Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2)

K240074 · Shenzhen Besdata Technology Co., Ltd. · FGB · Oct 4, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K240074
• Device Name: Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2)
• Applicant: Shenzhen Besdata Technology Co., Ltd.
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Oct 4, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Single use flexible ureteroscope has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. The Image processor is used in conjunction with the video endoscopes produced by BESDATA to process the images collected by the video endoscopes and send it to the display, and provide power for the endoscope.

Device Story

Single-use flexible ureteroscope system (models UR-D1, UR-D2, UR-F1, UR-F2) and image processor (MIP1001, MIP1002). Device inputs: optical signals from urinary tract/kidney via distal CMOS sensor and LED illumination. Transformation: CMOS sensor converts optical signals to electrical signals; image processor restores and processes signals for real-time display on integrated LCD. Operation: Physician-operated in hospital settings; handle features push rod for distal curvature control and buttons for image/video capture. Instrument channel allows passage of biopsy forceps or other accessories; provides water/air supply for lens cleaning. Benefits: Enables visualization and minimally invasive access to urinary tract/kidney for diagnostic and therapeutic procedures. System is sterile, single-use, and portable.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including optical performance (resolution, field of view, depth of field, geometric distortion), mechanical performance (bending angle, size), biocompatibility (ISO 10993), electrical safety (IEC 60601 series), and sterilization validation.

Technological Characteristics

Materials: PTFE, PEBAX, PC. Sensing: CMOS imaging module. Illumination: LED. Connectivity: Wired LEMO plug connection between ureteroscope and image processor. Sterilization: Ethylene Oxide (EO). Form factor: Flexible insertion tube (2.5mm-2.8mm diameter) with 275° bending angle. Standards: ISO 10993, IEC 60601-1, IEC 60601-2-18, ISO 11135.

Indications for Use

Indicated for adult patients requiring endoscopic or endoscopic surgical procedures within the urinary tract and interior of the kidney, using ancillary equipment such as biopsy forceps.

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

• Medical Video Endoscope System (K172098)

Reference Devices

• WiScope® OM Endoscope System (K210579)

Submission Summary (Full Text)

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October 4, 2024

Shenzhen Besdata Technology Co., Ltd. Xiaohong Lu General Manager 503, Building #2, Xinnantian Industrial Park, No. 3179 Laokeng Community, Longtian Street, Pingshan District Shenzhen, Guangdong 518128 CHINA

Re: K240074

> Trade/Device Name: Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: September 4, 2024 Received: September 4, 2024

Dear Xiaohong Lu:

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.

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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" (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 (OS) 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 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-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 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-device-advicecomprehensive-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-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

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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,

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

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

Submission Number (if known)

K240074

Device Name

Single use flexible ureteroscope (UR-D1/UR-D2/UR-F1/UR-F2); Image processor (MIP1001/MIP1002)

Indications for Use (Describe)

The Single use flexible ureteroscope has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.

The Image processor is used in conjunction with the video endoscopes produced by BESDATA to process the images collected by the video endoscopes and send it to the display, and provide power for the endoscope.

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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# 510(k) SUMMARY

# 510(k) Number: K240074

## I.SUBMITTER

Name: Shenzhen Besdata Technology Co.,Ltd.

Address: 503, Building #2, Xinnantian Industrial Park, No. 3179, Danzi Avenue, Laokeng

Community, Longtian Street, Pingshan District, Shenzhen

Name of contact person: Xiaohong Lu

Tel: [phone]

Fax: [phone]

E-mail: regulation(@besdatatech.com

Date prepared: October 2, 2024

### Proposed Device II.

Submission Number: K240074

Trade/Device name: Single use flexible ureteroscope system

Regulation number: 21CFR 876.1500

Classification Name: Ureteroscope and accessories, flexible/rigid

Regulation class: II

Review Panel: Gastroenterology/Urology

Product code: FGB

Common Name: Ureteroscope and accessories

## III. Predicate Device

510(k) Number: K172098 Trade/Device Name: Medical Video Endoscope System

Applicant: Zhuhai Pusen Medical Technology Co, Ltd.

