(88 days)
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No
The description focuses on standard video camera components and specifications, with no mention of AI/ML terms or image processing beyond basic signal conditioning.
No
This device is described as an endoscopic video camera used to transmit images for monitoring, which serves a diagnostic purpose rather than a therapeutic one.
No
The device is an endoscopic video camera used to transmit images for viewing, not for making a diagnosis. Its function is to provide visual information rather than interpret it or identify a disease or condition.
No
The device description explicitly lists hardware components such as a power source, video board, camera head, camera cable, and a CCD lens. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "transmit an image from an endoscope or arthroscope to a remotely located video monitor." This describes a device used for visualizing internal body structures during a medical procedure.
- Device Description: The components listed (power source, video board, camera head, cable, resolution, illumination, lens, etc.) are all consistent with a video camera system designed for capturing images.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing information about a patient's health status based on in vitro testing.
- Reagents, calibrators, or controls typically associated with IVD devices.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely image capture and transmission for visualization during a procedure.
N/A
Intended Use / Indications for Use
Endoscopic video camera to transmit an image from an endoscope or arthroscope to a remotely located video monitor
Product codes
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Device Description
- Power source
- Video board
- Camera head holding video chip
- Camera cable
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
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
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| Device Trade Name: | |
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| Video Data: |
nov. 1, 1996
Accessory to Endoscope
500.204 Daycam & 500.404 Endocam
Corin U.S.A. 10500 University Center Drive Suite 130 Tampa, Florida 33612 USA
New device
Endoscopic video camera to transmit an image from an endoscope or arthroscope to a remotely located video monitor
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Power source
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Video board
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Camera head holding video chip
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Camera cable
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628 lines resolution
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0.9 lux minimum illumination
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½" CCD lens
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+6 dB pre-signal conditioning
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Automatic iris 1:16000S
100 - 240V ± 10% 0 - 440H,
Power Source:
ﺔ ﻳﺎﺭ
510(K) Summary:
1
Safety Testing:
- TUV testing to IEC 601/1 1988 - DIN VDE 0750 TI/12.91 - EMC tested as part of IEC 601/1 1988
The specification of the Corin Endocam & Daycam camera systems are substantially equivalent to the legally marketed Dyonics Digital video camera system in the following areas: Power source, controls, functions, output, iris control, iris shutter speed and light requirement (see 7(g)).
Truthful and Accurate Statement: 9.
I hereby confirm that the attached information is, to the best of my knowledge, truthful and accurate.
| PRINT NAME: | Jack Thomas |
|---|---|
| SIGNED: | |
| POSITION: | President |
| DATE: | 10 October 1996 |