← Product Code [FSS](/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS) · K961971 # Q-5000 (K961971) _Stryker Endoscopy · FSS · Jun 28, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K961971 ## Device Facts - **Applicant:** Stryker Endoscopy - **Product Code:** [FSS](/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS.md) - **Decision Date:** Jun 28, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4580 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## 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. ## Regulatory 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 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} stryker K961971 ENDOSCOPY 2590 Walsh Avenue Santa Clara, CA 95051 (408) 567-9100 1-800-435-0111 Fax JUN 28 1996 Classification Name: Surgical Lamp Common and usual name: Light source, projector, Illuminator Proprietary Name: Q-5000 # SUMMARY OF SAFETY AND EFFECTIVENESS STATEMENT 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. The Q-5000 light source is AC powered and is designed to meet international medical devices safety standards (IEC 601-1, UL, CSA) to provide safe operation and eliminates or minimizes risks of burns, fire, explosion eye damage, electromagnetic interference or electrical shock that may be associated with it. Light sources have been used in endoscopic surgical procedures for at least 15 years. They have been safe and effective to provide adequate lighting to surgical sites. The Stryker Endoscopy Q-5000 light source is substantially equivalent to the Circon-ACMI MV9082 light source and raises no additional safety or effectiveness issues. ![img-0.jpeg](img-0.jpeg) Bader Bellahsène, Ph.D. Project Engineer 05/17/96 Q-5000 Light Source 510(k) Pre-Market Notification 6 05/17/96 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K961971](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K961971) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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