(36 days)
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No
The document describes a standard video camera system for endoscopy and does not mention any AI/ML capabilities, image processing beyond basic video output, or performance metrics typically associated with AI/ML algorithms.
No
The device is a video camera for observation, not directly involved in treating conditions. Its intended use is to provide a video image of the target area during endoscopic procedures.
No
The device is a video camera for observation during endoscopic procedures; it does not analyze or interpret medical data for diagnostic purposes.
No
The device description explicitly states that the system is supplied as a "Vista Single Chip Video Camera Head and a Camera Control Unit (CCU)," which are hardware components.
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 is to provide a video image of a target area during endoscopic procedures. This is for direct visualization of anatomical structures within the body.
- Device Description: The device is a video camera system used for observation within body cavities, organs, or canals. It works with endoscopes, light sources, and monitors to display images.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for direct visualization.
- No Mention of Specimen Analysis: There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis.
The device is clearly intended for direct visualization during surgical or diagnostic procedures performed on the patient, not for testing samples from the patient.
N/A
Intended Use / Indications for Use
The device is intended for use in all types of endoscopic and endoscopic assisted procedures.
The Vista Single Chip Camera System is intended for use with optical endoscopes to provide a video image of the target area.
Product codes (comma separated list FDA assigned to the subject device)
78 KOG
Device Description
The Vista Single Chip Video Camera is a device used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures. The product is a video camera. The system will be supplied as a Vista Single Chip Video Camera Head and a Camera Control Unit (CCU). The device is designed to work with commercially available light sources, V&C mount endoscope couplers and video monitors or head mounted displays.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Body cavities, organs, or canals through manmade or natural orifices
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Vista Single Chip Video Camera was designed and will be tested in compliance with the requirements of the following standards:
IEC 601-1 General Safety Requirements for Medical Electronic Equipment
IEC 601-1-2 Electromagnetic Compatibility Requirements and Tests
UL544 Standard for Safety Medical and Dental Equipment
Optical Test Data
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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