(297 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related concepts, nor does it describe features typically associated with AI/ML in medical imaging (like automated analysis, prediction, or complex image processing beyond standard visualization).
No
The device is used for surgical guidance during neurosurgery, which is a diagnostic or interventional aid rather than directly providing therapy.
No
Explanation: The device is described for frameless stereotactic cranial neurosurgery and intraoperative surgical guidance, which are therapeutic and interventional applications, not diagnostic ones.
Unknown
The provided 510(k) summary lacks a device description, which is crucial for determining if the device is software-only. Without this information, it's impossible to assess the nature of the device and its components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Frameless stereotactic cranial neurosurgery and intraoperative would be surgical guidance." This describes a device used during a surgical procedure on a patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Measuring biomarkers or other substances in a sample
This device appears to be a surgical guidance system, which falls under the category of medical devices used for treatment or procedural assistance, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
Frameless stereotactic cranial neurosurgery and intraoperative would be surgical guidance.
Product codes
84HAW
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cranial
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, formed by three overlapping human profiles.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 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 Requlations, 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 620) 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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 would be surgical guidance.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas b. Callister
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurologica! Devices 510(k) Number K962
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use