(6 days)
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No
The document describes a surgical light with LED technology and optional camera, but there is no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No
The device provides illumination for surgical fields, which assists in procedures but does not directly treat or diagnose a disease or condition.
No
Explanation: The device is described as a surgical light intended to illuminate the surgical field and operating site. Its purpose is to provide light for surgical procedures, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly describes a physical surgical light with hardware components like LEDs, swivel arms, and optional integrated cameras. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "provide visible illumination to the surgical field of the patient" and "illuminate locally the operating site on the patient's body". This is a direct interaction with the patient's body during a surgical procedure.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Description: The description details a surgical light with LEDs, swivel arms, and optional cameras. This is consistent with a device used for illumination during surgery, not for analyzing biological samples.
The information provided strongly indicates that this is a surgical light, which is a medical device used in vivo (within the body or directly on the body surface) during a procedure, not an IVD.
N/A
Intended Use / Indications for Use
The CHROMOPHARE® E 668 is intended to be used to provide visible illumination to the surgical field of the patient. The surgical lights BERCHTOLD CHROMOPHARE® E 668 is 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 668 surgical light is suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in this light, 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
operating site on the patient's body
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
FEB 2 3 2009
510 (k) Summary
Submitter:
BERCHTOLD Holding GmbH Ludwigstaler Straße 125 D- 78532 Tuttlingen Germany
Contact Person:
Preparation Date:
February 06, 2009
Silke Goral
Phone:
Fax:
Regulatory Affairs
CHROMOPHARE® E 668 Trade Name:
Common Name:
Surgical lamp
Light, Surgical, Ceiling mounted Classification Name:
Predicate Device:
BERCHTOLD CHROMOPHARE® E 558 (K083066)
0049 7461 181-155
0049 7461 181-8155
Device Description:
The new BERCHTOLD CHROMOPHARE® E 668 surgical light is suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in this light, 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:
Indications for Use:
The CHROMOPHARE® E 668 is intended to be used to provide visible illumination to the surgical field of the patient.
The surgical lights BERCHTOLD CHROMOPHARE® E 668 is 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 668 is substantially equivalent to the surgical light BERCHTOLD CHROMOPHARE®E 558 (K083066). Similarities and differences are tabulated below. Any differences between the CHROMOPHARE E 668 and the predicate device do not alter the safety or efficacy of the device.
| | Legally marketed device
CHROMOPHARE® E 558 | New device
CHROMOPHARE® E 668 |
|----------------------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------|
| Intended use | Illumination of the operating
site on a patient's body | Same |
| Input power | 120V, 1- phase lines, 60Hz | Same |
| Protection against
electrical shock | Class I | Same |
| Diameter of light body | 568mm | 638mm |
| Diameter of reflectors | 36 reflectors: 35mm
36 reflectors: 40mm | 48 reflectors: 35mm
48 reflectors: 40mm |
| Lamp technology | Light Emitting Diode | Same |
| Reflector | 72 individual reflectors | 96 individual reflectors |
| Power consumption of
bulb |