The Flexible Ureterorenoscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral 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 Flexible Ureterorenoscope (Model: US27F-12-EU; US27F-12-US) is intended to be used with the Video Processor (cleared via K211169). The Flexible Ureterorenoscope is inserted through the natural orifice urethra and when used with the compatible Video Processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Ureterorenoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording, a Luer port for insertion of accessory devices and irrigation to the working channel and a LED for illumination. The insertion section contains one working channel, wiring to transmit the image signals to the Video Processor, and two optical fibers to transmit illumination from the handle to the distal tip. The distal bending section of the insertion section is controlled by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the Video Processor, optical fibers for transmitting illumination from the LED inside the Handle, and the distal opening of the working channel. The Endoscope Connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope.

Mechanism of action:
The light emitted from the distal tip of the Flexible Ureterorenoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LED on the endoscope.

Flexible Ureterorenoscope has the following physical and performance characteristics:

Maneuverable tip controlled by the user
Flexible insertion cord
Camera at the distal tip
LED in the handle and transmitted to the distal tip by optical fibers
Sterilized by Ethylene Oxide
For single use

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the Flexible Ureterorenoscope (K243857) does not contain details about a study evaluating AI performance directly or outlining acceptance criteria for such a study.

This document primarily focuses on the substantial equivalence of a medical device (endoscope) based on its physical properties, performance characteristics (mechanical, optical), electrical safety, biocompatibility, sterilization, and packaging. The "non-clinical tests summary & conclusions" explicitly state "Clinical Testing: Not Applicable."

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI performance, human reader improvement with AI, or standalone AI performance, as this information is not present in the provided text.

The closest relevant information is about the device's optical performance and image quality, which are foundational for any imaging device, and would implicitly establish a baseline for an AI to process.

Here's what I can provide based on the given information, primarily highlighting the device's tested performance attributes, which serve as foundational acceptance criteria for the hardware itself, not an AI component:

Acceptance Criteria and Device Performance (Flexible Ureterorenoscope - K243857)

Since the provided document is for a medical imaging device (uroscope) and not an AI/software as a medical device (SaMD), the "acceptance criteria" discussed are for the physical and functional performance of the endoscope itself, rather than for an AI algorithm built upon imagery from such a device. There is no mention of AI in this clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document lists "applicable parts" of standards and general categories of testing rather than specific numerical acceptance thresholds or quantitative performance metrics. The reported performance is adherence to these standards and the successful execution of these tests.

Criteria Category	Acceptance Standard/Test	Reported Device Performance
Electrical Safety	ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]	In compliance with the standard
Electromagnetic Compatibility	ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021]	In compliance with the standard
Particular Requirements for Endoscopic Equipment	IEC 60601-2-18 Edition 3.0 2009-08	In compliance with the standard
Electromagnetic Phenomena - Guidance on Basic EMC Aspects	IEC/TR 60601-4-2 Edition 1.0 2016-05	In compliance with the standard
Photobiological Safety	IEC 62471:2006 (Medical electrical equipment, Photobiological safety of lamps and lamp systems)	Tested according to the standard and found compliant
Mechanical Performance	Applicable parts of ISO 8600	Leakage tightness, bending, deflection endurance, and tensile strength testing performed and met requirements
Optical Performance	Applicable parts of ISO 8600	Optical measurements performed and met requirements
	Image Quality Parameters (Comparative to Predicate)	Direction of view, field of view, MTF/DOF, color performance, SNR/Dynamic Range, Resolution, and Image intensity uniformity compared favorably to the predicate to support substantial equivalence.
Biocompatibility	ISO 10993-1 and FDA Guidance	Cytotoxicity, Sensitization, Irritation, Material-mediated pyrogenicity, Acute systemic toxicity tests conducted and met requirements
Sterilization Validation	ISO 11135:2014	Validated, determined routine control and monitoring parameters
EO/ECH Residuals	ISO 10993-7:2008	Test performed and met requirements
Shelf Life (Accelerated Aging)	ASTM F1980-21	Determined based on stability study (aging test)
Package Validation	ISO 11607-1:2019 and ISO 11607-2:2019	Conducted according to standards
Package Integrity (Seal Strength)	ASTM F88/F88M-21	Conducted according to standard
Package Integrity (Dye Penetration)	ASTM F1929-15	Conducted according to standard
Transport & Shipping	ASTM D4169-22	Testing performed and met requirements

2. Sample Size and Data Provenance for Test Set

Sample Size: Not explicitly stated for specific tests (e.g., how many units were tested for mechanical performance). The testing is primarily bench/lab-based.
Data Provenance: The tests are non-clinical, hardware-focused performance evaluations. Data is generated during these laboratory tests performed by the manufacturer, Shanghai AnQing Medical Instrument Co., Ltd. (China). This is implied to be prospective testing for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The document explicitly states "Clinical Testing: Not Applicable." Ground truth, in this context, would relate to clinical outcomes or expert review of images for diagnostic purposes, which are not part of this 510(k) submission for the device itself. Performance is evaluated against engineering standards and specifications.

4. Adjudication Method for Test Set

Not applicable. No clinical test set or expert review requiring adjudication is mentioned.

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

No. The document explicitly states "Clinical Testing: Not Applicable." No MRMC study or AI assistance evaluation is mentioned.

6. Standalone Performance (Algorithm Only)

Not applicable. This submission is for the endoscope hardware, not a standalone AI algorithm. No algorithm performance is described.

