Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)

K243155 · Dongguan Zsr Biomedical Technology Company Limited · FGB · Feb 11, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K243155
• Device Name: Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
• Applicant: Dongguan Zsr Biomedical Technology Company Limited
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Feb 11, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04): This product is used in medical institutions, in conjunction with our Electronic Endoscope Imaging Processor, for imaging in examination, diagnosis or treatment of urinary system diseases. Electronic Endoscope Imaging Processor (ZSR-EOS10): This product is used in medical institutions, in conjunction with our Single-Use Digital Flexible Ureteroscope, for imaging in examination, diagnosis or treatment of urinary system diseases.

Device Story

System comprises single-use digital flexible ureteroscope (F-URS) and electronic endoscope imaging processor (ZSR-EOS10). Ureteroscope features flexible insertion tube, operating handle with directional control, and CMOS sensor for digital video capture. Processor unit (aluminum alloy chassis) receives video signal from ureteroscope, processes data, and displays images on external monitor. Used by skilled medical staff in hospitals/clinics for urinary tract/kidney visualization. System facilitates endoscopic diagnosis and surgery. Benefits include single-use design eliminating reprocessing requirements and reducing cross-contamination risk.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench performance testing, including optical performance (ISO 8600 series, ISO 12233, ISO 15739), biocompatibility (ISO 10993-1), and sterility/shelf-life validation (ISO 11135, ASTM F1980).

Technological Characteristics

System includes flexible ureteroscope and imaging processor. Features CMOS digital video technology, LED illumination, 120° field of view, 0° direction of view, and 275° up/down bending. Insertion portion width 2.50-2.85mm; working length 670mm. Sterilization via ethylene oxide (EO). Processor utilizes aluminum alloy chassis with motherboard/power supply. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for imaging in the examination, diagnosis, or treatment of urinary system diseases in adults within medical institutions.

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

• Single-Use Flexible Ureteroscope (K230200)

Reference Devices

• Single-Use Video Flexible Ureterorenoscope System (K221158)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION" also in blue.

February 11, 2025

Dongguan ZSR Biomedical technology Company Limited % Kang Kyra Director Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza, West Guangzhong Road 555, Jingan District Shanghai, 200072 CHINA

Re: K243155

> Trade/Device Name: Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Received: January 3, 2025

Dear Kang Kyra:

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.

{1}------------------------------------------------

Page

2

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 (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 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

{2}------------------------------------------------

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 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

{3}------------------------------------------------

### Indications for Use

510(k) Number (if known) K243155

#### Device Name

Single-Use Digital Flexible Ureteroscope(F-URS)(ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) Electronic Endoscope Imaging Processor(ZSR-EOS10)

### Indications for Use (Describe)

Single-Use Digital Flexible Ureteroscope (F-URS)(ZSR-URS-02, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) : This product is used in medical institutions, in conjunction with our electronic endoscope image processor. for imaging in examination, diagnosis or treatment of urinary system diseases.

Endoscope Imaging Processor (ZSR-EOS10) :

Applicable to medical institutions, which are connected with electronic endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors.

| 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."

{4}------------------------------------------------

# 510(k) Summary

### l. Submitter

Dongguan ZSR Biomedical technology Company Limited Unit 448, Qingfeng Road, Taihu Village, Sanzhong Village Committee, Qingxi Town, 523651 Dongguan City, Guangdong Province,PEOPLE'S REPUBLIC OF CHINA Contact person: Mrs. Sharon Wen Position: Management Representative Tel.:[phone] E-mail: [e-mail]

Preparation date: January 30, 2025

Submission Correspondent Ms. Kyra Kang Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: [e-mail]

## II. Proposed Device

| Device Trade Name: | Single-Use Digital Flexible Ureteroscope (F-URS: ZSR-<br>URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)<br>Electronic Endoscope Imaging Processor (ZSR-EOS10) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Endoscope and Accessories |
| Regulation Number: | 21 CFR 876.1500 |
| Regulatory Class: | Class II |
| Product code: | FGB |
| Review Panel: | Gastroenterology/Urology |

### III. Predicate Devices

| 510(k) Number: | K230200 |
|-----------------|------------------------------------------|
| Trade name: | Single-Use Flexible Ureteroscope |
| Common name: | Endoscope and Accessories |
| Classification: | Class II |
| Product Code: | FGB |
| Manufacturer | Hunan Vathin Medical Instrument Co., Ltd |

### IV. Reference Devices

{5}------------------------------------------------

K243155 Page 2 of 6

| 510(k) Number: | K221158 |
|-----------------|---------------------------------------------------|
| Trade name: | Single-Use Video Flexible Ureterorenoscope System |
| Common name: | Endoscope and Accessories |
| Classification: | Class II |
| Product Code: | FGB |
| Manufacturer | Guangzhou Red Pine Medical Instrument Co., Ltd. |

### V. Device description

- > Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
Single-Use Digital Flexible Ureteroscope (F-URS) is used in medical institutions, in conjunction with our electronic endoscope image processor, for imaging in examination, diagnosis or treatment of urinary system diseases. This device uses ethylene oxide (EO) sterilization process. This product consists of two main parts: an operating handle with directional control and connecting wires, as well as a flexible insertion tube.

#### > Electronic Endoscope Imaging Processor (ZSR-EOS10)

Applicable to medical institutions, which are connected with electronic endoscopes during endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors. The device is composed of aluminum alloy chassis and motherboard and power supply components.

The Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) and Electronic Endoscope Imaging Processor make up the video ureteroscope system.

#### VI. Indication for use

Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04): This product is used in medical institutions, in conjunction with our Electronic Endoscope Imaging Processor, for imaging in examination, diagnosis or treatment of urinary system diseases.

