(121 days)
Not Found
No
The summary describes basic image processing and signal transfer, with no mention of AI, ML, or related concepts like deep learning, algorithms for analysis, or performance metrics typically associated with AI/ML devices.
No.
The device's description and intended use focus on image processing and display for endoscopic diagnosis and observation, not direct therapeutic intervention. While it can be used during therapeutic procedures, it is not performing the therapy itself.
Yes
Explanation: The "Intended Use / Indications for Use" states the device is designed for "endoscopic diagnosis." While its primary function is image processing and display, its stated use in facilitating diagnosis classifies it as a diagnostic device.
No
The device description explicitly states it "receives and processes image signals from a digital endoscope and transfers these signals to a connected monitor," implying it is a hardware component that handles physical signal processing and transfer, not solely 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. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The description clearly states the Digital Video Processor is used with endoscopes to process and display image signals from within the body during endoscopic procedures. It is a component of a system used for in vivo (within the body) diagnosis and treatment, not for analyzing samples in vitro.
- Intended Use: The intended use is for "endoscopic diagnosis, treatment and video observation," which are procedures performed directly on the patient.
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Digital Video Processor is designed to be used with Vathin medical endoscopes, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Product codes
FGB
Device Description
The Digital Video Processor is used in conjunction with Vathin endoscopes, and other accessories for endoscopic image processing during endoscopic diagnostic and therapeutic procedures. When used, it receives and processes image signals from a digital endoscope and transfers these signals to a connected monitor.
The Digital Video Processor is for use in professional Healthcare Facility Environment.
Mentions image processing
The Digital Video Processor is used in conjunction with Vathin endoscopes, and other accessories for endoscopic image processing during endoscopic diagnostic and therapeutic procedures.
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
Intended user: For use by trained clinicians/physicians only.
Care Setting: The device is for use in professional Healthcare Facility Environment.
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)
Non-clinical tests conducted include:
- Electrical safety and electromagnetic compatibility (EMC) testing, complying with IEC 60601-1 and IEC60601-2-18 for safety and IEC 60601-1-2 for EMC.
- Software Verification and Validation Testing, following FDA guidance "Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions''.
- Performance testing, including Field of view, Depth of field, Geometric distortion, Image intensity uniformity, and Color performance.
Key results: The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
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.
January 29, 2025
Hunan Vathin Medical Instrument Co., Ltd, Jing Du RA Manager 1/F, Building 12, Innovation Entrepreneurship Service Center No.9 Chuangi West Road, Jiuhua Economic Development Zone Xiangtan, Hunan 411100 CHINA
Re: K243117
Trade/Device Name: Digital Video Processor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Received: December 27, 2024
Dear Jing Du:
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.
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.
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 Rule"). 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
2
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).
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
3
Indications for Use
Submission Number (if known)
Device Name
Digital Video Processor
Indications for Use (Describe)
The Digital Video Processor is designed to be used with Vathin medical endoscopes, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
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
Image /page/4/Picture/0 description: The image shows the word "VATHIN" in blue. The letters "VA" are stylized with three parallel lines each, in a lighter shade of blue. The letters "THIN" are in a darker shade of blue, with a small blue circle above the "I".
K243117
Page 1 of 3
Premarket Notification 510(k) Submission
510(k) Summary
I Submitter
| Device submitter: | Hunan Vathin Medical Instrument Co., Ltd.
