ENDOCAM
Device Facts
| Record ID | K963046 |
|---|---|
| Device Name | ENDOCAM |
| Applicant | Corin USA |
| Product Code | GCJ · Gastroenterology, Urology |
| Decision Date | Nov 1, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
Intended Use
Endoscopic video camera to transmit an image from an endoscope or arthroscope to a remotely located video monitor
Device Story
Endoscopic video camera system; transmits images from endoscope/arthroscope to remote video monitor. Components: power source, video board, camera head with 1/2" CCD chip, camera cable. Operation: captures optical input via CCD; performs pre-signal conditioning (+6 dB); automatic iris control (1:16000S). Used in clinical settings (OR/clinic) by physicians/surgeons. Output displayed on external monitor for real-time visualization. Benefits: enables remote viewing of internal anatomy during minimally invasive procedures.
Clinical Evidence
Bench testing only. Safety testing conducted per IEC 601/1 1988 and DIN VDE 0750 TI/12.91. EMC testing performed per IEC 601/1 1988.
Technological Characteristics
1/2" CCD sensor; 628 lines resolution; 0.9 lux minimum illumination; automatic iris (1:16000S); +6 dB pre-signal conditioning. Power: 100-240V, 0-440Hz. Compliance: IEC 601/1 1988, DIN VDE 0750 TI/12.91.
Indications for Use
Indicated for use as an endoscopic video camera to transmit images from endoscopes or arthroscopes to remote video monitors for visualization during endoscopic or arthroscopic procedures.
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
- Dyonics Digital video camera system
Related Devices
- K982965 — ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES · Richard Wolf Medical Instruments Corp. · Nov 23, 1998
- K974391 — KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM · Karl Storz Imaging, Inc. · Jan 30, 1998
- K132785 — STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY · Stryker Endoscopy · Dec 16, 2013
- K081585 — ENDOSCOPY VIDEO CAMERA SYSTEM · Vision Systems Group, A Division of Viking Systems · Jun 20, 2008
- K991416 — ENDOSCOPIC CAMERA · Genzyme Surgical Product (Genzyme Biosurgery) · Jul 20, 1999
