(95 days)
The CHROMOPHARE® X 65 is intended to be used to provide 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.
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.
The provided text is for a 510(k) premarket notification for a surgical lamp (CHROMOPHARE® X 65). This type of device approval primarily relies on demonstrating substantial equivalence to a previously approved predicate device, rather than performing clinical studies with specific acceptance criteria and outcome measurements like those for diagnostic AI devices.
Therefore, the requested information about acceptance criteria, device performance, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this submission.
Here's why and what information is provided:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. For a surgical lamp, "acceptance criteria" would generally refer to adherence to design specifications, electrical safety standards (e.g., IEC 60601-1), electromagnetic compatibility (EMC), and performance specifications like illumination intensity, color temperature, and shadow reduction. The document does not provide a formal table of such criteria against measured performance for the CHROMOPHARE® X 65.
- What is reported: The device "realizes a higher illumination intensity with a lower heat radiation." This is a qualitative claim of improvement over the predicate, but not quantitative data against defined acceptance criteria within the provided text.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. There is no "test set" in the context of clinical performance data for this device. The assessment is primarily based on engineering design, specifications, and comparison to existing technology.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. No experts were used for establishing a "ground truth" for a test set, as this is not a diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method akin to clinical performance studies were used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a surgical lamp, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. Ground truth in the context of clinical diagnostic accuracy is not relevant here. The "ground truth" for a surgical light's performance would be objective measurements of its physical properties (e.g., lux values, color rendering index, temperature at surgical site). These are not detailed in the summary.
8. The sample size for the training set:
- Not Applicable. There is no "training set" for this device, as it is not an AI/ML product.
9. How the ground truth for the training set was established:
- Not Applicable. (See point 8).
Summary of Relevant Information from the Provided Text:
The entire submission is focused on demonstrating substantial equivalence of the new device (CHROMOPHARE® X 65) to a legally marketed predicate device (BERCHTOLD CHROMOPHARE® D650, K965130).
- Rationale for Equivalence: "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."
- Key Technological Difference/Improvement: The new light uses "gas-discharging lamps" which enables "a higher illumination intensity with a lower heat radiation."
- Intended Use: To provide visible illumination of the surgical field or the patient.
- Predicate Device: BERCHTOLD CHROMOPHARE® D650 (K965130).
In essence, for this type of device, the "study" is the comparison against the predicate device based on technical specifications and design principles, rather than clinical performance data with specific acceptance criteria that would be expected for a diagnostic or therapeutic AI device.
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510(k) Summary
| Submitter: | BERCHTOLD Holding GmbHLudwigstaler Str. 25D-78532 Tuttlingen Germany | MAR 21 2003 |
|---|---|---|
| Contact Person: | Jörg SchneiderRegulatory AffairsPhone: 0049 7461 181155Fax: 0049 7461 181100joerg.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 lightis suitable for all types of surgical procedures.With the use of `gas-discharging lamps in the new lightBERCHTOLD realizes a higher illumination intensity with alower heat radiation.The light incorporates easy-to-operate swivel arms autoswitching on the second lamp in case of failure of the mainlamp and an easy-to-exchange lamp cartridge. Also an optionalCCD-video-camera is available and a special versionwith "EndoLite" for endoscopical working.The light could be combined with other BERCHTOLD lights. | |
| Intended Use ofthe Device: | The CHROMOPHARE® X 65 is intended to be used to provideused to provide visible illumination of the surgical field or thepatient. | |
| Substantial Equivalence: | The BERCHTOLD CHROMOPHARE® X65 is substantiallyequivalent to the surgical light BERCHTOLDCHROMOPHARE® D650 (K965130).Any difference that exists between the CHROMOPHARE®D650 and the X 65 has no negative effect on safety or efficacyand actually enhances the usefulness in the chosenapplication. |
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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 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.
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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
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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
§ 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.