The UroViu Uro-V cystoscope is a handheld, battery-operated portable cystoscope. It includes a sterile, single-use disposable cannula and a reusable handle. The disposable cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and one channel for infusion of irrigating fluid. The handle is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the disposable cannula. The handle contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or to start/stop a video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.

AI/ML Overview

The provided text describes the Uro-V Cystoscope and its substantial equivalence to a predicate device, focusing on its design, intended use, and performance data from various bench tests. However, it does not contain information typically found in a clinical study report or a detailed validation study, especially regarding human-in-the-loop performance, ground truth establishment with experts, or comparative effectiveness studies with human readers.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table for performance metrics like sensitivity, specificity, or accuracy. It lists various tests conducted to ensure compliance with standards and safety. The "reported device performance" is primarily a statement of compliance with these standards.

Acceptance Criteria Category	Specific Tests/Standards Met	Reported Device Performance
Design & Functionality	Design verification and validation studies	"All necessary performance testing was conducted with bench testing and included: Design verification and validation studies." (General statement of completion)
Packaging & Shelf-Life	Packaging and shelf-life studies	"Packaging and shelf-life studies" (General statement of completion)
Transit	Transit testing	"Transit testing" (General statement of completion)
Biocompatibility	ISO 10993 - Part 1 (for short duration indwelling device)	"Testing was conducted on the device to verify that it is compliant with biocompatibility requirements for a short duration indwelling device, as specified in ISO 10993 - Part 1. The device was found to meet the compliance requirements..."
Sterilization	Sterilization procedure validation; ISO 11135-1; ISO 11607; AAMI TIR12:2010; AAMI TIR30:2011	"Due to the cannula being labeled as sterile, the cannula underwent sterilization validation and shelf life testing to confirm the label shelf life complies with the following standards: ISO 11135-1, ISO 11607, AAMI TIR12:2010, and AAMI TIR30:2011." (Implied compliance as part of validation)
Software	Software verification and validation	"Software verification and validation" (General statement of completion)
Physical Characteristics	Surface and edges evaluation; Cannula dimensions (maximum insertion width, minimum instrument channel width)	"Surface and edges evaluation; Cannula dimensions (maximum insertion width, minimum instrument channel width)" (General statement of completion)
Electrical Safety & EMC	ISO 60601-1; ISO 60601-1-2; IEC 60601-2-18 ("Medical electrical equipment -- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment," including thermal safety)	"The device was found to meet the compliance requirements for electrical safety as specified in ISO 60601-1 including provisions for EMC safety in ISO 60601-1-2 and IEC 60601-2-18 Medical electrical equipment -- Part 2-18: 'Particular requirements for the basic safety and essential performance of endoscopic equipment,' including thermal safety."
Mechanical	Mechanical characteristics testing	"Mechanical characteristics were also tested, with successful results."
Optical	Field of view accuracy; Direction of view accuracy; Optical resolution	"Optical tests: Field of view accuracy, Direction of view accuracy, Optical resolution." (General statement of completion for these tests)

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

The document specifies "bench testing" and "design verification and validation studies." It does not mention a test set in the context of patient data, clinical images, or AI performance evaluation. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective). The testing focused on device specifications and compliance rather than clinical performance with patient data.

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

Not applicable. This device is a hardware cystoscope, and the testing described is engineering and regulatory compliance testing, not a study involving human experts establishing ground truth for diagnostic accuracy (e.g., in an AI context).

4. Adjudication method for the test set

Not applicable for the same reasons as #3.

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 conducted. This document describes a traditional 510(k) submission for a medical device (cystoscope), which involves demonstrating substantial equivalence primarily through technical specifications, safety, and performance bench testing. It is not an AI-powered device, and therefore, an MRMC study related to AI assistance for human readers is irrelevant and was not performed.

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

No, a standalone algorithm-only performance study was not done. The device itself is a physical endoscope, not an algorithm, and the testing described focuses on its physical and electrical characteristics, sterilization, and biocompatibility.

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

For the various bench tests, the "ground truth" would be established by engineering specifications, validated test methods, and regulatory standards. For example, for biocompatibility, the ground truth is whether the materials meet ISO 10993. For electrical safety, it's whether the device passes the tests outlined in ISO 60601-1. This is not clinical ground truth from patient pathology or expert consensus.

8. The sample size for the training set

Not applicable. This document pertains to a physical medical device (cystoscope), not an AI algorithm. Therefore, there is no concept of a "training set" in this context.

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

Not applicable for the same reasons as #8.

Summary

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January 30, 2018

UroViu Corporation Thomas Lawson, Ph.D. Vice President, Regulatory Affairs 5337 - 14th Place SE Bellevue, WA 98006

Re: K171500

Trade/Device Name: Uro-V Cystoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ Dated: December 21, 2017 Received: December 22, 2017

Dear Thomas Lawson:

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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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 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.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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Division Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171500

Device Name Uro-V Cystoscope

Indications for Use (Describe)

The Uro-V cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. SUBMITER:

UroViu Corporation 5337 14th Place SE Bellevue, WA 98006 Phone: 650 397 5174 Fax: 888 388 1420

Contact Person: Thomas Lawson, PhD

Phone: 510 206 1794 eMail: thom@urosee.com

May 11, 2017 Submission Date:

II. DEVICE

Device Name: Uro-V Cystoscope Common Name: Cystoscope Classification Name: Endoscope and Accessories (21 CFR 876.1500) Regulatory Class: II Product Code: FAJ Classification Panel: 78

III. PREDICATE DEVICE

VISCERA Cystovideoscope Type CYF V, Olympus American, Inc. K021074

DEVICE DESCRIPTION IV.

