(130 days)
The intended use of the Stryker Visum™ Surgical Lighting System is to illuminate the operative site during surgical procedures with high intensity light.
The Stryker Visum™ Surgical Lighting System is intended to illuminate the operative site during surgical procedures. Light functions can be controlled from within the sterile field, from a wall mounted control panel, or through the Stryker Switchpoint device. The Stryker Visum™ Surgical Lighting System is suitable for all major and minor surgical procedures throughout the hospital. The light moves via an easy to move pivoting suspension and has a completely sealed lighthead for safety and hygiene. Intensity is variable from 75,000 Lux and each lighthead has an automatic reserve bulb. The bulbs are easy to exchange and require no special tools. The light quality is based upon a facetted reflector combined with a heat removing filtration device to provide shadow free, cool light. All systems are ceiling, wall, or mobile mounted lights and each provides sufficient illumination for all types of surgical procedures. The ceiling mounted lights are available in single, dual, and triple configurations and may also be combined with a separate arm to hold a viewing monitor.
The provided text is for a 510(k) premarket notification for the Stryker Visum™ Surgical Lighting System, which is a surgical lamp. The purpose of this type of submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than to prove its direct safety and effectiveness through extensive clinical trials as might be required for a novel device. Therefore, the information typically requested in your query (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies, detailed ground truth establishment) is not usually part of a 510(k) submission for a device like a surgical light, which is primarily evaluated against performance standards and existing predicate devices.
Instead, the submission focuses on demonstrating that the device meets relevant performance standards and is comparable to a predicate device in terms of design, materials, and function.
Here's the information extracted from the provided text, re-organized to fit your requested fields where applicable, and noting where the requested information is not available or not relevant for this type of submission:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Standard / Requirement) | Reported Device Performance |
|---|---|
| FDA Guidance for Surgical Lamps | The Stryker Visum™ Surgical Lighting System meets the requirements set forth in FDA Guidance for Surgical Lamps. |
| Electrical Safety Standards IEC 60601-2-41 | The Stryker Visum™ Surgical Lighting System meets electrical safety standards IEC 60601-2-41. |
| Sterility Requirements AAMI ST37 (for disposable handles) | The sterile, disposable handles meet the sterility requirements of AAMI ST37, to and SAL of 10. |
| Illumination Intensity (Variable) | Intensity is variable from 75,000 Lux. |
| Automatic Reserve Bulb | Each lighthead has an automatic reserve bulb. |
| Ease of Bulb Exchange | Bulbs are easy to exchange and require no special tools. |
| Shadow-free, Cool Light | Light quality based upon a facetted reflector combined with a heat removing filtration device to provide shadow free, cool light. |
| Sufficient Illumination for various procedures | Each provides sufficient illumination for all types of surgical procedures. |
| Substantial Equivalence to Predicate Device | The system is substantially equivalent in materials, design, and function to the Berchtold D650 Surgical Lighting System (K922836). |
Study Details (Based on 510(k) Submission for a Surgical Lamp)
Given the nature of a 510(k) submission for a surgical lighting system (a Class II device), traditional clinical studies with test sets, training sets, and expert evaluations as typically seen for diagnostic AI/ML algorithms are generally not required or performed in the same manner. The evidence typically relies on compliance with recognized standards and comparison to a predicate device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided in the text. For a surgical light, "testing" typically involves engineering verification and validation against performance standards, rather than clinical efficacy studies with human subjects or data sets in the way an AI algorithm would be tested. The text indicates compliance with standards like IEC 60601-2-41 and AAMI ST37, which would involve specific test methods defined by those standards.
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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/Not provided in the text. Ground truth in the context of clinical expert consensus is not relevant for demonstrating substantial equivalence of a surgical light. "Ground truth" here would be objective measurements against specified engineering and performance criteria.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided in the text. Adjudication methods for expert consensus are not relevant for this device.
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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:
- No, not done. MRMC studies are used for evaluating diagnostic devices, particularly those involving interpretation by human readers, often with AI assistance. This device is a surgical light, and its function does not involve human "readers" or AI assistance in this context.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical surgical lighting system, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Objective performance measurements against established industry standards and regulatory guidance. The "ground truth" for this device's performance is adherence to specifications (e.g., illuminance, sterility, electrical safety) as defined by standards like IEC 60601-2-41, AAMI ST37, and FDA Guidance for Surgical Lamps.
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The sample size for the training set:
- Not applicable/Not provided in the text. "Training set" is a concept for AI/ML algorithms. For a physical device like this, product development involves design, prototyping, and testing, not a "training set" in the computational sense.
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How the ground truth for the training set was established:
- Not applicable. As above, the concept of a training set and its ground truth is not relevant for this device.
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Ko31068 1/1
AUG 1 2 2003
5900 Optical Court
San Jose, CA 95138
(408) 754.2148
Fax (408) 754.2521
melissam@strykerendo.com
SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
Classification Name: Common Name: Proprietary Name:
Light, Surgical; 21CFR §878.4580; Class II Surgical Light, Surgical Lamp Stryker Visum™ Surgical Lighting System
Predicate Device
Berchtold D650 Surgical Lighting System, currently marketed by Berchtold Corporation under the premarket notification K922836.
Indications for Use:
The intended use of the Stryker Visum™ Surgical Lighting System is to illuminate the operative site during surgical procedures with high intensity light.
Summary
This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of the Safe Medical Devices Act, 1990.
The Stryker Visum™ Surgical Lighting System is intended to illuminate the operative site during surgical procedures. Light functions can be controlled from within the sterile field, from a wall mounted control panel, or through the Stryker Switchpoint device.
The Stryker Visum™ Surgical Lighting System will be used in indications the same as other surgical lights currently offered for commercial distribution in the United States.
The Stryker Visum™ Surgical Lighting System is suitable for all major and minor surgical procedures throughout the hospital. The light moves via an easy to move pivoting suspension and has a completely sealed lighthead for safety and hygiene. Intensity is variable from 75,000 Lux and each lighthead has an automatic reserve bulb. The bulbs are easy to exchange and require no special tools.
The light quality is based upon a facetted reflector combined with a heat removing filtration device to provide shadow free, cool light.
All systems are ceiling, wall, or mobile mounted lights and each provides sufficient illumination for all types of surgical procedures. The ceiling mounted lights are available in single, dual, and triple configurations and may also be combined with a separate arm to hold a viewing monitor.
The Stryker Visum™ Surgical Lighting System meets the requirements set forth in FDA Guidance for Surgical Lamps, as well as electrical safety standards IEC 60601-2-41. The sterile, disposable handles meet the sterility requirements of AAMI ST37, to and SAL of 10 . Therefore, the system is substantially equivalent in materials, design, and function to the Berchtold D650 Surgical Lighting System (K922836).
Contact:
Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 (408) 754-2148
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Image /page/1/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used to represent the U.S. government's health and human services programs.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2003
Ms. Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, California 95138
Re: K031068
Trade/Device Name: Stryker Visum™ Surgical Lighting System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSY Dated: August 5, 2003 Received: August 6, 2003
Dear Ms. Murphy:
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 - Ms. Melissa Murphy
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. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,
Wag Witt
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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February 17, 2003
510(k) Number if know:_K031066
INDICATIONS FOR USE:
The intended use of the Stryker Visum™ Surgical Lighting System is to illuminate the operative site during surgical procedures with high intensity light.
(Division
Division of ( رب and Neurole.
510(k) Number K031068
(PLEASE DO NOT WRITE BELOW THIS LINE –CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-counter Use __
§ 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.