Ureterorenoscope System

K201293 · Shanghai AnQing Medical Instrument Co., Ltd. · FGB · Jul 24, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K201293
• Device Name: Ureterorenoscope System
• Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Jul 24, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Ureterorenoscope System is intended for visualization purposes during urological diagnostic and therapeutic procedures. The Ureterorenoscope System consists of a sterile single-use 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 Story

System comprises sterile single-use flexible ureteroscope and reusable video processor. Ureteroscope features CMOS imager, internal LED light source, and 275-degree up/down deflection. Device introduced into urinary tract for visualization of kidney interior. Physician operates scope to navigate anatomy; video processor handles image processing for display. Used in clinical settings for diagnostic and therapeutic procedures. Output provides real-time visualization to assist physician in performing interventions, potentially improving diagnostic accuracy and therapeutic outcomes.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing, including biocompatibility (ISO 10993-5, ISO 10993-10), sterilization validation (ISO 11135, ISO 11737-1, ISO 10993-7), sterile packaging integrity, and mechanical performance (water resistance, bending reliability).

Technological Characteristics

Flexible ureteroscope (9.3 Fr, 650mm length, 275° deflection). Materials: LCP, TPU, Fluoroelastomers, Epoxy glue, Pebax, PTFE. CMOS imager, internal LED light source. Forward viewing, 110° FOV. EO sterilization (SAL 10^-6). Reusable video processor for image processing.

Indications for Use

Indicated for endoscopic examination of the urinary tract, including the interior of the kidney, in patients requiring diagnostic or therapeutic urological procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Shanghai AnQing Medical Ureterorenoscope System (K180367)

Submission Summary (Full Text)

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July 24, 2020

Shanghai AnQing Medical Instrument Co., Ltd. Shuwen FAN, RA Manager 3rd & 4th Floor, No.2 Building 366 Huiging Road Zhangjiang High-Tech Park Shanghai, 201201 CHINA

Re: K201293

> Trade/Device Name: Ureterorenoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: June 23, 2020 Received: June 25, 2020

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 (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

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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 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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Martha Betz Acting 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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## Section 4 Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

**Indications for Use**

| Form Approved: OMB No. 0910-0120 |
|----------------------------------|
| Expiration Date: 06/30/2020 |
| See PRA Statement below. |

| 510(k) Number (if known) | K201293 |
|--------------------------|-------------------------|
| Device Name | Ureterorenoscope System |

**Indications for Use (*Describe*)**

The Ureterorenoscope System consists of a sterile single-use 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
track and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic
and therapeutic procedures.

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> |

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## Section 5 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of AnQing's knowledge.

| Submitter: | Shanghai AnQing Medical Instrument Co., Ltd<br>3 &4 Floor, No.2 Building, 366 Huiqing Rd ,<br>East Zhangjiang High-Tech Park, Shanghai, China |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Shuwen Fan<br>Regulatory Affairs Manager<br>Email: [e-mail]<br>Tel: [phone]<br>Fax: [phone] |
| Date of<br>Preparation: | July 23, 2020 |
| Type of 510(k)<br>Submission: | Special 510(k)<br>K201293 |
| Device<br>Identification: | Trade Name: Ureterorenoscope System<br>Common Name: Ureteroscope and accessories, flexible/rigid<br>Classification Name: Endoscope and accessories (21 CFR Part 876.1500) |
| Regulatory<br>Class: | II |
| Product Code: | FGB |
| Predicate<br>Device(s): | Shanghai AnQing Medical Ureterorenoscope System (K180367)<br>This predicate has not been subject to a design-related recall. |
| Device<br>Description: | The Ureterorenoscope System consists of a sterile single-use Flexible<br>Ureteroscope to be introduced within the urinary tract and a non-sterile<br>repeat use Video Processor for clinical image processing. |

