(111 days)
NuVasive® Navigation Instruments are intended to be used during the preparation and placement of NuVasive screws (Armada, Reline, Precept, MAS PLIF, and VuePoint fixation systems) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. NuVasive® Navigation Instruments are designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
NuVasive Navigation Instruments are manual, non-sterile, re-usable, surgical instruments intended for use with Medtronic StealthStation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of NuVasive screws during spinal surgery.
The document provided does not contain a study that proves the device meets specific acceptance criteria in terms of reported device performance based on quantitative metrics. The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria.
The "Performance Data" section (G) on page 4 mentions "Accuracy testing," "Compatibility testing," and "Performance testing" were performed, and concludes that "results demonstrate that the subject NuVasive Navigation Instruments are substantially equivalent to the predicate." However, it does not provide details about the specific acceptance criteria for these tests, the reported performance metrics, the sample sizes, data provenance, ground truth establishment, or any information related to expert involvement or comparative effectiveness.
Therefore, I cannot provide the requested information from the given document as it is not present.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2017
NuVasive, Incorporated Manthan Damani Senior Regulatory Affairs Specialist 7475 Lusk Blvd. San Diego, California 92121
Re: K172623 Trade/Device Name: NuVasive Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 21, 2017 Received: November 22, 2017
Dear Manthan Damani:
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 devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K172623
Device Name NuVasive® Navigation Instruments
Indications for Use (Describe)
NuVasive® Navigation Instruments are intended to be used during the preparation and placement of NuVasive screws (Armada, Reline, Precept, MAS PLIF, and VuePoint fixation systems) during spinal surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Nu Vasive® Navigation Instruments are designed for use with the Medronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in capital letters to the right. The leaf shape is divided into two parts, with the top part in purple and the bottom part in gray. The text is also in gray.
Traditional 510(k) Submission Nu Vasive® Navigation Instruments
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
Submitted by: A.
Manthan J. Damani Senior Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: August 31, 2017
B. Device Name
| Trade or Proprietary Name: | NuVasive® Navigation Instrument |
|---|---|
| Common or Usual Name: | Orthopedic Stereotaxic Instrument |
| Classification Name: | Stereotaxic instrument |
| Device Class: | Class II |
| Classification: | 21 CFR § 882.4560 |
| Product Code: | OLO |
C. Predicate Devices
The subject device is substantially equivalent to the primary predicate device Alphatec Spine Navigation Instruments (K153603). Additional predicate devices are Medtronic Navigated CD Horizon Solera Screwdriver and Taps (K140454), and Globus Navigation Instruments (K153203).
D. Device Description
NuVasive Navigation Instruments are manual, non-sterile, re-usable, surgical instruments intended for use with Medtronic StealthStation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of NuVasive screws during spinal surgery.
E. Indications for Use
NuVasive® Navigation Instruments are intended to be used during the preparation and placement of NuVasive screws (Armada, Reline, Precept, MAS PLIF, and VuePoint fixation systems) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. NuVasive® Navigation Instruments are designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
F. Comparison of Technological Characteristics with Predicate Device
As was established in this submission, the subject NuVasive Navigation Instruments are substantially equivalent to other predicate devices cleared by the FDA for commercial
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Image /page/4/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf is split into two colors, with the top portion being purple and the bottom portion being gray.
Traditional 510(k) Submission Nu Vasive® Navigation Instruments
distribution in the United States. The subject device was shown to be substantially equivalent to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject NuVasive® Navigation Instruments are substantially equivalent to the predicate device. The following testing was performed:
- Accuracy testing
- Compatibility testing
- o Performance testing
The results demonstrate that the subject NuVasive Navigation Instruments are substantially equivalent to the predicate.
H. Conclusions
The subject NuVasive Navigation Instruments have been shown to be substantially equivalent to legally marketed predicate devices for their intended use.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).