The Uro-G cystoscope is a handheld, battery-operated portable cystoscope consisting of a sterile, disposable steerable endoscopic cannula and a reusable handle with a video monitor. 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 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 510(k) summary for the Uro-G Cystoscope. This document primarily focuses on establishing substantial equivalence to a predicate device (Uro-V Cystoscope) rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for an AI/ML device.

The "acceptance criteria" for a medical device like a cystoscope typically refer to the performance standards and safety requirements it must meet to be considered safe and effective, often demonstrated through engineering bench testing, biocompatibility, and electrical safety. The "study that proves the device meets the acceptance criteria" in this context refers to these non-clinical tests.

There is no mention of AI/ML components in the Uro-G Cystoscope from the provided text, nor are there any acceptance criteria, sample sizes, or ground truth establishment relevant to AI/ML or comparative effectiveness studies with human readers. The device is a physical endoscope.

Therefore, I will interpret "acceptance criteria" and "study" in the context of a medical device submission focused on equivalence for a non-AI physical device.

Here's the breakdown based on the provided document:

Acceptance Criteria and Study for Uro-G Cystoscope (Non-AI Device)

The Uro-G Cystoscope is a physical medical device. The "acceptance criteria" are based on demonstrating substantial equivalence to a legally marketed predicate device (Uro-V Cystoscope) and compliance with relevant safety and performance standards through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion (Implicit/Explicit)	Reported Device Performance/Comparison
Predicate Equivalence	Intended Use: "The Uro-G flexible cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra."	EXACTLY THE SAME as predicate (Uro-V Cystoscope).
	Indications for Use: Symptomatic voiding dysfunction, Hematuria, Bladder tumor surveillance, Recurrent lower urinary tract infection, Pelvic pain syndromes.	EXACTLY THE SAME as predicate.
	Route of Advancement: Advanced to the bladder via the urethra.	SAME as predicate.
	Site of Use: Hospitals and physician offices.	SAME as predicate.
	Components: Reusable handle with video screen; Attachable cannula with working channel, illumination source, and camera at tip.	SAME as predicate (handle is identical, cannula has modifications but core components are the same).
	Image Transmission/Display: Image transmitted from video camera at tip to video monitor on handle; 3.5-inch LCD Display.	SAME as predicate.
	Field of View: 140 degrees.	SAME as predicate.
	Direction of View: 0 degrees (forward viewing).	SAME as predicate.
	Operational Characteristics: Adjustable illumination brightness, capture still images/video, cleaning/disinfection protocol, frequency/duration of use.	SAME as predicate for these operational aspects.
	Tissue Contact Materials: Compliant with ISO 10993.	SAME as predicate, and cannula materials passed all applicable biocompatibility tests (see details below).
	Differences and Rationale: Changes in Outer Diameter (5.5mm vs 4.2mm); Working Length (380mm vs 254mm); Working Channel ID (2.2mm); Flexible Tip Deflection (up to 210° up and 130° down); Focal Length (5-50mm vs 3-50mm). Rationale provided for each difference to demonstrate no new safety/effectiveness issues.	Acceptable; Differences are addressed and do not raise new issues of safety or effectiveness. For example, increased OD is still within anatomical limits for patients, increased working length allows better access, improved tip deflection enhances ease of use without compromising safety due to continuous imaging.
Performance Data (Bench/Non-Clinical)	Design Verification & Validation: Ensure device performs as intended and meets specifications.	Conducted with successful results.
	Packaging & Shelf-Life: Maintain sterility and integrity over time.	Conducted for the sterile cannula, confirming labeled shelf life compliance.
	Biocompatibility: Meet ISO 10993 Part 1 requirements for short-duration (<24 hours) indwelling device concerning Cytotoxicity, Irritation, Sensitization, and Systemic Toxicity (acute).	Device passed all tests.
	Sterilization Procedure Validation: Compliance with ISO 11135-1 (Ethylene Oxide), ISO 11607 (Packaging), AAMI TIR12 (Reusable device reprocessing), AAMI TIR30 (Cleaning reusable devices).	Conducted for the sterile cannula; compliance confirmed.
	Software Verification & Validation: Ensure firmware and software function correctly and safely.	Conducted with successful results.
	Electrical Safety & Electromagnetic Compatibility (EMC): Compliance with ISO 60601-1, ISO 60601-1-2 (EMC), and IEC 60601-2-18 (Endoscopic equipment, including thermal safety).	Device found to meet compliance requirements. (Note: The handle component's electrical safety and EMC testing from the U-Scope 8000 submission K132384 was applicable).
	Mechanical Characteristics: Proper functioning of mechanical components (e.g., deflection mechanism).	Tested with successful results.

