(203 days)
Not Found
No
The summary describes a standard surgical light and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is described as a surgical light intended to illuminate the operating site, indicating it is an assistive tool for surgeons and not a device that directly treats or provides therapy to the patient.
No
Explanation: The device is described as a surgical light intended to illuminate the operating site, which is a therapeutic or supportive function, not a diagnostic one.
No
The device description clearly states it is a "Surgical light," which is a hardware device used to illuminate the operating site. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states the device is a "Surgical light" intended to "illuminate locally the operating site on the patient's body". This is a device used on the patient's body during a surgical procedure, not for testing samples taken from the body.
The function of a surgical light is to provide illumination for a surgical field, which is a completely different purpose than an IVD.
N/A
Intended Use / Indications for Use
The Surgical light. CHROMOPHARE®D-650. is intended to illuminate locally the operating site on the patient's body with a high light intensity. "cold" light.
Product codes
FSY
Device Description
The Surgical light. CHROMOPHARE®D-650. is intended to illuminate locally the operating site on the patient's body with a high light intensity. "cold" light.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Wolfram Hill Manager, R&D Berchtold GmbH and Company Ludwigstaler Strasse 25 D-78505 Tuttlingen GERMANY
JUL 1 4 1997
- Re : K965130 CHROMOPHARE® Regulatory Class : II Product Code: FSY Dated: April 11, 1997 Received: April 15, 1997
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, Druq, 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 Requlation (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
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Page 2 - Mr. Wolfram Hill
comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
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/2/Picture/0 description: The image shows the logo for BERCHTOLD. The logo consists of the word "BERCHTOLD" in all caps, followed by two parallel diagonal lines and a solid black circle. A registered trademark symbol is located to the right of the circle.
JULY 11, 1997
INDICATION FOR USE
The Surgical light. CHROMOPHARE®D-650. is intended to illuminate locally the operating site on the patient's body with a high light intensity. "cold" light.
William D. Fugate, Sr.
William D. Fugate. Sr Regulatory Affairs. USA
2-11-97
Date
Prescription Use
(Per 21 CFR 801.109)
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(Division Sign-Off) Divisiol 510k) Nun
1950 Hanahan Road • P.O. Box 60399 800-243-5135 • 803-569-6100
Charleston, SC 29419-0399 Fax: 803-569-6133