7. Type of Ground Truth Used

Engineering/Technical Standards: The "ground truth" for this device's performance is adherence to established international and national standards (e.g., IEC, ISO, ASTM, ANSI AAMI) for medical device safety, electrical performance, optical quality, biocompatibility, sterilization, and mechanical integrity. Performance is measured against these technical specifications.

8. Sample Size for Training Set

Not applicable. There is no mention of an AI component requiring a training set.

9. How Ground Truth for Training Set Was Established

Not applicable. There is no mention of an AI component or a training set.

Summary

FDA 510(k) Clearance Letter - K243857

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 11, 2025

Shanghai AnQing Medical Instrument Co., Ltd.
Shuwen Fan
RA Manager
3 & 4 Floor, No.2 Building, 366 Huiqing Rd,
East Zhangjiang High-Tech Park
Shanghai, 201201
CHINA

Re: K243857
Trade/Device Name: Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FGB
Dated: March 14, 2025
Received: March 14, 2025

Dear Shuwen Fan:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K243857 - Shuwen Fan Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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

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K243857 - Shuwen Fan Page 3

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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 J. Antonino -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K243857

Device Name
Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

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

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."

Page 5

510(k) Summary

510(k) #: K243857
Prepared on: 2025-03-14

Contact Details

21 CFR 807.92(a)(1)

Field	Value
Applicant Name	Shanghai AnQing Medical Instrument Co., Ltd.
Applicant Address	3 & 4 Floor, No.2 Building, 366 Huiqing Rd, East Zhangjiang High-Tech Park Shanghai 201201 China
Applicant Contact Telephone	+86-21-61117375
Applicant Contact	Ms. Shuwen Fan
Applicant Contact Email	ra_dept@anqing-sh.com

Device Name

21 CFR 807.92(a)(2)

Field	Value
Device Trade Name	Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)
Common Name	Endoscope and accessories
Classification Name	Ureteroscope And Accessories, Flexible/Rigid
Regulation Number	876.1500
Product Code(s)	FGB

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate#	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K220159	Flexible Ureterorenoscope	FGB

Device Description Summary

21 CFR 807.92(a)(4)

Mechanism of action:
The light emitted from the distal tip of the Flexible Ureterorenoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LED on the endoscope.

Flexible Ureterorenoscope has the following physical and performance characteristics:

Maneuverable tip controlled by the user
Flexible insertion cord

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K243857 Page 2 of 3

Camera at the distal tip
LED in the handle and transmitted to the distal tip by optical fibers
Sterilized by Ethylene Oxide
For single use

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

21 CFR 807.92(a)(5)

The indication for use of the subject device and the predicate device(s) are the same.

Technological Comparison

21 CFR 807.92(a)(6)

The subject and predicate devices have the same fundamental technology, insertion section length, deflection, direction of view, depth of field, type of imager, number of uses and sterilization method.

The subject device differs from the predicate in distal end outer diameter, field of view and patient-contacting materials. These differences do not raise different questions of safety and effectiveness as compared to the predicate, and can be evaluated through performance testing.

Both the subject device and predicate device provides LED illumination to the procedural site, which in the case of the predicate device is provided by the LEDs in the distal tip, whereas in the case of the subject device, the illumination is generated by the LED inside of the handle and transmitted to the distal tip via optical fibers. This difference does not raise different questions of safety and effectiveness as compared to the predicate, and can be evaluated through performance testing.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

Electrical Safety and Electromagnetic Compatibility Summary
The electrical safety and EMC testing included in the submission is in compliance with the following FDA recognized standards:

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021]
IEC 60601-2-18 Edition 3.0 2009-08
IEC/TR 60601-4-2 Edition 1.0 2016-05

Photobiological safety
The proposed device was tested according to the following FDA recognized standards:

IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps and lamp systems

Mechanical and Optical Performance
The proposed device was designed to comply with applicable parts of ISO 8600. Optical measurements were performed according to applicable part of ISO 8600 standard.
Mechanical characteristics were tested and include leakage tightness, bending, deflection endurance, and tensile strength testing.
In addition, comparative testing related to image quality parameters including direction of view, field of view, MTF/DOF, color performance, SNR/Dynamic Range, Resolution,and Image intensity uniformity was performed for proposed device and the predicate device to support substantial equivalence.
The biocompatibility evaluation for the patient contacting components of the proposed device was performed according to ISO 10993-1 and FDA Guidance. The following tests were conducted: Cytotoxicity, Sensitization, Irritation, Material-mediated pyrogenicity, Acute systemic toxicity.
Sterilization and shelf life testing
The sterilization method has been validated to ISO 11135:2014, which has thereby determined the routine control and monitoring parameters.
EO/ECH residual test was performed according to ISO 10993-7:2008.
The shelf life of the proposed device is determined based on stability study which includes aging test according to ASTM F1980-21, Standard Guide for Accelerated Aging of Sterile Barrier.
Package Validation

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K243857 Page 3 of 3

Package validation was conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, and ASTM F88/F88M-21 and ASTM F1929-15
Transport and shipping testing as per ASTM D4169-22.

Clinical Testing: Not Applicable.

The conclusions drawn from the nonclinical tests demonstrate that the subject device, the Flexible Ureterorenoscope is as safe, as effective, and performs as well as the legally marketed device identified above.

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.