The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and video processor for clinical image processing. The device is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Device Description

The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and endoscope operating system for clinical image processing.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Ureterorenoscope System. It outlines the device, its indications for use, comparison with predicate devices, and performance data provided in support of substantial equivalence. However, it does not contain information related to acceptance criteria, specific study designs, or performance metrics in a way that would allow for a detailed response to all aspects of your request.

Specifically, the document discusses "performance data" in general terms, such as "Biocompatibility testing," "Sterilization and shelf life testing," "Electrical safety and electromagnetic compatibility (EMC)," "Software Verification and Validation Testing," "Optical performance testing," and "Mechanical performance testing." It states that "All evaluation acceptance criteria were met" for biocompatibility and that the system "complies with" various ISO and IEC standards for other tests, but it does not provide:

A table of specific acceptance criteria and reported device performance values. It only gives broad statements of compliance.
Sample sizes used for test sets or data provenance for these performance tests (e.g., country of origin, retrospective/prospective).
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or any effect size. This type of study is more common for AI/diagnostic support systems, which this device is not described as.
If a standalone (algorithm only) performance study was done. This is not an AI algorithm; it's a medical device.
The type of ground truth used (e.g., pathology, outcomes data). While it mentions testing, it does not specify how "ground truth" was established for, say, optical or mechanical performance beyond compliance with standards.
Sample size for the training set. This is not an AI device that would typically have a "training set" in the machine learning sense.
How ground truth for the training set was established.

Therefore, based on the provided text, I can only extract the following limited information regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Description of Acceptance Criteria	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1:2009 for "Surface – Mucosal Membrane" contact (< 24 hours), including tests for Cytotoxicity, Irritation, and Sensitization.	All evaluation acceptance criteria were met.
Sterilization & Shelf Life	Validation to ISO 11135; shelf life determined by stability study including aging test.	The sterilization method has been validated to ISO 11135. Shelf life determined based on stability study.
Electrical Safety & EMC	Compliance with IEC 60601-1 and IEC 60601-2-18 (safety); IEC 60601-1-2 (EMC).	The system complies with IEC 60601-1, IEC60601-2-18, and IEC 60601-1-2.
Software Verification & Validation	Adherence to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Device considered "moderate" concern).	Software verification and validation testing were conducted and documentation provided as recommended.
Optical Performance	Compliance with ISO 8600 series.	The optical performance of the system complies with ISO 8600 series.
Mechanical Performance	Performance in tests for leaking, bending, articulating, and irrigation.	Mechanical characteristics including leaking, bending, articulating and irrigation tests were performed.

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

Not specified in the provided text. The document states that various performance tests were conducted (e.g., Biocompatibility, Electrical Safety, Optical Performance, Mechanical Performance) but does not provide details on the sample sizes used for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective). These are typically bench and lab tests, not clinical studies with patient data in the sense of AI/diagnostic algorithms.

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

Not applicable/Not specified in the provided text. The "ground truth" for these types of engineering and biocompatibility tests is typically established by fulfilling predefined engineering specifications and international standards, rather than expert human interpretation of data in the way medical images are interpreted. No information about experts or their qualifications is provided.

4. Adjudication method for the test set:

Not applicable/Not specified in the provided text. Adjudication methods like 2+1 or 3+1 are relevant for interpreting medical data (e.g., images) where human judgment might vary. For the performance tests described (e.g., electrical safety, mechanical, biocompatibility), the assessment is typically against objective, quantifiable standards, not subjective expert adjudication.

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 done. The Ureterorenoscope System is described as a medical device (endoscope) for visual examination and procedures, not an AI or diagnostic assistance tool that would typically involve human readers interpreting output or benefiting from AI assistance.

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

Not applicable. This device is a physical ureterorenoscope system, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the various performance tests (e.g., Biocompatibility, Electrical Safety, Optical Performance, Mechanical Performance) was compliance with established international and national standards (e.g., ISO 10993-1, ISO 11135, IEC 60601 series, ISO 8600 series) and predefined engineering specifications. This is not medical ground truth like pathology or outcomes data.

