VECTORVISION

K962939 · Brainlab, Inc. · HAW · May 22, 1997 · Neurology

Device Facts

• Record ID: K962939
• Device Name: VECTORVISION
• Applicant: Brainlab, Inc.
• Product Code: HAW · Neurology
• Decision Date: May 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Frameless stereotactic cranial neurosurgery and intraoperative surgical guidance.

Device Story

VectorVision is a frameless stereotactic system for cranial neurosurgery and intraoperative guidance. System utilizes spatial tracking technology to correlate patient anatomy with preoperative imaging data. Used in clinical settings by neurosurgeons to navigate surgical instruments relative to patient anatomy during procedures. Provides real-time visualization of instrument position, assisting in surgical planning and execution. Benefits include enhanced precision in targeting intracranial structures and potential reduction in surgical invasiveness.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

Frameless stereotactic navigation system; utilizes spatial tracking for intraoperative surgical guidance; integrates with preoperative imaging data; intended for cranial neurosurgical applications.

Indications for Use

Indicated for frameless stereotactic cranial neurosurgery and intraoperative surgical guidance.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 22 1997

Mr. Stefan Vilsmeier
President
BrainLAB USA, Inc.
600 Glen Court
Moorestown, New Jersey 08057

Re: K962939
Trade Name: VectorVision
Regulatory Class: II
Product Code: 84HAW
Dated: March 7, 1997
Received: March 10, 1997

Dear Mr. Vilsmeier:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Stefan Vilsmeier

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K962939

Device Name: BrainLAB VectorVision

Indications For Use: Frameless stereotactic cranial neurosurgery and intraoperative surgical guidance.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K962939

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