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| Intended Use: | The Ureterorenoscope System is intended for visualization purposes during<br>urological diagnostic and therapeutic procedures. | | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------|
| Indications For<br>Use: | The Ureterorenoscope System consists of a sterile single-use Flexible<br>Ureteroscope to be introduced within the urinary tract and video processor for<br>clinical image processing. The device is indicated for endoscopic examination<br>in the urinary tract and can be used to examine the interior of the kidney, and<br>using additional accessories, to perform various diagnostic and therapeutic<br>procedures. | | |
| Technological<br>Characteristics: | Comparison Table: Subject vs. Predicate Device | | |
| | | Subject Device | Predicate Device, K180367 |
| | Physical Characteristics | | |
| | Type of Scope | Flexible | Same as the Subject device |
| | Distal end outer<br>diameter | 9.3 Fr | Same as the Subject device |
| | Insertion<br>Section length | 650mm | 650mm |
| | Deflection | 275 °up/275 °down | Same as the Subject device |
| | Optical Characteristics | | |
| | Type of Imager | CMOS | Same as the Subject device |
| | Direction of<br>View | Forward Viewing | Same as the Subject device |
| | Field of View | $110 °±5%$ | Same as the Subject device |
| | Light Source | Internal LED | Same as the Subject device |
| | Patient Contacting Materials | | |
| | Direct | LCP, TPU, Fluoro<br>elastomers, Expoxy<br>glue | LCP, TPU |
| | Indirect | Pebax, PTFE | Pebax |
| | Sterilization Methods | | |
| | Number of<br>Users | Endoscope: Single-Use<br>Video Processor:<br>reusable | Same as the Subject device |
| | Endoscope<br>Primary<br>Package | Material: PETG &<br>Tyvek<br>Size: 1063*131*43 mm | Material: PETG & Tyvek<br>Size: 495*270*43 mm |
| | Endoscope<br>Sterilization | EO Sterilized, SAL 10-6 | Same as the Subject device |

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| Non-Clinical<br>Performance<br>Data: | The subject and predicate devices have the same fundamental technology, insertion section length, field and direction of view, light source, image display, number of uses and sterilization. The subject ureteroscope differs from the predicate in patient-contacting materials, and size of the primary package. These differences do not raise different questions of safety and effectiveness as compared to the predicate. |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The indication for use of the subject and the predicate device are identical. |
| | As part of demonstrating substantial equivalence to the predicate, a risk analysis was completed to identify the risks associated with the endoscope material changes and package size change. Verification testing were conducted to evaluate the modifications. The following tests associated with the device modifications were performed on the subject device according to methods and acceptance criteria outlined in the predicate device (K180367). The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device. |
| | Biocompatibility Summary |
| | The biocompatibility evaluation for the patient contacting components of the Flexible Ureterorenoscope was performed according to ISO 10993-1 and FDA Guidance. The following tests were conducted based contact category of “Surface -Mucosal Membrane” with a contact duration of “Limited (< 24 hours): |
| | • Cytotoxicity per ISO 10993-5:2009/(R) 2014 |
| | •Irritation per ISO 10993-10:2010 |
| | •Sensitization per ISO 10993-10:2010 |
| | Sterilization |
| | The sterilization method has been validated to ISO11135:2014, which has thereby determined the routine control and monitoring parameters. |
| | • Bioburden per ISO 11737-1:2018 |
| | • EO and ECH residuals per ISO 10993-7:2008 |
| | Accelerated Aging followed by sterile packaging integrity test<br>Simulated Shipping distribution followed by sterile packaging integrity test |
| | Mechanical Performance test |
| | • Water Resistance<br>• Bending Reliability |

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| Clinical<br>Performance<br>Data: | Clinical testing was not required to demonstrate the substantial equivalence to<br>the predicate devices. Non-clinical bench testing was sufficient to establish<br>the substantial equivalence of the modifications. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the subject<br>device, the Ureterorenoscope System is substantially equivalent to the<br>predicate devices. |