The Flexible CMOS Video-Cysto-Urethroscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract including the bladder and urethra.

Device Description

The Flexible CMOS-Video-Cysto-Urethroscope system consists of an endoscope and a monitor. The endoscope is a single device and can be said to be made up of an instrument handle, a shaft and a video connector cable. The handle has three camera control buttons, a deflection control lever and a luer connector to the working channel. An LED located in the handle and is use to provide the illumination for visualization of the anatomy under examination. The light is transmitted from the LED to the distal tip via glass fiber light bundles, where it is used to illuminate the body cavity under examination. The CMOS imaging sensor is located at the distaltip of the endoscope shaft captures the reflected light and converts it to a standard NTSC video signal. The luer connector and working channel are used as an introduction port for irrigation fluid and endoscopic instruments. The 8402ZX monitor provides visualization of the image being captured by the CMOS chip in the endoscope. During the procedure, the physician can use the control buttons on the monitor to perform functions, such as video and single image capture.

AI/ML Overview

The KARL STORZ Flexible CMOS-Video-Cysto-Urethroscope is a medical device designed for visualizing and providing operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra. The submission does not explicitly list acceptance criteria in a table format with performance metrics. However, it states that "Testing demonstrated that the device is as safe & effective and performs as well as or better than the predicate devices." The predicates are KARL STORZ Video-Urethro-Cystoscope System (K062918) and KARL STORZ Flexible Fiber Optic Cystoscope (K945185).

Therefore, the implicit acceptance criteria are that the device meets or exceeds the safety and effectiveness of these predicate devices. The study conducted to prove this involves various non-clinical performance and safety tests.

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria are not provided in a quantifiable table, the table below reflects the comparison to predicate devices, which serves as the basis for substantial equivalence.

Parameter	Acceptance Criteria (Performance equivalent to or better than predicate devices)	Reported Device Performance (Flexible CMOS-Video-Cysto-Urethroscope)
Mechanical Performance	Equivalent to predicate devices	Verified through bench testing
Optical Performance	Equivalent to predicate devices	Verified through bench testing
Illumination Performance	Equivalent to predicate devices	Verified through bench testing
Basic Safety & Performance	Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18	Conforms to specified IEC standards
Cleaning Validation	Effective cleaning as per instructions	Validated for cleaning instructions in IFU
Disinfection Validation	High-level disinfection (HLD) with Resert XL to SAL of 10⁻⁶	Validated for HLD with Resert XL to SAL of 10⁻⁶
Sterilization Validation	Sterilization with STERRAD 100NX to SAL of 10⁻⁶	Validated for sterilization with STERRAD 100NX to SAL of 10⁻⁶
Biocompatibility	Patient-contacting parts comply with ISO 10993-1:2009	Evaluated per ISO 10993-1:2009
Risk Analysis	In accordance with ISO 14971	Performed in accordance with ISO 14971
Software Validation	Software performs as intended	Software verified through testing
Intended Use	Identical to predicate devices	Identical: Visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract including the bladder and urethra
Technological Characteristics	Comparable to predicate devices	Shows similar key specifications (Distal Tip, Shaft, Working Channel, Working Length, Deflection) with some updates (CMOS chip, LED illumination)

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes bench testing (non-clinical) and does not mention human subject testing or specific data sets in terms of images or patient cases. Therefore, there is no information on a "test set" in the context of image analysis or algorithm performance, nor is there information on data provenance (country of origin, retrospective/prospective). The testing focused on physical, electrical, and material performance of the device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The study is based on bench testing of the device's physical and functional properties against engineering standards and comparison to predicate devices, not on interpretation of outputs by human experts to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no human expert adjudication of a test set is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. The submission does not describe a MRMC study or any study comparing human readers with AI assistance versus without. The device itself is an endoscope, not an AI-powered diagnostic tool requiring human-in-the-loop analysis.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is an endoscope, which is a tool for visualization and access, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Conformance to recognized international standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, ISO 8600-1, ISO 8600-3, ISO 8600-4.
Results from bench testing for mechanical, optical, and illumination performance.
Successful validation studies for cleaning, disinfection, and sterilization protocols.
Biocompatibility testing per ISO 10993-1:2009.
Software verification testing.
The intended use and technological characteristics being substantially equivalent to legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This device is an endoscope, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this device.

Summary

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Submitter:	KARL STORZ Endoscopy America Inc.
Date of Preparation:	May 8, 2013
Sponsor Company Name:	KARL STORZ Endoscopy America Inc. (KSEA)
Phone Number:	(424) 218 8322
Street Address:	2151 East Grand Avenue
Fax Number:	(424) 218 8519
City:	El Segundo
State:	California
Country:	USA
Zip Code:	90245

Prepared By:	Shiven Gandhi
Contact Title:	Regulatory Submission Specialist
Email Address:	shiven.gandhi@karlstorz.com

Manufacturing Company Name:	Karl Storz Endovision, Inc.
Establishment Registration Number:	1221826
Street Address:	91 Carpenter Hill Rd
City:	Charlton
State/Province:	MA
Country:	USA
Zip Code:	01507

Manufacturing Company Name:	Karl Storz Video Endoscopy Estonia
Establishment Registration Number:	3004644065
Street Address:	Akadeemia Tee 21 A
City:	Tallinn
State/Province:	Estonia
Country:	Europe
Zip Code:	12618

