(102 days)
Not Found
No
The summary describes image-guided navigation and automatic registration based on spatial position information and paired point matching, which are standard image processing and registration techniques, not explicitly AI/ML. There is no mention of AI, ML, deep learning, or training/test sets.
No
This device is an image-guided localization system for surgical planning and navigation, assisting surgeons in performing procedures, rather than directly treating a medical condition.
No
Explanation: This device is described as an intraoperative image-guided localization system that enables computer-assisted navigation for surgery. It assists surgeons in performing procedures by linking surgical instruments to virtual images and allowing for planning and navigation. It does not provide a diagnosis of a disease or condition.
No
The device description explicitly mentions linking a surgical instrument tracked by a passive marker sensor system, indicating the inclusion of 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The BrainLAB VectorVision fluoro3D is an image-guided localization system used during surgery to assist the surgeon in navigating based on medical images (CT, MR, fluoroscopy). It links surgical instruments to the patient's anatomy as visualized in the images.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is entirely focused on spatial tracking and image-based navigation within the surgical field.
Therefore, the device's intended use and operation clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BrainLAB VectorVision fluoro3D is intended as 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 or Intraoperative 2D or 3D image data.
VectorVision fluoro3D enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system.
The software offers screw implant size planning and navigation on rigid bone structures with precalibrated and additional individually-calibrated surgical tools.
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, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
VectorVision fluoro 3D is a device that allows surgical planning and navigation. It links a surgical instrument, (tracked by passive marker sensor system) to a location on a virtual computer image, which is either based on patient's intraoperative 3D information acquired with a 3D C-arm or based on patient's intraoperative acquired 2D fluoro image(s) of an analog or digital c-arm.
The device enables the navigation based on 3D data and / or based on acquired fluoro images. Based on 2D fluoro images, the registration is done automatically by using the exact spatial position information of the intra-operatively acquired fluoro images.
Based on 3D data, the registration is also done automatically by using the exact spatial position information of the start position of the scan. Beforehand, the 3D Siemens C-arm has to be calibration with the navigation svstem.
For 3D data, the paired point matching and the 2D 3D fluoro matching are also available as reregistration methods. The last registration method uses two fluoro images (one in lateral position) to regain accuracy on previously acquired 3D scans. This may become necessary if the reference on the patients bone has become lose.
The device assists the surgeon in performing certain surgical procedures as described in the indications for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
preoperative or Intraoperative 2D or 3D image data, CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction
Anatomical Site
skull, the pelvis, a long bone 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)
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.
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
APR 2 3 2007
510 {k} Summary of Safety and Effectiveness for VectorVision fluoro 3D
| Manufacturer: | BrainLAB AG |
|---|---|
| Address: | Kapellenstrasse 12 |
| 85622 Feldkirchen | |
| Germany | |
| Phone: | +49 89 99 15 68 0 |
| Fax: | +49 89 99 15 68 33 |
| Contact Person: | Mr. Per Persson |
| Summary Date: | April 18, 2007 |
Device Name:
Trade name:
VectorVision fluoro 3D
Common/Classification Name:
BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Predicate Device:
VectorVision fluoro 3D (K024192) VectorVision spine (K053159).
Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II
Intended Use.
BrainLAB VectorVision fluoro3D is intended as 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 or Intraoperative 2D or 3D image data.
VectorVision fluoro3D enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system.
The software offers screw implant size planning and navigation on rigid bone structures with precalibrated and additional individually-calibrated surgical tools.
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, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
1
Device Description:
VectorVision fluoro 3D is a device that allows surgical planning and navigation. It links a surgical instrument, (tracked by passive marker sensor system) to a location on a virtual computer image, which is either based on patient's intraoperative 3D information acquired with a 3D C-arm or based on patient's intraoperative acquired 2D fluoro image(s) of an analog or digital c-arm.
The device enables the navigation based on 3D data and / or based on acquired fluoro images. Based on 2D fluoro images, the registration is done automatically by using the exact spatial position information of the intra-operatively acquired fluoro images.
Based on 3D data, the registration is also done automatically by using the exact spatial position information of the start position of the scan. Beforehand, the 3D Siemens C-arm has to be calibration with the navigation svstem.
For 3D data, the paired point matching and the 2D 3D fluoro matching are also available as reregistration methods. The last registration method uses two fluoro images (one in lateral position) to regain accuracy on previously acquired 3D scans. This may become necessary if the reference on the patients bone has become lose.
The device assists the surgeon in performing certain surgical procedures as described in the indications for use.
Substantial equivalence:
VectorVision fluoro 3D 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 BrainLAB VectorVision fluoro 3D version 1.0 (K024192) and BrainLAB VectorVision spine version 5.5.1 (K053159).
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2007
BrainLAB AG % Mr. Per Persson Manager Regulatory Affairs Kapellenstraße 12 85622 Feldkirchen Germany
Re: K070106
Trade/Device Name: Vector Vision fluoro 3D Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 3, 2007 Received: February 5, 2007
Dear Mr. Persson:
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. Per Persson
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 yours,
Mark N. Melkerson
Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K070106
Device Name: Vector Vision fluoro 3D
Indications For Use:
BrainLAB VectorVision fluoro3D is intended as 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 or Intraoperative 2D or 3D image data.
VectorVision fluoro3D enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system.
The software offers screw implant size planning and navigation on rigid bone structures with precalibrated and additional individually-calibrated surgical tools.
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, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
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)
currence of CDRH, Office of Device Evaluation (ODE)
Aloha
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
ೆ 10(k) Number