The ureteroscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

Device Description

The RenaNav Ureteroscope System is comprised of a single-use ureteroscope and a multi-use video processing unit (VPU). The RenaNav Single-Use Digital Flexible Ureteroscope is a sterile, single use device and is compatible with the multi-use System Video Processing Unit. The Ureteroscope is used by physicians to access, visualize, and perform procedures in the urinary tract. The flexible shaft of the ureteroscope includes one working channel which enables the delivery of therapeutic accessories and irrigation/ contrast solutions to the distal tip and desired anatomical location.

AI/ML Overview

The provided text describes a 510(k) submission for the RenaNav Ureteroscope System, asserting its substantial equivalence to a predicate device (LithoVue System, K153049). It lists various performance tests conducted to assure this equivalence and functionality, but it does not include specific acceptance criteria values or the quantitative results of those tests. It also does not detail any comparative effectiveness studies (MRMC) with human readers or standalone algorithm performance, as the device is a medical instrument (ureteroscope) for visualization and procedures, not an AI/imaging analysis software.

Therefore, many of the requested details cannot be extracted from the given text. Below is an attempt to address the points based on the provided information, noting where information is absent.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests, but it does not provide specific numerical acceptance criteria or the reported device performance for each metric. It generally states that "All test results met the requirements" or "The device passed the following tests."

Test Category	Specific Test / Metric	Acceptance Criteria (Not provided in detail)	Reported Device Performance (Not provided in detail)
Biocompatibility	Per ISO 10993-1	Met requirements	No adverse biocompatibility risks
Sterilization	Per ANSI/AAMI/ISO 11135	Validated	Passed
Packaging	Per ANSI/AAMI/ISO 11607-1	Validated	Passed
Electrical Safety & EMC	Per IEC 60601-1, -1-2, -2-18	Complies with applicable clauses	Passed
Simulated Use Testing	Use with ancillary devices	Performed	Passed
Dimensional Verification	Proximal/distal OD, working length & ID, channel length, curl diameter, umbilical cable length	Verified	Passed
Deflection	Up/Down Deflection (270 degrees, both directions)	Verified	Passed
Image Testing	Illumination verification	Verified	Passed
	Field of View and direction measurement	Measured	Passed
	Camera function	Verified	Passed
	Camera light ingress and glare	Verified	Passed
HDMI Compatibility	N/A	Verified	Passed
Image Functionality	Gain function	Verified	Passed
Sheath Compatibility	N/A	Verified	Passed
Leak Test	N/A	Verified	Passed
Tensile Tests	N/A	Verified	Passed
Optics Testing	Resolution, Depth of Field, Field of View, Geometric distortion, Signal-to-Noise Ratio, Dynamic Range, Image intensity uniformity, color performance	Evaluated	Passed

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

The document states that "All testing was performed on test units representative of finished devices." However, it does not specify the exact sample size for each test (e.g., number of ureteroscopes tested). There is no mention of data provenance in terms of country of origin or whether testing was retrospective or prospective, as the tests relate to device performance rather than patient data.

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

This information is not applicable and therefore not provided in the document. The device is a ureteroscope for direct visualization and procedures, not an AI or imaging analysis system that generates diagnostic interpretations requiring expert ground truth for a test set. The "ground truth" for the device's performance would be established through engineering specifications and objective measurements (e.g., measuring dimensions, image quality metrics, deflection angles), not expert consensus on medical images.

4. Adjudication Method for the Test Set

This information is not applicable. As explained above, the tests are primarily engineering and functional assessments of the physical device, not an AI diagnostic system requiring adjudicated interpretations.

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 such study was done or mentioned. This type of study is relevant for AI-powered diagnostic aids, not for a direct visualization medical device like a ureteroscope. The document focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing.

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

Not applicable. The device is a ureteroscope, a physical instrument for visualizing and performing procedures. It does not operate as a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the RenaNav Ureteroscope System's performance is established through engineering specifications, physical measurements, and industry standards (e.g., ISO, IEC). For example:

Dimensional Verification: Measured against design specifications.
Image Testing: Objectively measured against predefined optical and image quality parameters.
Biocompatibility: Demonstrated through lab tests against ISO 10993-1.
Electrical Safety & EMC: Verified against IEC 60601 series standards.

There is no "expert consensus, pathology, or outcomes data" as ground truth in the context of this device's performance testing for 510(k) clearance.

8. The Sample Size for the Training Set

Not applicable. The device is a physical medical instrument, not an AI model that requires a "training set."

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

Not applicable. As there is no AI model or training set, this question is not relevant.

Summary

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July 31, 2023

CenterPoint Systems, LLC Marybeth Gamber VP. Regulatory & Quality 3338 Parkway Blvd. West Valley City, UT 84119

Re: K223097

Trade/Device Name: RenaNav Ureteroscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: June 29, 2023 Received: June 30, 2023

Dear Marybeth Gamber:

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.

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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) 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,

Mark R. Kreitz -S

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

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Indications for Use

510(k) Number (if known) K223097

Device Name RenaNav Ureteroscope System

Indications for Use (Describe)

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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5 510(K) SUMMARY

5.1 Submitter

Name	CenterPoint Systems LLC
Address	3338 Parkway BlvdWest Valley City UT
Phone	877-848-0828
Contact Person:	Marybeth Gamber, Vice President Regulatory Affairs & Quality Assurance
Date Prepared:	July 25, 2023

5.2 Device

Name of Device:	RenaNav Ureteroscope System
Common or Usual Name	Ureteroscope System
Regulation Name:	Endoscope and Accessories
Regulatory Class:	Class II per 21 CFR 876.1500
Product Code:	FGB

Predicate Device 5.3

Predicate Name and 510(k) Number: LithoVue System, K153049

This predicate has not been subject to a design-related recall.

