(95 days)
Not Found
No
The description focuses on traditional lighting technology, mechanical features, and basic electrical redundancy. There is no mention of AI/ML terms, image processing, or data-driven functionalities.
No.
The device is a surgical light intended for illumination, not for treating a disease or condition.
No
Explanation: The device is a surgical light intended for illumination during surgical procedures, not for diagnosing medical conditions.
No
The device description clearly describes a physical surgical light with hardware components like gas-discharging lamps, swivel arms, and an optional video camera. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing visible illumination of the surgical field or the patient's body during surgical procedures. This is a physical function performed on the patient or the environment around the patient.
- Device Description: The description details a surgical light with features related to illumination, heat reduction, maneuverability, and optional video capabilities. None of these functions involve testing samples taken from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely external to the patient's internal biological processes.
N/A
Intended Use / Indications for Use
The CHROMOPHARE® X 65 is intended to be used to provide visible illumination of the surgical field or the patient.
The surgical light BERCHTOLD CHROMOPHARE® X65 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® X 65 surgical light is suitable for all types of surgical procedures. With the use of gas-discharging lamps in the new light BERCHTOLD realizes a higher illumination intensity with a lower heat radiation. The light incorporates 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. Also an optional CCD-video-camera is available and a special version with "EndoLite" for endoscopical working. The light could be combined with other BERCHTOLD lights.
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)
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
510(k) Summary
| Submitter: | BERCHTOLD Holding GmbH
Ludwigstaler Str. 25
D-78532 Tuttlingen Germany | MAR 21 2003 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Jörg Schneider
Regulatory Affairs
Phone: 0049 7461 181155
Fax: 0049 7461 181100
joerg.schneider@berchtold.de | |
| Preparation Date: | December 02, 2002 | |
| Trade Name: | CHROMOPHARE® X 65 | |
| Common Name: | Surgical lamp | |
| Classification Name: | Light, Surgical, Ceiling Mounted | |
| Device Description: | The new BERCHTOLD CHROMOPHARE® X 65 surgical light
is suitable for all types of surgical procedures.
With the use of `gas-discharging lamps in the new light
BERCHTOLD realizes a higher illumination intensity with a
lower heat radiation.
The light incorporates 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. Also an optional
CCD-video-camera is available and a special version
with "EndoLite" for endoscopical working.
The light could be combined with other BERCHTOLD lights. | |
| Intended Use of
the Device: | The CHROMOPHARE® X 65 is intended to be used to provide
used to provide visible illumination of the surgical field or the
patient. | |
| Substantial Equivalence: | The BERCHTOLD CHROMOPHARE® X65 is substantially
equivalent to the surgical light BERCHTOLD
CHROMOPHARE® D650 (K965130).
Any difference that exists between the CHROMOPHARE®
D650 and the X 65 has no negative effect on safety or efficacy
and actually enhances the usefulness in the chosen
application. | |
1
Image /page/1/Picture/1 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. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2003
Mr. Jörg Schneider Regulatory Affairs Berchtold Holding GmbH Ludwigstaler Str. 25 Tuttlingen, Germay D-78532
Re: K024132
Trade/Device Name: CHROMOPHARE® X65 Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSY Dated: February 13, 2003 Received: February 19, 2003
Dear Mr. Schneider:
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 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.
2
Page 2 - Mr. Jörg Schneider
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, permits 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number K024132
INDICATION FOR USE
The surgical light BERCHTOLD CHROMOPHARE® X65
is intended to illuminate locally the operating site on the patient's body
with a high intensity, shadow free, "cold" light.
for Mark N. Melluson
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K0241132