Single-use Video Ureterorenoscope (SVU-220US)

K241639 · Huger Medical Instrument Co., Ltd. · FGB · Jul 1, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K241639
• Device Name: Single-use Video Ureterorenoscope (SVU-220US)
• Applicant: Huger Medical Instrument Co., Ltd.
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Jul 1, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: PCCP

Intended Use

Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging.

Device Story

Single-use Video Ureterorenoscope (SVU-220US) is a flexible, single-channel endoscope designed for use in hospital settings. It connects to a Medical Video Processor (K230475) to capture and display video images of the urinary tract and kidney interior. The device features a CMOS sensor at the distal end, which provides a 120° field of view and 0° direction of view. It includes a bending section for navigation (up/down 270°). The device is intended for single use and is sterilized via ethylene oxide. It is operated by clinicians to visualize the anatomy, facilitating diagnostic or surgical procedures. The output is displayed on a monitor via the processor, assisting the physician in clinical decision-making during endoscopic interventions.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing, including biocompatibility (ISO 10993-5, -10), sterilization validation (ISO 10993-7), and performance testing (ISO 8600 series, IEC 60601 series, IEC 62471).

Technological Characteristics

Flexible single-use endoscope; CMOS sensor; 2.9mm outer diameter; 700mm working length; 1.2mm instrument channel. Materials: TPU (bending/insertion), PC (distal end/valve), Pebax/Barium sulfate (channel), Epoxy resin (glue). Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: Wired connection to Medical Video Processor. Standards: ISO 8600, ISO 10993, IEC 60601-1/2-18, IEC 62471.

Indications for Use

Indicated for use in the urinary tract and interior of the kidney to provide video imaging when connected to a Medical Video Processor.

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 Video Ureterorenoscope (model: SVU-220) (K230475)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

July 1, 2024

HUGER Medical Instrument Co., Ltd. Shen Junjie RA Specialist Building 26A, No. 3825, Xinzhuan Highway, Dongjing Town, Songjiang District Shanghai. 201619 CHINA

Re: K241639

Trade/Device Name: Single-use Video Ureterorenoscope (SVU-220US) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Received: June 7, 2024

Dear Shen Junjie:

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.

The FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is

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consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.

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.

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

510(k) Number (if known) K241639

Device Name

Single-use Video Ureterorenoscope (SVU-220US)

Indications for Use (Describe)

Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging.

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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Image /page/4/Picture/0 description: The image shows the logo for Huger Endoscopy System. The word "HUGER" is in large, red, bold letters. Below the word is a thin red line, and below that is the phrase "ENDOSCOPY SYSTEM" in smaller, black letters.

Page 1 of 7 HUGER Medical Premarket Notification Special 510(k) Single-use Video Ureterorenoscope Section 2 510(k) Summary

K241639

Section 2: 510 (k) Summary

SVU-220US Single-use Video Ureterorenoscope

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Image /page/5/Picture/0 description: The image contains the logo for "HUGER ENDOSCOPY SYSTEM". The word "HUGER" is in large, bold, red letters. Underneath "HUGER" is a red line. Below the red line, the words "ENDOSCOPY SYSTEM" are written in a smaller, black font.

# 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number:

- 1. Date of Preparation: 02/16/2023
- 2. Submitter Identification

## HUGER Medical Instrument Co., Ltd.

Building 26A, No. 3825, Xinzhuan Highway, Dongjing Town, Songjiang District, 201619, Shanghai, China.

Establishment Registration Number: Not yet registered.

Contact Person: Shen Junjie Position: RA Specialist Tel: [phone] Fax: [phone] Email: junjie.shen(@huger.cn

#### 3. Identification of Proposed Device

Trade Name/ Common Name: Single-use Video Ureterorenoscope

Classification Name: Ureteroscope and Accessories, Flexible/rigid Classification: II Product Code: FGB Regulation Number: 21CFR 876.1500 Review Panel: Gastroenterology/Urology

### Intended use/ Indications for Use:

Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging.

### Device Description:

The Single-use Video Ureterorenoscope (SVU-220US) is intended to be used with the HUGER'S Medical Video Processor (cleared in K230475). The Single-use Video Ureterorenoscope is a single use device. The Single-use Video Ureterorenoscope is consist of distal end, bending section, insertion portion, operational portion and connection portion. The Single-use Video Ureterorenoscope is a single-channel endoscope. Only one instrument channel is in the distal end

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Image /page/6/Picture/0 description: The image shows the logo for Huger Endoscopy System. The word "HUGER" is in large, red, bold letters. Underneath the word "HUGER" is a thin red line. Below the red line, the words "ENDOSCOPY SYSTEM" are written in smaller, black letters.

