(89 days)
The NuVasive MaXcess Light Guide is intended to provide surgical site illumination from a high intensity light source.
The NuVasive MaXcess Light Guide is a fiberoptic surgical light designed to be compatible with a variety of high intensity light sources.
I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary and an FDA clearance letter for the NuVasive MaXcess Light Guide.
This type of document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance study data against specific quantitative acceptance criteria. The text mentions that "Engineering drawings, and labeling have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device." However, it does not provide the specifics of any performance study, test sets, ground truth establishment, or statistical analyses typically associated with proving a device meets acceptance criteria.
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VII. 510(k) Summary
K 04 2034
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of In accordance with the Sale Medial. 2017), and in particular §807.92, the following summary of safety and effectiveness information is provided:
A. Submitted by
Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 10065 Old Grove Road San Diego, CA 92131 Telephone: (858) 527-1918 Date Prepared: July 28, 2004.
B. Device Name
NuVasive MaXcess Light Guide Trade or Proprietary Name: Fiberoptic Light Common or Usual Name: Light, Surgical, Fiberoptic Classification Name:
C. Predicate Devices
The subject device is substantially equivalent to similar previously cleared devices.
D. Device Description
The NuVasive MaXcess Light Guide is a fiberoptic surgical light designed to be compatible with a variety of high intensity light sources.
E. Intended Use
NuVasive MaXcess Light Guide is intended to provide surgical site illumination from a high intensity light source.
F. Substantial Equivalence
As was established in this submission, the subject device is substantially equivalent to other devices cleared by the agency for commercial distribution in the United States.
Engineering drawings, and labeling have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wings or feathers.
Public Health Service
OCT 2 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laetitia M. Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Inc. 10065 Old Grove Road San Diego, California 92131
Re: K042034
Trade/Device Name: NuVasive MaXcess Light Guide Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FST Dated: July 28, 2004 Received: July 29, 2004
Dear Ms. Cousin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) pe device is substantially equivalent (for the indications felerenced above and have actering as a legally marketed predicate devices marketed in interstate for use stated in the encount) to tegans annent date of the Medical Device Amendments, or to comments provision to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been receised in assee approval of a premarket approval application (PMA). and Cosment Act (Act) that to not required to the general controls provisions of the Act. The 1 ou may, therefore, manel the Act include requirements for annual registration, listing of gencral controls providio of the tice, 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 If your device is classified (600 a0070) als. Existing major regulations affecting your device can may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Overning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Drivision that your device complies with other requirements of the Act that I DT has Inado a actorized administered by other Federal agencies. You must or any I caefar status and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT an 607); idoomig (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic form in the qualis) by econo (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Laetitia M. Cousin
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin manoting your and equivalence of your device to a legally premarket notification. THC PDF miding of basification 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 If you desire specific auvice ion 500 - 300 (240) 276-0115. Also, please note the regulation entitled, Comact the Office of Compunance as (2 % // 21 % Part 807.97). You may obtain Misolanding of reference to premaiton on your responsibilities under the Act from the Division of Small other general informational 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 yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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A. Indications for Use
| 510(k) Number (if known): | K042034 |
|---|---|
| --------------------------- | --------- |
Device Name: NuVasive MaXcess Light Guide
Indications for Use:
The NuVasive MaXcess Light Guide is intended to provide surgical site illumination from a high intensity light source.
Prescription Use X (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)
uriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.