(79 days)
K 040368, K 014256
Vector Vision® hip 3.0(K 040368), Kolibri™ Image Guided Surgery System (K 014256)
No
The summary describes an image-guided localization system based on tracking passive markers and registering them to pre-operative images or intra-operative landmarks. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is an intraoperative image-guided localization system that aids surgeons in navigating surgical tools and implants; it does not directly treat a medical condition.
No
The device is described as an intraoperative image-guided localization system that aids surgeons in navigating surgical tools and implants. Its primary function is to assist in surgical procedures by providing guidance and navigation, not to diagnose a medical condition.
No
The device description explicitly mentions linking a surgical instrument tracked by flexible passive markers and using a passive marker sensor system, indicating the presence 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 diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The BrainLAB VectorVision hip is an intraoperative image guided localization system. Its purpose is to assist surgeons during surgery by providing navigation and guidance based on pre-operative imaging data or intraoperative landmark acquisition. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states it's for "intraoperative image guided localization" and "aids the surgeon to accurately navigate a hip endoprothesis". This is a surgical navigation tool, not a diagnostic test.
- Device Description: The description focuses on linking surgical instruments to virtual image space and assisting with surgical planning and navigation. It does not mention any analysis of biological samples.
Therefore, the BrainLAB VectorVision hip falls under the category of a surgical navigation system, which is a medical device used during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BrainLAB VectorVision hip is intended to be an intraoperative image guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space either on a patient's preoperative image data being processed by a VectorVision or a Ci™ workstation or 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 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 Tumor resection and bone/joint reconstruction
Product codes
HAW
Device Description
BrainLAB VectorVision®hip 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 either based on a patients preoperative image data or generated through acquiring multiple landmarks on the bone surface. VectorVision® hip 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.
VectorVision® hip 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. Using the CT based module the patient data can be used additionally for surgery, the patient data is then is provided by the CT data stored on a standard data storage media.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, X-ray, MR
Anatomical Site
rigid anatomical structure, such as the skull, a long bone, or vertebra, hip (femur and pelvis).
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)
The validation proves the safety and effectiveness of the system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Vector Vision® hip 3.0(K 040368), Kolibri™ Image Guided Surgery System (K 014256)
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
NOV - 2 2005
KOSTALS
510 (k) Summary of Safety and Effectiveness for VectorVision® hip
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. Per Persson |
|---|---|
| ----------------- | ----------------- |
Summary Date: October 7th, 2005
Device Name:
Trade name:
DePuy hip Navigation Software
Common/Classification Name:
VectorVision, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Predicate Device: Vector Vision® hip 3.0(K 040368) Kolibri™ Image Guided Surgery System (K 014256)
Device Classification Name: Instrument, Stereotaxic Requlatory Class: Class II
Intended Use:
BrainLAB VectorVision hip is intended to be an intraoperative image guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space either on a patient's preoperative image data being processed by a VectorVision or a Ci™ workstation or 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 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 Tumor resection and bone/joint reconstruction
1
Device Description:
BrainLAB VectorVision®hip 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 either based on a patients preoperative image data or generated through acquiring multiple landmarks on the bone surface. VectorVision® hip 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.
VectorVision® hip 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. Using the CT based module the patient data can be used additionally for surgery, the patient data is then is provided by the CT data stored on a standard data storage media.
Substantial equivalence:
VectorVision® hip 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 Vector Vision® hip 3.0(K 040368) and Kolibri™ Image Guided Surgery System (K 014256).
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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized graphic 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
NOV - 2 2005
Per Persson Quality Manager BrainLab AG Ammerthalstrasse 8 85551 Heimstetten
Re: K052213
Trade/Device Name: VectorVision hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: October 7, 2005 Received: October 11, 2005
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
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Barbara BuehrmD
tr
Mark N. Melkerson Acting 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): K052213
Device Name: VectorVision hip
Indications For Use:
BrainLAB VectorVision hip is intended to be an intraoperative image quided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space either on a patient's preoperative image data being processed by a VectorVision or a Citt workstation or on an individual 3Dmodel 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 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 Tumor resection and bone/joint reconstruction
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)
Barbara michu
Colatu
| CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) |
| Division of General, Restorative, and Neurological Devices |
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| 510(k) Number | K052213 |
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