(104 days)
VIDA LED Surgical Lighting System - X series provide illumination for surgery or examination at operating room.
The VIDA LED Surgical Lighting System-X series provide illumination for surgery or examination at operating room. The VIDA LED Surgical Lighting System-X series (VIDA X) use high-efficacy light-emitting diodes (LED) for surgical operations and diagnostic purposes. LEDs provide bright and shadow reduced light. Thanks to its modular design. VIDA X also offers many options for configurations and can be installed in operating rooms with or without laminar air flow systems. A lighthead to the main spindle can be rotated horizontally with 360°. the spring arms can be rotated horizontally with 360° and moved vertically with 45° downwards and 30° upwards. The VIDA LED Surgical Lighting System-X series consists of Mounting Module, Horizontal Arm module, Suspension Device Module, sterile handle cover and Optional Accessories.
The provided document describes a 510(k) submission for the "VIDA LED Surgical Lighting System-X series," a surgical lamp. The submission focuses on demonstrating substantial equivalence to a predicate device, the "Mach LED SC," rather than presenting a study where acceptance criteria are directly defined and proven for the device's performance in a clinical setting.
Therefore, the document does not contain information for many of the requested categories because it's a regulatory submission based on substantial equivalence to an existing device, not a de novo clinical trial proving novel performance against predefined acceptance criteria.
Here's an attempt to extract relevant information and explain why other information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device (a surgical lighting system), "acceptance criteria" are primarily established by conformity to recognized medical device standards and demonstrating performance comparable to a predicate device, rather than patient-centric clinical outcomes. The performance metrics are generally technical specifications.
| Performance Metric (Acceptance Criterion implied by predicate comparison) | VIDA LED Surgical Lighting System-X series Performance (X70 model) | Predicate Device Performance (Mach LED SC) |
|---|---|---|
| Intended Use | Illumination for surgery or examination at operating room | Illumination for examination area and surgical field at hospital and doctor's practice |
| Light Source | LED | LED |
| Color Rendering Index (CRI) | 95 | 95 |
| Central Illumination (at 1m) (lux) | 160,000 lux | 160,000 lux (for 5sc model) |
| Color Temperature (Kelvin) | 4200 K | 4500 K |
| Light Field Diameter (D10) | 20-32 cm | 20-32 cm (for 5sc model) |
| Depth of Illumination (L1+L2 20%) | 140 cm | 145 cm (for 5sc model) |
| Depth of Illumination (L1+L2 60%) | 71 cm | 82 cm (for 5sc model) |
| Total Irradiance at maximum intensity |
§ 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.