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

Test Set Sample Size: Not applicable in the context of an AI/ML test set. For physical device testing, sample sizes would refer to the number of units tested for each specific bench test (e.g., number of cannulas tested for biocompatibility, sterility, or mechanical deflection). These specific numbers are not provided in this summary, but the document states "All necessary performance testing was conducted with bench testing."
Data Provenance: The data comes from the manufacturer's (UroViu Corporation) internal bench testing and verification/validation activities. The document does not specify the country of origin for the data or whether any retrospective/prospective studies (which are clinical by nature) were performed. Since no clinical studies were deemed necessary, the data is entirely from non-clinical (benchtop) sources.

3. Number of Experts and Qualifications for Ground Truth Establishment

Not Applicable: This pertains to AI/ML model ground truth, which is not relevant for this physical device. The "ground truth" for this device's performance is established by direct physical measurements, chemical tests, electrical tests, and adherence to engineering specifications and international standards (e.g., ISO, IEC).

4. Adjudication Method for the Test Set

Not Applicable: This pertains to expert review and consensus for AI/ML ground truth. For this physical device, "adjudication" is not needed in the same sense; rather, test results are assessed against predefined engineering and regulatory specifications.

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

No: An MRMC comparative effectiveness study was not performed. This type of study is relevant for AI/ML diagnostic aids to assess human reader improvement, which is not applicable to a physical endoscope.

6. Standalone Performance (Algorithm Only)

Not Applicable: There is no AI/ML algorithm in this device. Its performance is entirely dependent on its physical and electrical characteristics.

7. Type of Ground Truth Used

Engineering Specifications and Standard Compliance: The "ground truth" for the device's performance relies on meeting pre-defined engineering specifications, international safety and performance standards (e.g., ISO 10993 for biocompatibility, ISO 60601-1 for electrical safety, ISO 11135-1 for sterilization), and demonstrating physical functionality (e.g., image quality, fluid infusion, tip deflection).

8. Sample Size for the Training Set

Not Applicable: This device does not use an AI/ML training set. Its design and manufacturing process are based on engineering principles and established medical device production.

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

Not Applicable: As there is no AI/ML training set, this question is not relevant.

Summary for this specific product (Uro-G Cystoscope):

The FDA 510(k) clearance process for the Uro-G Cystoscope primarily relied on demonstrating substantial equivalence to a predicate device (Uro-V Cystoscope) and meeting general safety and performance requirements through a series of benchtop engineering tests. Questions related to AI/ML-specific validation (e.g., "AI acceptance criteria," "sample sizes for test/training sets," "expert ground truth," "MRMC studies") are not relevant for this particular device as described in the provided document, as it is a physical, non-AI medical instrument.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 4, 2021

UroViu Corporation Thomas Lawson, Ph.D. Vice President, Regulatory Affairs 5337 - 145th Place SE Bellevue, WA 98006

Re: K202921 Trade/Device Name: Uro-G Cystoscope Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: April 1, 2021 Received: April 2, 2021

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. 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 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.

