(221 days)
Not Found
No
The document describes standard image processing and performance testing for an endoscopic system, with no mention of AI, ML, or related concepts. The performance studies focus on optical and mechanical properties, not algorithmic performance metrics typically associated with AI/ML.
Yes
The "Single-Use Video Gastroscope" and "Single-Use Video Colonoscope" are explicitly stated to be used for "treatment" of the upper and lower digestive tract, indicating a therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Single-Use Video Gastroscope and Single-Use Video Colonoscope are used for "observation, diagnosis, photography and treatment." This indicates that diagnosis is a primary intended use of the device.
No
The device description explicitly includes hardware components: Single-Use Video Gastroscope, Single-Use Video Colonoscope, and Endoscopic Video Image Processor. The performance studies also detail testing of mechanical and optical performance, which are hardware characteristics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- Device Function: The described device is an endoscopic system used for direct visualization of the upper and lower digestive tract. It processes images captured inside the body.
- Intended Use: The intended use clearly states "observation, diagnosis, photography and treatment of upper digestive tract" and "observation, diagnosis, photography and treatment of lower digestive tract." This involves direct examination, not testing of samples.
- No Mention of Samples: There is no mention of collecting or analyzing biological samples.
The device is a medical device used for internal examination and visualization, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for 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 Gastroscope
This product is used in conjunction with Endoscopic Video Image Processor and other peripheral equipment for the observation, diagnosis, photography and treatment of upper digestive tract. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product is designed for use in adults.
Single-Use Video Colonoscope
This product is used in conjunction with Endoscopic Video Image Processor and other peripheral equipment for the observation, diagnosis, photography and treatment of lower digestive tract. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product is designed for use in adults.
Product codes (comma separated list FDA assigned to the subject device)
FDF, FDS, FET
Device Description
The proposed device, Digestive Endoscopy System, which includes a Single-Use Video Gastroscope and Single-Use Video Colonoscope, and Endoscopic Video Image Processor is intended for observation, diagnosis, photography and treatment of the upper and lower gastrointestinal tract.
The Single-Use Video Gastroscope is available in two models with different length of image processor connection section, RP-Gl-G02A, RP-Gl-G02B. The Single-Use Video Colonoscope is available in two models with different length of image processor connection section and different diameters, RP-GI-C02B. The Endoscopic Video Image Processor is available in four models with disk space, RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D.
The Single-Use Video Gastrocope and Single-Use Video Colonoscope are sterile and single-patient-use device. The Endoscopic Video lmage Processor is non-sterile and multi-patient-use device, and it will be cleaned and disinfected before first use.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video endoscopes
Anatomical Site
Upper digestive tract, Lower digestive tract
Indicated Patient Age Range
Adults
Intended User / Care Setting
Professional healthcare facility environments such as hospitals and clinics.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing:
The performance testing was conducted on the proposed Digestive Endoscopy System.
The performance testing includes optical performance, interoperability with accessories and image quality simulation test.
The optical performance testing includes ISO 8600 test, intensity uniformity, depth of field, signal-to-noise ratio, color reducibility, geometric distortion and dynamic range test.
The mechanical performance testing includes Surface and Edge, General Size, Water Supply System, Suction/Instrument Channel System, Bending Section Control System, Fatigue Test of Bending Knob, Vertical Pressure Test of Bending Section, Tensile Strength of Insertion Portion, Tensile Resistance Strength Between Image Processor Connection Section and Endoscopic Video Image Processor and Connecting Fore Test of Suction Connector, Auxiliary Water Supply Connector, Water Supply Connector, and Accessories.
Performance Testing-Image Frame Frequency and System Delay:
The Image Frame Frequency and System Delay testing was conducted on the proposed Digestive Endoscopy System.
Performance Comparison Testing:
The comparison testing includes optical performance, interoperability with accessories and image quality simulation test.
