(14 days)
The intended use of the Stryker Visum™ LED Surgical Lighting System is to illuminate the operative site during surgical procedures with high intensity light.
The Stryker Visum™ LED 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 SIDNE™ device (K022393). The Stryker Visum™ LED 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™ LED 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 50,000 Lux to 160,000 Lux and each lighthead has redundant light sources that are not affected by individual source failure. The light quality is based upon a multiple reflector design combined with a heat removing conductive path 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, K060802, describes a 510(k) premarket notification for the Stryker Visum™ LED Surgical Lighting System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria and detailed performance data. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in this type of regulatory submission.
However, based on the information provided, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device "meets the requirements set forth in FDA Guidance for Surgical Lamps, as well as electrical safety standards IEC 60601-1 and IEC 60601-2-41." It also mentions meeting "the sterility requirements of AAMI ST37 to achieve a SAL of 10^-6." The primary performance claim is its ability to "illuminate the operative site during surgical procedures with high intensity light."
While specific, quantifiable acceptance criteria are not presented in a table form in this document, the following can be inferred:
| Acceptance Criterion (Inferred from regulatory and performance statements) | Reported Device Performance |
|---|---|
| Electrical Safety Standards: | Meets IEC 60601-1 |
| Meets IEC 60601-2-41 | |
| Sterility Requirements for Reusable Handles: | Meets AAMI ST37 |
| Achieves a SAL of 10^-6 | |
| Illumination Intensity (range): | Variable from 50,000 Lux to 160,000 Lux |
| Light Source Redundancy: | Each lighthead has redundant light sources |
| Light Quality (Shadow-free, cool): | Based upon a multiple reflector design combined with a heat removing conductive path to provide shadow free, cool light |
| Substantial Equivalence to Predicate Devices: | Substantially equivalent to K031068 (Stryker Visum™ Surgical Lighting System) and K042382 (Med-General Technologies LLC's Dual LED Lite Engine) |
| Conformity to FDA Guidance: | Meets requirements set forth in FDA Guidance for Surgical Lamps |
2. Sample Size Used for the Test Set and Data Provenance:
This document does not describe a clinical study with a "test set" in the context of an AI/algorithm-driven device. It's a 510(k) submission for a physical medical device (surgical lighting system). Therefore, information on sample size and data provenance for a test set is not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable, as this is not a study requiring expert ground truth for an AI algorithm. The device's performance is likely evaluated against engineering specifications, standards, and comparative testing to predicate devices, rather than expert-established ground truth on a dataset.
4. Adjudication Method:
Not applicable for a 510(k) submission for a physical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study is not mentioned or implied, as this is not an AI-assisted diagnostic or interpretive device.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone algorithm performance study was not done. This device is a physical surgical lighting system, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this device's acceptance would be based on:
- Engineering Specifications: Adherence to design criteria for light intensity, color temperature, heat dissipation, maneuverability, etc.
- Regulatory Standards: Compliance with IEC 60601-1, IEC 60601-2-41, and AAMI ST37.
- Comparative Performance Data: Showing equivalence in performance characteristics to the predicate devices (K031068 and K042382).
- Safety Testing: Verifying electrical safety, sterility, and other physical safety parameters.
8. Sample Size for the Training Set:
Not applicable, as this is not an AI/machine learning device. The "training" for a physical device would involve design, prototyping, and iterative testing, not the use of a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in this context. The "ground truth" for the device's design and development comes from established engineering principles, international performance standards, and the performance characteristics of existing, legally marketed predicate devices.
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1410 Lakeside Parkway #100 Flower Mound, TX 75028 t: 972 410 7100 €: 972 410 7001 www.stryker.com
APR 7 2006
Communications
stryker
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
Classification Name: Common Name: Proprietary Namc:
Light, Surgical; 21CFR §878.4580; Class H Surgical Light, Surgical Lamp Stryker Visum™ LED Surgical Lighting System
The Stryker Visum™ LED Surgical Lighting System is substantially equivalent in safety and efficacy to the currently marketed Stryker Visum™ Surgical Lighting System, currently cleared under the pre-market notification K031068, and Med-General Technologies LLC's Dual LED Lite Engine with Illumination LED Cable Coupled to a LED Lite Head (K042382) Surgical Lamp, currently cleared under K042382.
The intended use of the Stryker Visum™ LED Surgical Lighting System is to illuminate the operative site during surgical procedures with high intensity light.
Summarv
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™ LED 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 SIDNE™ device (K022393). The Stryker Visum™ LED 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™ LED 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 50,000 Lux to 160,000 Lux and each lighthead has redundant light sources that are not affected by individual source failure. The light quality is based upon a multiple reflector design combined with a heat removing conductive path 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™ LED Surgical Lighting System meets the requirements set forth in FDA Guidance for Surgical Lamps, as well as electrical safety standards IEC 60601-1 and IEC 60601-2-41. The sterilizable, reusable handles meet the sterility requirements of AAMI ST37 to achieve a SAL of 10 * Therefore, the Stryker Visum™ LED Surgical Lighting System is substantially equivalent in material, design and performance to the Visum Surgical Lighting System (K031068) and is substantially equivalent in light source technology to Med General's Surgical Light (K042382).
Date:
Louis-Pierre Marcoux, RAC Associate RA/QA Manager Stryker Communications
Stryker Communications Visum™ LED Surgical Lighting System 510(k) Submission
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings, and a wavy line representing its legs. The seal is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2006 APR
Stryker Communications Corp. c/o Intertek Testing Services Mr. Daniel W. Lehtonen Staff Engineer - Medical Devices 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K060802
Trade/Device Name: Stryker Visum™ LED Surgical Lighting System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSY Dated: March 23, 2006 Received: March 24, 2006
Dear Mr. Lehtonen:
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 he 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
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Page 2 - Mr. Daniel W. Lehtonen
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. 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 (240) 276-0115. 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 vours.
elle
Mark N. Melkerson Director Division of General, Restorative
and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K060802
Device Name: Stryker Visum™ LED Surgical Lighting System
Indications For Use:
The intended use of the Stryker Visum™ LED Surgical Lighting System is to illuminate the operative site during surgical procedures with high intensity light.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ______________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
emell
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number_KOG 0802
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.