Single-Use Flexible Ureteroscope

K230200 · Hunan Vathin Medical Instrument Co., Ltd. · FGB · May 18, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K230200
• Device Name: Single-Use Flexible Ureteroscope
• Applicant: Hunan Vathin Medical Instrument Co., Ltd.
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: May 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.

Device Story

Single-use flexible ureteroscope used for visualization and surgical access in urinary tract and kidney. Device consists of insertion part (braided PEBAX sheath, bending section, distal end with CMOS sensor and LED), control part (ABS handle), and connection cable. Operates by inserting into ureter/kidney; CMOS sensor captures mucosal reflected light; converts to electrical signals; transmits to Vathin Display Unit (Model DVM-A1). Display unit processes signals for real-time visualization on screen. Used in hospitals/medical institutions by trained physicians. Enables diagnostic and therapeutic procedures (e.g., biopsy, stone removal) via ancillary accessories. Benefits include single-use sterility, eliminating reprocessing risks, and improved maneuverability (larger bending angles) compared to predicate.

Clinical Evidence

Bench testing only. No clinical data provided. Performance validated via biocompatibility (ISO 10993-1), sterility (ISO 11135, ISO 11607), electrical safety/EMC (IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2), and extensive functional, mechanical, and optical performance testing (e.g., bending angle, suction, image quality, SNR, color restoration).

Technological Characteristics

Materials: ABS (handle), PEBAX (sheath), snake bone (bending section). Sensing: CMOS image sensor. Illumination: LED. Connectivity: Wired connection to Vathin Display Unit. Sterilization: Ethylene Oxide (EO). Form factor: Flexible ureteroscope with 700mm working length, 110° FOV, 285° up/down bending. Models vary by suction/self-lock features and dimensions.

Indications for Use

Indicated for endoscopy and endoscopic surgery within the urinary tract and kidney in adults.

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)

Submission Summary (Full Text)

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May 18, 2023

Hunan Vathin Medical Instrument Co., Ltd. Du Jing RA Manager 1/F, Building 12, Innovation Entrepreneurship Service Center No.9 Chuangi West Road, Jiuhua Economic Development Zone Xiangtan, Hunan 411100 China

Re: K230200

> Trade/Device Name: Single-use Flexible Ureteroscope Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: April 18, 2023 Received: April 19, 2023

Dear Du Jing:

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 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 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 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

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# Indications for Use

510(k) Number (if known) K230200

Device Name Single-use Flexible Ureteroscope

Indications for Use (Describe)

The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.

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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# Section 5 510(k) summary

# Submitter

| Device submitter: | Hunan Vathin Medical Instrument Co., Ltd. | |
|-------------------|-------------------------------------------------------------------|--|
| Address: | 1/F, Building 12, Innovation and Entrepreneurship Service Center, | |
| | No 9 Chuanqi west road, Jiuhua Economic Development Zone, | |
| | 411100 Xiangtan, Hunan, China | |
| Contact person: | Du Jing | |
| | Title: RA Manager | |
| | Phone: [phone] | |
| | E-mail: [e-mail] | |

## Device

Trade Name of Device: Single-use Flexible Ureteroscope Common name: Ureteroscope and Accessories, Flexible/rigid Classification name: Endoscope and accessories Classification: Class II, 21 CFR 876.1500 Product Code: FGB Review Panel: Gastroenterology/Urology Date prepared: January 18, 2023

# Predicate Device

| Trade name: | Medical Video Endoscope system. |
|--------------------|----------------------------------------------|
| Regulation number: | 21 CFR 876.1500 |
| Regulation name: | Ureteroscope and Accessories, Flexible/rigid |
| Regulatory class: | Class II |
| Product code: | FGB |
| Submitter: | Zhuhai Pusen Medical Technology Co., Ltd. |
| 510(k) number: | K172098 |

# Device description

The Single-use Flexible ureteroscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and endoscopic surgery within urinary tract and kidney in adults. The Single-use Flexible ureteroscope is provided sterile (sterilized by EO) and intended to be singleuse.

The compatible Digital Video Monitor: Model: DVM-A1

The Single-use Flexible ureteroscope and Display Unit make up the video ureteroscope system. During diagnosis and treatment with the video ureteroscope system, the Single-use Flexible ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the

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image sensor (CMOS) at the end of the Single-use Flexible ureteroscope converts the received mucosal reflected light signals into electrical signals , transmitted to the Display Unit through the cable, the Display Unit receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display.

There are 4 models of Single-Use Flexible Ureteroscope, the difference between US-S170 and US-E170,US-S180 and US-E180 lies in the US-SXXX series with self-lock and suction function, US-EXXX series does not come with self-lock and suction functions, the rest is exactly the same. The difference between the 2 models of US-EXXX series lies in work channel ID, head OD and outer diameter of main hose OD, while the rest are exactly the same. The difference between the 2 models of US-SXXX series also lies in work channel ID, head OD and outer diameter of main hose OD, and the rest are the same.

The Single-use Flexible Ureteroscope includes insertion part, control part, connection part. The control part is made with ABS, contacted with users. The insertion part, as the part connected with patients, includes the sheath which is braided tube made with PEBAX tube, the bending section and the distal end. The bending section is made of snake bone, covered with snake bend eraser. The distal end is made of sensor and LED.

