(88 days)
Not Found
No
The description focuses on image-guided navigation and landmark-based registration, without mentioning AI or ML algorithms for tasks like image analysis, prediction, or automated decision-making.
No
The device is an image-guided localization system that aids surgeons in navigating during surgery and planning implants; it does not directly treat a medical condition.
No
Explanation: The device is described as an intraoperative image-guided localization system that aids surgeons in navigating a knee endoprosthesis and provides measurements. While it uses imaging data, its primary function is surgical guidance and planning, not diagnosing medical conditions.
No
The device description explicitly states it links a surgical instrument tracked by passive markers to a 3D model, indicating the presence of hardware components (surgical instruments, passive markers, sensor system) 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 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.
- Device Function: The BrainLAB uni-knee is an image-guided surgical navigation system. Its purpose is to assist surgeons during orthopedic procedures by providing real-time localization and guidance based on anatomical landmarks and pre-operative imaging. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's an "intraoperative image guided localization system" for minimally invasive surgery, aiding in the navigation of surgical instruments and implants.
- Device Description: The description focuses on software linking surgical instruments to 3D bone models for planning and navigation.
The device's function and intended use are entirely focused on surgical guidance and planning within the body, not on the analysis of samples taken from the body.
N/A
Intended Use / Indications for Use
BrainLAB uni-knee is intended to be an intraoperative image quided 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-rav, or MR-based model of the anatomy. The system aids the surgeon in accurately navigating a knee endoprosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by BrainLAB uni-knee.
Example orthopedic surgical procedures include but are not limited to:
- · Unicondylar Knee Replacement
- · Ligament Balancing
- · Range of Motion Analysis
- · Patella Tracking
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
BrainLAB uni-knee is intended to enable 3 dimensional implant planning and navigation for unicompartimental orthopedic knee surgery. The SW links a surgical instrument tracked by passive markers to a 3D-model of the patient's bone, which is generated by acquiring multiple landmarks on the bone surface. Uni-knee 2.0 uses the registered landmarks to navigate the femoral and tibial cutting quides to the preplanned position.
Uni-knee 2.0 allows 3-dimensional reconstruction of the mechanical axes and alignment of the implants. The uni-knee 2.0 software has been designed to read in implant data and tool data from different manufacturers and offers to individually choose the prosthesis during each surgery. The uni-knee 2.0 software registers the patient data needed for planning and navigating intra-operatively. No preoperative CT-scanning is necessary.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, X-ray, or MR-based model of the anatomy
Anatomical Site
rigid anatomical structure, such as the skull, a 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® uni-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 system.
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
K080678
510 (k) Summary of Safety and Effectiveness for BrainLAB uni-knee
Manufacturer:
JUN - 6 2008
| Address: | BrainLAB AG
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: | 16 January 2008 |
Device Name:
| Trade name: | Uni-knee 2.0 |
|---|---|
| Common/Classification Name: | BrainLAB uni-knee, BrainLAB Image Guided Surgery |
| System / Instrument, Stereotaxic |
Predicate Device:
Vector Vision® CT-free Knee (K021306) Ci TKR/UKR (K052966) VectorVision uni-knee (K041899)
Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II
Intended Use:
BrainLAB uni-knee is intended to be an intraoperative image quided 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-rav, or MR-based model of the anatomy. The system aids the surgeon in accurately navigating a knee endoprosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by BrainLAB uni-knee.
1
Example orthopedic surgical procedures include but are not limited to:
- · Unicondylar Knee Replacement
- · Ligament Balancing
- · Range of Motion Analysis
- · Patella Tracking
Device Description:
BrainLAB uni-knee is intended to enable 3 dimensional implant planning and navigation for unicompartimental orthopedic knee surgery. The SW links a surgical instrument tracked by passive markers to a 3D-model of the patient's bone, which is generated by acquiring multiple landmarks on the bone surface. Uni-knee 2.0 uses the registered landmarks to navigate the femoral and tibial cutting quides to the preplanned position.
Uni-knee 2.0 allows 3-dimensional reconstruction of the mechanical axes and alignment of the implants. The uni-knee 2.0 software has been designed to read in implant data and tool data from different manufacturers and offers to individually choose the prosthesis during each surgery. The uni-knee 2.0 software registers the patient data needed for planning and navigating intra-operatively. No preoperative CT-scanning is necessary.
Substantial equivalence:
VectorVision® uni-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 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® uni-knee (K041899). VectorVision® CT-free knee (K 021306) and Ci TKR/UKR (K052966).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2008
BrainLAB AG % Mr. Per Persson Kapellenstrenstrasse 12 85622 Feldkirchen Germany
Re: K080678 Trade/Device Name: uni-knee Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 6, 2008 Received: March 10, 2008
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse arents (Medical Device Reporting (MDR)), please contact the Division of Surveillance arvers at (240) 276-3464. 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. Mulhern
Mark N. Melkerson 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):
Device Name: uni-knee
Indications For Use:
BrainLAB uni-knee 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 pationt'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, or MR-based model of the anatomy.
The system aids the surgeon in accurately navigating a knee endoprosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by BrainLAB uni-knee.
Example orthopedic surgical procedures include but are not limited to:
- · Unicondylar Knee Replacement
- · Ligament Balancing
- · Range of Motion Analysis
- · Patella Tracking
Neil R. Osdalen
Division of General, Restorative, and Neurological Devices
510(k) Number K080678
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)