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V. INDICATIONS FOR USE

The Uro-V cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.

VI. SUBSTANTIAL EQUIVALENCE

The Uro-V device is substantially equivalent to the VISCERA cystovideoscope Type CYF V manufactured by Olympus America, Inc. (K021074) in terms of indications for use, route the devices are introduced and advanced within the body, capability to view the urethra and bladder, having a working channel to allow instillation of fluids and introduction of endourological tools, and being made from biocompatible materials.

	Subject deviceUro-V cystoscope(this submission)	Predicate deviceVISCERA Cystovideoscope TypeCYF VOlympus America, Inc.(K021074)
Indication for use	For endoscopic diagnosis andinfusion of fluids within thebladder and urethra.	This instrument has beendesigned to be used with anOlympus video system center,light source, documentationequipment, display monitor,endo-therapy accessories, andother ancillary equipment forendoscopic diagnosis andtreatment within the bladder andurethra.
Intended Use	The Uro-V cystoscope has beendesigned for endoscopicdiagnosis and infusion ofirrigating fluid within the bladderand urethra.	The cystovideoscope is used forendoscopic diagnosis andtreatment within the bladder andurethra.
Route ofAdvancement	Advanced to the bladder via theurethra	Advanced to the bladder via theurethra
Site of use	Hospitals and physician offices	Hospitals and physician offices
Device Features
Components	Reusable handle with videoscreen	Optic component with aninsertion tube that has oneworking channel
	Attachable cannula with aworking channel along its lengthand an illumination source andcamera at its tip	Additional components necessaryfor the visualization of theprocedure are a light source,video system center, and displaymonitor, which are providedseparately from thecystovideoscope itself
Cannula / InsertionTube Outer Diameter	4.2 mm	5.5 mm
Working length	254 mm	380 mm
Working channelinternal diameter	2.8 mm	2.2 mm
Illumination lightsource	LEDs	Xenon short-arc lamp
Image transmission	Image transmitted from a videocamera at the tip of the cannula toa video monitor on the handle	Either the physician will view bylooking through the cystoscope'seyepiece or by attaching acoupling lens to the eyepiece ofthe scope and sending that imageto a video monitor in theprocedure room
LCD display size	3.5 inches (diagonal) on thehandle	26 inches (diagonal) on thesystem tower
Field of View	140 degrees	120 degrees
Focal Length	5 to 25 mm	3 to 50 mm
Direction of Viewfrom Center Axis	30 degrees	0 degrees (forward viewing)
Adjust brightness ofillumination	Adjust by depressing a button onthe handle to change settings	Adjust by changing settings onthe ancillary light sourceequipment
Capture still imagesor video imagesduring the procedure	Capture still images or videoduring procedure by depressing acamera button on the handle	Capture still images or videoduring procedure by use of anancillary video system centerequipment
Duration of use	< 24 hours	< 24 hours
Sterilization	The handle is not provided sterile.The handle is cleaned,disinfected, or sterilizedfollowing company instructions.The disposable cannula isprovided sterile followingexposure to ethylene oxide (EO)and is single use; it is disposedafter the procedure following theinstitution's procedures.	Cystovideoscope is not providedsterile. The device is cleaned,disinfected, or sterilizedfollowing company instructions.
Frequency of use	Handle is reusable.Cannula is single patient use.	Cystovideoscope is reusable.
Tissue contactmaterials	Compliant with ISO 10993	Compliant with ISO 10993

Table I. Comparison of the Uro-V cystoscope to the predicate device, the Olympus VISCERA Cystovideoscope Type CYF V.

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Any differences between the Uro-V cystoscope and the predicate device do not alter the intended use of the Uro-V cystoscope.

VII. PERFORMANCE DATA

All necessary performance testing was conducted with bench testing and included:

Design verification and validation studies; ●
Packaging and shelf-life studies: ●
Transit testing;
Biocompatibility testing;
Sterilization procedure validation;
. Software verification and validation;
Surface and edges evaluation;
Cannula dimensions (maximum insertion width, minimum instrument ● channel width);
. Electrical safety, electromagnetic compatibility, and laser safety testing;
Temperature testing of the surface of the insertion of the device; and ●
Optical tests ●
- o Field of view accuracy

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Direction of view accuracy O
O Optical resolution.

Testing was conducted on the device to verify that it is compliant with biocompatibility requirements for a short duration indwelling device, as specified in ISO 10993 - Part 1. The device was found to meet the compliance requirements for electrical safety as specified in ISO 60601-1 including provisions for EMC safety in ISO 60601-1-2 and IEC 60601-2-18 Medical electrical equipment -- Part 2-18: "Particular requirements for the basic safety and essential performance of endoscopic equipment," including thermal safety. Mechanical characteristics were also tested, with successful results. Due to the cannula being labeled as sterile, the cannula underwent sterilization validation and shelf life testing to confirm the label shelf life complies with the following standards:

ISO 11135-1 Sterilization of health care products -- Ethylene oxide -Part 1: Requirements for development, validation and routine control of a sterilization process for medical device;
ISO 11607 Packaging for Terminally Sterilized Medical Devices; ●
AAMI TIR12:2010 Designing, testing, and labeling ● reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers; and
AAMI TIR30:2011 - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.

VIII. CONCLUSION

The Uro-V cystoscope and the VISCERA Cystovideoscope Type CYF V have the same intended use and indications for use and have equivalent technological characteristics. The minor differences between the Uro-V cystoscope and the predicate device do not raise any new issues of safety or effectiveness. The Uro-V cystoscope is substantially equivalent to the identified 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.