(156 days)
K 012448
Not Found
No
The description focuses on image-guided navigation and tracking, with no mention of AI or ML algorithms for image analysis, decision support, or other functions.
No.
The device is an image-guided localization system used for navigation during surgery, not directly for treating a medical condition.
No
The device is described as an image-guided localization system intended for pre- and intraoperative navigation to facilitate minimally invasive surgery, not for diagnosing medical conditions.
No
The device description explicitly mentions linking a surgical instrument tracked by passive markers and a VectorVision workstation, indicating hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the BrainLAB VectorVision trauma is an image-guided localization system used during surgery to help guide instruments based on pre- or intraoperative imaging of the patient's anatomy. It is a surgical navigation system.
- No Sample Analysis: The device does not analyze any biological samples from the patient. It uses imaging data to provide guidance for surgical procedures.
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 quided 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 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 patient's intraoperative image data being processed by a VectorVision workstation.
VectorVision trauma allows navigation of intraoperatively acquired images considering patient's 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
Yes
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)
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.
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.
K 012448
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
KO62358
510 (k) Summary of Safety and Effectiveness for VectorVision trauma
Manufacturer:
| Address: | BrainLAB AG
Kapellenstrasse 12
85622 Feldkirchen
Germany
Phone: +49 89 99 15 68 0
Fax: +49 89 99 15 68 33 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | August 10, 2006 |
| Device Name: | |
| Trade name: | VectorVision trauma |
| Common/Classification Name: | VectorVision, BrainLAB Image Guided Surgery System / Instrument
Stereotaxic |
Predicate Device: Vector Vision trauma (K 012448)
Device Classification Name: Instrument, Stereotaxic Regulatory Class: Glass Il
Intended Use:
BrainLAB VectorVision trauma is intended to be a pre- and intraoperative image quided 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 screwing or external fixation procedures in the tubular bones.
1
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 patient's intraoperative image data being processed by a VectorVision workstation.
VectorVision trauma allows navigation of intraoperatively acquired images considering patient's 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 the predicate device VectorVision trauma (K012448).
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes coiled around it, representing medicine and health. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BrainLAB AG % Rainer Birkenbach Executive Vice President Kapellenstrasse 12 85662 Feldkirchen Germany
JAN 1 7 2007
Re: K062358
Trade/Device Name: VectorVision trauma Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: December 26, 2006 Received: December 26, 2006
Dear Rainer Birkenbach:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 - 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely ours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO62358
Indications for Use
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 ilio-sacral screw fixation.
Fracture treatment procedures, such as intramedullary nailing or screwing or external fixation procedures in the tubular bones.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P.S.B. m
Pastorative. and Neurological I
510(k) Number L062358