(28 days)
No
The summary describes an image-guided localization system that uses pre-operative image data and mechanical support for surgical instruments. There is no mention of AI or ML in the intended use, device description, or any of the sections typically describing AI/ML components (training/test sets, performance metrics). The image processing mentioned appears to be standard image registration and visualization for navigation, not AI/ML-based analysis or decision support.
No
The device is described as an image-guided localization system that supports and guides surgical instruments, not as a device that directly treats a medical condition. Its function is to assist in surgical procedures.
No
The device is an intraoperative image-guided localization system used to assist in minimally invasive surgery by guiding a freehand probe within a virtual computer image space derived from a patient's preoperative image data. It supports and guides surgical instruments during procedures like biopsies and resections, but it does not diagnose medical conditions itself. Its purpose is surgical navigation and assistance, not diagnosis.
No
The device description explicitly mentions a "multiarticulated arm" and a "passive marker sensor system," which are hardware components. The system is described as linking a freehand probe, tracked by this sensor system, to virtual image space. This indicates a system that includes both hardware and software for image-guided localization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is an "intraoperative image guided localization system to enable minimally invasive surgery." It is used during surgical procedures to guide instruments based on pre-operative imaging.
- Device Description: The description focuses on the mechanical aspects of the system, such as the multiarticulated arm and its ability to support and guide surgical instruments.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The BrainLAB VectorVision Frameless Biopsy System is a surgical navigation and guidance system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BrainLAB VectorVision Frameless Biopsy System is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data being processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone or vertebra, can be identified relative to a CT, X-ray or MR based model of the anatomy.
Example procedures include but are not limited to:
Cranial Procedures: Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/ Pallidotomies.
Spinal Procedures: Spinal implant procedures such as pedicle screw placement.
ENT Procedures: Transphenoidal procedures. Intranasal procedures. Sinus procedures, such as Maximillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections and Frontal sinusotomies
Product codes
HAW
Device Description
The VectorVision Frameless Biopsy System contains features to improve the support and guidance of surgical instruments. A multiarticulated arm facilitates the use of miscellaneous instruments for serial approaches along a determined trajectory to a specific target as well as the guidance of a single instrument to multiple targets along the same trajectory. Combined with the IGS features of VectorVision's software, the determination and repeated locating of trajectories is considerably simplified. By mechanical support, the degrees of freedom of the instrument can be limited either to zero or to one, thus giving the surgeon's hand mechanical support for increased stability, alleviating the surgeon's task of holding or inserting instruments and enhancing the efficiency of the surgery.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, X-ray or MR
Anatomical Site
rigid anatomical structure, such as the skull, a long bone or vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, intraoperative
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510 (k) Summary of Safety and Effectiveness
Product; VectorVision Frameless Biopsy System
510 (k) application:
Manufacturer:
BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten Germany Phone: +49 89 99 15 68 0 Fax: +49 89 99 15 68 33
What is new?
The Vector/ision Frameless Biopsy System contains features to improve the support and guidance of surgical instruments. A multiarticulated arm facilitates the use of miscellaneous instruments for serial approaches along a determined trajectory to a specific target as well as the guidance of a single instrument to multiple targets along the same trajectory. Combined with the IGS features of VectorVision's software, the determination and repeated locating of trajectories is considerably simplified. By mechanical support, the degrees of freedom of the instrument can be limited either to zero or to one, thus giving the surgeon's hand mechanical support for increased stability, alleviating the surgeon's task of holding or inserting instruments and enhancing the efficiency of the surgery.
Indications for use:
The BrainLAB VectorVision Frameless Biopsy System is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data being processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone or vertebra, can be identified relative to a CT, X-ray or MR based model of the anatomy.
Example procedures include but are not limited to:
Cranial Procedures: Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/ Pallidotomies.
Spinal Procedures: Spinal implant procedures such as pedicle screw placement.
1
ENT Procedures: Transphenoidal procedures. Intranasal procedures. Sinus procedures, such as Maximillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections and Frontal sinusotomies
Substantial equivalence
The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with predicate devices such as the 510(k)-clearance of BrainLAB's VectorVision2 System (K983831, K003589).
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 6 2001
Mr. Stefan Vilsmeier President and CEO BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten Germany
Re: K012564
Trade/Device Name: Modification to VectorVision Frameless Biopsy System Regulation Number: 882.4560 Regulatory Class: II Product Code: HAW Dated: July 31, 2001 Received: August 9, 2001
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 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). 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 Current Good Manufacturing Practice requirements, 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 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.
3
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) 594-4659. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International 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,
Susan Walker, MD
Fer 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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Page ot
510(k) Number (if known):
Device Name:
Vector Vision Frameless Biopsy System
Indications For Use:
The BrainLAB VectorVision Frameless Biopsy System is intended to be an intraoperative image I he Diami.AD v coon v sion Frances Drops, is your esurgery. It links a frechand probe, tracked by a guided localization system to virtual computer image space on a patient's preoperative image data passive marker school system to virtual beatle the system is indicated for any medical condition in being processed by a Vector vision workshately and where a reference to a rigid anatomical winch the use of stereoment dargery and, or vertebra, can be identified relative to a CT, X-ray or MR based model of the anatomy.
Example procedures include but are not limited to:
Cranial Procedures: Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/ Pallidotomies.
Spinal Procedures: Spinal implant procedures such as pedicle screw placement.
ENT Procedures:
Transphenoidal procedures.
Intranasal procedures.
Sinus procedures, such as Maximillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections and Frontal sinusotomies
(PLEASE 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)
Lisa Wall
Division Sign-Off) Over-The-Counter Use _ Division of General, Restorative and Neurological Devices
(Optional Format I-2-96)
510(k) Number K612564