD) for the currently cleared Flexible HD Cysto-Urethroscope System (K182723). This submission is traditional 510(K) as since we are including two reports to supports the additions.

Submitter:	KARL STORZ Endoscopy-America, Inc.2151 E. Grand AvenueEI Segundo, CA 90245
Contact:	Irina FedorovRegulatory Affairs SpecialistPhone: (508) 248-1275Fax: (508) 248-9017
Date ofPreparation:	May 17, 2019
Type of 510(k)Submission:	Traditional
DeviceIdentification:	Trade Name: HD ViewCommon Name: Flexible HD Cysto-Urethroscope SystemClassification Name: Endoscope and accessories (21 CFR Part876.1500)
RegulatoryClass:	II
Product Code:	FAJ, FBO
GuidanceDocument:	Not Applicable for FAJ/FBO product codes
RecognizedConsensusStandards:	Not Applicable for FAJ/FBO product codes
PredicateDevice(s):	Predicate Device: KARL STORZ Flexible HD Cysto-Urethroscope(K182723)
DeviceDescription:	The components subject of this submission are: the Flexible HD Cysto-Urethroscope (Part Number: 11272VH(U)), the LUER ports (Part

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K191357 Page 2 of 3

Number: 11014L(U)), the Suction Valve (Part Number: 11301CE1/20), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).
Intended Use:	The Flexible HD Cysto-Urethroscope System is intended for visualization purposes during urological diagnostic and therapeutic procedures.
Indications For Use:	The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.
TechnologicalCharacteristics:		Subject Device	Predicate Device, K182723
		Cleaning and Sterilization Methods
	Cleaning	Manual	Same as the subject device
	Sterilization	STERRAD 100NX (FLEX and DUO Cycles) STERRAD NX (Advanced Cycle) V-PRO maX (Flexible Cycle) SS1E (Standard Cycle) V-PRO 60 Resert XL	STERRAD 100NX (FLEX and DUO Cycles) STERRAD NX (Advanced Cycle) V-PRO maX (Flexible Cycle) SS1E (Standard Cycle) None
Non-ClinicalPerformanceData:	Biocompatibility SummaryThe biocompatibility evaluation for the patient contacting components of the neuroscope was performed according to ISO 10993-1 and FDA Guidance. The following tests were conducted based contact type and duration: ISO 10993-5:2009/(R) 2014 ISO 10993-10:2010 ISO 10993-11:2006/(R) 2010 Reprocessing Validation SummaryThe Flexible HD Cysto-Urethroscope (Part Number: 11272V(H)) is provided non-sterile and is reusable. The users are required to reprocess it for initial and after each use. The subject device contacts intact mucosal membranes so it is a semi-critical device per Spaulding Classification. We performed validation activities for cleaning sterilization and HLD according to the FDA Guidance. The reprocessing data submitted is in compliance with the following standards: AAMI TIR 12:2010 ISO 15883-5:2005 AAMI TIR 30:2011 AAMI/ANSI/ISO 11737-1:2006/(R)2011

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K191357
Page 3 of 3

Image /page/5/Picture/1 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller, less bold font.

KARL STORZ Premarket Notification Flexible HD Cysto-Urethroscope System 007_510(k) Summary

	• ASTM E1837-96:2014
ClinicalPerformanceData:	Clinical testing was not required to demonstrate the substantialequivalence to the predicate devices. Non-clinical bench testing wassufficient to establish the substantial equivalence of the modifications.
Conclusion:	The conclusions drawn from the nonclinical tests demonstrate that thesubject device, the Flexible HD Cysto-Urethroscope System performsas well as or better than the legally marketed predicate device.

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.