The optical performance testing includes ISO 8600 test, intensity uniformity, depth of field, signal-to-noise ratio, color recucibility, geometric distortion and dynamic range test.
The mechanical performance testing includes Surface and Edge, General Size, Water Supply System, Suction/Instrument Channel System, Bending Section Control System, Fatigue Test of Bending Knob, Vertical Pressure Test of Bending Section, Tensile Strength of Insertion Tensile Resistance Strength Between Image Processor Connection Section and Endoscopic Video Image Processor and Connecting Fore Test of Suction Connector, Auxiliary Water Supply Connector, Water Supply Connector, and Accessories.
Performance-Backflow Prevention:
The Backflow Prevention Testing was conducted on the proposed Digestive Endoscopy System.
Comparison testing of the proposed device manufactured by Guangzhou Red Pine Co., Ltd. and the predicated device manufactured by OLYMPUS MEDICALSYSTEMS CORP was completed, the Single-Use Video Gastroscope has the same intended use as the EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE marketed by Olympus, and the Sincle-Use Video Colonoscope has the same intended use as the EXERA II COLONOVIDEOSCOPE marketed by Olympus. In terms of optical properties and interoperability with diagnostic accessories, the proposed device has proved to be predicate device. Meanwhile, in the image quality evaluation (simulation test), the image quality of the proposed device was similar to that of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 16, 2024
Guangzhou Red Pine Medical Instrument Co., Ltd. Ping Yang Regulatory Affairs Supervisor 12 F. No.87 Luoxuan Avenue, Guangzhou International Bioisland, Huangpu District Guangzhou, Guangdong 510000 China
Re: K232043
Trade/Device Name: Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDF, FDS, FET Dated: January 17, 2024 Received: January 17, 2024
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/cdrb/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.
1
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant 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
| Submission Number (if known) | |
|---|---|
| ------------------------------ | -- |
Device Name
Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V200B, RP-IPD-V2000C, RP-IPD-V2000D):
Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B);
Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)
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 Gastroscope
This product is used in conjunction with Endoscopic Video Image Processor and other peripheral equipment for the observation, diagnosis, photography and treatment of upper digestive tract. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product is designed for use in adults.
Single-Use Video Colonoscope
This product is used in conjunction with Endoscopic Video Image Processor and other peripheral equipment for the observation, diagnosis, photography and treatment of lower digestive tract. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product is designed for use 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)
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."
4
| 510(k) #: | K232043 | 510(k) Summary | K232043 - Page 1/3 | ||
|---|---|---|---|---|---|
| Prepared on: 2024-02-16 | |||||
| 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, | ||||
| Huangpu District Guangzhou Guangdong 510000 China | |||||
| Applicant Contact Telephone | +86 13902971205 | ||||
| Applicant Contact | Mr. Weihua Yang | ||||
| Applicant 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 | ||||
| Device Name | 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, | ||||
| RP-IPD-V2000C, RP-IPD-V2000D); | |||||
| Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B); | |||||
| Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B) | |||||
| Common Name | Endoscope and accessories | ||||
| Classification Name | Colonoscope And Accessories, Flexible/Rigid | ||||
| Regulation Number | 876.1500 | ||||
| Product Code | FDF, FDS, FET | ||||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K100584 | EVIS EXERA II 180 System | NWB, FDF, F | |||
| Device Description Summary | 21 CFR 807.92(a)(4) |
The proposed device, Digestive Endoscopy System, which includes a Single-Use Video Gastroscope and Single-Use Video Colonoscope, and Endoscopic Video Image Processor is intended for observation, diagnosis, photography and treatment of the upper and lower gastrointestinal tract.
The Single-Use Video Gastroscope is available in two models with different length of image processor connection section, RP-Gl-G02A, RP-Gl-G02B. The Single-Use Video Colonoscope is available in two models with different length of image processor connection section
5
and different diameters, RP-GI-C02B. The Endoscopic Video Image Processor is available in four models with disk space, RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D.