Regulation Number: 21 CFR 876.1500

Regulation Name: Endoscope and accessories

Regulation class: II

Review Panel: Gastroenterology/Urology

Product code: FGB

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

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## IV.Reference Device

510(k) Number: K210579 Device name: WiScope® OM Endoscope System Applicant: OTU Medical Inc. Regulation number:21 CFR 876.1500 Common/Usual Name: Endoscope and Accessories Regulation class: II Review Panel: Gastroenterology/Urology Product code: FBN, FGB Note: This reference device has not been subject to a design-related recall.

## V. Indications for use

Single use flexible ureteroscope has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.

The image processor is used in conjunction with the video endoscopes produced by BESDATA to process the images collected by the video endoscopes and send it to the display, and provide power for the endoscope.

## VI. Description of the Device

The Single use flexible ureteroscope system consists of a sterile Single use flexible ureteroscope and an Image processor.

## >Description of the ureteroscope

Name: Single use flexible ureteroscope

Model: UR-D1, UR-D2, UR-F1, UR-F2

There are four models of the Single use flexible ureteroscope. Different models are the same except for size and handle appearance. The ' D ' and ' F ' indicate that the appearance of different handles is different, ' 1 ' and ' 2 'represent different Maximum widths of insulation portion.

As shown in the table below:

| Model | Maximum widths of insulation portion | handle appearance |
|-------|--------------------------------------|--------------------------|
| UR-D1 | 2.8mm | Image: handle appearance |
| UR-D2 | 2.5mm | Image: handle appearance |
| UR-F1 | 2.8mm | Image: handle appearance |
| UR-F2 | 2.5mm | Image: handle appearance |

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The only difference in the appearance of the handle is to cater to the grip habits of different doctors.

Single use flexible ureteroscope is a sterile product for single use, and repeated use is prohibited.The Single use flexible ureteroscope is a portable equipment. The Single use flexible ureteroscope mainly consists of the distal, insertion portion, handle,connection cable and LEMO plug:

1)The distal including LED lighting, optical lens, CMOS imaging module.

2) The insertion portion includes the instrument channel and insertion tube.

3) The handle includes instrument channel ports, hand push rods, imaging control button switches and connecting the cable (with LEMO plug ).

Single use flexible ureteroscope is connected to the image processor through the LEMO plug on the connecting cable, and the patient's area is illuminated and imaged by the LED and camera of the insertion tube Distal. The CMOS sensor of the insertion tube Distal collects optical signals in imaging and converts them into electrical signals, which are transmitted to the image processor for display. There is an instrument channel in the insertion tube for operating diagnostic and therapeutic accessories (not configured on this device) through the instrument channel. The instrument channel can also provide water/air supply facilities for water/air supply through the instrument channel. Water supply is used to remove mucus attached to the surface of the camera, while air supply is used to remove residual water droplets on the camera. The handles each have two imaging button, and a push rod. The imaging button can control imaging (One button controls taking photos and one button controls recording), and the push rod can control the curvature of the insertion tube Distal.

The materials used in construction of the insertion of ureteroscope are Polytetrafluoroethylene (PTFE), Polyether-polyamide block copolymers (PEBAX), and polycarbonate (PC). The insertion portion is considered to contact a breached or compromised surface for a duration of less than 24 hours. The biocompatibility evaluation was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

The handle does not contact the patient.

>Description of the Image processor

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Name: Image processor

Model: MIP1001, MIP1002

The model MIP1001 and MIP1002 were identical except for position of button and different appearance size. As shown in the table below:

| Model | Size | position of button |
|---------|-------------------------|------------------------------------------------------|
| MIP1001 | 259 mm x 206 mm x 50 mm | The button is located at the top of the<br>device |
| MIP1002 | 252 mm x 278 mm x 55 mm | The button is located at the bottom of the<br>device |

Image processor is a lightweight endoscope video display, This device is composed of image processor, power adapter(power supply), LCD screen(image display) and image processing motherboard(function).