Classification Name:	Cysto Urethroscope
----------------------	--------------------

Information about devices to which Substantial Equivalence is claimed:

510 (K) Number	Trade/ Proprietary Name/Model Number	Manufacturer/
K062918	Flexible Video-Urethro-Cystoscope System	Karl Storz GmbH & Co. KG
K945185	Flexible Fiber Optic Cystoscope	Karl Storz GmbH & Co. KG

510(K) Summary of Safety and Effectiveness

Page 1 of 4

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Introduction:

Device Trade Name: Classification Name: Regulation Number: Product Code:

Flexible CMOS-Video-Cysto-Urethroscope Cysto Urethroscope 21 CFR 876.1500 FBO

Device Description:

Indication for Use

The flexible CMOS Video-Cysto-Urethroscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract including the bladder and urethra.

Summary of Substantial Equivalence:

The Flexible CMOS-Video-Cysto-Urethroscope system is substantially equivalent to the existing 510(k) cleared devices on the market i.e. Karl Storz's Video-Urethro-Cystoscope System (K945185 cleared January 17, 2007) and Karl Storz's Flexible Fiber Optic Cystoscope (K062918 cleared May 3, 1995). The indication for use of the Flexible CMOS-Video-Cysto-Urethroscope is identical to the predicate devices. The Flexible CMOS-Video-Cysto-Urethroscope does not incorporate any special technology or characteristics when compared to its predicate devices.

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Technological Characteristics:

Parameter	Flexible CMOS-Video-Cysto-Urethroscope(Subject Device)	Flexible Video-Urethro-Cystoscope(Predicate Device)	Flexible FiberOptic Cystoscope(Predicate Device)
Applicant	KARL STORZEndoscopy AmericaInc.	KARL STORZEndoscopy AmericaInc.	KARL STORZEndoscopy AmericaInc.
510(k) number	Not yet assigned	K062918	K945185
Intended Use	The flexible CMOSVideo-Cysto-Urethroscope is usedto providevisualization andoperative accessduring diagnostic andtherapeuticendoscopicprocedures of thelower urinary tractincluding the bladderand urethra	The Karl StorzVideo-Urethro-Cystoscope System isintended for use byphysicians in thevisual examinationand treatment of avariety of urologicalendoscopicprocedures. TheVideo-Urethro-Cystoscope isintended to provideoptical visualizationvia a video monitorand therapeuticaccess	Provide visual andoperative accessduring examination,diagnosis andtreatment ofdisorders in theinterior of the bladderand urethra.
Imaging technology	CMOS chip at distal tip	CCD chip at distal tip	Fiber optic
Illumination Source	LED	External LightSource	External LightSource
Distal Tip (mm)[Outer Diameter]	5.5	5.5	5.2
Shaft Diameter (mm)	5.3	5.3	5.25
Working ChannelDiameter (mm)	2.2	2.2	2.33
Working Length (mm)	370	370	370
Deflection (°)	210 up°/ 140° down	210 up°/ 140° down	210 up°/ 140° down

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Performing Testing

Bench testing (non-clinical) were conducted to verify the performance of the Flexible CMOS-Video-Cysto-Urethroscope. Design verification testing was conducted to evaluate the mechanical, optical and illumination performance. Basic safety and performance testing was performed in accordance with IEC 60601-1-2 and IEC 60601-1-2 and IEC 60601-2-18. The Karl Storz flexible CMOS Video-Cysto-Urethroscope was validated for the cleaning instructions provided in the Instruction for Use manual. The Flexible CMOS-Video-Cysto-Urethroscope has been validated for high level disinfection (HLD) with Resert XL and sterilization with STERRAD 100NX to provide a sterility assurance level of 100°. The device is provided nonsterile. The patient contacting part of the device was evaluated for biocompatibility per ISO 10993-1:2009. The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971. The software in the device was validated as per the Software verification Testing.

Performance standards under section 514 of the Code of Federal Regulations Title 21 have not been developed for this device however the manufacturer complies with the following voluntary standards:

IEC 60601-1
IEC 60601-1-2 ■
IEC 60601-2-18 트
트 ISO 8600-1
ISO 8600-3 ●
트 ISO 8600-4

Testing demonstrated that the device is as safe & effective and performs as well as or better than the predicate devices

Conclusion:

The Karl Storz Flexible CMOS-Video-Cysto-Urethroscope is substantially equivalent to the predicate device mentioned above and the non-clinical performance testing demonstrates that the device is as safe and effective and performs as well as or better than the legally marketed devices

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 2, 2014

KARL STORZ Endoscopy-America, Inc. Shiven Gandhi Regulatory Submission Specialist 2151 E. Grand Avenue El Segundo, CA 90245

K131364 Re:
Trade/Device Name: Flexible CMOS-Video-Cysto-Urethroscope Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBO Dated: November 22, 2013 Received: November 25, 2013

Dear Shiven Gandhi,

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. 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.

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Page 2 - Shiven Gandhi

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Benjamin Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): Not yet assigned K131364

Device Name: Flexible CMOS-Video-Cysto-Urethroscope

Indication for use: The Flexible CMOS Video-Cysto-Urethroscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract including the bladder and urethra.

Prescription Use ____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801.109 i.e. Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin 2014.01.02 14:05 00-05-00

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.