No reference predicates were used in this submission.

5.4 Device Description

The flexible shaft of the ureteroscope includes one working channel which enables the delivery of therapeutic accessories and irrigation/ contrast solutions to the distal tip and desired anatomical location.

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ર્ ર ર્ Indications for Use

The indications for use statement is identical to the predicate device.

5.6 Comparison of Technological Characteristics with the Predicate Device

The Proposed Device and Predicate Device are similar in indications for use, intended use, technological characteristics, and principles of operation.

The differences between the Proposed Device and the Predicate Device are minor and raise no different questions of safety and effectiveness, thus it was concluded that the Proposed Device is substantially equivalent to the Predicate Device. In accordance with 21CFR807.92(a)(6) a summary of how the technological characteristics of the Proposed Device compares to the Predicate Device is provided below.

Feature	RenaNav Single Use DigitalFlexible Ureteroscope (proposeddevice)	Primary Predicate: LithoVueSingle Use Digital FlexibleUreteroscope (K153049)	Same/DifferentbetweenProposed &Predicate
IntendedUse/Indications for Use	The ureteroscope is intended tobe used to visualize organs,cavities and canals in theurinary tract (urethra, bladder,ureter, calyces and renalpapillae) via transurethral orpercutaneous access routes. Itcan also be used in conjunctionwith endoscopic accessories toperform various diagnostic andtherapeutic procedures in theurinary tract.	The ureteroscope is intendedto be used to visualize organs,cavities and canals in theurinary tract (urethra, bladder,ureter, calyces and renalpapillae) via transurethral orpercutaneous access routes. Itcan also be used inconjunction with endoscopicaccessories to perform variousdiagnostic and therapeuticprocedures in the urinarytract.	Same
Device Class	II	II	Same
Product Code	FGB	FGB	Same
Regulationnumber	21 CFR 876.1500	21 CFR 876.1500	Same
Duration ofuse	Single-use, Transient	Single-use, Transient	Same
Insertion Site	Urethra or Percutaneous Access	Urethra or Percutaneous Access	Same
Sterilization	Ethylene Oxide	Ethylene Oxide	Same
PrescriptionDevice	Yes	Yes	Same
WorkingChannel	3.6F	3.6F	Same
WorkingLength	68cm	68cm	Same

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Feature	RenaNav Single Use DigitalFlexible Ureteroscope (proposeddevice)	Primary Predicate: LithoVueSingle Use Digital FlexibleUreteroscope (K153049)	Same/DifferentbetweenProposed &Predicate
BrightnessControl	Yes	Yes	Same
IlluminationType	LED	LED	Same
Up/DownDeflection	270 degrees, both directions	270 degrees, both directions	Same
GuidewireCompatibility	Max outside diameter 0.97mm(0.038")	Max outside diameter0.97mm (0.038")	Same
MinimumBend Radius	8mm	8mm	Same
Materials/Biocompatibility	Standard medical devicematerialsThe biocompatibility testsdemonstrate that there are noadverse biocompatibility risksassociated with use of thismaterial. All test results metthe requirements of ISO10993-1.	Standard medical devicematerials.The biocompatibility testsdemonstrate that there are noadverse biocompatibility risksassociated with use of thismaterial. All test results metthe requirements of ISO10993-1.	Same
Features	Handle, Articulation Lever,Umbilical Cable, AccessoryAccess Port, Irrigation Port	Handle, Articulation Lever,Umbilical Cable, AccessoryAccess Port, Irrigation Port	Same
EMC SafetyTesting	Complies with applicableclauses of IEC-60601	Complies with applicableclauses of IEC-60601	Same

The RenaNav Ureteroscope System is used for the same intended use in the same anatomical location using the same principles of operation as the predicate device. Therefore, the RenaNav Ureteroscope System can be considered substantially equivalent to the predicate device.

5.7 Performance Data

All necessary performance testing has been conducted on the RenaNav Ureteroscope System to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. The device passed the following tests:

. Biocompatibility testing per FDA Final Guidance Document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (2020)
. Sterilization validation per ANSI/AAMI/ISO 11135
Packaging validation per ANSI/AAMI/ISO 11607-1
. Electrical Safety and electromagnetic (EMC) Testing per applicable requirements of IEC 60601-1, IEC 60601-1-2, & IEC 60601-2-18.
Simulated use testing, including use with ancillary devices

510(k) Summary

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Traditional 510(k) Premarket Notification Submission: RenaNav Ureteroscope System

. Scope and VPU Dimensional verification, including proximal/distal OD, working length & ID, working channel length, curl diameter, umbilical cable length
Deflection verifications .
. Image testing, including illumination verification, Field of View and direction measurement, camera function, camera light ingress and glare
HDMI compatibility .
Image functionality and gain function
5.8 Conclusions
Sheath compatibility
Leak test ●
Tensile tests ●
Optics testing, including Resolution, ● Depth of Field, Field of View, Geometric distortion, Signal-to-Noise Ratio, Dynamic Range, Image intensity uniformity, color performance.

Upon reviewing the information provided in this submission and comparing the intended use, principle of operation and overall technological characteristics, the RenaNav Ureteroscope System is substantially equivalent to existing legally marketed devices.

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.