The Endoscopic Video Image Processor is used in conjunction with the Single-Use Video Flexible Cysto-Nephroscope (Models: RP-U-C01F, RP-U-C01FS) to process the images collected by the video endoscope and send them to the display, and provide power for the endoscope.

Device Description

The Endoscopic Video Image Processor is a video processing system intended for use during endoscopic procedures. It receives and processes image signals from a compatible video endoscope and produces live video images during endoscopic procedures. Apart from the image processing functions, it also provides the power supply for the endoscope.

The Endoscopic Video Image Processor is a reusable device. It does not require sterilization before use, as there is no direct/indirect patient contact. The device needs to be cleaned and disinfected before use. and the cleaning and disinfection method is outlined in the Instructions for Use.

AI/ML Overview

The provided text describes the Endoscopic Video Image Processor (RP-IPD-V1000F) as a video processing system for endoscopic procedures. It details its functions, such as processing image signals from compatible video endoscopes, producing live video images, and providing power to the endoscope. The document specifies that the device does not require sterilization as there is no direct/indirect patient contact but needs cleaning and disinfection before use.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific pass/fail thresholds alongside "reported device performance" in a quantitative manner as typically expected. Instead, it lists general performance characteristics that were tested and states that the "Performance Testing demonstrated that the subject device and the predicate device have similar performance, and the subject device is as safe and effective as the predicate device."

Here's a reconstruction based on the available information:

Acceptance Criteria (Implied)	Reported Device Performance
Direction of view	The testing showed similar performance to the predicate device.
Field of view	The testing showed similar performance to the predicate device.
Depth of field	The testing showed similar performance to the predicate device.
Resolution	The testing showed similar performance to the predicate device.
Signal-to-noise ratio	The testing showed similar performance to the predicate device.
Geometric distortion	The testing showed similar performance to the predicate device.
Image intensity uniformity	The testing showed similar performance to the predicate device.
Dynamic range	The testing showed similar performance to the predicate device.
Color performance	The testing showed similar performance to the predicate device.
Image Frame Frequency	The testing showed similar performance to the predicate device.
System Delay	The testing showed similar performance to the predicate device.

The standards referenced are:

ISO 8600-1:2015 Endoscopes - Medical endoscopes and endotherapy devices. General requirements
ISO 8600-3:2019 Endoscopes. Medical endoscopes and endotherapy devices. Part 3: Determination of field of view and direction of view of endoscopes with optics

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "the Cysto-Nephroscope System" as the subject of testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth. The testing appears to be primarily technical performance testing against ISO standards rather than a clinical evaluation requiring expert interpretation of medical images.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. Given that the testing appears to be technical performance testing of the device's imaging capabilities, a traditional adjudication method for medical image interpretation would likely not be applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document explicitly states "IX. Clinical Evidence N/A." This indicates that no human factors or comparative effectiveness study involving human readers with and without AI assistance was conducted or provided for this submission. The device is an image processor, not an AI-assisted diagnostic tool.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study was done in the form of "non-clinical performance testing." This testing evaluated the device's technical specifications and imaging capabilities (e.g., resolution, signal-to-noise ratio, color performance, image frame frequency, system delay) against relevant ISO standards. This is considered standalone performance as it assesses the device's intrinsic functional properties independent of human interaction or a clinical scenario.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance testing was based on technical specifications and compliance with international standards (ISO 8600-1:2015 and ISO 8600-3:2019), rather than expert consensus on medical findings, pathology, or outcomes data, as this device primarily processes images.

8. Sample Size for the Training Set

The document does not mention a training set. This is expected as the device described is an "Endoscopic Video Image Processor" and is not presented as an AI/ML-driven diagnostic algorithm that would typically require a training set. It processes existing video signals rather than performing analysis for diagnostic insights.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set, this information is not applicable.

Summary

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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 and 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.

February 7, 2025

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

Re: K243321

Trade/Device Name: Endoscopic Video Image Processor (RP-IPD-V1000F) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Received: January 7, 2025

Dear Ping 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.

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"

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K243321 - Ping Yang

(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 OS 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 Rue"). 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 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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

Submission Number (if known)

K243321

Device Name

Endoscopic Video Image Processor ( RP-IPD-V1 000F)

Indications for Use (Describe)

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."

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K243321 Page 1 / 3

510(k) Summary

510(k) Number: K243321

I. Contact Details

Submitter Name: Guangzhou Red Pine Medical Instrument Co., Ltd.

Submitter Address: 12 F, No.87 Luoxuan Avenue, Guangzhou International Bioisland, Huangpu District Guangzhou Guangdong 510000 China

Submitter Contact Telephone: +86 13902971205

Submitter Contact: Mr. Weihua Yang

Submitter Contact Email: regulation@gzredpine.com

Correspondent Name: Guangzhou Red Pine Medical Instrument Co., Ltd.

Correspondent Address: 12 F, No.87 Luoxuan Avenue, Guangzhou International Bioisland, Huangpu District Guangzhou Guangdong 510000 China

Correspondent Contact Telephone: +86 18565651640

Correspondent Contact: Ms. Ping Yang

Correspondent Contact Email: regulation(@gzredpine.com

Date prepared: January 22, 2025

II. Subject Device

Device Trade Name: Endoscopic Video Image Processor ( RP-IPD-V1000F)

Common Name: Endoscope and accessories

Classification Number: 21 CFR 876.1500

Classification Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Product Code: FET

III. Legally Marketed Predicate Device

Predicate 510(k) Number: K241500

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

Product Code: FAJ

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

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K243321 Page 2 / 3

IV. Device Description Summary

V. Indications for use

VI. Indications for Use Comparison

The Indications for Use of the subject device is nearly identical to the Indications for Use of the predicate device. The only change is the addition of the compatible endoscope to the Indications for Use of the subject device.

VII. Technological Comparison

The principles of operation, white balance, color tone adjustment, image enhancement, zoom, adjusting brightness, image freezing and compatible endoscope of the subject device are identical to the predicate device.

The product code, main configuration, dimension and weight of the subject device are different from or similar to the predicate device. The differences in product code, main configuration, video signal output, dimension and weight do not raise new question of safety and effectiveness.

VIII. Non-Clinical Tests Summary

1. Performance Testing

The Endoscopic Video Image Processor is compatible with the Single-Use Video Flexible Cysto-Nephroscope which was cleared under K241500 and is manufactured by Red Pine.

The Cysto-Nephroscope system includes the Endoscopic Video Image Processor and the Single-Use Video Flexible Cysto-Nephroscope.

The following performance testing was conducted on the Cysto-Nephroscope system:

1. Direction of view
1. Field of view
1. Depth of field
1. Resolution
1. Signal-to-noise ratio
1. Geometric distortion
1. Image intensity uniformity

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Dynamic range

1. Color performance.
  The performance testing complied with the following standards:

ISO 8600-1:2015 Endoscopes - Medical endoscopes and endotherapy devices. General requirements ISO 8600-3:2019 Endoscopes. Medical endoscopes and endotherapy devices. Part 3: Determination of field of view and direction of view of endoscopes with optics

Performance Testing-Image Frame Frequency and System Delay

Image Frame Frequency and System Delay testing was also conducted on the Cysto-Nephroscope System.

The Performance Testing demonstrated that the subject device and the predicate device have similar performance, and the subject device is as safe and effective as the predicate device.

IX. Clinical Evidence

N/A.

X. Conclusion

The results of nonclinical performance testing demonstrate that the subject device is as safe and effective as the predicate device to support a substantial equivalence determination.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.