(63 days)
The Synthes Light Guide is intended to transmit light to illuminate a surgical site during surgical procedures
The subject Synthes Light Guide uses a single 'fiberoptic' quartz fiber encased by medical grade stainless steel to externally illuminate a surgical site during surgical procedures. This light carrier is connected via standard adapters to currently marketed fiberoptic light cables which are sequentially connected to currently marketed Xenon or Halogen light sources. The materials and components of the Synthes Light Guide do not have patient contact or body fluid contact and therefore biocompatibility testing is not applicable. The device is approximately 310mm in length and 6mm in diameter. It is designed to be affixed via clamps to a ring retractor system which positions the device above the surgical site during a surgical procedure.
This document does not contain information on acceptance criteria or a study that proves the device meets acceptance criteria. It is a 510(k) summary and FDA clearance letter for a medical device called "Synthes Light Guide," which is a light source accessory used to illuminate surgical sites.
The document focuses on:
- Describing the device and its intended use.
- Comparing it to a predicate device to establish substantial equivalence.
- The FDA's decision to clear the device for market.
There is no mention of specific performance metrics, acceptance criteria, study designs, sample sizes, expert involvement, or any form of clinical or technical performance study data.
§ 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.