### of the endoscope.

The Single-use Urology Videoscope is sterilized by Ethylene Oxide Gas to achieve a SAL of 10t6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

#### 4. Identification of Predicate Device

510(k) Number: K230475

Product Name: Medical Video Endoscope system

### Information on Legally Marketed Predicate Device:

| Predicate# | Predicate Trade Name | Product Code |
|------------|-------------------------------------------------------|--------------|
| K230475 | Single-use Video Ureterorenoscope<br>(model: SVU-220) | FGB |

### Differences between the subject device and predicate device

The subject and predicate devices have the same fundamental technology, optical and physical characteristics, materials, structure, sterilization methods and components. The only difference is the deflection at the distal end. A comparison between the proposed device and predicate devices is included in the table below:

| ITEM | Subject Device<br>Single-use Video<br>Ureterorenoscope (model:<br>SVU-220US) | Predicate Device<br>Single-use Video<br>Ureterorenoscope (model:<br>SVU-220) | Remark |
|------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Product Code | FGB | FGB | Same |
| Regulation No. | 876.1500 | 876.1500 | Same |
| Class | II | II | Same |
| Structure and<br>components | Image: Subject Device Ureterorenoscope | Image: Predicate Device Ureterorenoscope | Same |
| Indications for Use | Single-use Video<br>Ureterorenoscope is intended to<br>connect with Medical Video | Medical Video Endoscope<br>System has been designed to be<br>used with endo-therapy | Similar, refer<br>to difference<br>analysis ① |
| | | | |
| | Processor to provide video<br>imaging | accessories such as a<br>biopsy forceps and other<br>ancillary equipment for<br>endoscopy and endoscopic<br>surgery within urinary tract<br>and interior of the kidney.<br>Medical Video Processor is<br>intended to be used in<br>conjunction with the endoscopes<br>to enhance and display the<br>image of the field of view of the<br>endoscope on the monitor, and<br>also provides functional supply<br>for the endoscope.<br>Single-use Video<br>Ureterorenoscope is intended to<br>connect with Medical Video<br>Processor to provide video<br>imaging. | below |
| Single use/ Reuse | Single use | Single use | Same |
| Sterile | Yes | Yes | Same |
| Anatomical Site | Urinary tract and interior of the<br>kidney | Urinary tract and interior of the<br>kidney | Same |
| Where used | Hospital | Hospital | Same |
| Label/Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| | Performance of Single-use Video Ureterorenoscope | | |
| Scope type | Flexible | Flexible | Same |
| Field of view | 120° | 120° | Same |
| Direction of view | 0° | 0° | Same |
| Depth of field | 2-100mm | 2-100mm | Same |
| Sensor type | CMOS | CMOS | Same |
| Max. outer<br>diameter of<br>insertion section | 2.9mm | 2.9mm | Same |
| Up/down deflection | Up:270° Down: 270° | Up:270° Down: 270° | Same |
| Work length | 700mm | 700mm | Same |
| Minimum<br>instrument channel<br>width | 1.2mm | 1.2mm | Same |
| Product<br>Performance | Comply with ISO 8600-1, ISO<br>8600-3, ISO 8600-4 and ISO<br>8600-7 | Comply with ISO 8600-1, ISO<br>8600-3, ISO 8600-4 and ISO<br>8600-7 | Same |
| Deflection | Refer to figure 1 below | Refer to figure 2 below | Different |
| | | | refer to<br>difference<br>analysis ②<br>below |
| Patient-contact component and material | | | |
| Bending section | Thermoplastic Polyurethane<br>(TPU) | Thermoplastic Polyurethane<br>(TPU) | Same |
| Insertion section | Thermoplastic Polyurethane<br>(TPU) | Thermoplastic Polyurethane<br>(TPU) | |
| Distal End Section | Polycarbonate (PC) | Polycarbonate (PC) | |
| CMOS Front End | Glass | Glass | |
| Instrument channel | Pebax and Barium sulfate | Pebax and Barium sulfate | |
| Tuohy Borst Valve<br>Assembly | Polycarbonate (PC) and<br>Polyethylene copolymer | Polycarbonate (PC) and<br>Polyethylene copolymer | |
| UV Glue | Epoxy resin | Epoxy resin | |
| Biocompatibility | Cytotoxicity: ISO 10993-5 | Cytotoxicity: ISO 10993-5 | Same |
| | Sensitization: ISO 10993-10 | Sensitization: ISO 10993-10 | |
| | Irritation: ISO 10993-10 | Irritation: ISO 10993-10 | |
| Sterilization method | | | |
| Method | EO sterilization | EO sterilization | Same |
| SAL | 10-6 | 10-6 | Same |

### Comparison Table: Subiect vs. Predicate Device (SVU-220US vs. SVU-220)

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Image /page/7/Picture/0 description: The image shows the logo for Huger Endoscopy System. The word "HUGER" is in large, red, bold letters. Below the word "HUGER" is a thin red line, and below that is the text "ENDOSCOPY SYSTEM" in smaller, black letters.

