(237 days)
Not Found
No
The summary describes a sensor-based system for measuring forces during knee surgery. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
Yes.
The device intends to adjust the femoral knee implant to reduce instability from flexion gap asymmetry, which is a therapeutic purpose.
No
The device is an intraoperative tool for adjustment and balancing of knee implants during surgery, rather than for diagnosing a medical condition.
No
The device description explicitly states the system includes an "instrumented trial tibial insert comprising an array of load sensors," which are hardware components.
Based on the provided information, this device 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 aid in implant placement and balancing.
- Device Description: The device is an "instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface after insertion into the space between the tibia and the femur." This is a physical device used to measure mechanical forces within the body during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens. It measures physical forces.
Therefore, this device falls under the category of a surgical instrument or aid, 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 force sensor is sterile, for single patient use.
Product codes
ONN
Device Description
Orthosensor Intra-Operative Load Sensor (IOLS) system provides a means to dynamically balance the knee during knee replacement surgery intraoperatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface 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 (femoral knee implant)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intraoperative orthopedic joint assessment aid / Surgery
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)
The proposed device has undergone a series of bench testing which includes mcchanical, engineering, and comparison studies The results of the testing have shown the device to perform in accordance with internal and customer requirements and the device performance has not shown any negative impact on the safety and effectiveness of the proposed device when compared to the predicate device.
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
510(k) SUMMARY (as required by 807.92(e))
OCT 1 9 2009
Regulatory Correspondent: Regulatory and Marketing Services, Inc. 962 Allegro Lane Apollo Beach, FL 33572 Jon Ward Phone: 813-645-2855 Fax: 813-645-2856 wardjp@ajwtech.com
Submitter of 510(k):
Orthosensor, Inc. 1560 Sawgrass Corporate Pkwy, 4th Floor Sunrise, FL 33323 Mark Stein Phone: 954-577-7770 Fax: 954-577-7343
Date of Summary:
Trade/Proprietary Name:
Classification Name:
Product Code:
Intended Use:
Device Description:
Intraoperative orthopedic joint assessment aid
OrthoRex Intra-Operative Load Sensor
September 27, 2009
ONN
For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The force sensor is sterile, for single patient use.
Orthosensor Intra-Operative Load Sensor (IOLS) system provides a means to dynamically balance the knee during knee replacement surgery intraoperatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface after insertion into the space between the tibia and the femur.
Predicate Device:
Elibra Dynamic Knee Balancer - K070108
1
Substantial Equivalence:
The Orthosensor, Inc. claims the proposed device to be substantially equivalent to the device previously cleared by FDA in K070108. Orthosensor, Inc. claims this equivalence because the proposed device has an equivalent intended use, 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 explained in the Substantial Equivalence Discussion which has been included in Section 10 of this submission. These differences identified have no impact on safety or effectiveness.
Performance Testing:
The proposed device has undergone a series of bench testing which includes mcchanical, engineering, and comparison studies The results of the testing have shown the device to perform in accordance with internal and customer requirements and the device performance has not shown any negative impact on the safety and effectiveness of the proposed device when compared to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized eagle or bird in flight, composed of three curved lines representing wings and a tail. The overall design is simple and recognizable, representing the department's role in public health and human services.
Orthosensor, Inc. % Mr. Jon Ward Regulatory and Marketing Services, Inc. 962 Allegro Lane Apollo Beach, Florida 33572
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
OCT 1 9 2009
Re: K090474
Trade/Device Name: OrthoRex Intra-Operative Load Sensor Regulation Number: 21 CFR 882,4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: ONN Dated: August 9, 2009 Received: August 13, 2009
Dear Mr. Ward;
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 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); 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.
3
Page 2 - Mr. Jon Ward
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/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,
Mark A. Milhurn
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
no osure
4
Indications for Use
!
510(k) Number (if known):
Device Name: OrthoRex Intra-Operative Load Sensor
Indications for Use: For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The force sensor is sterile, for single patient use
-1
Prescription Use Yes (Part 21 CFR 801 Subpart D)
10 - 2014/01/20 11:10:10 - 10/08/2017 11:00 10/08/2017 11:00 10/08/2017 11:00 10/08/2017 11:00 10/0
AND/OR
ショットではないと思ったけど、このコミニックにしたことになっています。 ここには、ここには、このことに、このことに、このことになったときになるということです。 この
Over-The-Counter Use No (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Omtu for mkm
Page 1 of 1
(Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090474