(427 days)
Not Found
No
The description focuses on sensor technology and data visualization, with no mention of AI or ML algorithms for analysis or decision support.
No
The device is described as an intra-operative tool for adjustment of the femoral knee implant during total knee arthroplasty, and it measures forces and angular positions. It does not directly treat or prevent a disease or condition.
Yes
The device measures forces and angular positional information to help the surgeon adjust the femoral knee implant and reduce instability from flexion gap asymmetry. This process of measuring and analyzing data to inform a medical intervention fits the definition of a diagnostic device.
No
The device description explicitly states the system includes an "instrumented trial tibial insert comprising an array of load sensors" and the "OrthoSensor LinkStation," which are hardware components. While software is required, the system is not software-only.
Based on the provided information, the VERASENSE Knee System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to assist surgeons during Total Knee Arthroplasty (TKA) by providing real-time data on knee balancing and instability. This is a surgical procedure performed in vivo (within the living body), not a diagnostic test performed in vitro (outside the living body) on biological samples.
- Device Description: The device is an instrumented trial tibial insert that measures forces and positional information within the knee joint during surgery. It's an intra-operative tool used directly on the patient during the procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition based on such analysis. The data it provides is related to the mechanical state of the knee during surgery.
In summary, the VERASENSE Knee System is a surgical instrument designed to aid in the performance of a medical procedure, not a device used for diagnosing a disease or condition through the analysis of biological samples.
N/A
Intended Use / Indications for Use
The VERASENSE Knee System is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.
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
ONN
Device Description
The VERASENSE Knee System provides a means to dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA) 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 femur.
The VERASENSE Knee System is compatible with the following knee implant systems:
- Biomet Vanguard
- . Stryker Triathalon
- Zimmer NexGen
- Smith & Nephew Journey II
- Smith & Nephew Legion
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)
Performance Data: N/A
Clinical Data: N/A
Summary of Testing: N/A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
4/15/2016
OrthoSensor, Incorporated Ms. Deborah Johnson Regulatory Affairs Manager 1855 Griffin Road, Suite A-310 Dania Beach, Florida 33004
Re: K150372
Trade/Device Name: VERASENSE Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: ONN Dated: March 17, 2016 Received: March 18, 2016
Dear Ms. Johnson:
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 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150372
Device Name VERASENSE Knee System
Indications for Use (Describe)
The VERASENSE Knee System is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 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 shapes, one in light blue, one in dark blue, and one in gray, arranged in a triangular formation. The company name, "ORTHOSENSOR," is written in a simple, sans-serif font, with "ORTHO" in gray and "SENSOR" in dark blue.
OrthoSensor Inc.
Traditional 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) 337-9222
deborah.johnson@orthosensor.com |
| ------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Establishment Registration 3008592715 Number:
Contact:
Deborah Johnson Regulatory Affairs Manager OrthoSensor, Inc. 1855 Griffin Road, Suite A-310 Dania Beach, FL 33004 Phone: (954) 577-7770 extension 158 Fax: (954) 246-0318 deborah.johnson@orthosensor.com
Date of Summary: April 14, 2016
Predicate 510(k) Number(s):
K131767 – Orthosensor VERASENSE™ Knee System K130380 - Orthosensor VERASENSE™ Knee System K090474 - Orthosensor VERASENSE™ Knee System
Traditional 510(k) Number: K150372
Trade/Proprietary: VERASENSE™ Knee System
Classification Name: Intraoperative Orthopedic Joint Assessment Aid
Product Code: ONN
Device Classification: Class II (21 CFR 882.4560)
4
Image /page/4/Picture/0 description: The image shows the logo for Orthosensor. The logo consists of a stylized symbol above the company name. The symbol is made up of three curved shapes, one in light blue, one in dark blue, and one in light gray, arranged in a triangular formation. The company name "ORTHOSENSOR" is written in a serif font, with "ORTHO" in light gray and "SENSOR" in dark blue.
Device Description:
The VERASENSE Knee System provides a means to dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA) 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 femur.
The VERASENSE Knee System is compatible with the following knee implant systems:
- Biomet Vanguard
- . Stryker Triathalon
- Zimmer NexGen
- Smith & Nephew Journey II
- Smith & Nephew Legion
Intended Use:
The VERASENSE Knee System is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.
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.
Description of Changes to the Device: The reason for this traditional 510(k) submission is to update the intended use statement.
Technological Characteristics:
The VERASENSE™ Knee System is an intra-operative device for use in primary or revision total knee arthroplasty (TKA), where all patient contacting components are made of biocompatible polycarbonate and adhesive.
The VERASENSE™ Knee System is an intelligent disposable tibial insert that wirelessly transmits the measured data to the OrthoSensor LinkStation for surgeon visualization. Individual VERASENSE™ devices are packaged sterile, for single patient use with a Shim Set for thickness adjustments.
The OrthoSensor LinkStation and VERASENSE™ Knee System Software Application are required for use of the VERASENSE™ Knee System device. The LinkStation
5
Image /page/5/Picture/0 description: The image is a logo for Orthosensor. The logo features a stylized symbol above the company name. The symbol consists of three curved shapes arranged in a triangular formation, with the top shape in blue, the middle shape in gray, and the bottom shape in a darker shade of blue. The company name "ORTHOSENSOR" is written in a serif font, with "ORTHO" in gray and "SENSOR" in a darker shade of blue.
contains a computer and all peripheral equipment required to display the measured data by providing a graphical and numerical presentation of the loads in both the medial and lateral compartments of the knee. VERASENSE™ Knee System devices are implant system specific due to variations in implant design.
Performance Data: N/A
Clinical Data: N/A
Substantial Equivalence:
The VERASENSE™ Knee System is substantially equivalent to the devices previously cleared by FDA in K131767, K130380 and K090474. This equivalency is determined because the VERASENSE™ Knee System has equivalent manufacturing materials, operating principles, and physical, operational specifications as compared to the predicate devices. The similarities and differences between the proposed and predicate devices have been identified and determined that they have no impact on safety or effectiveness.
Summary of Testing: N/A
Conclusion: Based on the predicate comparison, and equivalency assessment, the VERASENSE™ Knee System is substantially equivalent to the predicate device.