(10 days)
NuVasive MaXcess Light Guide, K042034
Not Found
No
The device description and intended use focus solely on providing illumination via fiber optics, with no mention of AI/ML or related concepts.
No
The device is described as providing illumination for surgical sites, transmitting light from a source to the site. It does not exert any direct therapeutic action on the patient.
No
This device is designed to provide illumination during surgery, which is a functional purpose, not a diagnostic one. It doesn't analyze or process physiological data to identify medical conditions.
No
The device description clearly states it consists of fiber optic cables and silicone tubing, which are physical hardware components, not software.
Based on the provided information, the Zimmer MIS Light is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide surgical site illumination. This is a function performed in vivo (within the living body) during surgery, not in vitro (outside the body) on biological samples.
- Device Description: The device transmits light to a surgical site. This is a direct interaction with the patient's body during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Zimmer MIS Light does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Zimmer MIS Light is intended to provide surgical site illumination from a high intensity light source.
Product codes (comma separated list FDA assigned to the subject device)
FST
Device Description
The Zimmer MiS Light consists of fiber optic cables contained within silicone tubing which can be connected on one end to a hospital provided light source and to a Zimmer surgical access instrument on the other end. Light is transmitted from the hospital light source through the cable directly to the surgical site. the Zimmer MIS Light is provided sterile for single-use only. The Light was tested for compatibility with different types of light sources ranging from 150 Watts to 300 Watts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical 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): 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.
NuVasive MaXcess Light Guide, K042034
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.
0
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Spine. The logo consists of a circle with a stylized letter "Z" inside, above the word "zimmer" in a sans-serif font. Below the word "zimmer" is the word "spine" in a smaller, different font.
510(k) SUMMARY Zimmer® MIS Light
Image /page/0/Picture/2 description: The image shows the text "510(k) Number" followed by a handwritten number. The handwritten number appears to be "080367". The text is black and is on a white background.
| Date of Summary Preparation: | February 11, 2008 |
|---|---|
| Manufacturer: | Zimmer Spine, Inc. |
| 7375 Bush Lake Road | |
| Minneapolis, MN 55439 | |
| Company Contact: | Elsa A. Linke |
| Senior Regulatory Affairs Specialist | |
| Device Name: | Zimmer ® MIS Light |
| Common Name: | MIS Light |
| Classification Name: | Light, Surgical, Fiber optic |
| Product Code: | FST |
| Regulation Number: | 21 CFR 878.4580 |
| Device Classification: | Class II |
| Predicate Devices: | NuVasive MaXcess Light Guide, K042034 |
Description of Device: The Zimmer MiS Light consists of fiber optic cables contained within silicone tubing which can be connected on one end to a hospital provided light source and to a Zimmer surgical access instrument on the other end. Light is transmitted from the hospital light source through the cable directly to the surgical site. the Zimmer MIS Light is provided sterile for single-use only. The Light was tested for compatibility with different types of light sources ranging from 150 Watts to 300 Watts.
Intended Use: The Zimmer MIS Light is intended to provide surgical site illumination from a high intensity light source.
Comparison of Technological Characteristics:
The Zimmer MIS Light shares the same technological characteristics as the predicate device. These characteristics include similar design, technical requirements, materials, and intended use.
Substantial Equivalence:
The Zimmer MIS Light is substantially equivalent to the predicate device in design, function and intended use.
to 22 cm.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is composed of three curved lines, giving it a modern and abstract appearance.
Public Health Service
FEB 22 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer Spine, Inc. % Ms. Elsa A. Linke Senior Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K080367 Trade/Device Name: Zimmer® MIS Light Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp. Regulatory Class: II Product Code: FST Dated: February 11, 2008 Received: February 12, 2008
Dear Ms Linke:
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.
2
Page 2 -- Ms. Elsa A. Linke
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Millhusan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known): K080636)
Device Name: Zimmer® MIS Light
Indications for Use: The Zimmer MIS Light is intended to provide surgical site illumination from a high intensity light source.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
510(k) Number
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milburn
(Division Sign-Off (Division of General, Restorative, and Neurologica
Zimmer MIS Light 510(k) Submission 11-February 2008
CONFIDENTIAL