(15 days)
Not Found
No
The summary describes a surgical light with LED technology and optional camera/endoscopic features, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is intended to provide illumination to the surgical field, which is a supportive function, not a direct therapeutic intervention on the patient's disease or condition.
No
The device is a surgical light intended to illuminate the surgical field, not to provide diagnostic information about a patient's condition.
No
The device description clearly describes physical hardware components (LEDs, swivel arms, optional integrated CCD video camera) and its primary function is to provide physical illumination, not solely software processing or analysis.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide visible illumination to the surgical field of the patient" and "illuminate locally the operating site on the patient's body". This describes a device used on the patient during a surgical procedure, not a device used to examine specimens from the patient outside the body.
- Device Description: The description focuses on the physical characteristics and function of a surgical light, such as LEDs, swivel arms, and optional cameras. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, urine, or any other biological specimen. There is no mention of reagents, assays, or diagnostic tests.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely to provide illumination during surgery.
N/A
Intended Use / Indications for Use
Intended Use of the device:
The CHROMOPHARE® E 778 and E 558 is intended to be used to provide visible illumination to the surgical field of the patient.
Indications for Use:
The surgical lights BERCHTOLD CHROMOPHARE® E 778 and E 558 are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
Product codes
FSY
Device Description
The new BERCHTOLD CHROMOPHARE® E 778 and E 558 surgical lights are suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in these lights, BERCHTOLD realizes high illumination intensity with a lower heat radiation and less pattern variation compared to previous generations of BERCHTOLD products. The light features easy-to-operate swivel arms. Each light functions with an optional integrated CCD video camera and/or with upward "EndoLite" and/or with downward "GuideLite" for endoscopic procedures. The lights could be combined among each other.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
This device conforms to IEC 60601-2-41:2001 specifications for performance of surgical lamps. This device conforms to IEC 60601-1 and IEC 60601-1-2 for electrical safety.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image contains a sequence of handwritten digits. The digits appear to be '1083066'. The numbers are written in a cursive style, with some connections between the digits. The image has a white background, and the digits are written in black ink.
OCT 3 0 2008
Submitter: BERCHTOLD Holding GmbH Ludwigstaler Straße 125 D- 78532 Tuttlingen Germany
- Contact Person: Silke Goral Regulatory Affairs Phone: 0049 7461 181-155 Fax: 0049 7461 181-8155 Silke.Goral@BERCHTOLD.biz
- Preparation Date: September 17, 2008
- Trade Name: CHROMOPHARE® E 778 CHROMOPHARE® E 558
- Common Name: Surgical lamp
- Classification Name: Light, Surgical, Ceiling mounted
Predicate Device: BERCHTOLD CHROMOPHARE® E 655 (K080857)
The new BERCHTOLD CHROMOPHARE® E 778 and E 558 surgical Device Description: lights are suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in these lights, BERCHTOLD realizes high illumination intensity with a lower heat radiation and less pattern variation compared to previous generations of BERCHTOLD products. The light features easy-to-operate swivel arms. Each light functions with an optional integrated CCD video camera and/or with upward "EndoLite" and/or with downward "GuideLite" for endoscopic procedures. The lights could be combined among each other.
Intended Use of the device: The CHROMOPHARE® E 778 and E 558 is intended to be used to provide visible illumination to the surgical field of the patient. Indications for Use: The surgical lights BERCHTOLD CHROMOPHARE® E 778 and E 558 are intended to illuminate locally the operating
site on the patient's body with a high intensity, shadow free, "cold" light.
1
Summary of technological characteristics compared to the predicate device:
The BERCHTOLD CHROMOPHARE® E 778 & E 558 are substantially equivalent to the surgical lights BERCHTOLD CHROMOPHARE® E 655 (K080857). Similarities and differences are tabulated below. Any differences between the CHROMOPHARE E 778 / E 558 and the predicate device do not alter the safety or efficacy of the device.
| | Legally marketed device
CHROMOPHARE® E 655 | New devices | |
|----------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| | | CHROMOPHARE® E 778 | CHROMOPHARE® E 558 |
| Intended use | Illumination of the operating
site on a patient's body | Same | Same |
| Input power | 120V, 1- phase lines, 60Hz | Same | Same |
| Protection against
electrical shock | Class I | Same | Same |
| Diameter of light body | 649mm | 763mm | 568mm |
| Diameter of reflectors | Polygon reflector: 520mm | 84 reflectors: 35mm
84 reflectors: 40mm | 36 reflectors: 35mm
36 reflectors: 40mm |
| Number of mirrored
reflector elements | 720 | None | None |
| Lamp technology | Metal halide discharging | Light Emitting Diode | Light Emitting Diode |
| Reflector | single-piece polygon reflector | 168 individual reflectors | 72 individual reflectors |
| Power consumption of
bulb | 72W |