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-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,

for Mark J. Antonino, M.S. Assistant 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K202921

Device Name Uro-G Cystoscope

Indications for Use (Describe)

The Uro-G flexible 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

General Information

Submitter	UroViu Corporation
Address	UroViu Corporation5337 145th Place SEBellevue, WA 98006
FDA Registration Number	Not assigned yet
Correspondence Person	Thomas Lawson, PhD
Contact Information	Email:thom@uroviu.com
Date Prepared	16 November 2020

Proposed Device

Trade Name	Uro-G Cystoscope
Common Name	Uro-G
Regulation Number andClassification Name	21 CFR§876.1500, Endoscope and Accessories
Product Code	FAJ
Regulatory Class	II

Predicate Device

Trade Name	Uro-V Cystoscope
Common Name	Uro-V
Premarket Notification	K171500
Regulation Numberand Classification	21 CFR§876.1500, Endoscope and Accessories
Product Code	FAJ
Regulatory Class	II
Note: The predicate device has not been subject to a design-related recall.

Reference Device

Trade Name	U-Scope 8000 System with HSC+EMB Cannula
Common Name	U-Scope 8000
Premarket Notification	K132384

{4}------------------------------------------------

Regulation Numberand Classification	21 CFR§884.1690, Hysteroscope and accessories
Product Code	HIH
Regulatory Class	II
Note: The reference device has not been subject to a design-related recall.

Device Description

Indications for Use

The indications for use for the Uro-G Cystoscope is:

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

Comparison of Technological Characteristics with the Predicate Device

Uro Viu Corp. has identified the Uro-V Cystoscope (K171500, Uro Viu Corp.) as the predicate device. The Uro-V disposable cystoscope is substantially equivalent to the predicate device based upon the following similarities:

1. The indications for use of both the predicate device and the Uro-G cystoscope are exactly the same: symptomatic voiding dysfunction, hematuria, bladder tumor surveillance, recurrent lower urinary tract infection, and pelvic pain syndromes;

{5}------------------------------------------------

1. Both devices are introduced into the body via the urethra and then advanced to the bladder under visualization (that is, not a blind advancement);
1. Both devices have illumination and optic components to permit visualization of the urethra and bladder;
1. Both devices have the capability to view the urethra and bladder via video monitors;
1. Both devices have a working channel to allow infusion of fluids; and
1. Both devices are made from biocompatible materials.

These similarities are not surprising in that the subject and predicate devices are manufactured for Uro Viu Corporation by the same contract manufacturer and both use the same handle with an integrated video screen.

The U-Scope 8000 is a reference device since the same handle is used in the Uro-G cystoscope and so the electrical safety and EM compatibility testing performed in its review-K132384-is applicable for the handle of the Uro-G cystoscope. This is the only part of the submission applicable, so the U-Scope 8000 is not present in the SE comparison table.

	Subject DeviceUro-G Cystoscope(UroViu Corp.)This Submission	PredicateDeviceUro-V Cystoscope(UroViu Corp.)K171500
Device Class	II	II
FDA Product Code	FAJ	SAME
ProductClassification	876.1500	SAME
Intended Use	The Uro-G Cystoscope hasbeen designed for endoscopicdiagnosis and infusion ofirrigating fluid within thebladder and urethra.	The Uro-V cystoscopehas been designed forendoscopic diagnosisand infusion of irrigatingfluid within the bladderand urethra.
Indications for Use	Symptomatic voiding dysfunctionHematuriaBladder tumor surveillanceRecurrent lower urinary tractinfectionPelvic pain syndromes	SAME
Route of Advancement	Advanced to the bladder via the urethra.	SAME
Site of Use	Hospitals and physician offices	SAME
Technical Characteristics
Components of the Set	Reusable handle with video screenAttachable cannula with a working channel and an illumination source and camera at its tip	SAME
Outer Diameter (OD) of Cannula	5.5 mm	4.2 mm
Working Length of the Cannula	380 mm	254 mm
Image Transmission	Image transmitted from a video camera at the tip of the cannula to a video monitor on the handle	SAME
LCD Display Size	3.5 inches (diagonal) on the handle	SAME
Field of View	140 degrees	SAME
Focal Length	5 to 50 mm	3 to 50 mm
Direction of View from Center Axis	0 degrees (forward viewing)	SAME
Operational Characteristics
Adjust Brightness of Illumination	Adjust by depressing a button on the handle to change settings	SAME
Images or Video	Capture still images orvideo during a procedureby depressing a camerabutton on the handle	SAME
Cleaning, Disinfecting, andSterilization	The handle is notprovided sterile. Thehandle is cleaned anddisinfected followinginstructions in the usermanual (IFU).The disposable cannula isprovided sterile followingexposure to ethyleneoxide (EO) and is forsingle use. It is disposedafter the procedurefollowing the institution'sprocedures.	SAME
Frequency of Use	Handle is reusableCannula is single patientuse	SAME
Duration of Use	< 24 hours	SAME
Tissue Contact Materials	Compliant withISO 10993	SAME

Comparison of the Uro-G Cystoscope to the predicate device, the Uro-V Cystoscope.

