Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

K241500 · Guangzhou Red Pine Medical Instrument Co., Ltd. · FAJ · Jul 12, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K241500
• Device Name: Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
• Applicant: Guangzhou Red Pine Medical Instrument Co., Ltd.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Jul 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Endoscopic Video Image Processor: This device is used in conjunction with the video endoscopes produced by our company to process the images collected by the video endoscopes and send them to the display, and provide power for the endoscope. Single-Use Video Flexible Cysto-Nephroscope: This product shall be used in conjunction with the Endoscopic Video Image Processor and other perioheral equipment for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product shall not be used for other purposes.

Device Story

System comprises a single-use flexible video cysto-nephroscope and a multi-use endoscopic video image processor. The scope captures visual data from the bladder, urethra, and kidney; the processor receives this input, performs image processing, and outputs the video signal to a display while providing power to the scope. Used in hospitals and clinics by healthcare professionals for diagnostic and therapeutic procedures. The processor is cleaned/disinfected between uses; the scope is sterile and single-patient-use. The system enables visualization for clinical decision-making and patient treatment.

Clinical Evidence

Bench testing only. Performance testing included optical (direction of view, depth of field, resolution, SNR, distortion, intensity uniformity, dynamic range, color) and mechanical (size, surface, water delivery, sealing, fatigue, tensile strength, connector performance) evaluations. Compliance with ISO 8600 and IEC 62471 (photobiological safety) was demonstrated. Comparative testing against the predicate confirmed similar optical and mechanical performance.

Technological Characteristics

System includes a single-use flexible video cysto-nephroscope and a video image processor. Optical performance follows ISO 8600 standards. Photobiological safety verified per IEC 62471:2006. Processor provides power and image processing for the scope. Connectivity involves proprietary scope-to-processor interface. Sterilization: Scope is sterile (single-use); processor is non-sterile (multi-use, requires disinfection).

Indications for Use

Indicated for observation, diagnosis, photography, and treatment within the bladder, urethra, and kidney in professional healthcare facility environments (hospitals/clinics).

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

• EVIS EXERA II 180 System (K133538)

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 12, 2024

Guangzhou Red Pine Medical Instrument Co., Ltd. Weihua Yang Regulatory Affairs Director 12 F, No.87 Luoxuan Avenue, Guangzhou International Bioisland, Huangpu District Guangzhou, Guangdong 510000 CHINA

Re: K241500

> Trade/Device Name: Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: May 27, 2024 Received: May 28, 2024

Dear Weihua Yang:

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 (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.

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

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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)

K241500

Device Name

Endoscopic Video Image Processor (RP-IPD-V2000EF):

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

Indications for Use (Describe)

Endoscopic Video Image Processor

This device is used in conjunction with the video endoscopes produced by our company to process the images collected by the video endoscopes and send them to the display, and provide power for the endoscope.

Single-Use Video Flexible Cysto-Nephroscope

This product shall be used in conjunction with the Endoscopic Video Image Processor and other perioheral equipment for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney.

The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product shall not be used for other purposes.

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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K241500 Page 1 of 3

| 510(k) Summary | | K241500 Page 1 of 3<br>Prepared on: 2024-05-27 |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Guangzhou Red Pine Medical Instrument Co., Ltd. | |
| Applicant Address | 12 F, No.87 Luoxuan Avenue, Guangzhou International Bioisland,<br>Huangpu District Guangzhou Guangdong 510000 China | |
| Applicant Contact Telephone | [phone] | |
| Applicant Contact | Mr. Weihua Yang | |
| Applicant Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Endoscopic Video Image Processor (RP-IPD-V2000EF);<br>Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | |
| Common Name | Cystoscope And Accessories, Flexible/Rigid | |
| Classification Name | Endoscope and accessories | |
| Regulation Number | 876.1500 | |
| Product Code(s) | FAJ | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K133538 | EVIS EXERA II 180 System | NWB |
| Device Description Summary<br>21 CFR 807.92(a)(4) | | |

The proposed device, Cysto-Nephroscope System, which includes a Single-Use Video Flexible Cysto-Nephroscope and an Endoscopic Video Image Processor is intended for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney.

