(225 days)
Not Found
No
The summary describes image processing and navigation based on tracked instruments and patient movement, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is an image-guided localization system that enables minimally invasive surgery and helps with implant positioning, screw placement, and bone reduction. It assists in surgical procedures by providing navigation and guidance through imaging but does not directly "treat" a condition.
No
The device is described as an image-guided localization system intended for surgical navigation, enabling minimally invasive surgery by linking a freehand probe to virtual computer image space on a patient's image data. It assists in surgical procedures like implant positioning and screw placement, rather than providing a diagnosis of a patient's condition.
No
The device description explicitly mentions a "freehand probe, tracked by a passive marker sensor system" and a "VectorVision workstation," indicating the presence of hardware components beyond just software.
Based on the provided text, the BrainLAB VectorVision Trauma is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- VectorVision Trauma's Function: The description clearly states that VectorVision Trauma is an image-guided localization system used during surgery. It links surgical instruments to pre- or intraoperative image data to assist with navigation and placement of implants or screws.
- No Specimen Analysis: The device does not involve the analysis of any biological specimens taken from the patient. Its function is entirely based on processing and utilizing medical imaging data and tracking surgical instruments in relation to that data.
Therefore, the BrainLAB VectorVision Trauma falls under the category of a surgical navigation or image-guided surgery system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BrainLAB VectorVision Trauma is intended to be a pre- and 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 pre- or intraoperative 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 bone structure like tubular bones, pelvic, calcaneus and talus, or vertebra, can be identified relative to a CT, fluoroscopic, X-ray or MR based model of the anatomy.
Example procedures include but are not limited to:
Spinal Procedures and spinal implant procedures such as pedicle screw placement. Pelvis and acetabular fracture treatment such as screw placement or ilio-sacral screw fixation. Fracture treatment procedures, such as intramedullary nailing or screwing or external fixation procedures in the tubular bones.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
BrainLAB VectorVision® Trauma is intended to enable operational navigation in spinal, orthopedic and traumatologic surgery, It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on a patients intraoperative image data being processed by a VectorVision workstation.
VectorVision® Trauma allows navigation of intraoperative acquired images considering patients movement in correlation to calibrated surgical instruments. This allows implant positioning, screw placement and bone reduction in different views and reduces the need for treatments under permanent fluoroscopic radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, fluoroscopic, X-ray or MR based model of the anatomy.
Anatomical Site
rigid anatomical structure, such as the skull, a bone structure like tubular bones, pelvic, calcaneus and talus, 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)
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 VectorVision2 (K983831).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Ko1244f
MAR 1 4 2002
510 (k) Summary of Safety and Effectiveness for VectorVision® Trauma
Manufacturer:
BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten Germany Phone: +49 89 99 15 68 0 Fax: +49 89 99 15 68 33
Device Name:
Trade Name: Common/Classification Name: Vector Vision® Trauma VectorVision, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Predicate Device:
VectorVision2® (K983831) VectorVision cranial, ENT, spine (K003589)
Device Classification Name : Instrument, Stereotaxic Regulatory Class: Class II
Indications for use:
BrainLAB VectorVision Trauma is intended to be a pre- and 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 pre- or intraoperative 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 bone structure like tubular bones, pelvic, calcaneus and talus, or vertebra, can be identified relative to a CT, fluoroscopic, X-ray or MR based model of the anatomy.
Example procedures include but are not limited to:
Spinal Procedures and spinal implant procedures such as pedicle screw placement. Pelvis and acetabular fracture treatment such as screw placement or ilio-sacral screw fixation. Fracture treatment procedures, such as intramedullary nailing or screwing or external fixation procedures in the tubular bones.
1
K%/244f
Device Description:
BrainLAB VectorVision® Trauma is intended to enable operational navigation in spinal, orthopedic and traumatologic surgery, It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on a patients intraoperative image data being processed by a VectorVision workstation.
Vector/sion® Trauma allows navigation of intraopative acquired images considering patients movement in correlation to calibrated surgical instruments. This allows implant positioning, screw placement and bone reduction in different views and reduces the need for treatments under permanent fluoroscopic radiation.
Substantial equivalence:
VectorVision® Trauma has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system. 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 VectorVision2 (K983831),
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle. The text is in a sans-serif font and is evenly spaced around the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2002
Mr. Rainer Birkenbach BrainLab AG Ammerthalstrasse 8 85551 Heimstetten Germany
Re: K012448
Trade/Device Name: VectorVision Trauma Regulation Number: 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: December 20, 2001 Received: December 26, 2001
Dear Mr. Birkenbach:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regars) and entirent date of the Medical Device Amendments, or to conninered pror to May 20, 1978, as can and with the provisions of the Federal Food. Drug. de necs that have occh recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrore, mailer of the Act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your device to such 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); 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.
3
Page 2 – Mr. Rainer Birkenbach
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 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,
iriam C. Provost
for 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
4
510(k) Number (if known):
Device Name:
VectorVision Trauma
Indications For Use:
BrainLAB VectorVision Trauma is intended to be a pre- and 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 pre- or intraoperative 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 bone structure like tubular bones, pelvic, calcaneus and talus, or vertebra, can be identified relative to a CT, fluoroscopic, X-ray or MR based model of the anatomy.
Example procedures include but are not limited to:
Spinal Procedures and spinal implant procedures such as pedicle screw placement. Pelvis and acetabular fracture treatment such as screw placement or illo-sacral screw fixation. Fracture treatment procedures, such as intramedullary nailing or plating or external fixation procedures in the tubular bones.
(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)
OR
Over-The-Countor Use
(Optional Formar 1-2-96)
iriam C. Provost
al. Restorative
510(k) Number K012448