{6}------------------------------------------------

{7}------------------------------------------------

These devices are further noted to be substantially equivalent by their indications for use following such determinations outlined in 21 CFR 807(f):

	Uro-V Cystoscope(predicate device)	Uro-G Cystoscope(subject device)
Intended Use	Endoscopic diagnosis andinfusion of irrigating fluid withinthe bladder and urethra	EXACTLY THE SAME.
Indicationsfor Use	Symptomatic voidingdysfunctionHematuriaBladder tumor surveillanceRecurrent lower urinary tractinfectionPelvic pain syndromes	EXACTLY THE SAME
Method of introduction into the body		EXACTLY THE SAME
Characteristics of equivalence of indications for use defined in 21 CFR 807(f)
Materials	Handle: not patient contact but the outer shell is plasticCannula:Lens - Zeonex F52R Lenscoating - WR-110/NCamera housing – SS 304Camera tip - PolycarbonateFluid channel – Teflon (PTFE)Fluid hub - PolycarbonateCannula shaft - NylonAdhesives - Loctite 3211 & 3218The cannula materials passed all applicable biocompatibility tests.	Handle: Exactly the same handle as is used with the Uro-V cannula.Cannula:Lens - Zeonix F53RLens coating - WR-110/NCamera housing - SS 304Camera tip - PolycarbonateFluid channel – Teflon (PTFE)Fluid hub - PolycarbonateCannula shaft - Thermoplastic polyurethaneDistal section of cannula – Fluororubber TPAdhesives – Loctite 3211 & 3218The cannula materials passed all applicable biocompatibility tests.
Design	Handle: contains the electronics, a video processor, a rechargeable battery, and an LCD display. The handle is curve slightly so that the user can hold it easily in one hand.Cannula:1.Contains a miniature CMOS camera and LED illumination at its tip.2.Contains a working channel for fluid infusion.3.The tip can be deflected manually prior to use and rotated during a procedure.4.Connects to the handle.5.Provided sterile.	Handle: Exactly the same handle as is used with the Uro-V cannula.Cannula:1.Contains a miniature CMOS camera and LED illumination module at its tip.2.Contains a working channel for fluid infusion.3. The tip can be deflected and rotated during a procedure4. Connects to the handle.5. Provided sterile.
Energy Used	Handle: powered by a 3.7 V rechargeable batteryCannula: while the tip of the cannula contains both a camera	Handle: Exactly the same handle as is used with the Uro-V cannula.Cannula: while the tip of the cannula contains both a camera
OperationalPrinciples	Handle: Rather than run a cablefrom the cystoscope to a separatevideo monitor that is required ofall other cystoscopes, an LCDdisplay is integrated into thehandle of UroViu cystoscopes sothat the user can see directlyimages of the tissue andanatomical structures as thecystoscope is being advanced tothe bladder.	Handle: Exactly the same handleas is used with the Uro-Vcannula.
	Cannula: the light at the tipilluminates the field so that thecamera can transmit images backto the LCD display on the handle.It is a semi-rigid shaft with a tipangle originating by thecompany, SO the user eithernavigates the urethra and lookswithin the bladder by rotating thecannula or can modify the angleof the tip manually beforeinserting the cannula into theuretheral orifice.	Cannula: the light at the tipilluminates the field so that thecamera can transmit images backto the LCD display on the handle.The angle of the tip can bemodified by moving a deflectionlever on the proximal portion ofthe cannula, so that the user cannavigate the urethra and lookwithin the bladder by changing thetip angle after inserting thecannula into the urethral orifice.

