(90 days)
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Not Found
No
The description explicitly states the device uses a "fixed algorithm with user-variable parameters" and does not mention AI, ML, or related terms.
No.
It is an accessory that enhances image quality for diagnostic and therapeutic interventions, but it does not directly perform a therapeutic function on a patient.
No
Explanation: The device is described as an image processor that enhances video images for use during diagnostic and therapeutic interventions. It does not perform diagnostic functions itself but acts as an accessory to improve image quality for other diagnostic tools.
No
The device description explicitly states it is a "Video Image Processor" and is "connected between video camera and video monitor," indicating it is a physical hardware device that processes video signals. The performance studies also mention testing according to hardware safety standards (IEC601-1, UL2601-1).
Based on the provided information, the Video Image Processor ENDO VIP 5588 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to enhance video images during diagnostic and therapeutic interventions in video endoscopy and video microscopy. This involves processing images of the body in vivo, not analyzing samples taken from the body (which is the core of IVD).
- Device Description: The device processes video signals from a camera connected to a monitor. This is image processing of live or recorded video, not analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with IVD testing.
Therefore, the Video Image Processor ENDO VIP 5588 is an accessory for medical imaging systems used during procedures, not a device for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
Video Image Processor ENDO VIP 5588 is a video contrast enhancer and is used in connection with a video system. It enhances the detail definition of medical video images. It is used as an accessory during diagnostic and therapeutic interventions in video endoscopy and video microscopy.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Video Image Processor ENDO VIP 5588 enhances the detail definition of medical video images. It is connected between video camera and video monitor. The enhancement level is manual controlled in 3 steps.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
video images
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Independent laboratories tested the Video Image Processor ENDO VIP 5588 according to specified standards IEC601-1. IEC601-1-2 and UL2601-1.
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.
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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.
0
510(k) Summary of Safety and Effectiveness
大963323 Nov. 21, 1996
- 1.0 Classification Name: Endoscope and/or accessories
- Common/Usual Name: 2.0 Video Image Processor/Video Enhancer
- 3.0 Trade Name: ENDO VIP
4.0 Equivalence:
The device is equivalent to devices sold by Karl Storz.
Description: 5.0
The Video Image Processor ENDO VIP 5588 enhances the detail definition of medical video images. It is connected between video camera and video monitor. The enhancement level is manual controlled in 3 steps.
6.0 Intended Use:
Video Image Processor ENDO VIP 5588 is a video contrast enhancer and is used in connection with a video system. It enhances the detail definition of medical video images. It is used as an accessory during diagnostic and therapeutic interventions in video endoscopy and video microscopy.
Technological Characteristics: 7.0
The Video Image Processor ENDO VIP 5588 has a digital video processor and uses a fixed algorithm with user-variable parameters to improve detail visibility in video images. Y/C video signals, which are compatible with NTSC and PAL video standards, are processed in real time.
8.0 Performance Data:
Independent laboratories tested the Video Image Processor ENDO VIP 5588 according to specified standards IEC601-1. IEC601-1-2 and UL2601-1.
9.0 Clinical Tests:
No clinical tests performed.
10.0 Data Conclusion:
Video Image Processor ENDO VIP 5588 is designed and tested to guarantee the safety and effectiveness, if the device is used according to the instruction manual.
By:
Robert L. Casaux
Robert L. Casarsa
Date: Aug 22, 1996