Q-5000
Device Facts
| Record ID | K961971 |
|---|---|
| Device Name | Q-5000 |
| Applicant | Stryker Endoscopy |
| Product Code | FSS · General, Plastic Surgery |
| Decision Date | Jun 28, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4580 |
| Device Class | Class 2 |
Intended Use
The Stryker Endoscopy Q-5000 light source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), and endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope. The light source is an integral component of a visualization system which consists of the a video camera, a video monitor, a light cable and a scope.
Device Story
Q-5000 light source; provides illumination for minimally invasive surgery. Input: AC power. Transformation: generates light transmitted via optical cable and scope to surgical site. Output: high-intensity light for visualization. Context: used in OR/clinic as part of visualization system (camera, monitor, cable, scope). Operator: surgeon/clinical staff. Benefit: enables visualization of internal anatomy during procedures.
Clinical Evidence
No clinical data. Bench testing only; device relies on established history of light source use in endoscopic surgery (15+ years) and compliance with international safety standards.
Technological Characteristics
AC powered light source; designed for integration with video camera, monitor, light cable, and scope. Compliance: IEC 601-1, UL, CSA. Mitigation of thermal, electrical, and optical hazards.
Indications for Use
Indicated for illumination of surgical sites during minimally invasive procedures including arthroscopy, laparoscopy, and endoscopy (general, gastroenterological, and ENT).
Regulatory Classification
Identification
A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.
Special Controls
*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
Predicate Devices
- Circon-ACMI MV9082 light source
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