(178 days)
Not Found
No
The summary describes a landmark-based image-guided surgery system and does not mention AI or ML. The performance studies focus on system functionality and comparison to previous products, not AI/ML model performance.
No.
This device is an intraoperative image-guided localization system that aids surgeons in navigating knee prosthesis and performing ligament balancing and bone alignment measurements. It is a surgical navigation tool, not a device that directly treats a medical condition.
No
The device is described as an "intraoperative image guided localization system" that aids the surgeon in navigating a knee prosthesis and provides measurements for "ligament balancing and measurements of bone alignment". It does not appear to diagnose a condition, but rather assists in performing a surgical procedure.
No
The device description explicitly states it is an "image guided surgery system" that "links a freehand probe, tracked by a passive marker sensor system to virtual computer image space". This indicates the system includes hardware components (probe, sensor system) in addition to software.
Based on the provided information, the Brainlab Knee device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "intraoperative image guided localization system" used to aid surgeons in navigating surgical procedures and making measurements during surgery. It is not used to examine specimens (like blood, tissue, or urine) in vitro to provide diagnostic information.
- Device Description: The description reinforces that it's an "image guided surgery system" for use during total knee replacement surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic results, or being used for screening, diagnosis, or monitoring of diseases or conditions based on in vitro testing.
The device is a surgical navigation system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
Brainlab knee is an image guided surgery system for total knee replacement surgery . based on landmark based visualization of the femur and tibia.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, x-ray, MR-based model
Anatomical Site
skull, a long bone, or vertebra (specifically knee for procedures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
To verify the correct functionality of the system Brainlab knee, all relevant test documentation coming from the risk analysis and specifications of each component has been compiled into one system. The system guarantees that all risks and associated tests are traceable and verify that no open risks or untested specifications occur. All inherited modules such as hardware platform, instruments, licenses etc. are taken into account.
The functionality is verified on all released platforms. BrainLAB industrial designers verified compliance of the interface to Brainlab standard. Workbench test have been performed on precisely milled model bones. Cut and implant positions have been compared to theoretical values.
The following validation methods were used to validate system Brainlab Knee:
- Comparison of the design to a previous product having an established history . of successful use
- Literature research and corresponding database search ●
- Testing and evaluation under real world conditions .
- Usability tests, prototyping and simulations .
- Design reviews .
- t Software Validation
Validation activities have successfully been performed according to the indications for use. The validation is supported by design reviews with many of the initial design surgeons and a cadaver test.
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
K102990
APR - 4 2011
510 (k) Summary of Safety and Effectiveness for Brainlab knee
Manufacturer:
Address:
BrainLAB AG Kapellenstrasse 12 85622 Feldkirchen Germany +49 89 99 15 68 0 Phone: ് +49 89 99 15 68 33 Fax:
Mr. Alexander Schwiersch
Contact Person:
Summary Date:
Device:
| Trade name: | Brainlab knee |
|---|---|
| Common/Classification Name: | Brainlab knee, BrainLAB Image Guided Surgery |
| System / Instrument, Stereotaxic | |
| Regulation Number: | 21 CFR 852.4560 |
| Product code: | OLO |
Predicate Device:
Brainlab knee (K073615) PiGalileo Total Knee Replacement (TKR) System (K061362 )
Device Classification Name: Instrument, Stereotaxic Requlatory Class: Class II
Intended 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.
Page 1 of 2
1
Example orthopedic surgical procedures include but are not limited to:
- · Total Knee Replacement
- · Ligament Balancing
- · Range of Motion Analysis
- · Patella Tracking
Device Description:
Brainlab knee is an image guided surgery system for total knee replacement surgery . based on landmark based visualization of the femur and tibia.
Substantial equivalence:
Brainlab knee has been verified and validated according to BrainLAB procedures for product design and development. The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device Brainlab knee (K073615) and "PiGalileo Total Knee Replacement (TKR) System (K061362)".
Changes to Predicate Device
Brainlab knee has changed in the following from Predicate Device:
- Compatibility to Smith&Nephew's Motorized Cutting Guide (MCG). Which . itself has FDA clearance under PiGalileo Total Knee Replacement (K061362). The MCG is brings the cutting block into the position, which is planned in the software.
- Alignment Verification Procedure. A condensed workflow, based entirely on . existing algorithms without the necessity to attach reference arrays to the bone. This procedure allows measurement of the alignment of a static cutting block with patient anatomy.
- Disposable Clip-on Remote Control. A facultative enhancement of the existing . pointer. Instead of pivoting the user can press a button on the clip to acquire points. It is also possible to acquire direction with a simple button click instead of holding the pointer still.
Verification/validation summary
To verify the correct functionality of the system Brainlab knee, all relevant test documentation coming from the risk analysis and specifications of each component has been compiled into one system. The system guarantees that all risks and associated tests are traceable and verify that no open risks or untested specifications occur. All inherited modules such as hardware platform, instruments, licenses etc. are taken into account.
The functionality is verified on all released platforms. BrainLAB industrial designers verified compliance of the interface to Brainlab standard. Workbench test have been
2
performed on precisely milled model bones. Cut and implant positions have been compared to theoretical values.
The following validation methods were used to validate system Brainlab Knee:
- Comparison of the design to a previous product having an established history . of successful use
- Literature research and corresponding database search ●
- Testing and evaluation under real world conditions .
- Usability tests, prototyping and simulations .
- Design reviews .
- t Software Validation
Validation activities have successfully been performed according to the indications for use. The validation is supported by design reviews with many of the initial design surgeons and a cadaver test.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration i 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
BrainLAB AG % Mr. Alexander Schwiersch Kapellenstrasse 12 85622 Feldkirchen. Germany
APR - 4 2511
Re: K102990
Trade/Device Name: Brainlab Knee Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: March 24, 2011 Received: March 28, 2011
Dear Mr. Schwiersch:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 – Mr. Alexander Schwiersch
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ay B. Rh
fr
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): |