(254 days)
No
The description focuses on image-guided localization and navigation based on landmark registration and 3D modeling, without mentioning AI or ML techniques.
No
Explanation: The device is described as an image-guided localization system that aids surgeons in navigation, planning, and measurements, rather than directly treating a medical condition.
No
Explanation: The device is an intraoperative image-guided localization and navigation system for surgical procedures, aiding the surgeon in accurate positioning of implants and providing measurements for ligament balancing and bone alignment. It does not diagnose medical conditions.
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, 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.
- BrainLAB Knee Function: The description clearly states that BrainLAB knee is an intraoperative image guided localization system used during surgery. It helps the surgeon navigate instruments and implants based on a 3D model of the patient's bone.
- No Sample Analysis: There is no mention of analyzing biological samples from the patient. The system relies on imaging data (CT, x-ray, MR) and intraoperative tracking of instruments.
Therefore, BrainLAB knee falls under the category of a surgical navigation or guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Brainl AB/knee is intended to be an intraoperative image guided localization system to eBrainLAB/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 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 prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by BrainLAB knee.
Example orthopedic surgical procedures include but are not limited to:
- · Total Knee Replacement
- Smeenter Knee Replacement
- · Ligament Balancing
- · Range of Motion Analysis
- Cruciate Ligamoni Sargers
- · Patella Tracking
Product codes
HAW
Device Description
BrainLAB knee is intended to enable operational planning and/navigation in orthopedic surgery. It links a surqical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is gegerated through acquiring multiple landmarks on the bone surface. BrainLAB knee uses the registered landmarks to navigate the femoral and tibial cutting guides and the implant to the planned optimally position.
BrainLAB knee allows 3-dimensional reconstruction of the mechanical axis and alignment of the implants. BrainLAB 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 of the anatomy. No preoperative CT-scanning is necessary.
Anatomical Site
rigid anatomical structure, such as the skull, a long bone, or vertebra, knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, Prescription Use
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
BrainLAB 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® CT-free knee (K021306), VectorVision® Uni-Knee (K041899) and of Ci TKR/UKR (K052966).
Key Metrics
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
510 (k) Summary of Safety and Effectiveness for BrainLAB knee
| 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: | December 5, 2007 |
SSEP-520008
| Device Name: | |
|---|---|
| Trade name: | BrainLAB knee essential, BrainLAB knee unlimited |
| Ci™ knee, Ci™ knee unlimited | |
| Common/Classification Name: | BrainLAB Image Guided Surgery System / Instrument, |
| Stereotaxic |
Predicate Devices:
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:
Brainl AB/knee is intended to be an intraoperative image guided localization system to eBrainLAB/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 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 prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by BrainLAB knee.
1
Example orthopedic surgical procedures include but are not limited to:
- · Total Knee Replacement
- Smeenter Knee Replacement
- · Ligament Balancing
- · Range of Motion Analysis
- Cruciate Ligamoni Sargers
- · Patella Tracking
Device Description:
BrainLAB knee is intended to enable operational planning and/navigation in orthopedic surgery. It links a surqical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is gegerated through acquiring multiple landmarks on the bone surface. BrainLAB knee uses the registered landmarks to navigate the femoral and tibial cutting guides and the implant to the planned optimally position.
BrainLAB knee allows 3-dimensional reconstruction of the mechanical axis and alignment of the implants. BrainLAB knee software registers the, patient data needed for planning and navigating the surgery intraoperatively. No preoperative CT-scanning is necessary.
Substantial equivalence:
BrainLAB 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® CT-free knee (K021306), VectorVision® Uni-Knee (K041899) and of Ci TKR/UKR (K052966).
Page 2 of 2
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BrainLAB AG % Mr. Per Persson Kapellenstrasse 12 Feldkirchen Germany 85622
SEP - 5 2008
Re: K073615
Trade/Device Name: BrainLab knee Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: August 25, 2008 Received: September 2, 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 (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 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 events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems 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 M. Mullean
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
K073615 510(k) Number (if known):
Device Name: BrainLAB knee
Indications For Use:
BrainLAB 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 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 prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by BrainLAB knee.
Example orthopedic surgical procedures include but are not limited to:
- · Total Knee Replacement
- · Ligament Balancing
- Range of Motion Analysis
- · Patella Tracking
| Prescription Use
(Per 21 CFR 801 Subpart D) | X | 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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | 16073618 |
|---|---|
| --------------- | ---------- |
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