The Single-Use Video Gastrocope and Single-Use Video Colonoscope are sterile and single-patient-use device. The Endoscopic Video lmage Processor is non-sterile and multi-patient-use device, and it will be cleaned and disinfected before first 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 Gastroscope
This product is used in conjunction with Endoscopic Video Image Processor and other peripheral equipment for the observation, diagnosis, photography and treatment of upper digestive tract.
- The device is suitable for professional healthcare facility environments such as hospitals and clinics.
- This product is designed for use in adults.
Single-Use Video Colonoscope
This product is used in conjunction with Endoscopic Video Image Processor and other peripheral equipment for the observation, diagnosis, photography and treatment of lower digestive tract.
The device is suitable for professional healthcare facility environments such as hospitals and clinics.
This product is designed for use in adults.
Indications for Use Comparison
The indication for use of the proposed device and the predicate device is similar. They have the same principle of operation, target population and target location. The indication for use of the proposed device is only different in expression. The difference will not affect the safety and effectiveness of the proposed device.
Technological Comparison
The principles of operation, color tone adjustment, Minimum instrument channel width, working length of colonoscope, bending angle, field of view of gastroscope, direction of view and depth of field of the proposed device are same as the predicate device.
The main configuration, single use or reuse, sterile, dimension and weight, white balance, zoom, outer diameter of insertion tube, working length of gastroscope and field of view of colonoscope 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 comparison test report of the proposed device and predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Performance testing
The performance testing was conducted on the proposed Digestive Endoscopy System.
The performance testing includes optical performance, interoperability with accessories and image quality simulation test.
The optical performance testing includes ISO 8600 test, intensity uniformity, depth of field, signal-to-noise ratio, color reducibility, geometric distortion and dynamic range test.
The mechanical performance testing includes Surface and Edge, General Size, Water Supply System, Suction/Instrument Channel System, Bending Section Control System, Fatigue Test of Bending Knob, Vertical Pressure Test of Bending Section, Tensile Strength of Insertion Portion, Tensile Resistance Strength Between Image Processor Connection Section and Endoscopic Video Image Processor and Connecting Fore Test of Suction Connector, Auxiliary Water Supply Connector, Water Supply Connector, and Accessories.
Performance Testing-Image Frame Frequency and System Delay The Image Frame Frequency and System Delay testing was conducted on the proposed Digestive Endoscopy System.
Performance Comparison Testing
21 CFR 807.92(a)(6)
6
K232043 - Page 3/3
The comparison testing includes optical performance, interoperability with accessories and image quality simulation test.
The optical performance testing includes ISO 8600 test, intensity uniformity, depth of field, signal-to-noise ratio, color recucibility, geometric distortion and dynamic range test.
The mechanical performance testing includes Surface and Edge, General Size, Water Supply System, Suction/Instrument Channel System, Bending Section Control System, Fatigue Test of Bending Knob, Vertical Pressure Test of Bending Section, Tensile Strength of Insertion Tensile Resistance Strength Between Image Processor Connection Section and Endoscopic Video Image Processor and Connecting Fore Test of Suction Connector, Auxiliary Water Supply Connector, Water Supply Connector, and Accessories.
Performance-Backflow Prevention
The Backflow Prevention Testing was conducted on the proposed Digestive Endoscopy System.
Not Applicable
Comparison testing of the proposed device manufactured by Guangzhou Red Pine Co., Ltd. and the predicated device manufactured by OLYMPUS MEDICALSYSTEMS CORP was completed, the Single-Use Video Gastroscope has the same intended use as the EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE marketed by Olympus, and the Sincle-Use Video Colonoscope has the same intended use as the EXERA II COLONOVIDEOSCOPE marketed by Olympus. In terms of optical properties and interoperability with diagnostic accessories, the proposed device has proved to be predicate device. Meanwhile, in the image quality evaluation (simulation test), the image quality of the proposed device was similar to that of the predicate device.