(118 days)
Not Found
No
The document describes a standard LED surgical light system with variable intensity and optional camera. There is no mention of AI or ML in the intended use, device description, or the specific sections checked for AI/ML terms. The device's function is illumination, not data analysis or algorithmic decision-making.
No.
The device's sole purpose is illumination of the operative site, not to directly treat or diagnose a medical condition.
No
The device is described as a surgical light system intended for illumination during procedures, not for diagnosis. Its function is to provide high-intensity light for visibility in healthcare settings.
No
The device description clearly outlines multiple hardware components including light heads, a pivoting suspension system, mounting plates, a power supply box, and optional end effectors and a camera. This is not a software-only device.
Based on the provided information, the Visum Blade LED Surgical Light is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "illuminate the operative site during surgical procedures." This is a function related to providing light for a surgical procedure, not for examining specimens from the human body to provide diagnostic information.
- Device Description: The description details a surgical light system with LED lights, suspension systems, and controls. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.
- Performing tests on specimens.
The Visum Blade LED Surgical Light is clearly described as a surgical light intended to provide illumination during surgery. This falls under the category of a surgical instrument or accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Visum Blade LED Surgical Light is intended to illuminate the operative site during surgical procedures with high intensity light.
The Visum Blade LED Surgical Light System is indicated to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms, and all other health care facilities where the need for additional illumination exists.
Product codes (comma separated list FDA assigned to the subject device)
FSY
Device Description
The Visum Blade LED Surgical Light System (Blade) is suitable for all major and minor surgical procedures in operating rooms and all other healthcare facilities where the need for illumination exists. The light intensity is variable up to 160,000 Lux. The light quality is based upon high quality LED's to provide cool light with reduced shadow resolution.
A system consists of 1 - 4 light heads supported by a pivoting suspension system that is attached to the heath care facility's super structure by a mounting plate. The system requires at least one of the following: a power supply box, ceiling cover, drop tube, central axis and spring arm. The system may include optional end effectors such as but not limited to monitor mounts. The mounting plates may be configured to accommodate a single or tandem mount suspension system.
Independent, control of each light's intensity is via the light handle. An optional electronic wall control panel may be installed in the operating room for control by non-sterile users. Blade allows for an in-light camera option that may be added to a light head. This option requires a wall control for camera operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
operating rooms, examination rooms, emergency rooms, and all other health care facilities where the need for additional illumination exists.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
See Section 18, Performance, Bench.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Burton's AIM 200 OR Major Surgical Light (K101537). Stryker's Visum LED Surgical Light System (K060802)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is capitalized. There is a registered trademark symbol to the upper right of the word. The word is likely a company logo or brand name.
DEC 3 0 2013
1410 Lakeside Parkway, #100 Flower Mound, TX 75028 t: 972 410 7100 f: 972 410 7001 www.stryker.com
Communications
Section 5 - 510(k) Summary for the Visum Blade LED Surgical Light System
PER 21 CFR 807.92
| Date: | December 26, 2013 |
|---|---|
| 510(k) Owner/Sponsor: | Stryker Communications |
| Address: | 1410 Lakeside Parkway, #100 |
| Flower Mound, Texas 75028 | |
| Establishment Number: | 2031963 |
| Telephone Number: | (972) 410-7181 |
| Fax Number: | (972) 410-7201 |
| Contact Person: | Trey Thorsen; Senior Regulatory Compliance Analyst |
| Email Address: | trey.thorsen@stryker.com |
| Proposed Device: | Visum Blade LED Surgical Light System (Blade) |
| Device Common Name: | Surgical Light, Surgical Lamp |
| Product Code: | FSY |
| FDA Regulation Number: | 21 CFR 878.4580 |
| Device Classification: | Class II |
| Predicate Devices: | Burton's AIM 200 OR Major Surgical Light (K101537). Stryker's Visum LED Surgical Light System (K060802) |
| Device Common Name: | Surgical Light, Surgical Lamp |
| Product Code: | FSY |
| FDA Regulation Number: | 21 CFR 878.4580 |
| Device Classification: | Class II |
Device Description
The Visum Blade LED Surgical Light System (Blade) is suitable for all major and minor surgical procedures in operating rooms and all other healthcare facilities where the need for illumination exists. The light intensity is variable up to 160,000 Lux. The light quality is based upon high quality LED's to provide cool light with reduced shadow resolution.
A system consists of 1 - 4 light heads supported by a pivoting suspension system that is attached to the heath care facility's super structure by a mounting plate. The system requires at least one of the following: a power supply box, ceiling cover, drop tube, central axis and spring arm. The system may include optional end effectors such as but not limited to monitor mounts. The mounting plates may be configured to accommodate a single or tandem mount suspension system.
1
Independent, control of each light's intensity is via the light handle. An optional electronic wall control panel may be installed in the operating room for control by non-sterile users. Blade allows for an in-light camera option that may be added to a light head. This option requires a wall control for camera operation.
Intended Use
The Visum Blade LED Surgical Light is intended to illuminate the operative site during surgical procedures with high intensity light.
Indications for Use
The Visum Blade LED Surgical Light System is indicated to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms, and all other health care facilities where the need for additional illumination exists.
Technological Comparison
Like its predicates, Blade is a ceiling mounted surgical light that is available in single or tandem light head configurations. Both of the predicates and Blade provide illumination with reduced shadow resolution. All three devices have a removable, sterilizable light handle.
Blade uses an LED light source with Fresnel lenses to direct the light. Predicate devices use LED or halogen light sources with reflectors to direct the light.
Blade has two options for control of light intensity. Control is on the light head that allows the surgeon to control the light intensity from the sterile field. This is different than the predicates. Blade also allows light intensity to be controlled through a wall control, which is an optional feature.
The predicates have spot size adjustment (mechanical focus mechanism). Blade does not have this feature. The absence of this feature reduces cost, size, and complexity of the luminaire allowing Blade be marketable to a broader range of healthcare facilities.
The differences in the technological characteristics do not impact safety or effectiveness. For a complete comparison refer to Section 13 Substantial Equivalence of this premarket notification.
Performance Testing
See Section 18, Performance, Bench.
2
Conclusion
The submitted information in this premarket notification shows that Blade raises no new questions of safety and effectiveness and the performance can be considered equivalent to the predicate devices. This conclusion is based on the comparison of Blade to indications/intended use, design, energy used/delivered, materials, performance, safety, effectiveness, and labeling of the predicate devices.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure embracing or protecting another figure, representing the department's mission of protecting the health of all Americans and providing essential human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 30, 2013
Stryker Communications Mr. Trev Thorsen Senior Regulatory Compliance Analyst 1410 Lakeside Parkway, Suite 100 Flower Mound, Texas 75028
Re: K132747
Trade/Device Name: Visum Blade LED Surgical Light System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY Dated: November 8, 2013 Received: November 12, 2013
Dear Mr. Thorsen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Trey Thorsen
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Binita S. Ashar -- S 2013.12.30 75:56:53 -05'00'
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1410 Lakeside Parkway, #100 Flower Mound, TX 75028 t: 972 410 7100 f: 972 410 7001 www.stryker.com
Communications
Indications for Use
510(k) Number (if known): __K132747
Device Name: Visum Blade LED Surgical Light System
Indications for Use:
The Visum Blade LED Surgical Light System (Blade) is indicated to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms, and all other health care facilities where the need for additional illumination exists.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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for BSA
(Division Sign-off) Division of Surgical Devices 510(k) Number: K132747