(144 days)
No
The summary describes a system with sensors to measure forces and angular position, but there is no mention of AI or ML being used to process this data or make recommendations.
No
The device is a tool used during knee replacement surgery to assist in balancing the knee implant. It is not directly used to treat a disease or condition in a patient.
Yes
The device measures forces and angular positional information to help adjust a femoral knee implant, which indicates it provides diagnostic-like information about the knee's balance and stability.
No
The device description explicitly states the system includes an "instrumented trial tibial insert comprising an array of load sensors," indicating a hardware component is integral to the device's function.
Based on the provided information, the OrthoSensor VERASENSE™ Knee System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry." This describes a surgical tool used during a procedure to guide the placement and balancing of an implant.
- Device Description: The device is an "instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface and angular positional information." This describes a device that measures physical parameters (force and position) within the body during surgery.
- Lack of Diagnostic Activity: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens. It is used in vivo (within the body) to provide real-time feedback during surgery.
Therefore, the OrthoSensor VERASENSE™ Knee System is a surgical tool or instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE™ Knee System is sterile, for single patient use.
Product codes (comma separated list FDA assigned to the subject device)
ONN
Device Description
OrthoSensor VERASENSE™ Knee System provides a means to dynamically balance the knee during knee replacement surgery intra-operatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface and angular positional information (such as alignment, varus/valgus, posterior and anterior slope positioning, etc.) after insertion into the space between the tibia and the femur.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
Not Found
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.
K130380 - OrthoSensor Knee Balancer
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.
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).
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Image /page/0/Picture/1 description: The image shows the logo for Orthosensor. The logo consists of a stylized symbol above the company name. The symbol is composed of three curved lines converging towards the center, forming a triangular shape. The text "ORTHOSENSOR" is written in a serif font below the symbol.
1855 Griffin Road, Suite A-310 Dania Beach, FL 33004 Phone: (954) 577-7770 Fax: (954) 577-7343
Special 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92
Submitter:
OrthoSensor, Inc. 1855 Griffin Road, Suite A-310 Dania Beach, FL 33004 Phone: (954) 577-7770 Fax: (954) 577-7343 mgaray@orthosensor.com
Establishment Registration 3008592715 Number:
Contact:
Martha Garay Regulatory Affairs & Quality Assurance Manager OrthoSensor, Inc. 1855 Griffin Road, Suite A-310 Dania Beach, FL 33004 Phone: (954) 577-7770 Fax: (954) 577-7343 mgaray@orthosensor.com
Date of Summary: October 14, 2013
Predicate 510(k) Number: K130380 - OrthoSensor Knee Balancer
Special 510(k) Number: K131767
Trade/Proprietary:OrthoSensor Knee Balancer (Trade / Proprietary names = OrthoSensor VERASENSE™ Knee System).
Classification Name: Intraoperative Orthopedic Joint Assessment Aid
Product Code: ONN
Device Classification: Class II (21 CFR 882.4560)
Intended Use: For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE™ Knee System is sterile, for single patient use.
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Image /page/1/Picture/1 description: The image shows the logo for Orthosensor. The logo consists of a stylized triangle shape above the word "ORTHOSENSOR". The triangle shape is made up of three curved lines that meet at a point at the top. The text is in all caps and in a simple sans-serif font.
1855 Griffin Road, Suite A-310 Dania Beach, FL 33004 Phone: (954) 577-7770 Fax: (954) 577-7343
Device Description: OrthoSensor VERASENSE™ Knee System provides a means to dynamically balance the knee during knee replacement surgery intra-operatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface and angular positional information (such as alignment, varus/valgus, posterior and anterior slope positioning, etc.) after insertion into the space between the tibia and the femur.
Description of Changes to the Device: The reason for this proposed special 510(k) submission is to include a modification to the package label (specifically the outer label) to reflect the use of the OrthoSensor VERASENSE™ Knee System with the Biomet Vanguard Knee System (K113550). In addition to this change on labeling, this submission also covers the changes to the device surface contours and dimensions (specific to the condylar surface of the Biomet Vanguard Knee System), as well as the addition of a new color of Polycarbonate (for Makrolon Rx 1851).
Completion of Design Control Activities:
The modifications to the Orthosensor VERASENSE™ Knee System were evaluated under design controls, and met the same performance criteria as the predicate device. Dimensional changes were implemented to meet customer needs (BIOMET), with new sizes and catalog numbers. The design control process was followed and the risk analysis method used to determine assess risks associated with these changes was Failure Mode Effects Analysis (FMEA), which has been updated appropriately.
Substantial Equivalence:
The proposed updated submission has the same intended use as the predicate and same technological characteristics that do not raise different types of questions of safety and effectiveness. The proposed updated submission is therefore substantially equivalent to the predicate device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 28, 2014
OrthoSensor, Incorporated Ms. Martha Garay Regulatory Affairs & Quality Assurance Manager 1855 Griffin Road, Suite A-310 Dania Beach, Florida 33004
Re: K131767
Trade/Device Name: OrthoSensor VERASENSETM Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: ONN Dated: September 6, 2013 Received: September 9, 2013
Dear Ms. Garay:
This letter corrects our substantially equivalent letter of September 6, 2013.
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
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Page 2 - Ms. Martha Garay
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours. Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Orthosensor. The logo consists of the word "ORTHOSENSOR" in a light gray, sans-serif font. Above the word is a stylized symbol that looks like three curved lines converging at a point, also in light gray. The overall impression is clean and modern.
K131767
Indications for Use Statement
Device Name: OrthoSensor Knee Balancer (Proprietary name=VERASENSE™ Knee System).
Indications for Use: For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE™ Knee System is sterile, for single patient use.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D
Division of Orthopedic Devices
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