(107 days)
Not Found
No
The summary describes standard video image processing and power supply functions, with no mention of AI, ML, or related concepts.
No.
The device is described as an "Endoscopic Video Image Processor" that processes images and provides power for an endoscope; it does not perform any therapeutic function itself.
No
The device processes and displays images from an endoscope for visualization during procedures, but it does not perform any analysis or interpretation of these images for diagnostic purposes. Its function is to facilitate image viewing, not to generate diagnostic information.
No
The device description explicitly states it is a "video processing system" that "receives and processes image signals" and "provides the power supply for the endoscope," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Endoscopic Video Image Processor processes image signals from a video endoscope used during an endoscopic procedure. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's used in conjunction with a cysto-nephroscope to process images collected by the endoscope and send them to a display. This is a function related to visualizing internal anatomy, not analyzing biological samples.
- Device Description: The description reinforces that it's a video processing system for use during endoscopic procedures, receiving and processing image signals.
The device is a component of an endoscopic system used for visualization within the body, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
FET
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following performance testing was conducted on the Cysto-Nephroscope system:
-
- Direction of view
-
- Field of view
-
- Depth of field
-
- Resolution
-
- Signal-to-noise ratio
-
- Geometric distortion
-
- Image intensity uniformity
- Dynamic range
-
- Color performance.
Image Frame Frequency and System Delay testing was also conducted on the Cysto-Nephroscope System.
- Color performance.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
2
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Endoscopic Video Image Processor ( RP-IPD-V1 000F)
Indications for Use (Describe)
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.
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
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.
V. Indications for use
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.
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:
-
- Direction of view
-
- Field of view
-
- Depth of field
-
- Resolution
-
- Signal-to-noise ratio
-
- Geometric distortion
-
- Image intensity uniformity
6
- Dynamic range
-
- Color performance.
The performance testing complied with the following standards:
- Color performance.
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.