(203 days)
Not Found
No
The summary does not mention AI, ML, or related concepts like deep learning, neural networks, or training/test sets. The description focuses on image processing and registration based on pre-operative and intra-operative imaging.
No
The device is an image-guided localization system for minimally invasive surgery; it does not directly treat a medical condition.
No
The device is an intraoperative image-guided localization system for minimally invasive surgery, primarily used for navigation and operational planning during procedures, rather than diagnosing medical conditions.
No
The device description explicitly mentions a "freehand probe, tracked by a passive marker sensor system" and a "VectorVision workstation," indicating hardware components are integral to the system.
Based on the provided text, 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® Fluoro3D is an "intraoperative image guided localization system." It uses imaging modalities (CT, X-ray, MR) and a tracking system to guide surgical procedures on the patient's body.
- No Sample Analysis: There is no mention of analyzing samples taken from the patient. The system works with images and physical tracking relative to the patient's anatomy.
Therefore, the device's function and intended use fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
BrainLAB VectorVision® Fluoro3D 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: Spinal Procedures: Spinal implant procedures as pedicle screw placement.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
VectorVision® Fluoro3D intends to enable "touchless" patient registration for operational planning and navigation in surgery. It allows using automatic registered intra-operatively acquired image modalities (e.g. volume data calculated from a set of x-ray images) processed by a VectorVision workstation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, X-ray, MR, intra-operatively acquired image modalities (e.g. volume data calculated from a set of x-ray images)
Anatomical Site
rigid anatomical structure, such as the skull, a long bone, or vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Minimally invasive surgery, stereotactic surgery
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): 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.
Vector Vision® 2 (K983831), Vector Vision® Spine (K981508), Vector Vision® CT/Fluoro (K010968
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
JUN 1 1 2003
510 (k) Summary of Safety and Effectiveness for VectorVision® Fluoro3D
Manufacturer:
| Address: | BrainLAB AG
Ammerthalstrasse 8
85551 Heimstetten
Germany
Phone: +49 89 99 15 68 0
Fax: +49 89 99 15 68 33 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | February 12, 2003 |
Device Name:
Trade name:
Common/Classification Name:
VectorVision® Fluoro3D
VectorVision, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Predicate Device:
Vector Vision® 2 (K983831) Vector Vision® Spine (K981508) Vector Vision® CT/Fluoro (K010968)
Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II
Intended Use:
BrainLAB VectorVision® Fluoro3D 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.
1
Image /page/1/Picture/0 description: The image shows a handwritten string of characters, which appears to be a code or identifier. The string is "Kc24192". The characters are written in a cursive style, with some connections between the letters and numbers. The image is in black and white.
Example procedures include but are not limited to:
Spinal Procedures:
- Spinal implant procedures as pedicle screw placement. -
Device Description:
VectorVision® Fluoro3D intends to enable "touchless" patient registration for operational planning and navigation in surgery. It allows using automatic registered intra-operatively acquired image modalities (e.g. volume data calculated from a set of x-ray images) processed by a VectorVision workstation.
Substantial equivalence:
VectorVision® Fluoro3D Module has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device VectorVision® (K983831), VectorVision® Spine Software (K981508), Vector Vision® (K010968
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol of medicine and healing. The caduceus is composed of three lines that form the shape of a human profile.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 2003
Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten Germany
Re: K024192
Trade/Device Name: VectorVision Fluoro3D Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 2, 2003 Received: April 8, 2003
Dear Mr. 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 - 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), 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) you may obtain. 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.
Miriam C. Provost
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): | K024192 |
|---|---|
| --------------------------- | --------- |
Device Name:
VectorVision Fluoro3D
Indications For Use:
BrainLAB VectorVision® Fluoro3D 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:
Spinal Procedures:
Spinal implant procedures such as pedicle screw placement. -
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
024192 510(k) Number.
(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-Counter Use
(Optional Format I-2-96)