(88 days)
Not Found
No
The description focuses on the physical characteristics and basic functionalities of surgical lights, with no mention of AI or ML.
No
The device is described as surgical lights intended to illuminate the operating site, which is an ancillary function to surgery, not a therapeutic intervention itself.
No
Explanation: The device is a surgical light designed to illuminate the operating site, not to diagnose medical conditions or provide diagnostic information.
No
The device is a surgical light, which is a physical hardware device used to illuminate the operating site. The description details hardware components and features.
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 is a function performed on the patient's body during a surgical procedure.
- Device Description: The description details the physical characteristics and features of surgical lights, such as light intensity, swivel arms, and lamp systems. These are all related to providing illumination for surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (on the body) to provide illumination during surgery.
N/A
Intended Use / Indications for Use
The surgical lights, CHROMOPHARE® D 500 and D 530, 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® D 500 and D 530 surgical lights are suitable for all types of surgical procedures and offer the physician a natural (whiter) and "colder" light. The light quality is based on a optical double filter technique.
The CHROMOPHARE® D 530 provides a light intensity of up to 110000 lux and the CHROMOPHARE® D 500 up to 85000 lux.
The lights have features like easy-to-operate swivel arms, auto-switching on the second lamp in case of failure of the main lamp and an easy to exchange lamp cartridge. For the CHROMOPHARE® D 530 there is also an optional CCD-video camera available and a special version with "EndoLite" for endoscopical procedures. The lights could be combined with other Berchtold lights. The lights have been designed to and meet the requirements of the IEC 601 and UL 2601 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
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.
0
BERCHTOLD
K 974433
Image /page/0/Picture/2 description: The image is a black and white logo. The logo appears to be a stylized representation of the number 75. The number 7 is represented by three parallel lines, with the middle line being thicker than the other two. The number 5 is represented by a circle with a curved line extending from the bottom right of the circle.
FEB 2 0 1998 K. 510(k) SUMMARY (As Required By 21 CFR 807.3): FÜNFUNDSIEBZIG JAHRI
Date:
November 20, 1997
Submitter:
Berchtold GmbH & Co Ludwigstaler Str. 25 D-78532 Tuttlingen Germany
- 0049 7461 181-0 Phone number: 0049 7461 181 100 Fax number:
- Wolfram K. Hill Contact person: Manager R & D
Device Name:
- CHROMOPHARE® D 500 Trade Name: CHROMOPHARE® D 530
Classification name: Light, Surgical, Ceiling Mounted
Device Description:
The new Berchtold CHROMOPHARE® D 500 and D 530 surgical lights are suitable for all types of surgical procedures and offer the physician a natural (whiter) and "colder" light. The light quality is based on a optical double filter technique.
The CHROMOPHARE® D 530 provides a light intensity of up to 110000 lux and the CHROMOPHARE® D 500 up to 85000 lux.
The lights have features like easy-to-operate swivel arms, auto-switching on the second lamp in case of failure of the main lamp and an easy to exchange lamp cartridge. For the CHROMOPHARE® D 530 there is also an optional CCD-video camera available and a special version with "EndoLite" for endoscopical procedures. The lights could be combined with other Berchtold lights. The lights have been designed to and meet the requirements of the IEC 601 and UL 2601 regulation for safety.
Intended Use:
The surgical lights, CHROMOPHARE® D 500 and D 530, are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
1
Image /page/1/Picture/0 description: The image is a logo for Berchtold's 75th anniversary. The logo features the word "BERCHTOLD" at the top, followed by a stylized "75" with geometric shapes. Below the "75" is the text "FÜNFUNDSIEBZIG JAHRE", which translates to "Seventy-Five Years" in German. The logo is in black and white.
Substantial Equivalence:
The CHROMOPHARE® D 500 and D 530 surgical lights are substantially equivalent to
the surgical light CHROMOPHARE® D 650 which is approved by FDA under K965130.
Any difference that exists between the CHROMOPHARE® D 500/530 and the 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 2601.
2
Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are stacked on one line. The text appears to be extracted from a document or sign.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/3 description: The image shows the text "FEB 20 1998". The text is in a simple, sans-serif font and is arranged horizontally. The letters and numbers are evenly spaced and of uniform size, creating a clear and legible date.
Mr. Wolfram K. Hill Manager R & D Berchtold GmbH & Company Ludwigstaler Street 25 D-78532 Tuttlingen Germany
Re: K974433 CHROMOPHARE® D 500 and D 530 Surgical Lights Trade Name: Regulatory Class: II Product Code: FSY Dated: November 21, 1997 Received: November 24, 1997
Dear Mr. Hill:
We have reviewed your Section 510 (k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are 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 devices can be found in the Code of Federal Regulations, Title=21; Parts: 800 to 895. Har man and a substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your devices 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 requlations.
Image /page/2/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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Page 2 - Mr. Wolfram K. Hill
This letter will allow you to begin marketing your devices as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your device and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling requlation (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 devices, 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
-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/4/Picture/0 description: The image shows a logo with the word "BERCHTOLD" at the top and the number 75 in a stylized font in the middle. Below the number 75, the words "FÜNFUNDSIEBZIG JAHRE" are written. The logo is black and white and appears to be for a company or organization celebrating its 75th anniversary.
M. INDICATION FOR USE:
The surgical lights, CHROMOPHARE® D 500 and D 530, are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
Wolfram Hill
Nov. 21, 97
Date
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number F974433