(265 days)
Not Found
No
The summary describes a standard endoscopic image processor that processes and displays images. There is no mention of AI, ML, or any advanced image analysis beyond basic processing and display. The performance studies focus on electrical safety, optical performance, and service life, not on algorithmic performance metrics typically associated with AI/ML.
No
The device processes and transfers images from an endoscope to a monitor, but it does not directly treat or diagnose a medical condition.
No
The device is described as an "Endoscopic Image Processor" that processes images collected by an endoscope and transfers them to a monitor for imaging. Its function is to facilitate the visualization of internal body structures, not to interpret or analyze the images to determine a diagnosis.
No
The device description explicitly states it is composed of a "Full HD Endoscopic Image Processor host, foot switch, power cable, and video cable," which are all hardware components. While it performs image processing (a software function), it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the product is used to "process the image collected by the electronic endoscope and transfer them to the monitor for imaging." This describes a function related to medical imaging and visualization within the body, not the analysis of samples outside the body (which is the core of IVD).
- Device Description: The description reinforces the intended use, focusing on image processing and transfer from an endoscope.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
The device is an image processor for an endoscope, which is a medical device used for internal examination. While the images produced might be used by a healthcare professional for diagnosis, the device itself is not performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
EOQ
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.
Mentions image processing
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
§ 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.
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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)
Device Name
Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)
Indications for Use (Describe)
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.
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)
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
5
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)