(64 days)
Not Found
No
The device description and intended use focus on providing illumination via fiber optic cables, with no mention of AI/ML terms or functionalities.
No
The device is described as a component intended to provide surgical site illumination and does not appear to treat or diagnose a disease or condition.
No
Explanation: The device is intended for surgical site illumination, which is a functional purpose during surgery, not for diagnosing a condition or disease.
No
The device description explicitly states it is a physical component consisting of fiber optic cables within silicone tubing, which connects to a light generator and a decompression tube. This is a hardware device, not software.
Based on the provided information, the Stryker Spine LITe® Decompression System - Light Cable is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide surgical site illumination during a surgical procedure. This is a direct interaction with the patient's body during surgery, not an examination of specimens in vitro (outside the body).
- Device Description: The description details a fiber optic cable for light delivery, which is a surgical tool, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, tissue, urine, etc.), diagnostic testing, or any function related to determining a medical condition or state of health based on in vitro analysis.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Stryker Spine LITe® Decompression System - Light Cable does not fit this definition.
N/A
Intended Use / Indications for Use
The Stryker Spine LITe® Decompression System - Light Cable is intended to provide surgical site illumination from a high intensity light source when Stryker decompression tubes are in use.
Product codes
FST
Device Description
The Stryker Spine LITe® Decompression System - Light Cable is a single use, sterile and disposable component. The Stryker Spine LITe® Decompression System - Light Cable consists of fiber optic cables contained within silicone tubing which can be connected to a light generator on one end and the tube of the Stryker Spine LITe® Decompression System on the other end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
NuVasive MaXcess Light Guide: K042034, Zimmer MIS Light: K080367
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.
0
510K Summary
Stryker Spine - LITc® Dccompression System - Light Cable Traditional 510(k) Premarket Notification
11222 037
2010 10 10 0 2 2 0 3 7
5 10 (k) Simmaryof Safety and Effectiveness
Stryker Spine - Life® Decompression System - Light Cable
NOV 1 2012
.
| Submitter: | Stryker Spine
2 Pearl Court
Allendale, New Jersey 07401 |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Tina Mornak
Regulatory Affairs Associate
Phone: 201-760-8193
Fax: 201-962-4193
Email: tina.mornak@stryker.com |
| Date Prepared | October 25, 2012 |
| Trade Name | Stryker Spine - LITe® Decompression System - Light Cable |
| Proposed Class | Class II |
| Classification Name
and Number | Light, Surgical, Fiber optic
21 CFR 878.4580 |
| Common Name | Surgical lamp |
| Product Code | FST |
| Predicate Devices | NuVasive MaXcess Light Guide: K042034
Zimmer MIS Light: K080367 |
| Device Description | The Stryker Spine LITe® Decompression System - Light Cable is a
single use, sterile and disposable component. The Stryker Spine LITe®
Decompression System - Light Cable consists of fiber optic cables
contained within silicone tubing which can be connected to a light
generator on one end and the tube of the Stryker Spine LITe®
Decompression System on the other end. |
| Intended Use | The Stryker Spine LITe® Decompression System - Light Cable is
intended to provide surgical site illumination from a high intensity
light source when Stryker decompression tubes are in use. |
| Summary of the
Technological
Characteristics | The LITe® Decompression System - Light Cable shares the same
technological characteristics as the predicate devices. These
characteristics include similar design, technical requirements, |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized image of an eagle, which is a common symbol of the United States.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
NOV
1 2012
Stryker Spine % Ms. Tina Mornak Regulatory Affairs Associate 2 Pearl Court Allendale, New Jersey 07401
Re: K122637
Trade/Device Name: Stryker LITe ® Decompression System-Light Cable Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FST Dated: August 23, 2012 Received: August 29, 2012
Dear Ms. Mornak:
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
2
Page 2 - Ms. Tina Mornak
forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S 2012.11.05 10:44:24 -05'00'
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Stryker Spine - LITe® Decompression System - Light Cable Traditional 510(k) Premarket Notification Confidential
Indications for Use
510(k) Number (if known): K_12243)
Device Name: Stryker LITe® Decompression System - Light Cable
Indications for Use:
The Stryker Spine LITe® Decompression System - Light Cable is intended to provide surgical site illumination from a high intensity light source when Stryker decompression tubes are in use.
Nilre Osle for nxm
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
AND/OR
510(k) Number K122637
Prescription Use _ X (Part 21 CFR 801 Subpart D) 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)
2