(184 days)
K 010612
Not Found
No
The description focuses on image-guided navigation based on landmark registration and 3D modeling, without mentioning AI/ML algorithms for image analysis, planning, or decision support.
No.
The device is an image-guided localization system that aids surgeons in navigation and planning during orthopedic surgery. It does not directly treat or cure a medical condition.
No
This device is an image-guided localization and navigation system used during surgery to aid the surgeon, not to diagnose a medical condition.
No
The device description explicitly mentions linking a surgical instrument tracked by flexible passive markers and a passive marker sensor system, indicating the presence of hardware components beyond just software.
Based on the provided text, the BrainLAB VectorVision device is not an IVD (In Vitro Diagnostic).
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.
- BrainLAB VectorVision's Function: The description clearly states that BrainLAB VectorVision is an intraoperative image guided localization system. Its purpose is to aid surgeons in navigating surgical instruments and implants during surgery based on anatomical landmarks and pre- or intraoperative imaging data.
- No Specimen Analysis: The device does not involve the collection, preparation, or analysis of any specimens taken from the patient's body. It works with imaging data and physical tracking of instruments relative to the patient's anatomy.
Therefore, based on the provided information, BrainLAB VectorVision falls under the category of a surgical navigation or guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BrainLAB VectorVision 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 an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. 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, MR based model of the anatomy. The system aids the surgeon to accurately navigate a knee endoprothesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by VectorVision® CT-free knee.
Example orthopedic surgical procedures include but are not limited to:
Knee Procedures: Total Knee Replacement Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Cruciate Ligament Surgery Patella Tracking
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
BrainLAB VectorVision® CT-free knee is intended to enable operational planning and navigation in orthopedic surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. VectorVision® CT-free knee uses the registered landmarks to navigate the femoral and tibial cutting guides and the implant to the planned optimally position.
VectorVision® CT-free knee allows 3-dimensional reconstruction of the mechanical axis and alignment of the implants. The VectorVision® CT-free knee software has been designed to read in data from different implant manufacturers and offers to individually choose the prosthesis during each surgery. The VectorVision® CT-free knee software registers the patient data needed for planning and navigating the surgery intraoperatively. No preoperative CT-scanning is necessary.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, X-ray, MR based model
Anatomical Site
Knee, skull, 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)
VectorVision® CT-free knee 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 predicate devices such as the 510(k)-clearance of VectorVision® knee (K 010612).
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 010612
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
OCT 2 5 2002
510 (k) Summary of Safety and Effectiveness for VectorVision® CT-free knee
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: | October 22, 2002 |
Device Name:
Trade name:
VectorVision® CT-free knee
Common/Classification Name:
VectorVision® CT-free knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
1 of 2
Predicate Device: Vector Vision® Knee (K 010612)
Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II
Intended Use:
BrainLAB VectorVision 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 an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. 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, MR based model of the anatomy. The system aids the surgeon to accurately navigate a knee endoprothesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by VectorVision® CT-free knee.
1
Example orthopedic surgical procedures include but are not limited to:
Knee Procedures: Total Knee Replacement Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Cruciate Ligament Surgery Patella Tracking
Device Description:
BrainLAB VectorVision® CT-free knee is intended to enable operational planning and navigation in orthopedic surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. VectorVision® CT-free knee uses the registered landmarks to navigate the femoral and tibial cutting guides and the implant to the planned optimally position.
VectorVision® CT-free knee allows 3-dimensional reconstruction of the mechanical axis and alignment of the implants. The VectorVision® CT-free knee software has been designed to read in data from different implant manufacturers and offers to individually choose the prosthesis during each surgery. The VectorVision® CT-free knee software registers the patient data needed for planning and navigating the surgery intraoperatively. No preoperative CT-scanning is necessary.
Substantial equivalence:
VectorVision® CT-free knee 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 predicate devices such as the 510(k)-clearance of VectorVision® knee (K 010612).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BrainLAB AG Rainer Birkenbach Executive Vice President Ammerthalstrasse 8 85551 Heimstetten Germany
Re: K021306
Trade/Device Name: VectorVision CT-Free Knee Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: July 25, 2002 Received: August 1, 2002
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 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" (21 CFR 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,
Muriam 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
Page 1 of 1
510(k) Number (if known):
Device Name:
Vector Vision® CT-free knee
Indications For Use:
BrainLAB VectorVision is intended to be an intrapperative 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 an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. 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, MR based model of the anatomy. The system aids the surgeon to accurately navigate a knee endoprothesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by VectorVision® CT-free Knee.
Example orthopedic surgical procedures include but are not limited to:
Knee Procedures: Total Knee Replacement Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Cruciate Ligament Surgery Patella Tracking
(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)
miriam
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021306