(10 days)
The Zimmer MIS Light is intended to provide surgical site illumination from a high intensity light source.
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.
This document describes the 510(k) submission for the Zimmer® MIS Light. This device is a fiber optic cable intended to provide surgical site illumination. The submission focuses on demonstrating substantial equivalence to a predicate device, the NuVasive MaXcess Light Guide (K042034), rather than establishing new performance criteria through extensive clinical studies.
Therefore, many of the typical sections related to device performance, such as a detailed table of acceptance criteria, sample sizes for test sets, expert consensus, and MRMC studies, are not directly applicable or explicitly stated in this type of submission.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or detailed performance results in the way one might expect for a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a legally marketed predicate device.
The reported device "performance" is described in terms of its technological characteristics, which are stated to be the same as the predicate device:
| Acceptance Criteria (Implicit from Substantial Equivalence to Predicate) | Reported Zimmer® MIS Light Performance |
|---|---|
| Similar design to predicate device | Shares "similar design" with predicate device. |
| Similar technical requirements to predicate device | Shares "similar technical requirements" with predicate device. |
| Similar materials to predicate device | Shares "similar materials" with predicate device. |
| Similar intended use to predicate device | "Intended Use: The Zimmer MIS Light is intended to provide surgical site illumination from a high intensity light source." This is consistent with the predicate's intended use. |
| Compatibility with common light sources | "The Light was tested for compatibility with different types of light sources ranging from 150 Watts to 300 Watts." (This is a specific functional test mentioned.) |
| Provided sterile for single-use | The Zimmer MIS Light is "provided sterile for single-use only." |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of a clinical performance study with human data. The "testing" mentioned is likely engineering verification and validation (V&V) related to compatibility and functionality. No human data or specific sample sizes for such tests are provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This type of submission for a surgical light guide does not involve establishing ground truth from experts on clinical interpretations or diagnoses.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Zimmer® MIS Light is a passive surgical illumination device, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used
Not applicable in the context of clinical outcomes or expert consensus for diagnosis. The "ground truth" for this device would be its ability to physically transmit light effectively and safely, which is assessed through engineering testing and comparison to the predicate's established performance.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
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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 RoadMinneapolis, MN 55439 |
| Company Contact: | Elsa A. LinkeSenior 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.
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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.
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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
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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
§ 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.