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Image /page/8/Picture/0 description: The image contains the word "HUGER" in large, bold, red letters. Below the word "HUGER" is a thin red line. Underneath the red line, the words "ENDOSCOPY SYSTEM" are written in a smaller, thinner font, also in red. The text appears to be a logo or brand name.

Difference analysis:

- (1) For the difference on Indications of use, since the predicate device includes indications of use of medical video endoscope System, medical video processor and Single-use Video Ureterorenoscope, only the indications of use of single-use Video Ureterorenoscope of the predicate device has been adopted for the subject device SVU-220US. In conclusion, the indications of use of subject device is identical with that of single-use video Ureterorenoscope SVU-220 of predicate device.
- (2) The only difference between the subject device and predicate device is deflection at the distal end. For SVU-220US, the direction of the clockwise rotation is marked "up", and that of the counterclockwise rotation is marked as "down". For SVU-220, the direction of the clockwise rotation is marked "down", and that of the counterclockwise rotation is marked as "up".

Figure 1. Deflection of subject device (SVU- Figure 2. Deflection of predicate device 220US) (SVU-220)

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Image /page/9/Picture/0 description: The image shows the logo for Huger Endoscopy System. The word "HUGER" is in large, red, bold letters. Underneath the word "HUGER" is a thin red line, and underneath the line is the phrase "ENDOSCOPY SYSTEM" in smaller, black letters.

Image /page/9/Figure/2 description: The image shows a diagram of a hand holding a medical instrument. The diagram shows the instrument being moved up and down. The words "Up" and "Down" are written above the instrument to indicate the direction of movement. There are two sets of diagrams, one on the left and one on the right, showing the same movement.

#### ડ. Non-Clinical Test Conclusion

Since the subject device is exactly the same as the predicate device in terms of fundamental technology, optical and physical characteristics, structure, sterilization methods and components, the only difference between these models is deflection at their distal end, and through a risk analysis was completed to identify the risks associated with assembly process in production, but not in product design. HUGER Medical believed that the verification testing of Predicate device (SVU-220) can be fully covered with subject device (SVU-220US).

Therefore, the subject device also complies with the following standards:

- > ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- > ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials
- A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- > ISO 8600-1:2015 Endoscopes-Medical endoscopes and endotherapy devices - Part 1: General requirements
- > ISO 8600-3:1997/Amd1:2003 Optics and optical instruments -Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics
- A ISO 8600-4:2014 Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
- A ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- A ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- > 60601-1-2005+CORR.1:2006+CORR.2:2007+AM1:2012, IEC Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance, including the US National Differences
- > IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic disturbances -

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Image /page/10/Picture/0 description: The image shows the logo for Huger Endoscopy System. The word "HUGER" is in large, red, bold letters. Below the word "HUGER" is a thin red line. Below the red line, the words "ENDOSCOPY SYSTEM" are in smaller, black letters.

Requirements and tests

- > IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and > Systems
- A ISO 14971:2019 Medical Devices - Application of risk management to medical devices
- > IEC 62471:2006 Photobiological safety of lamps and lamp systems

### Biocompatibility testing

Since the raw materials of the subject device is exactly the same as that of predicate device The contact level of the subject device is mucosal membrane, and the contact duration is limited contact (<24 hours). Therefore, the biocompatibility testing results of the predicate device apply to the subject device. The results of the biocompatibility testing as following showed that there are no negative impacts from the materials that are used in the predicate device.

- A Cytotoxicity,
- A Sensitization,
- > Intracutaneous,

## Bench performance testing

### Optical performance testing

- A Photobiological safety test was performed according to IEC 62471: 2006 on predicate device;
### Physical/functional performance testing

- A Irrigation valve leakage test was performed on the predicate device.
### Endoscope and video processor use-life testing

The optical performance comparison test was conducted on the un-aged Single-use Video Ureterorenoscope (SVU-220) and aged Single-use Video Ureterorenoscope (SVU-220). The test results demonstrate that the optical performance of the aged endoscope is similar as those of the unaged endoscope.

#### 6. Clinical Test Conclusion

No Clinical study is included in this submission

#### 7. Substantially Equivalent (SE) Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, the Singleuse Video Ureterorenoscope (Model: SVU-220US) is substantially equivalent to the predicate devices.