(46 days)
Endoscopic light source to provide illumination for fibre optic endoscopy to joint cavities and abdominal space.
Endoscopic light source with Power Source and Xenon Microdischarge Lamp. Light intensity 35W, Lamp life - 4000 hours, Color temperature - 3700K. Power Source: 100 - 240V ± 10% 0 - 440 Hz.
This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The provided text describes a 510(k) summary for a medical device called "Endobeam," outlining its classification, intended use, major components, and safety testing. It also includes a comparison to a predicate device ("Autobrite") and a legally marketed endoscopic light source ("Dyobrite 3000 Xenon Illuminator").
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the given text.
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- Detailed Similarities/Differences Comparison: (g)
- Endospot 510(k) Device Power Source On/Off Button Manual Illumination Control Automatic Illumination Control UV/IR Filters 35 Watt Xenon Microdischarge Lamp 1 Lamp in Unit 4000 Lamp Hours
SEP 2 0 1996 Autobrite (Predicate Device) Power Source On/Off Button Manual Illumination Control Automatic Illumination Control UV/IR Filters 100 Watt Xenon Lamp Module 1 Lamp in Unit Stepless Light Intensity Adjustment Stepless Light Intensity Adjustment 1000 Lamp Hours
510(k) Summary: 8.
| Classification Name: | Accessory to Endoscope |
|---|---|
| Device Trade Name: | Endobeam |
| Sponsor: | Corin U.S.A.10500 University Center DriveSuite 130Tampa, FL 33612USA |
| Reason for Submission: | New device |
| Intended Use: | Endoscopic light source to provideillumination for fibre optic endoscopy tojoint cavities and abdominal space. |
| Major Components: | - Power Source- Xenon Microdischarge Lamp |
| Lamp/Data | - Light intensity 35W- Lamp life - 4000 hours- Color temperature - 3700K |
| Power Source: | 100 - 240V ± 10% 0 - 440 H₂ |
| Safety Testing: | - TUV tested to IEC 601/1 1988- DIN VDE 0750 TI/11.91- Electromagnetic compatibilitytested |
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Comparison to Legally Marketed Endoscopic Light Source:
Dyobrite 3000 Xenon Illuminator Smith and Nephew Dyonics 160 Dascomb Road Andover, Massachusetts 01810 USA
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: | 1 August 1996 |
§ 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.