## Indications for use

The indications for use of subject and predicate device are the same. Both of the subject and predicate device are indicated for endoscopy and endoscopic surgery within urinary tract and kidney. The indications for use of subject device: The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults. The indications for use of predicate device: This instrument 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.

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# Comparison of technological characteristics with the predicate devices

The Single-Use Flexible Ureteroscope is like the predicate device in the following areas:

- Intended use (including application field, intended user and patient population) .
- . Principal operation
- Design and performance specifications .
- Digital video technology and illumination source .
- It allows for irrigation .
- It is single-use and delivered sterile .

The Single-Use Flexible Ureteroscope is different to the predicate device in the following areas:

- The bending angle is larger than the predicate .
- There are 4 specifications while predicate device has 2 specifications .
- Working length is 700mm while working length of predicate device is 650mm .

The differences between the Single-Use Flexible Ureteroscope and predicate device do not alter suitability of the proposed device for its intended use.

| Device feature | Proposed Device | Predicate Device |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Single-Use Flexible Ureteroscope | Medical Video Endoscope<br>system(K172098) |
| Classification<br>Name | Endoscope and accessories | Endoscope and accessories |
| Product Code | FGB | FGB |
| Regulation<br>Number | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Indications for use | The Single-use Flexible Ureteroscope is<br>designed for use with Vathin Display<br>Units, endotherapy accessories and other<br>ancillary devices for the endoscopy and<br>endoscopic surgery within urinary tract<br>and kidney in adults. | This instrument has been designed to be<br>used with endo-therapy accessories such<br>as a biopsy forceps and other ancillary<br>equipment for endoscopy and endoscopic<br>surgery within urinary tract and interior of<br>the kidney. |
| Application<br>field | The device is for use in a hospital or<br>qualified medical institution. | The Medical Video Endoscope system is<br>for use in a hospital or qualified medical<br>institution. |
| Intended user | The device is only to be used by skilled<br>medical staff trained in clinical endoscopic<br>techniques and procedures. | The system is only to be used by skilled<br>physicians trained in clinical endoscopic<br>techniques and procedures. |

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| Device feature | Proposed Device | Predicate Device |
|----------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Trade Name | Single-Use Flexible Ureteroscope | Medical Video Endoscope<br>system(K172098) |
| Patient<br>population | Adults | Adults |
| Scope type | Flexible | Flexible |
| Field of view<br>(degree) | 110° | 120° |
| Direction<br>of<br>view (degree) | 0° | 0° |
| Bending angle<br>(degree) | Up: 285°<br>Down: 285° | Up: 270°<br>Down: 270° |
| Maximum<br>insertion<br>portion<br>width(mm) | US-S170、US-E170: 3.15<br>US-S180、US-E180: 3.25 | 3.2 |
| Minimum<br>insertion<br>channel<br>width(mm) | US-S170、US-E170: 1.2<br>US-S180、US-E180: 1.4 | 1.0 |
| Working length<br>(mm) | 700 | 650 |
| Digital<br>video<br>technology | CMOS | CMOS |
| Illumination<br>source | LED | LED |
| Single-use | Yes | Yes |
| Biocompatibili<br>ty | No Cytotoxicity<br>No Irritation to Skin<br>No significant evidence of sensitization | No Cytotoxicity<br>No Irritation to Skin<br>No significant evidence of sensitization |
| Sterilization | EO | EO |

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# Summary of Non-clinical tests:

# Biocompatibility testing

Biocompatibility of the Single-Use Flexible Ureteroscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "breached or compromised surface" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation, Sensitization, Pyrogenicity and Acute systemic toxicity. All evaluation acceptance criteria were met.

# Sterility testing

Sterile barrier systems were evaluated in accordance with ISO 11607. Sterilization Process has been validated accordance with ISO 11135.

# Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Single-Use Flexible Ureteroscope. The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC.

## Performance testing

The following performance testing was conducted on the Single-Use Flexible Ureteroscope.

# Functional performance

- Appearance ●
- . Working length
- Work channel ID ●
- Head OD .
- Outer diameter of main hose .
- . Maximum outer diameter of the insertion part
- Bending angle
- Product weight ●
- . Rotating sleeve
- Handle-based photographing function
- Self-locking function
- . Wire length
- Image display
- . Waterproofness
- . Lens fogging
- Image quality
- LED illuminance test ●
- LED color temperature test ●
- . Air tightness test
- Suction ability .
- Water delivery ability .

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- . LED temperature test
## Mechanical performance

- Handle-based camera button reliability test .
- Passively bent part reliability test
- . Self-locking component reliability test
- Insertion end tension
- . Pull out tension of plug end

## Optical performance

- . Direction of view
- field of view test
- observation depth of field test
- geometric distortion test .
- . SNR test
- . dynamic tolerance test
- . brightness uniformity test

## Color performance

- . color restoration test
# Conclusion

The Single-Use Flexible Ureteroscope is substantially equivalent to predicate device.

The non-clinical testing demonstrates that the device is as effective and performs as well as the legally marketed device.