The endoscopic video image processor can process the image collected by the endoscope and display the image in real time through the LCD module. Users can use the LCD module for humanmachine interaction.

The principle of optical imaging: the light source illuminates the inspected site of the patient, which is imaged by the photosensitive surface of endoscope's CMOS camera module. The optical signal received by the CMOS sensor is converted into electrical signal after processing. The electrical signal is then transmitted by the cable to the signal processing chip embedded on the Image processor where it is restored after processing and finally displayed on the screen of Image processor.

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## VIII.Comparison with the Predicate Devices

## >Comparison of Indications with the Predicate Devices

Regarding the indications for use, although the subject device lacks integrated biopsy functionality compared to the predicate device, the intended use of both of them are the same.

## >Comparison of Technological Characteristics with the Predicate Devices

Subjective device and the predicate device have intended use. The subject and predicate device have similar technological characteristics as evidenced by the table below. All differences have been discussed in detail and chat these differences in technological characteristics do not raise new questions regarding safety or effectiveness of the subject device.

a. The following basic technological elements are the same or similar for the subject and predicate devices :

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# Table 1 General Comparison

| Item | Proposed Device<br>Single use flexible<br>ureteroscope | Predicate Device<br>Pusen Single Use Flexible<br>Video Ureteroscope | Reference Device<br>WiScope® OM<br>Endoscope System | Remark |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 510(k) number | K240073 | K172098 | K210579 | |
| Product Code | FGB | FGB | FBN, FGB | Same |
| Regulation<br>Number | 21CFR 876.1500 | 21CFR 876.1500 | 21CFR 876.1500 | Same |
| Indications for<br>Use | Single use flexible ureteroscope has<br>been designed to be used with endo<br>therapy accessories such as a biopsy<br>forceps and other ancillary equipment<br>for endoscopy and endoscopic surgery<br>within urinary tract and interior of the<br>kidney. | This instrument has been<br>designed to be used with endo<br>therapy accessories such as a<br>biopsy forceps and other ancillary<br>equipment for endoscopy and<br>endoscopic surgery within urinary<br>tract and interior of the kidney. | WiScope® OM Endoscope<br>System is intended to be<br>used by physicians to access,<br>visualize, and perform<br>procedures in the urinary<br>tract and the kidney.<br>WiScope® OM Endoscope<br>System is also intended to be<br>used by physicians through<br>percutaneous insertion to<br>access, visualize, and | Note1 |
| Item | Proposed Device | Predicate Device | Reference Device | Remark |
| 510(k) number | Single use flexible<br>ureteroscope | Pusen Single Use Flexible<br>Video Ureteroscope | WiScope® OM<br>Endoscope System | |
| | K240073 | K172098 | K210579 | |
| | perform procedures in the<br>pancreaticobiliary system<br>including the hepatic ducts<br>and the common bile duct.<br>The instrument enables<br>delivery and use of<br>accessories such as biopsy<br>forceps, laser fibers, graspers<br>and retrieval baskets at a<br>surgical site. | | | |
| Patient<br>Population | Adult | Adult | Adult | Same |
| where used | Hospitals | Hospitals | Hospitals | Same |
| Item | Proposed Device<br>Single use flexible<br>ureteroscope | Predicate Device<br>Pusen Single Use Flexible<br>Video Ureteroscope | Reference Device<br>WiScope® OM<br>Endoscope System | Remark |
| 510(k) number | K240073 | K172098 | K210579 | |
| Digital video technology | CMOS | CMOS | CMOS | Same |
| Light source | LED | LED | LED | Same |
| Field of view(degree) | 120° | 120° | 100° | Same as the Predicate Device |
| Direction of view(degree) | 0° | 0° | 0° | Same |
| Resolution ratio | $400×400$ | Unknow | 16.0 million pixels | Note 2 |
| Depth of field | 3-50mm | 3-50mm | 2-50mm | Same as the Predicate Device |
| Instrument channel width | UR-D1: Φ1.2mm<br>UR-D2: Φ1.2mm<br>UR-F1: Φ1.2mm<br>UR-F2: Φ1.2mm | 1.0 mm | 3.6Fr | Note 3 |
| | Maximum width of<br>insertion tube | UR-D1: Φ2.8mm<br>UR-D2: Φ2.5mm<br>UR-F1: Φ2.8mm<br>UR-F2: Φ2.5mm | 3.2 mm | 8.6Fr |
| Working length of the | | 650mm | 650 mm | 670mm |
| Item | Proposed Device<br>Single use flexible<br>ureteroscope | Predicate Device<br>Pusen Single Use Flexible<br>Video Ureteroscope | Reference Device<br>WiScope® OM<br>Endoscope System | Remark |
| 510(k) number | K240073 | K172098 | K210579 | |
| insertion section | | | | |
| Bending angle(degree) | Upper: 275°<br>Down: 275° | Upper: 270°<br>Down: 270° | Upper: 275°<br>Down: 275° | Same as the Reference Device |
| Ureteroscope | Single-Use | Single-Use | Single-Use | Same |
| Sterilization | EO<br>SAL: 10-6 | EO<br>SAL: 10-6 | EO<br>SAL: 10-6 | Same |
| White balance | Yes | Yes | Yes | Same |
| Brightness Control | Yes | Yes | Yes | Same |