The Single-Use Video Flexible Cysto-Nephroscope is available in two models with the different position of "U" and "D" mark on the handle and different deflection, RP-U-C01F, RP-U-C01F5. The Endoscopic Video Image Processor has only one model, RP-IPD-V2000EF.

The Single-Use Video Flexible Cysto-Nephroscope is sterile and single-patient-use device. The Endoscopic Video Image Processor is nonsterile and multi-patient-use device, and it will be cleaned and disinfected before first use and after each use.

# Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Endoscopic Video Image Processor

This device is used in conjunction with the video endoscopes produced by our company to process the images collected by the video endoscopes and send them to the display, and provide power for the endoscope.

Single-Use Video Flexible Cysto-Nephroscope

This product shall be used in conjunction with the Endoscopic Video Image Processor and other peripheral equipment for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney. The device is suitable for professional healthcare facility environments such as hospitals and clinics.

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This product shall not be used for other purposes.

# Indications for Use Comparison

The indication for use of the proposed device and the predicate device is similar.

The indication for use of proposed device is covered in the predicate device. For the target location, the proposed device is not intended to used in ureter, so the ureter is not included in the indications for use of the proposed device. The difference will not affect the safety and effectiveness of the proposed device.

# Technological Comparison

The principles of operation, color tone adjustment, image enhancement, working length, field of view of the proposed device are same as the predicate device. Minimum instrument channel width of the proposed device is also extremely close to the predicate device.

The main configuration, single use or reuse, sterile, dimension and weight, white balance, zoom, insertion tube width, maximum insertion portion width, bending and depth of field of the proposed device are different from or similar as the predicate device. These differences will not raise new question on safety and effectiveness of the proposed device based on the comparative test report of the proposed device and predicate device.

#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

1. Performance testing

The performance testing was conducted on the proposed Cysto-Nephroscope System, the performance testing includes optical performance and mechanical performance testing includes ISO 8600 test, and the ISO 8600 test results demonstrated that the proposed system complies with the standard requirements.

The optical performance testing includes direction of view, depth of field, resolution, signal-to-noise ratio, geometric distortion, image intensity uniformity, dynamic range and color performance.

The mechanical performance testing includes basic size, surface and edges, water delivery system, sealing performance, compatibility with accessories, fatigue test of rocker and bending section, tensile strength of insertion portion, performance of cable connector, comprehensive performance of luer connector.

## 2. Performance comparative testing

The performance comparative testing was conducted on the proposed Cysto-Nephroscope system and predicate system, the performance testing includes optical performance and mechanical performance.

The performance comparative testing includes ISO 8600 test results demonstrated that the proposed system complies with the standard requirements.

The optical performance testing includes direction of view, depth of field, resolution, signal-to-noise ratio, geometric distortion, image intensity uniformity, dynamic range and color performance.

The mechanical performance testing includes basic size, surface and edges, water delivery system, sealing performance, fatigue test of rocker and bending section portion and performance of cable connector. And the image quality evaluation is performed.

The test results demonstrate that the optical performance of the proposed system is similar as those of the predicate device.

3. Performance Testing-Image Frame Frequency and System Delay

The Image Frame Frequency and System Delay testing was conducted on the proposed Cystem and aged proposed Cysto-Nephroscope System.

## 4. Performance Testing- Photobiological Safety Test

The primary components of the proposed Cyste-Nephroscope System, includes a Single-Use Video Flexible Cysto-Nephroscope and an Endoscopic Video Image Processor, are tested per the following standard, to evaluate their photobiological safety. The test results demonstrated that the proposed system complies with the standard requirements of EC 62471:2006 Photobiological Safety of lamps and lamp systems.

The Performance Comparative Testing and Performance Testing was completed and the proposed device and the predicate device have same or similar design features and performance specifications (both of optical performance and mechanical performance). Although there are some differences on the mechanical parameters between the subject device,

# K241500 Page 2 of 3

## 21 CFR 807.92(a)(5)

## 21 CFR 807.92(a)(6)

01 CEP 807 02/b

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such differences will not affect the effectiveness and safety of the proposed device. Therefore, the tests demonstrate that the proposed device is as safe, as effective, and performs as well as the predicate device.