(14 days)
No
The description focuses on the physical and functional aspects of a surgical lighting system, with no mention of AI or ML capabilities. The control options are described as standard interfaces (sterile field controls, wall panel, or a separate device), not intelligent or adaptive systems.
No
The device is described as a surgical lighting system intended to illuminate the operative site, which is a supportive function during surgery, not a direct therapeutic intervention on the patient.
No
The device is described as a surgical lighting system intended to illuminate the operative site during surgical procedures, not to diagnose medical conditions.
No
The device description clearly details physical hardware components such as lightheads, suspension systems, control panels, and mounting options (ceiling, wall, mobile), indicating it is a hardware device with integrated software for control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "illuminate the operative site during surgical procedures." This is a function performed on the patient during surgery, not on a sample taken from the patient outside of the body.
- Device Description: The description focuses on the physical characteristics and functionality of a surgical light, such as intensity, mounting options, and control methods. It does not mention any analysis of biological samples.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) to provide information about a patient's health status. This device does not perform any such analysis.
The device is clearly described as a surgical light used to illuminate the surgical field, which is a standard medical device used in surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
FSY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
operative site
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.
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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
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