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# K240074

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# Table 2 Performance Comparison

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## K240074

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# b. Discussion on differences between the subject and the predicate device

| | Regarding the indications for use, compared to the predicate device, the intended use of both of them are the same. |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 1 | The intended use of the subject device is the same as that of the reference device in the urinary tract and the kidney, with only |
| Indications for | slight differences in description. The indications of reference device contain two aspects, to performing various diagnostic and<br>therapeutic procedures within the urinary tract (code "FGB") and to examining and performing procedures within the bile ducts. |
| Use | |
| | (code "FBN"). The aspect compared with the proposed device is to performing various diagnostic and therapeutic procedures |

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| 1 |
|---|
| C |

| | within the urinary tract (code “FGB”). The indications which represented by code “FBN” are not in the scope of comparison. So<br>the product codes and the indications of use can be judged as equal. |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 2 | Same as the reference Device. |
| Resolution ratio | The different with Predicate Device does not adversely impact safety and effectiveness of proposed device. |
| Note 3 | The instrument channel width of the subject device is the same as the reference device, but larger than the predicate device. The<br>larger the indicator, the more advantageous it is for clinical application.<br>Therefore, the different does not adversely impact safety and effectiveness of subject device. |
| Instrument<br>channel width | |
| Note 4 | The Maximum width of insertion tube of the subject device is smaller than the predicate devices, The smaller of the Maximum<br>width of insertion tube, the more advantageous it is for clinical application. Therefore, the different does not adversely impact<br>safety and effectiveness of subject device. |
| Maximum width<br>of insertion tube | The subject device offers a variety of sizes for flexible selection. |

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## IX.Summary of Non-clinical Performance

All non-clinical testing performed on new devices is to demonstrate the substantial equivalence to the predicate device and reference device. Tests setup and execution were performed in accordance with applicable standards. Results of the testing demonstrate compliance to the standards and matching the performance of subject device to the reference device. The following performance data were provided in support of the substantial equivalence determination.

### > Biocompatibility

The biocompatibility evaluation for the Single use flexible ureteroscope was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The insertion portion of Single use flexible ureteroscope is considered to contact a breached or compromised surface for a duration of less than 24 hours; therefore, the following tests are considered and passed:

| Biocompatibility testing summary | |
|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Test | Testing Summary |
| Cytotoxicity test (ISO 10993-5:2009 “Biological evaluation of<br>medical devices – Part 5: Tests for in vitro cytotoxicity) | No Cytotoxicity |
| Skin sensitization test (ISO 10993-10:2010 “Biological evaluation<br>of medical devices – Part 10: Tests for irritation and sensitization) | No evidence of skin<br>sensitization |
| Vaginal irritation Test (ISO 10993-23:2021<br>Biological evaluation of medical devices-Part 10: Tests for irritation<br>and vaginal irritation) | No evidence of<br>irritation |
| Acute Systemic Toxicity Test(ISO 10993-11:2017 “Biological<br>evaluation of medical devices – Part 11: Tests for systemic<br>toxicity” ) | No evidence of Acute<br>Systemic Toxicity |