1/F, Building 12, Innovation and Entrepreneurship Service Center, No 9
Chuanqi west road, Jiuhua Economic Development Zone, 411100
Xiangtan, Hunan, China | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Address: | | |
| Contact person: | Du Jing
Title: Regulatory Affairs Manager
Phone: +86-731-5558558
E-mail: charlene@vathin.com | |
| Date of preparation | December 26 2024 | |
II Device
| Trade Name of
| Device: | Digital Video Processor |
|---|---|
| Common name | Endoscope and Accessories |
| Classification name | Ureteroscope And Accessories, Flexible/Rigid |
| Classification | Class II, 21 CFR 876.1500 |
| Product Code: | FGB |
| Review Panel: | Gastroenterology/Urology |
III Predicate device and reference device
| Predicate device | |
|---|---|
| Trade name: | Digital Video Monitor |
| Regulation number: | 21 CFR 876.1500 |
| Classification name: | Ureteroscope And Accessories, Flexible/Rigid |
| Regulatory class: | Class II |
| Product code: | FGB |
| Submitter: | Hunan Vathin Medical Instrument Co., Ltd. |
| 510(k) number: | K231135 |
5
Image /page/5/Picture/0 description: The image shows the logo for Vathin. The logo is blue and features the word "VATHIN" in a stylized font. The "VA" portion of the logo is made up of three parallel lines, while the "THIN" portion is in a solid, bold font. There is a small blue circle above the "I" in "THIN".
Premarket Notification 510(k) Submission
IV Device description
The Digital Video Processor is used in conjunction with Vathin endoscopes, and other accessories for endoscopic image processing during endoscopic diagnostic and therapeutic procedures. When used, it receives and processes image signals from a digital endoscope and transfers these signals to a connected monitor.
The Digital Video Processor is for use in professional Healthcare Facility Environment.
V Indications for use
The Digital Video Processor is designed to be used with Vathin medical endoscopes, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
VI Comparison of technological characteristics with the predicate devices
A comparison of the technological characteristics between the subject and predicate devices is provided below.
| Device feature | Proposed Device | Predicate Device |
|---|---|---|
| Trade Name | Digital Video Processor | Digital Video Monitor |
| Classification | ||
| Name | Ureteroscope And Accessories, | |
| Flexible/Rigid | Ureteroscope And Accessories, | |
| Flexible/Rigid | ||
| Product Code | FGB | FGB |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Models | Digital Video Processor: | |
| DVP-C10 | Digital Video Monitor: | |
| DVM-B1 | ||
| Intended use | This Digital Video Processor is designed to | |
| be used with Vathin medical endoscopes, | ||
| and other ancillary equipment for | ||
| endoscopic diagnosis, treatment and video | ||
| observation. | The Digital Video Monitor is specially | |
| designed to be used with Vathin medical | ||
| endoscopes and other auxiliary equipment | ||
| for the purposes of endoscopic diagnosis, | ||
| treatment and video observation. | ||
| Application field | The device is for use in professional | |
| Healthcare Facility Environment. | The device is for use in professional | |
| Healthcare Facility Environment. | ||
| Intended user | For use by trained clinicians/physicians | |
| only. | For use by trained clinicians/physicians | |
| only. | ||
| Max. resolution | Resolution of output signal: | |
| HDMI, SDI, DVI: 1920*1080 | ||
| CVBS/S-Video: 720*576 | 1280 x 800 |
6
Image /page/6/Picture/1 description: The image shows the logo for Vathin. The logo is made up of the word "Vathin" in blue letters. The "V" and "A" are stylized with three parallel lines, while the "THIN" is in a solid blue font. There is a small blue circle above the "I" in "Vathin."
Premarket Notification 510(k) Submission
| Device feature | Proposed Device | Predicate Device |
|---|---|---|
| Display type | / | 12.1" touch screen |
| USB connection | USB3.0 A-type, USB2,0 A-type | A type |
| Video output | HDMI, SDI, CVBS, S-VIDEO, DVI | HDMI, USB 2.0 |
| Image/Video | ||
| capture | Yes | Yes |
VII Summary of Non-clinical tests:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the device complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions''.
Performance testing
The following performance testing was conducted on the device to demonstrate equivalency and ensure the device meets its intended use.
- Field of view ●
- Depth of field
- Geometric distortion ●
- Image intensity uniformity
- Color performance
VIII Conclusion
The device is substantially equivalent to predicate device. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed predicate device.