8. The sample size for the training set:

Not applicable. The Ureterorenoscope System is a hardware medical device and does not involve AI or machine learning that would require a "training set."

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

Not applicable. As the device does not involve AI/ML, there is no training set or corresponding ground truth establishment process.

Summary

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July 3, 2018

Shanghai AnOing Medical Instrument CO., Ltd. Lina Fei Quality Manager 150 Cailun Road, Zhangjiang High-Tech Park Shanghai, 201210 China

Re: K180367 Trade/Device Name: Ureterorenoscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: May 18, 2018 Received: May 29, 2018

Dear Lina Fei:

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 comprehensive regulatory information about medical devices and radiation-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,

Glenn B. Bell -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K180367

Device Name Ureterorenoscope System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

l Submitter

Device submitter: Shanghai AnQing Medical Instrument CO., Ltd.

Room 202, 2nd Floor, No.7 Building & Room 202, 200 Floor No.4 Building, 150 Cailun Road, Zhangjiang High-Tech Park, 201210, Shanghai, China

Contact: Lina FEI, Quality Manager Phone: +86 137 7425 3128 Fax: +86 21 5019 1132 - 8004 Email: Lina@anqing-sh.com

II Device

Trade name of Device: Ureterorenoscope System Common name: Ureteroscope and Accessories, Flexible/Rigid Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscopes and Accessories Regulatory Class: II Product code: FGB

III Predicate Devices

Trade name:	Karl Storz Flexible Video-Uretero-Renoscope System
Common name:	Ureteroscope and accessories, Flexible/Rigid
Classification:	Class II, 21 CFR 876.1500
Product Code:	FGB
Premarket Notification:	K131369

Trade name:	Boston Scientific Corporation LithoVue System
Common name:	Ureteroscope and accessories, Flexible/Rigid
Classification:	Class II, 21 CFR 876.1500
Product Code:	FGB
Premarket Notification:	K153049

IV Device description

The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and endoscope operating system for clinical image processing.

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V Device characteristics

The system consists of an EO sterilized single-use Flexible Ureteroscope and a non-sterile repeat use Video Processor. The Video processor is connected to mains power and provides power to the Flexible Ureteroscope.

The material inserted into the urine tract of the patient is TPU. The contact duration equals to the time of the Ureteroscopy, which is less than 24 hours. The biocompatibility of the material complies with ISO10993 series.

The device is intended to be used at hospitals or health clinics by trained physicians.

VI Operation principle

The Flexible Ureteroscope is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are transmitted to the user by the video processor with a CMOS chip at the distal end of the endoscope and the images showing on a monitor.

VII Indications for use

VIII Comparison of technological characteristics with the predicate devices

The Ureterorenoscope System has the same technological characteristics and fundamental design as the predicate devices. The Ureterorenoscope System and the predicate devices are all designed to provide real-time images to the physician in order to facilitate diagnostic and therapeutic procedures in the urinary tract. The differences between the Ureterorenoscope System and predicate devices do not alter suitability of the proposed device for its intended use.

IX Performance data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

Biocompatibility of the Ureterorenoscope System was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation and Sensitization. All evaluation acceptance criteria were met

Sterilization and shelf life testing

The sterilization method has been validated to ISO11135, which has thereby determined

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the routine control and monitoring parameters. The shelf life of the Flexible Ureterorenoscope is determined based on stability study which includes ageing test.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Ureterorenoscope System. The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

Optical performance testing

Optical performance testing was conducted on the Ureterorenoscope System. The optical performance of the system complies with ISO 8600 series.

Mechanical performance testing

Mechanical characteristics including leaking, bending, articulating and irrigation tests were performed.

X Conclusion

The Ureterorenoscope System is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the 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.