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| Pyrogen Test(ISO 10993-11:2017 “Biological evaluation of | No evidence of |
|-----------------------------------------------------------|----------------|
| medical devices - Part 11: Tests for systemic toxicity” ) | Pyrogen |

#### A Electrical Safety and Electromagnetic Compatibility

Electrical safety and EMC testing were conducted on the Single use flexible ureteroscope and image processor, and the device complies with the following standards:

- · IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
• IEC 60601-2-18: 2009 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment.

• IEC 60601-1-2: 2014 + A1: 2020 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances -Requirements and tests.

• IEC TR 60601-4-2:2016 Medical electrical equipment- Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.

### A Photobiological safety

The subject device was tested according to the following FDA recognized standards: • IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps and lamp systems.

#### > Sterilization Validation

The EO sterilization of the Single use flexible ureteroscope has been validated according to the following applicable standards:

• ISO11135:2014: Sterilization of medical device- validation and routine control of ethylene oxide sterilization

· ISO 11737-2:2019 Sterilization of Medical Device-Microbiological methods part 2: Tests of sterility performed in the validation of a sterilization process

• ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

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• USP <85> Bacterial endotoxins test

#### A Shelf Life and Sterile Barrier System (Packaging)

Shelf Life and Sterile Barrier System of the Single use flexible ureteroscope has been validated according to the following applicable standards:

• ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

• ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems

• ISO11607-1:2020 Packaging for terminally sterilized Medical Device Part 1:

Requirement for materials, sterile barrier systems and packaging systems

• ISO11607-2:2020 Packaging for terminally sterilized Medical Device Part 2:

Validation Requirement for forming, sealing and assembly process

• ASTM F 1929-15 Standard Test Method for Detecting Seal Leaks in Porous

Medical Packaging by Dye Penetration

• ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials

• DIN 58953-6:2016 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized

• ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

• ASTM F1608-16 Standard Test Method for Microbial Ranking of Porous

Packaging Materials (Exposure Chamber Method)

#### A Performance Data - Bench

The following performance data were provided in support of the substantial equivalence, as shown in the table below.

The optical performance testing was conducted in accordance with applicable parts of ISO 8600-1:2015, ISO 8600-3:2019, ISO 12233-2017, ISO15739-2017 and ISO/CIE 11664-4 standards, and the mechanical performance testing was conducted in accordance with applicable parts of ISO 8600-1:2015, ISO 8600-4:2014, YY/T 1028-2023 standards. The field of view was measured according to the test method in the article: Wang et al.,

{17}------------------------------------------------

"Endoscope field of view measurement." Biomedical Optics Express 8, no. 3 (2017): 1441-1454, and geometric distortion was measured according to section 3 of the article: Wang, et al., "Development of the local magnification method for quantitative evaluation of endoscope geometric distortion." Journal of Biomedical Optics 21, no. 5 (2016): 056003.

| Test category | Test item |
|---------------------------|----------------------------------|
| Optical<br>performance | Resolution |
| | Direction of view |
| | Depth of Field |
| | Field of view |
| | Geometric Distortion |
| | Signal-To-Noise Ratio |
| | Dynamic Range |
| | Image Intensity Uniformity (IIU) |
| | Color Performance |
| Mechanical<br>performance | Basic Size |
| | Bending angle(degree) |

#### A Performance Data - Animal

N/A, no animal studies are available for the subject device.

## X.Clinical Evidence

N/A.

## XI.Conclusion

In conclusion, the technological characteristics, features, specifications, and intended use of the subject device are substantially equivalent to the predicate device quoted above. The differences between the subjective device and the predicate device do not raise new questions of safety and effectiveness. Performance testing demonstrated that the subject device is as safe and effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate device.