{8}------------------------------------------------

{9}------------------------------------------------

The changes to the design of the Uro-G cystoscope centers on the cannula for this model; the handle has not changed from what it was in the Uro-V cystoscope submission (K171500). Cytoscopes are available in rigid, semi-rigid, or flexible configurations. Rigid cystoscopes typically are constructed of stainless steel and the shaft/cannula is not intended to bend or deflect. Their use requires that the physician forcethe non-flexible shaft up, down or to the side in order to navigate anatomic structures and obstructions within the urethra and bladder. The Uro-V cystoscope is considered a semi-rigid cystoscope in that its cannula comes out of the pouch in a pre-curved angle of 25° but the user has the ability to change the angle of the cannula before or during the procedure by manually bending the shaft of the cannula to a desired angle. As the Uro-V cystoscope is being advanced, the user can negotiate structures and obstructions my turning the cannula so that the tip advances away from structures/obstructions as it makes its way to the bladder. The Uro-G cystoscope builds on this by providing the user with the ability to change the angle of the cannula's tip by moving a deflection control lever on the proximal portion of the cannula. This capability to manipulate the cannula's tip during use improves ease of use for the physician but does not introduce a reduction in safety since the user can monitor the deflection with continual imaging so that structures can either be avoided or targeted directly if that was the purpose of the procedure.

The specific modifications with the Uro-G cannula are:

{10}------------------------------------------------

1. The outer diameter (OD) was increased to 5.5 mm. The OD of the Uro-G cystoscope was increased in order to permit an increase in the ID of the working channel to 2.2 mm. Since the urethral diameter of malesranges from 8 to 9 mm and the diameter in females averages 6 mm, this OD does not increase any risk to the device's use. This risk is further reduced since it is standard practice to infuse fluid as a cystoscope is advanced so that the urethra dilates ahead of the tip's position.
1. The working length was increased to 380 mm, which is about 5 inches longer than the Uro-V model. In clinical work, the length of the Uro-V cystoscope is adequate, but in some patients does not always allow the tip to extend to the distal bladder wall in some male patients. This increase in 5 inches permits tip access to all parts of the bladder and is comparable to the lengths of other cystocopes, which range from 370 to 400 mm.
1. The working channel has an ID of 2.2 mm.
The flexible tip can deflect up to 210 degrees up and 130 degrees down from 4. a straight, non-deflected orientation. Deflection wires embedded into the wall of the cannula that compress or extend basedupon movement of the deflection control lever accomplish this. Active tip deflection is a standard feature of some cystoscopes.
1. The focal length of the camera is 5 to 50 mm. It is important to maintain focus of an area of interest or surrounding tissue as a cystoscope is being advanced or when targeting a specific anatomical area. This focal length is equivalent to that of the Uro-V cystoscope and also to those of cystoscopes marketed by Storz and Olympus.

Performance Data

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

Design verification and validation studies; ●
. Packaging and shelf-life studies;
. Biocompatibility testing;
. Sterilization procedure validation:
Software verification and validation; and ●
Electrical safety and electromagnetic compatibility testing. ●

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.

{11}------------------------------------------------

K202921

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.

Biocompatibility testing

Testing was conducted on the cannula of the Uro-G cystoscope to verify that it is compliant with biocompatibility requirements for a short duration (<24 hours) indwelling device, as specified in ISO 10993 - Part 1, for the following tests:

о Cytotoxicity,
Irritation. o
Sensitization, and O
Systemic Toxicity (acute). O

The device passed all tests.

Animal Testing

No preclinical testing of the subject device was necessary; the bench top testing was sufficient to determine the performance of the device.

Clinical Studies

No clinical testing of the subject device was necessary; the bench top testing was sufficient to determine the performance of the device.

{12}------------------------------------------------

Conclusion

The Uro-G and Uro-V cystoscopes have the same intended use, the exact same indications for use, and have equivalent technological characteristics. The minor differences between the Uro-V and the Uro-G cystoscopes do not raise any new issues of safety or effectiveness.

Therefore, the Uro-G 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.