(14 days)
Not Found
No
The description focuses on basic lighting technology, mechanical features, and safety standards, with no mention of AI or ML.
No
The device is a surgical light intended to illuminate the surgical field. It does not provide any therapeutic effect.
No
Explanation: The device is a surgical light intended to illuminate the surgical field or patient, not to diagnose a condition.
No
The device description clearly details physical hardware components such as gas-discharging lamps, Halogen bulbs, swivel arms, and optional integrated CCD video cameras. It is a physical surgical light system, not a software-only device.
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 of the surgical field or the patient's operating site. This is a direct interaction with the patient's body during a surgical procedure.
- Device Description: The description details a surgical light with features for illumination, positioning, and optional video capabilities. These are all related to providing light and potentially recording the surgical field.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information about a patient's health status based on in vitro analysis
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely to illuminate the surgical area.
N/A
Intended Use / Indications for Use
Intended Use The CHROMOPHARE® Exxx is intended to be used to provide of the device: visible illumination of the surgical field or the patient.
Indications for Use: The surgical lights BERCHTOLD CHROMOPHARE® E805, E800, E 655, E 650, E 550 and E 520 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® E805, E800, E655, E650, E550, and E520 (collectively known and referred to in this document as CHROMOPHARE® Exxx) surgical lights are suitable for all types of surgical procedures. With the use of gas-discharging lamps or Halogen bulbs 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, auto switching to the secondary lamp in case of failure of the primary lamp, and an easy-to-exchange lamp cartridge. Each light functions with an optional integrated CCD video camera and/or with upward "EndoLite" 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
operating site on the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BERCHTOLD CHROMOPHARE® D650 (K965130), BERCHTOLD CHROMOPHARE® X65 (K024132)
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
Submitter:
BERCHTOLD Holding GmbH Ludwigstaler Straße 125 D- 78532 Tuttlingen Germany
Contact Person:
Silke Goral Requiatory Affairs Phone: 0049 7461 181-155 Fax: 0049 7461 181-8155 Silke.Goral@BERCHTOLD.biz
..............................................................................................................................................................................
January 16, 2008 Preparation Date:
Trade Name:
CHROMOPHARE® E 805 CHROMOPHARE® E 800 CHROMOPHARE® E 655 CHROMOPHARE® E 650
CHROMOPHARE® E 550 CHROMOPHARE® E 520
Common Name: Surgical lamp
Classification Name: Light, Surgical, Ceiling mounted
BERCHTOLD CHROMOPHARE® D650 (K965130) Predicate Device: BERCHTOLD CHROMOPHARE® X65 (K024132)
Device Description: The new BERCHTOLD CHROMOPHARE® E805, E800, E655, E650, E550, and E520 (collectively known and referred to in this document as CHROMOPHARE® Exxx) surgical lights are suitable for all types of surgical procedures. With the use of gas-discharging lamps or Halogen bulbs 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, auto switching to the secondary lamp in case of failure of the primary lamp, and an easy-to-exchange lamp cartridge. Each light functions with an optional integrated CCD video camera and/or with upward "EndoLite" for endoscopic procedures. The lights could be combined among each other.
Intended Use The CHROMOPHARE® Exxx is intended to be used to provide of the device: visible illumination of the surgical field or the patient.
The surgical lights BERCHTOLD CHROMOPHARE® E805, Indications for Use: E800, E 655, E 650, E 550 and E 520 are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
APR 1 0 2008
4080857
1
Summary of technological: characteristics compared to the predicate device
. . .
The BERCHTOLD CHROMOPHARE® Exxx is substantially equivalent to the surgical lights BERCHTOLD CHROMOPHARE® D 650 (K96513 ) and CHROMOPHARE® X 65 (K024132) Similarities and differences are tabulated below. Any differences between the CHROMOPHARE Exxx and the predicate devices do not alter the safety or efficacy of the device.
