(76 days)
The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible illumination of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff.
The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible illumination of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. The system consists of a center-mounted lighthead suspension, which supports horizontal arms of possible differing lengths and lighthead assemblies and operates via an electronic control system. Optional features for the system include a fiber optic light for task lighting, voice control of the system via the HERMES system, a camera integrated in surgical lighthead, optional standard or flat screen monitor or a high end audio visual system. The system components can be arrayed to produce various system configurations depending upon the needs of the user. The Amsco Harmony Surgical Lighting and Media System has a sterile disposable sheath for postioning of the sterile field during surgical procedures. The sterile sheath is latex free and is made of approved medical grade material. The Amsco Harmony Surgical Lighting and Media System is designed to assure compilance with IEC 60601-2-41 (Ed.1.0 (2000-02) Medical Electrical Equipment - Part 2-41: Particular Requirements for the Safety of Surgical Luminaires and Luminaires for Diagnosis, IEC 60601-1 (Electrical Safety US, Canada). The device carries the ETL (to UL 2601-1) and cETL (to CAN/CSA C22.2 No. 601.1-M90) markings.
The provided document is a 510(k) premarket notification for the Amsco® Harmony Surgical Lighting and Media System. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, it explicitly states that clinical testing was not performed, and therefore, no study proving the device meets specific acceptance criteria is included.
The document focuses on non-clinical testing and comparison to predicate devices' specifications.
Here's an analysis based on the information provided, highlighting the absence of a study proving the device meets acceptance criteria:
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A table of acceptance criteria and the reported device performance
The document provides a comparative table of specifications between the Amsco Harmony Surgical Lighting and Media System and its predicate devices. While these are specifications and not explicitly labeled acceptance criteria, the implication is that matching or demonstrating similar performance to predicate devices is a form of acceptance criterion for substantial equivalence.
Item Predicate Device (Amsco SQ240, Hill-Rom BrightStar, Berchtold Chromophare "D-series") Amsco Harmony Surgical Lighting and Media System Performance Illumination Area (Range from 7-8.5" to 11" for diameter, 20-31.5" for depth) large: 6-14" (diameter), medium: 5-12" (diameter), small: 8" (diameter) Light beam diameter 30" (depth) Light beam depth Light focusing mechanism Fixed or Adjustable (varies by predicate) Adjustable Illumination @ 1m 9,293 (100,000) to 12,000 (130,000) Foot-candles (Lux) large: 13,000 (140,000), medium: 12,000 (130,000), small: 6,000 (65,000) Color Temperature (°K) 4,200°K to 4,500°K 4,400°K UV (≤400nm) Output
§ 878.4580 Surgical lamp.
(a)
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.(b)
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.