(185 days)
No
The summary describes an image-guided localization system that links a probe to image data. It mentions image processing but does not include any terms or descriptions indicative of AI/ML, such as algorithms, training data, performance metrics related to AI/ML, or specific AI/ML functionalities.
No.
The device is described as an "intraoperative image guided localization system," indicating its purpose is for navigation and localization during surgery, not for directly treating a medical condition.
No
This device is an intraoperative image-guided localization system used for surgical navigation. It assists in guiding surgical instruments relative to a patient's anatomy, but it does not diagnose medical conditions.
No
The device description explicitly mentions a "freehand probe, tracked by a passive marker sensor system," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for intraoperative image guided localization during surgery. This involves guiding surgical instruments based on imaging data, which is a procedure performed on the patient, not on a sample taken from the patient.
- Device Description: The description reinforces the idea of a system that links a probe to virtual image space for surgical guidance.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.) or providing diagnostic information based on such analysis. IVDs are designed to perform tests in vitro (outside the body) on these types of samples to diagnose or monitor medical conditions.
This device falls under the category of a surgical navigation or image-guided surgery system, which is a different type of medical device than an IVD.
N/A
Intended Use / Indications for Use
BrainLAB VectorVision Spine Module is intended to be an intraoperative image guided localization system to enable open or percutaneous surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's images data being processed by a BrainSCAN workstation (K915819). The system is indicated for any medical condition where a reference to a rigid anatomical structure, such as the skull, a long bone or vertebra can be identified relative to a C.I hased model of the anatomy where surgically appropriate.
Product codes
HAW
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skull, a long bone or vertebra
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)
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines that resemble a person in motion. The figure is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1998
Mr. Stefan Vilsmeier President BrainLAB USA, Inc. 3100 Hansen Way Building 4A, Mailstop E233 Palo Alto, California 94304
Re: K981508 VectorVision Spine Trade Name: Regulatory Class: II Product Code: HAW Dated: August 06, 1998 Received: August 10, 1998
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. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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.
1
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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page l of I
| 510(k) Number (if known): | K981508 |
|---|---|
| --------------------------- | --------- |
Vector Vision Spine Device Name:
Indications For Usc:
BrainLAB VectorVision Spine Module is intended to be an intraoperative image guided localization system to enable open or percutaneous surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's images data being processed by a BrainSCAN workstation (K915819). The system is indicated for any medical condition where a reference to a rigid anatomical structure, such as the skull, a long bone or vertebra can be identified relative to a C.I hased model of the anatomy where surgically appropriate.
(I'LEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981508GESAMT SEITEN 02