(252 days)
Not Found
No
The summary describes a traditional image-guided navigation system based on landmarks and virtual models, with no mention of AI or ML terms or functionalities.
No.
The device is an image-guided navigation system that assists in planning and navigation during surgery; it does not directly treat a disease or condition.
No
Explanation: The device is described as an image-guided navigation system used during surgery for planning and drilling, not for diagnosing a condition. Its purpose is to assist in surgical procedures for ligament replacement, not to identify a disease or condition.
No
The device description explicitly mentions a "freehand probe, tracked by 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 such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The BrainLAB ACL system is an image-guided surgical navigation system. Its purpose is to assist surgeons during anterior cruciate ligament (ACL) replacement procedures by providing real-time guidance for planning and drilling bone tunnels. It uses intra-operatively acquired landmarks and links a physical probe to a virtual model.
- Lack of Biological Sample Analysis: The description does not mention the analysis of any biological samples (blood, tissue, etc.). The system operates on anatomical landmarks and imaging data (though the input modality isn't specified, it's clearly not analyzing biological samples).
Therefore, the BrainLAB ACL system falls under the category of a surgical navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BrainLAB ACL is intended to be used as an intraoperative image-guided navigation system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system, to a virtual computer image space on the model of a bone, overlaid with individually acquired patient landmarks.
The system is indicated for any surgical anterior cruciate ligament procedure in which the use of stereotactic surgery for the planning and navigation of interosseous canals may be appropriate, and where a reference to a rigid anatomical structure can be established.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
ACL is an image quided surgery system for the replacement of torn ligaments in the knee joint. It is based on intra-operatively acquired landmarks that are used for planning and navigation. It supports the surgeon in the planning and drilling of transplants canals in the position to regain the stability of the knee joint.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Substantial equivalence:
BrainLAB ACL has been verified and validated according to BrainLAB's procedures for product design and development.
To conclude the substantial equivalence, the following verification aspects were performed:
- . Design review meetings
- Evaluation at special sites t
- Tracking of software versions .
- Subsystem & System Verification using Xtool .
- Non-Xtool tests .
- License group tests .
- Installer tests .
- Startup tests .
To conclude the substantial equivalence, the following validation aspects were performed:
- Testing and evaluation under real world conditions .
- Desian reviews .
- Software validation .
- Literature research .
- Literature evaluation ◆
- Comparison with a previously marketed medical device .
- Indications for use/Changed indications for use .
- . Non-clinical validation
- Preclinical and clinical validation .
- Side effects .
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.
VectorVision® ACL (K042512), BrainLAB Knee (K073615)
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
1093118 510 (k) Summary of Safety and Effectiveness for BrainLAB ACL
Manufacturer:
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. Alexander Schwiersch
May 21, 2010 Summary Date:
Device Name:
Trade name:
BrainLAB ACL
Common/Classification Name:
BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Predicate Device:
VectorVision® ACL (K042512) BrainLAB Knee (K073615)
Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II
Intended Use:
Indications For Use:
BrainLAB ACL is intended to be used as an intraoperative image-guided navigation system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system, to a virtual computer image space on the model of a bone, overlaid with individually acquired patient landmarks.
The system is indicated for any surgical anterior cruciate ligament procedure in which the use of stereotactic surgery for the planning and navigation of interosseous canals may be appropriate, and where a reference to a rigid anatomical structure can be established.
1
Device Description:
ACL is an image quided surgery system for the replacement of torn ligaments in the knee joint. It is based on intra-operatively acquired landmarks that are used for planning and navigation. It supports the surgeon in the planning and drilling of transplants canals in the position to regain the stability of the knee joint.
Substantial equivalence:
BrainLAB ACL has been verified and validated according to BrainLAB's procedures for product design and development.
To conclude the substantial equivalence, the following verification aspects were performed:
- . Design review meetings
- Evaluation at special sites t
- Tracking of software versions .
- Subsystem & System Verification using Xtool .
- Non-Xtool tests .
- License group tests .
- Installer tests .
- Startup tests .
To conclude the substantial equivalence, the following validation aspects were performed:
- Testing and evaluation under real world conditions .
- Desian reviews .
- Software validation .
- Literature research .
- Literature evaluation ◆
- Comparison with a previously marketed medical device .
- Indications for use/Changed indications for use .
- . Non-clinical validation
- Preclinical and clinical validation .
- Side effects .
The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device VectorVision® ACL (K042512) and BrainLAB Knee (K073615)
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
BrainLAB AG % Mr. Stefan Wimmer Kapellenstrasse 12 85622 Feldkirchen Germanv
JUN 1 1 2010
Re: K093118
Trade/Device Name: BrainLAB ACL Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: June 04, 2010 Received: June 09, 2010
Dear Mr. Wimmer:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Mr. Stefan Wimmer
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/CDRH/CDRHOffices/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,
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K09318
Device Name: ACL
Indications For Use:
BrainLAB ACL is intended to be used as an intraoperative image-guided navigation system to enable minimally invasive surgery. It links a freehand probe, tracked by a bystein to enable minimal computer image space on the model of a bone, overlaid with individually acquired patient landmarks.
The system is indicated for any surgical anterior cruciate ligament procedure in which the use of stereotactic surgery for the planning and navigation of interosseous canals may be appropriate, and where a reference to a rigid anatomical structure can be established.
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)
Nilses. Ryden Loc. mnr
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K093118