(119 days)
Not Found
No
The summary describes a sensor-based device that measures forces and angles. There is no mention of AI, ML, or any data processing beyond direct measurement and display for the surgeon.
No
The device is used to measure forces and angular information to assist a surgeon in adjusting a knee implant. It is a diagnostic and measurement tool, not directly therapeutic itself.
No
The device is described as a "tool for adjustment" and "means to dynamically balance the knee during knee replacement surgery," which suggests an interventional or assistive role rather than a diagnostic one. While it measures forces and angular position, these measurements appear to guide the surgical adjustment rather than to diagnose a medical condition or disease.
No
The device description explicitly states it includes an "instrumented trial tibial insert comprising an array of load sensors," which is a hardware component.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Knee Balancer is an instrumented trial tibial insert used intra-operatively during knee replacement surgery. It measures forces and angular position within the body to help adjust the implant.
- Intended Use: The intended use is to "adjust the femoral knee implant to reduce instability from flexion gap asymmetry," which is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical tool used to guide and optimize a surgical procedure, not to diagnose a condition based on a biological sample.
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 Knee Balancer is sterile, for single patient use.
Product codes (comma separated list FDA assigned to the subject device)
ONN
Device Description
OrthoSensor Knee Balancer 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 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)
The changes to the OrthoSensor Knee Balancer were evaluated under design controls and met the same criteria as the original device. The Risk Analysis method used to assess the impact of the modification on the device was Failure Mode and Effects Analysis. The results of risk analysis have determined that there are no new risks associated with the modification on the device. The results of risk analysis are identical for the load data as well as the angular positional data. The verification activity required, based on the Risk Analysis, was bench top performance verification testing as well as design validation and usability testing performed in a cadaver lab setting.
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
K130380
JUN 1 3 2013
Special 510(k) Summary (as required by 807.92(c))
Regulatory Correspondent:
Kimberlee A. Washburn Regulatory & Quality Manager OrthoSensor, Inc. 1560 Sawgrass Corp. Pkwy, 4th Floor Sunrise, FL 33323 Phone: (954) 577-7770 Fax: (954) 577-7343 kwashburn@orthosensor.com
Submitter of 510(k):
Kimberlee A. Washburn Regulatory & Quality Manager OrthoSensor, Inc. 1560 Sawgrass Corp. Pkwy, 4th Floor > Sunrise, FL 33323 Phone: (954) 577-7770 Fax: (954) 577-7343 kwashburn@orthosensor.com
Date of Summary: February 8, 2013
Predicate 510(k) Number: K090474
Special 510(k) Number: K130380
Trade / Proprietary Names: OrthoSensor Knee Balancer
Classification Name: Intraoperative Orthopedic Joint Assessment Aid
Product Code: ONN
Device Classification: Class II
Intended Use: For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The Knee Balancer is sterile, for single patient use.
Device Description: OrthoSensor Knee Balancer 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
Page 1 of 2
1
measure the forces applied on its surface and angular positional information after insertion into the space between the tibia and the femur.
Description of Changes to the Device: The proposed updated submission is only to remove the "qualitative reference only" designation from the angular positional information as described in the original submission. The angular positional information, which is displayed alongside the load data, is used with the load data to achieve the same intended use. This results in no change to the device itself as it has the same intended use, operating principles, and physical, operational specifications as compared to the predicate device. The proposed updated submission does not alter the fundamental scientific technology of the device.
The intended use of the modified device, as described in the labeling, has not changed as a result of the proposed updated submission.
Predicate Device: OrthoRex Intra-Operative Load Sensor (OrthoSensor Knee Balancer )- 510(k) # K090474
Completion of Design Control Activities: The changes to the OrthoSensor Knee Balancer were evaluated under design controls and met the same criteria as the original device. The Risk Analysis method used to assess the impact of the modification on the device was Failure Mode and Effects Analysis. The results of risk analysis have determined that there are no new risks associated with the modification on the device. The results of risk analysis are identical for the load data as well as the angular positional data. The verification activity required, based on the Risk Analysis, was bench top performance verification testing as well as design validation and usability testing performed in a cadaver lab setting.
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 and the proposed updated submission is therefore substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
June 13, 2013
Orthosensor, Inc. % Ms. Kimberlee Washburn Manager, Regulatory Affairs and Quality Assurance 1560 Sawgrass Corporate Parkway, 4th Floor Sunrise, Florida 33323
Re: K130380
Trade/Device Name: Orthosensor Knee Balancer Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: ONN Dated: April 22, 2013 Received: May 07, 2013
Dear Ms. Washburn:
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 - Ms. Kimberlee Washburn
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/ReportaProblem/default.him 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 vours, For
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Device Name: OrthoRex Intra-Operative Load Sensor (Trade / Proprietary name = OrthoSensor Knee Balancer)
Indications for Use: For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The Knee Balancer is sterile, for single patient use.
Prescription Use: Yes (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)
Joshua C. Nipper -S
For
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130380
Page 1 of 1