ENDOBEAM
Device Facts
| Record ID | K963044 |
|---|---|
| Device Name | ENDOBEAM |
| Applicant | Corin USA |
| Product Code | GCT · Gastroenterology, Urology |
| Decision Date | Sep 20, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
Intended Use
Endoscopic light source to provide illumination for fibre optic endoscopy to joint cavities and abdominal space.
Device Story
Endobeam is an endoscopic light source providing illumination for fibre optic endoscopy in joint cavities and abdominal space. Device utilizes a 35W Xenon microdischarge lamp with 4000-hour life and 3700K color temperature. Operated via manual or automatic illumination control with stepless intensity adjustment. Used in clinical settings by physicians; provides light via fibre optic cables to surgical sites. Safety tested to IEC 601/1 1988 and DIN VDE 0750 standards; includes electromagnetic compatibility testing.
Clinical Evidence
Bench testing only. Device tested for safety per IEC 601/1 1988 and DIN VDE 0750 TI/11.91, and for electromagnetic compatibility.
Technological Characteristics
Xenon microdischarge lamp (35W, 3700K, 4000-hour life). Features manual/automatic illumination control, stepless intensity adjustment, and UV/IR filters. Power input 100-240V, 0-440 Hz. Safety standards: IEC 601/1 1988, DIN VDE 0750 TI/11.91. Electromagnetic compatibility compliant.
Indications for Use
Indicated for patients undergoing fibre optic endoscopy of joint cavities and abdominal space.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Autobrite
Reference Devices
- Dyobrite 3000 Xenon Illuminator (Smith and Nephew Dyonics)
Related Devices
- K962595 — KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS · KARL STORZ Endoscopy-America, Inc. · Sep 4, 1996
- K963043 — ENDOSPOT · Corin USA · Sep 20, 1996
- K023468 — ENDOSCOPIC LIGHT SOURCE XL180/L3 · World of Medicine Lemke GmbH · Jan 14, 2003
- K021717 — ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 · World of Medicine Lemke GmbH · Aug 20, 2002
- K992050 — LUMENON XENON LIGHT SOURCE · Walter Lorenz Surgical, Inc. · Sep 14, 1999
