(157 days)
Not Found
No
The description focuses on image-guided navigation based on landmark registration and 3D reconstruction, without mentioning AI/ML algorithms for image analysis, planning, or navigation. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
The device is an image-guided localization system that aids surgeons in navigation during surgery, rather than directly providing a therapeutic effect.
No
The device is described as an "intraoperative image guided localization system" and a "navigation" system for surgery, which aids the surgeon in accurately placing implants and tools. It does not provide a diagnosis.
No
The device description explicitly states it "links a surgical instrument, tracked by flexible passive markers" and "uses the registered landmarks to navigate the needed surgical tools". This indicates the system includes hardware components (passive markers, tracking system, surgical instruments) beyond just software.
Based on the provided information, the BrainLAB VectorVision system 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, monitoring, or treatment of disease or conditions.
- BrainLAB VectorVision's Intended Use: The intended use of BrainLAB VectorVision is described as an "intraoperative image guided localization system" to aid surgeons in navigating surgical tools and implants during surgery. It uses imaging data (CT, X-ray, MR) and anatomical landmarks to create a 3D model and guide surgical procedures.
- Lack of Specimen Examination: The description does not mention the collection, preparation, or examination of any specimens from the patient's body. The system works with imaging data and the patient's anatomy directly.
Therefore, the BrainLAB VectorVision system 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 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 considered to be safe and effective 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 hip endoprothesis to the preoperatively or intraoperatively planned position.
Example orthopedic surgical procedures include but are not limited to:
Total Joint Replacement (TJR) Revision surgery of TJR Minimal Invasive Orthopedic Surgery Tumor resection and bone/joint reconstruction
Product codes
HAW
Device Description
BrainLAB VectorVision® hip Software 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, generated through acquiring multiple landmarks on the bone surface either by a pointer probe or by acquiring pairs of registered fluoroscopic images. VectorVision® hip Software uses the registered landmarks to navigate the needed surgical tools like cup reamer, cup inserter, stem rasp, bone saw and the implant to the planned position. If no implant data is available it is possible to provide information in order to achieve a generally targeted alignment relative to the bone orientation as defined by the operating surgeon.
Vector\Vision® hip Software allows 3-dimensional reconstruction of the relevant mechanical axes and planes of femur and pelvis and alignment of the implants. The VectorVision® hip Software has been designed to read in data of implants and tools if provided by the implant manufacturer and offers to individually choose the prosthesis during each surgery. The VectorVision® hip Software registers the patient data needed for planning and navigating the surgery intra-operatively within the CT free module. The System can be used to generally align tool orientations according to the anatomy described and defined by the landmarks acquired by the surgeon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, X-ray, MR, fluoroscopic images
Anatomical Site
skull, a long bone, or vertebra, hip
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
1-06-0727
510 (k) Summary of Safety and Effectiveness for VectorVision® hip Software
| Manufacturer: | BrainLAB AG | |||
|---|---|---|---|---|
| Address: | Kapellenstr. 12 | |||
| 85622 Feldkirchen | ||||
| Germany | ||||
| Phone: +49 89 99 15 68 0 | ||||
| Fax: +49 89 99 15 68 33 | AUG 2 1 2006 | |||
| Contact Person: | Mr. Per Persson | |||
| Summary Date: | July 7th, 2006 | |||
| Device Name: | ||||
| Trade name: | VectorVision® hip Software | |||
| Common/Classification Name: | VectorVision, BrainLAB Image Guided Surgery System / Instrument, | Stereotaxic |
Predicate Device: Vector Vision® HIP 3.0 (K040368)
Device Classification Name: Instrument, Stereotaxic Requiatory 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 considered to be safe and effective 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 hip endoprothesis to the preoperatively or intraoperatively planned position.
Example orthopedic surgical procedures include but are not limited to:
Total Joint Replacement (TJR) Revision surgery of TJR Minimal Invasive Orthopedic Surgery Tumor resection and bone/joint reconstruction
1
Device Description:
BrainLAB VectorVision® hip Software 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, generated through acquiring multiple landmarks on the bone surface either by a pointer probe or by acquiring pairs of registered fluoroscopic images. VectorVision® hip Software uses the registered landmarks to navigate the needed surgical tools like cup reamer, cup inserter, stem rasp, bone saw and the implant to the planned position. If no implant data is available it is possible to provide information in order to achieve a generally targeted alignment relative to the bone orientation as defined by the operating surgeon.
Vector\Vision® hip Software allows 3-dimensional reconstruction of the relevant mechanical axes and planes of femur and pelvis and alignment of the implants. The VectorVision® hip Software has been designed to read in data of implants and tools if provided by the implant manufacturer and offers to individually choose the prosthesis during each surgery. The VectorVision® hip Software registers the patient data needed for planning and navigating the surgery intra-operatively within the CT free module. The System can be used to generally align tool orientations according to the anatomy described and defined by the landmarks acquired by the surgeon.
Substantial equivalence:
VectorVision® hip Software has been verified and validated according to BrainLABs 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:
- VectorVision® Hip 3.0 (K040368) -
- VectorVision® Trauma (K012448) -
- -Hip Module for the StealthStation System (K021980)
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black. The logo is simple and recognizable, and it is used to represent the Department of Health and Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2006
BrainLAB AG % Mr. Peter Drumm Project Manager Ammerthalstrasse 8 85551 Heimstetten Germany
Re: K060727
Trade/Device Name: VectorVision® hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: July 28, 2006 Received: August 3, 2006
Dear Mr. Drumm:
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. This letter will allow you to
3
Page 2 - Mr. Peter Drumm ﯨﭗ ﺑ
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,
F.N. D.P.L.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ﻧﺴﻌﺮ 510(k) Number (if known):
K 060727
Device Name:
VectorVision® hip
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 considered to be safe and effective 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 hip endoprothesis to the preoperatively or intraoperatively planned position.
Example orthopedic surgical procedures include but are not limited to:
Total Joint Replacement (TJR) Revision surgery of TJR Minimal Invasive Orthopedic Surgery Tumor resection and bone/joint reconstruction
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over - The - Counter Use
(Optional Format 1-2-96)
Fision Sign-Off) Division of General, Restorative Devices
3(k) Number K060727