Electronic Endoscope Imaging Processor (ZSR-EOS10): This product is used in medical institutions, in conjunction with our Single-Use Digital Flexible Ureteroscope, for imaging in examination, diagnosis or treatment of urinary system diseases.

### VII.Comparison of technological characteristics with the predicate devices

{6}------------------------------------------------

| Character<br>istics | Proposed device | Predicate device<br>(K230200) | Discussion | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-----------|
| Trade<br>name | Single-Use Digital Flexible<br>Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-<br>URS-03, ZSR-URS-04)<br><br>Electronic Endoscope Imaging<br>Processor (ZSR-EOS10) | Single-Use Flexible<br>Ureteroscope | / | |
| Classification<br>Name | Ureteroscope And<br>Accessories, Flexible/Rigid | Ureteroscope And<br>Accessories, Flexible/Rigid | Same | |
| Product<br>Code | FGB | FGB | Same | |
| Regulation<br>Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same | |
| Indications<br>for<br>use | Single-Use Digital Flexible<br>Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-<br>URS-03, ZSR-URS-04): This<br>product is used in medical<br>institutions, in conjunction with<br>our Electronic Endoscope<br>Imaging Processor, for<br>imaging in examination,<br>diagnosis or treatment of<br>urinary system diseases.<br><br>Electronic Endoscope Imaging<br>Processor (ZSR-EOS10): This<br>product is used in medical<br>institutions, in conjunction with<br>our Single-Use Digital Flexible<br>Ureteroscope, for imaging in | The Single-use Flexible<br>Ureteroscope is<br>designed for use with Vathin<br>Display<br><br>Units, endotherapy<br>accessories and other<br>ancillary devices for the<br>endoscopy and<br>endoscopic surgery within<br>urinary tract<br><br>and kidney in adults. | Same | |
| | | treatment of urinary system diseases. | | |
| Application | field | The device is for use in a hospital or qualified medical institution. | The device is for use in a hospital or qualified medical institution. | Same |
| Intended | user | The device is only to be used by skilled medical staff trained in clinical endoscopic techniques and procedures. | The device is only to be used by skilled medical staff trained in clinical endoscopic techniques and procedures. | Same |
| Patient | | Adults | Adults | Same |
| population | | | | |
| Scope | type | Flexible | Flexible | Same |
| Field of | view (degree) | $120°±10°$ | $110°$ | Same |
| Direction | of view (degree) | $0°$ | $0°$ | Same |
| Bending | angle (degree) | Up 275 °/down 275 ° (tolerance -10%, upper limit not included) | Up: 285°<br>Down: 285° | Same |
| Maximum | insertion portion width(mm) | ZSR-URS-01, ZSR-URS-02: 2.85<br>ZSR-URS-03, ZSR-URS-04: 2.50 | US-S170, US-E170: 3.15<br>US-S180, US-E180: 3.25 | Similar 1 |
| Minimum | insertion channel width(mm) | ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04: 1.2 | US-S170, US-E170: 1.2<br>US-S180, US-E180: 1.4 | Same |
| Working<br>length<br>(mm) | 670mm, tolerance ± 10% | 700 | Same | |
| | Digital<br>video<br>technology | CMOS | CMOS | Same |
| Illuminatio<br>n<br>source | LED | LED | Same | |
| Single-use | Yes | Yes | Same | |
| Biocompat<br>ibili<br>ty | No Cytotoxicity<br>No Irritation to Skin<br>No significant evidence of<br>sensitization | No Cytotoxicity<br>No Irritation to Skin<br>No significant evidence of<br>sensitization | Same | |
| Sterilizatio<br>n | EO | EO | Same | |

{7}------------------------------------------------

{8}------------------------------------------------

Analysis 1 -

Only differences in specifications and dimensions. All the performance was tested and the results met the standard requirements, this difference will not raise any issues in safety and effectiveness.

### VIII.Non-Clinical Testing

The device described in this summary was tested and demonstrated to be in conformance with the following standards:

### Performance testing:

- ISO16926-6:2014 >
- ISO 8600-5:2020 V
- > IEC 62471:2006
- V ISO 8600-1:2015
- > ISO 8600-4:2014
- ISO 12233:2017 V
- ISO 15739:2017 >

{9}------------------------------------------------

- ISO/CIE 11664-4 >
- > Wanq, et al., "Development of the local maqnification method for quantitative evaluation of endoscope geometric distortion." Journal of Biomedical Optics 21, no. 5 (2016): 056003Wang et al., "Endoscope field of view measurement." Biomedical Optics Express 8, no. 3(2017):1441-1454.
- > Wei-Chung Cheng, "Color Performance Review (CPR): A Color Performance Analyzer for Endoscopy Devices" in Journal of Imaging Science and Technology, 2023, pp1 -9, https://doi.org/10.2352/.lmagingSci.Technol.2023.67.5.050406

## Biocompatibility testing

Biocompatibility of the Disposable Ureteral Guide Sheath was evaluated in accordance with the FDA quidance "Use of International Standard ISO 10993-1" The following testing was conducted:

- > Cytotoxicity
- > Sensitization
- > Irritation
- > Acute Systemic
- > Pyrogenicity

### Sterility and Shelf -life

- ISO 11135:2014 V
- > ISO 11737-1:2018
- ISO11737-2:2019 >
- > ISO 10993-7: 2008
- > ASTM F1980-2016
- > ASTM F88/F88M-15
- ASTM D4169-23e1 >

### IX. Clinical Testing

No clinical study is included in this submission.

### X. Conclusion

The proposed device has the same indications for use and has similar design features and technological characteristics as the predicate device. Performance testing data demonstrates that the proposed device is as safe and effective as the predicate device. Accordingly, the proposed device is substantially equivalent to the predicate device.