(13 days)
Not Found
No
The device description focuses on basic mechanical and electrical components (halogen lamps, mounting configurations, laser pilot, magnetic brakes) and does not mention any computational or learning capabilities. The performance studies focus on safety and electrical standards, not AI/ML performance metrics.
No.
The device's intended use is to illuminate an operating or examination area, which is a supportive function for medical procedures rather than directly treating a condition or disease.
No
Explanation: The device is described as surgical lights intended to illuminate an operating or examination area, not to diagnose a condition. While it mentions "luminaries for diagnosis" in the performance studies, the primary intended use and device description focus on illumination for surgical or examination procedures, not diagnostic assessment.
No
The device description clearly details physical hardware components such as lamp housings, halogen lamps, mounting configurations, a laser pilot, and magnetic brakes, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "locally illuminate an operating or examination area of the patient's body with high intensity light." This is a direct interaction with the patient's body for visualization during procedures.
- Device Description: The description details a surgical light with features for illumination and positioning. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such tests.
The device is a surgical light, which is a medical device used in a clinical setting, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Trumpf surgical lights are intended to locally illuminate an operating or examination area of the patient's body with high intensity light.
Product codes (comma separated list FDA assigned to the subject device)
FSY
Device Description
Four models of the Trumpf surgical lights will be available: 301, 501, 701 and 1001. The versions differ in the diameter of the lamp housing (300 mm, 500 mm, 700 mm and 1000 mm, respectively). All lights are equipped with one or two halogen lamps and are available in either ceiling-mounted ("D") or wall-mounted ("W") configurations. The Model 301 is also available in a floor standing/mobile ("S") configuration. The lights may be mounted individually, but more typically are mounted as two- or three-unit aggregates. An optional laser pilot is available on the Models 501, 701 and 1001. The laser pilot exactly marks the center of the light field. This makes it easier for the user to focus the light field with precision even if the operating area is very small. Whenever the operating light is moved/repositioned, the laser pilot is activated. When the operating light comes to a standstill, the laser pilot continues to be in operation for another two seconds. The laser pilot can be deactivated via the control panel. The laser wavelength is 635 nm with a nominal output power of
§ 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.
0
510(k) Summary of Safety & Effectiveness
Trumpf Medical Systems, Inc. Submitter 415 Jessen Lane Wando, SC 29492 Mr. William Apperson Contact President and CEO (843) 534-0606 Fax: (843) 534-0206 BAPP1024@aol.com May 7, 2001 Date Device Trade Name: Trumpf Surgical Light . Common Name: Surgical Light, Examination Light Classification: 21 CFR 878.4580 - Surgical Light - Class II ● Product Code FSY ● Drager Sola Surgical Light legally marketed under 510(k) premarket Predicate Device notification K984611. The Trumpf surgical lights are intended to locally illuminate an operating or Indications for Use examination area of the patient's body with high intensity light. Device Four models of the Trumpf surgical lights will be available: 301, 501, 701 and 1001. The versions differ in the diameter of the lamp housing (300 mm, Description 500 mm, 700 mm and 1000 mm, respectively). All lights are equipped with one or two halogen lamps and are available in either ceiling-mounted ("D") or wall-mounted ("W") configurations. The Model 301 is also available in a floor standing/mobile ("S") configuration. The lights may be mounted individually, but more typically are mounted as two- or three-unit aggregates.
Continued on next page
011693
1
510(k) Summary of Safety & Effectiveness, Continued
An optional laser pilot is available on the Models 501, 701 and 1001. The Device laser pilot exactly marks the center of the light field. This makes it easier for Description, the user to focus the light field with precision even if the operating area is continued very small. Whenever the operating light is moved/repositioned, the laser pilot is activated. When the operating light comes to a standstill, the laser pilot continues to be in operation for another two seconds. The laser pilot can be deactivated via the control panel. The laser wavelength is 635 nm with a nominal output power of