This product is used in combination with Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) to process the image collected by the electronic endoscope and transfer them to the monitor for imaging.

Device Description

Full HD Endoscopic Image Processor is used in combination with Single-use Broncho Videoscope (SBV-1A-B, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) to process the image collected by the electronic endoscope and transfer them to the monitor for imaging.

This product is composed of Full HD Endoscopic Image Processor host, foot switch, power cable. Video cable includes SDI video cable and DVI video cable. The foot switch is optional.

There are four models (HDVS-S200B, HDVS-S200B, HDVS-S200D) for Full HD Endoscopic Image Processor, and the difference between the four models is only the difference in structure configuration.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Full HD Endoscopic Image Processor). It details the device's characteristics, intended use, and substantial equivalence to a predicate device. However, it does not contain information about the acceptance criteria and the detailed study results that specifically prove the device meets these criteria in the way you've outlined for AI/human performance studies.

The document states:

"The following performance data were provided in support of the suivalence determination. The test results demonstrated that the subject device complies with the standard requirements."
"The nonclinical test were conducted to demonstrate that the subject is as safe and effective as the predicate."
"The clinical data is not applicable."

This indicates that the submission relies on non-clinical performance testing (electrical safety, EMC, optical performance, service life, package validation) to demonstrate substantial equivalence, rather than clinical studies or studies involving human readers/AI assistance in the manner of a diagnostic AI device. The device is an image processor, not a diagnostic AI algorithm that interprets images.

Therefore, I cannot extract the information requested for acceptance criteria and study proving device meets acceptance criteria, as the document does not provide this type of data. The questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are typically relevant for diagnostic AI/CADe devices, which is not what this device appears to be based on the provided summary.

In summary, the provided text does not contain the information required to answer your prompt because the device (Full HD Endoscopic Image Processor) is not a diagnostic AI device that would undergo such types of performance evaluations.

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 & 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.

October 23, 2024

Scivita Medical Technology Co., Ltd. Dan Jiang Regulatory Affair Specialist No.2, Qingqiu Street, Suzhou Industrial Park Suzhou, Jiangsu 215000 China

Re: K240289

Trade/Device Name: Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: September 24, 2024 Received: September 24, 2024

Dear Dan Jiang:

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.

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 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-regulatory

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assistance/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,

Joyce C. Lin -S

for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K240289

Device Name

Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)

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)

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510(k) Summary 510(k) #: K240289 Prepared on: 2024-10-22 Contact Details 21 CFR 807.92(a)(1) Scivita Medical Technology Co.,Ltd. Applicant Name No.2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Applicant Address Prov., P.R.CHINA Suzhou 215000 China Applicant Contact Telephone 86-512-81877788 Applicant Contact Mrs. Wu Ruqin Applicant Contact Email wurugin@scivitamedical.com Correspondent Name Scivita Medical Technology Co.,Ltd. No.2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Correspondent Address Jiangsu Prov., P.R.CHINA Suzhou 215000 China Correspondent Contact Telephone 86-512-81877788 Correspondent Contact Ms. Jiang Dan Correspondent Contact Email ra@scivitamedical.com Device Name 21 CFR 807.92(a)(2) Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, Device Trade Name HDVS-S200C, HDVS-S200D) Common Name Bronchoscope (flexible or rigid) and accessories Classification Name Bronchoscope (Flexible Or Rigid) Regulation Number 874.4680 Product Code EOQ Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate Trade Name (Primary Predicate is listed first) Predicate # Product Code K210379 Endoscopic Image Processor EOQ Device Description Summary 21 CFR 807.92(a)(4)

This product is composed of Full HD Endoscopic Image Processor host, foot switch, power cable. Video cable includes SDI video cable and DVI video cable. The foot switch is optional.

There are four models (HDVS-S200B, HDVS-S200B, HDVS-S200D) for Full HD Endoscopic Image Processor, and the

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difference between the four models is only the difference in structure configuration.

Intended Use/Indications for Use

This product is used in combination with Single-use Broncho Videoscope (SBV-1A-P, SBV-18-P, SBV-18-P, SBV-1C-P, SBV-1C-P, SBV-1C-P, SBV-1C-P, SBV-1C-P, to process the image collected by the electronic endoscope and transfer them to the monitor for imaging.

Indications for Use Comparison

Indications for Use of the subject device is basically the same as the predicate device. Both the subject device is intended to connect with the electronic endoscopic diagnosis and therapies, process the image and transfer the image signal to the monitor for imaging. The indications for use of the predicate device are only different in expression. This difference will not affect the safety and effectiveness of the subject device.

Technological Comparison

Full HD Endoscopic Image Processor (subject device) and the Endoccopic Image Processor (predicate device, Scivita, K210379) share the same technological characteristics. Full HD Endoscopic Image Processor is an upgrade of the Endoscopic Image Processor. Compared with Endoscopic Image Processor, Full HD Endoscopic Image Processor has two kinds of electronic endoscope port, round plug and square plug, which support electronic endoscope with any of two interface types. In addition, Full HD Endoscopic Image Processor has menu selection and image adjustment functions. Users can switch the endoscope display of different pixels, displays type, date setting, replay of pictures or video, and adjust the imaging clarity level. These different question of safety and effectiveness of the subject device.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CER 307 9215

The following performance data were provided in support of the suivalence determination. The test results demonstrated that the subject device complies with the standard requirements.

Electrical Safety and Electromagnetic Compatibility Summary:

The electrical safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1.2002 +A2:2020 (Edition 3.2), IEC 60601-2-18:2009 (Edition 3.0) and IEC 60601-1-2:2014+A1:2020 (Edition 4.1).

Optical performance characteristics:

Optical performance comparison testing was conducted on the subject device. The optical performance test includes:

Resolution; Depth of field .; Color Reproduction; Noise and Dynamic Range; Intensity Uniformity; Geometric Distortion; Image Frame Frequency and System Delay test.

Service life (Use Life) of the Image Processor

A use-life verification was conducted to determine the system's use life. After accelerating aging and running, the qualitative optical performance were conducted on the Full HD Endoscopic Image Processor.

Package Validation:

Simulated distribution was conducted per ASTM D4169-22 after accelerated aging.

The clinical data is not applicable.

The nonclinical test were conducted to demonstrate that the subject is as safe and effective as the predicate.

21 CER 807.92(a)(5)

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.