(141 days)
Not Found
No
The description focuses on the optical and mechanical features of a surgical light, with no mention of AI or ML capabilities.
No
The device is a surgical light used for illumination during procedures, not for treating any medical condition or anatomical site.
No.
The device is a surgical light intended to illuminate the operating site, not to diagnose medical conditions.
No
The device description clearly describes a physical surgical light with hardware components like a suspension mechanism, lamps, and filters, 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 "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 samples from the patient (like blood, urine, or tissue) outside of the body.
- Device Description: The description focuses on the physical characteristics and function of a surgical light, such as light intensity, filtration techniques, suspension mechanisms, and safety regulations. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status based on sample analysis
- Reagents or assays
Therefore, the CHROMOPHARE® D 530 LDR surgical light is a medical device used for illumination during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The surgical light, CHROMOPHARE® D 530 LDR is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
The surgical light, CHROMOPHARE® D 530 LDR, 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® D 530 LDR surgical light is suitable for all types of surgical procedures and offers the physician a natural (whiter) and "colder" light. The light quality is based on an optical double filter technique.
The CHROMOPHARE® D 530 LDR provides a light intensity of up to 85000 lux.
The light has features like a suspension mechanism will allow to move the light head motordriven up and down, auto-switching on the second lamp in case of failure of the main lamp and an easy to exchange lamp cartridge. The new suspension allows the surgeon to move the light out of the treatment area, which is of interest e.g. in labor and delivery rooms. The light has been designed to and meets the requirements of the IEC 601 and UL 544 regulation for safety.
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
physician, surgeon (in labor and delivery rooms)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/1 description: The image shows the logo for BERCHTOLD. The logo consists of the word "BERCHTOLD" in all caps, followed by two vertical lines and a solid black circle. The circle has a registered trademark symbol next to it.
K. 510(k) SUMMARY (As Required By 21 CFR 807.3):
Date:
June 7. 1997
12990656
Submitter:
Berchtold GmbH & Co Ludwigstaler Str. 25 D-78532 Tuttlingen Germany
0049 7461 181-0
0049 7461 181-100
Phone number: Fax number:
Wolfram K. Hill Contact person: Manager R & D
Device Name:
CHROMOPHARE® D 530 LDR Trade Name:
Light, Surgical, Ceiling Mounted Classification name:
Device Description:
The new Berchtold CHROMOPHARE® D 530 LDR surgical light is suitable for all types of surgical procedures and offers the physician a natural (whiter) and "colder" light. The light quality is based on an optical double filter technique.
The CHROMOPHARE® D 530 LDR provides a light intensity of up to 85000 lux.
The light has features like a suspension mechanism will allow to move the light head motordriven up and down, auto-switching on the second lamp in case of failure of the main lamp and an easy to exchange lamp cartridge. The new suspension allows the surgeon to move the light out of the treatment area, which is of interest e.g. in labor and delivery rooms. The light has been designed to and meets the requirements of the IEC 601 and UL 544 regulation for safety.
Intended Use:
The surgical light, CHROMOPHARE® D 530 LDR is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
Substantial Equivalence:
The CHROMOPHARE® D 530 LDR surgical light is substantially equivalent to the surgical light CHROMOPHARE® D 500 which is approved by FDA under K974433.
Any difference that exists between the CHROMOPHARE® D 530 LDR and the CHROMOPHARE® D 500 has no negative effect on safety or efficacy and actually enhances the usefulness in the chosen application. Safety of the lights, as indicated above, has been established by meeting the requirements of IEC 601 and UL 544.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 1999
Mr. Wolfram K. Hill Manager, Research and Development Berchtold GmbH & Co. Ludwigstaler Str. 25 Postfach 4052 D-78505 Tuttlingen, Germany
Re: K990656
Trade Name: CHROMOPHARE® D 530 LDR Regulatory Class: II Product Code: FSY Dated: June 7, 1999 Received: June 11, 1999
Dear Mr. Hill:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Wolfram K. Hill
This letter will allow you to begin marketing your device as described in your 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, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the word "BERCHTOLD" in all capital letters on the left side of the image. To the right of the word is a logo that consists of two parallel diagonal lines and a solid black circle. A small registered trademark symbol is located to the bottom right of the circle.
M. INDICATION FOR USE:
The surgical light, CHROMOPHARE® D 530 LDR, is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
Wolfram Hill
Wolfram Hill
June 7, 99
Date
990656
510(k) Number
Acòlla
(Division Sign-Off) (Division of General Restorative Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
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