| Legally marketed device | New devices | ||
|---|---|---|---|
| CHROMOPHARE® X65 | CHROMOPHARE® E805 | CHROMOPHARE® E655 | |
| 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 | 650mm | 799mm | 649mm |
| Diameter of polygon | |||
| reflectors | 580mm | 680mm | 520mm |
| Number of mirrored | |||
| reflector elements | 800 | 720 | 720 |
| Lamp technology | Metal halide discharging | same | same |
| Polygon Reflector | Multi-piece | Single piece | Single piece |
| Power consumption of | |||
| bulb | 72W | 150W | same |
| Light / heat filter | |||
| technology incl. UV light | |||
| filter mechanism | ThermoSorb® | same | same |
| Color rendering index Ra | 94 | same | same |
| Color temperature | 4500°K | 4300°K | 4300°K |
| Central illuminance (at 1m) | 80000 - 160000lux | same | same |
| Light field diameter | 170 - 280mm | 200 - 330mm | same |
| Depth of Illumination | 1250mm | 1200mm | 1300mm |
| Total irradiance Ee | 550W/m² | 560W/m² | 560W/m² |
| UV- irradiance (≤400nm) | 2.0W/m² | same | same |
| Light focusing mechanism | Rotating of Handle | same | same |
| Life time of bulb | 5000h | same | same |
| Bulb life time indicator | Yes | same | same |
| Automatic switching to the | |||
| reserve bulb | Yes | same | same |
| Bulb replacement indicator | Yes | same | same |
| Reusable steam | |||
| sterilizable lamp handle | Yes | same | same |
| Additional light controls in | |||
| separate wall box | Standard | same | same |
| EndoLite in the light head | |||
| (ambient illumination for | |||
| minimally invasive | |||
| surgeries) | Optional feature | same | same |
| CCD video camera located | |||
| in sterilizable lamp handle | Optional feature | same | same |
| Automatic regulation of | |||
| intensity | No | AUTOlux | No |
| | Legally marketed
device
CHROMOPHARE®
D650 | New devices | | | |
|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|----------------------|----------------------|----------------------|----------------------|
| | | CHROMOPHARE®
E800 | CHROMOPHARE®
E650 | CHROMOPHARE®
E550 | CHROMOPHARE®
E520 |
| Intended use | Illumination of the
operating site on a
patient's body | same | same | same | Same |
| Input power | 120V, 1- phase lines,
60Hz | same | same | same | Same |
| Protection
against
electrical shock | Class I | same | same | same | Same |
| Diameter of
light body | 650mm | 799mm | 649mm | 579mm | 579mm |
| Diameter of
polygon
reflectors | 580mm | 680mm | 520mm | 460mm | 460mm |
| | | | | | |
| Number of
mirrored
reflector
elements | 800 | 720 | 720 | 720 | 720 |
| Lamp
technology | Halogen | same | same | same | Same |
| Polygon
Reflector | Multi-piece | Single piece | Single Piece | Single piece | Single piece |
| Power
consumption of
bulb | 150W | same | same | same | 150W |
| Light / heat
filter
technology incl.
UV light filter
mechanism | ThermoSorb® | same | same | same | Same |
| Color rendering
index Rₐ | 94 | 93 | 93 | 93 | 93 |
| Color
temperature | 4500°K | 4300°K | 4300°K | 4300°K | 4300°K |
| Central
illuminance (at
1m) | 70000 - 130000lux | 80000 - 160000lux | 80000 - 160000lux | 65000 - 130000lux | 80000lux |
| Light field
diameter | 150 - 280mm | 200-300mm | 170 - 280mm | 150 - 250mm | 200mm |
| Depth of
illumination | 1200mm | same | 1300mm | 1250mm | 1250mm |
| Total irradiance
Eₑ | 485W/m² | 560W/m² | 507W/m² | 455W/m² | 280W/m² |
| UV- irradiance
(≤400nm) | 2.6W/m² | same | Same | same | Same |
| Light focusing
mechanism | Rotating of handle | same | Same | same | No |
| Life time of
bulb | 1000h | same | Same | same | Same |
| Bulb life time
indicator | No | same | Same | same | Same |
| Automatic
switching to the
reserve bulb | Yes | same | Same | same | Same |
| Bulb
replacement
indicator | Yes | same | Same | same | Same |
| Reusable
steam
sterllizable
lamp handle | Yes | same | Same | same | Same |
| Additional light
controls in
separate wall
box | Optional feature | Standard | Standard | Standard | No |
| EndoLite in the
light head
(ambient
illumination for
minimally
invasive
surgeries) | Optional feature | same | Same | same | No |
| CCD video
camera located
In sterilizable
lamp handle | Optional feature | same | Same | same | No |
2
Performance Summary:
·
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.
.
.
·
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2008
Berchtold Holding GmbH % Underwriters Laboratories, Inc. Mr. Jeff D. Rongero Senior Project Engineer 12 Laboratory Drive Research Triangle Park, North Carolina 27709
Re: K080857
I Trade/Device Name: CHROMOPHARE® E 805, CHROMOPHARE® E 800, CHROMOPHARE® E 655, CHROMOPHARE® E 650, CHROMOPHARE® E 550, CHROMOPHARE® E 520 Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSY Dated: March 25, 2008 Received: March 27, 2008
Dear Mr. Rongero:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
4
Page 2 – Mr. Jeff D. Rongero
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, pcrmits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Milburn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K080857
Device Name:
CHROMOPHARE® E 805 CHROMOPHARE® E 800 CHROMOPHARE® E 655 CHROMOPHARE® E 650 CHROMOPHARE® E 550 CHROMOPHARE® E 520
Indications for Use:
The surgical lights BERCHTOLD CHROMOPHARE® E 805, E 800, E 655, E 650, E 550 and E 520 are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free,
"cold" light.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division
Division of Gascal, Restorative,
and Neurological Dovices
Page 5 of 27
510(k) Number: K680857