(256 days)
No
The description focuses on a force sensor and display providing numerical feedback, with no mention of AI/ML terms, image processing, or data-driven analysis beyond basic force measurement and display.
No.
The device functions as a measuring tool to aid surgeons in balancing soft tissue during knee replacement, rather than directly treating a disease or condition itself.
No
The device is described as a tool for adjustment and balancing during a surgical procedure, showing relative forces to aid the surgeon. It does not provide a diagnosis of a disease or condition.
No
The device description explicitly states it consists of a force sensor and an electronic display, both of which are hardware components. The performance studies also include mechanical, force, and electrical safety testing, which are relevant to hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a surgical tool used during a total knee replacement procedure. It measures forces within the knee joint in vivo (within the living body) to help the surgeon balance soft tissues.
- No Specimen Analysis: The device does not analyze any specimens taken from the patient. It directly interacts with the patient's knee joint during surgery.
Therefore, based on its intended use and function, this device falls under the category of a surgical instrument or device, not an In Vitro Diagnostic.
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
The device consists of one unit, containing the force sensor and an electronic display. The eLIBRA® Soft-Tissue Force Sensor for a total knee replacement is a single use battery powered device designed to show relative forces on the integrated display. The eLIBRA® Unit is a non-reusable battery powered device designed to receive an electronic signal from the integrated force sensor. The unit displays a number from 0-20 for both the medial and lateral compartments in the knee joint to aid the surgeon in balancing soft tissue structures during a total knee arthroplasty (TKA).
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
Surgeon
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
Bench tests were performed. Bench testing included mechanical testing, force testing, electrical safety, EMC, and sterility testing, including EO residues. Software validation and risk analysis was conducted. The results were satisfactory and revealed no concerns over safety and effectiveness as compared to our predicate device. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.
Key Metrics
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
MAR 2 1 2014
K132104 (page 1/2)
510(K) Summary K132104
Image /page/0/Picture/3 description: The image shows the logo for Synvasive Technology, Inc. The logo consists of a stylized "S" made of three curved lines, followed by the word "SYNVASIVE" in bold, sans-serif font. Below "SYNVASIVE" is the text "TECHNOLOGY, Inc." in a smaller font. Underneath the logo is the phrase "Operative Solutions to Enhance Reconstructive Surgery".
Synvasive Technology, Inc. 8690 Technology Way Reno, NV 89521 Phone: 916-939-3913 Contact: Michael G. Fisher, President Date prepared: September 4, 2013
- Trade Name: eLibra® Soft Tissue Force Sensor 1. Common Name: Intraoperative orthopedic joint assessment aid Classification Name: Stereotaxic instrument., product code ONN, Regulation: 882.4560 Class of device: Class 2. Type of submission: Device Modification, Special 510(k).
- The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : K070108 eLibra 2. Dynamic Knee Balancer.
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- Description of device: The device consists of one unit, containing the force sensor and an electronic display. The eLIBRA® Soft-Tissue Force Sensor for a total knee replacement is a single use battery powered device designed to show relative forces on the integrated display. The eLIBRA® Unit is a non-reusable battery powered device designed to receive an electronic signal from the integrated force sensor. The unit displays a number from 0-20 for both the medial and lateral compartments in the knee joint to aid the surgeon in balancing soft tissue structures during a total knee arthroplasty (TKA).
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- Intended use: For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The unit is sterile, for single patient use. (Unchanged from our predicate devices)
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- Technological characteristics: The technological characteristics are essentially identical to our predicate device with only one difference. The display was formerly reusable and wireless. The display is now integrated into the force sensor. The materials and construction techniques have not changed. The units are still battery operated. The sterilization and packaging techniques have not changed.
1
Image /page/1/Figure/6 description: The image shows a comparison between a predicate device labeled K070108 and a modified device. The predicate device features a rectangular unit with a display screen and buttons, along with separate right and left sensors. The modified device integrates the sensor into the display unit, as indicated by the text, and includes the word "SYNVASIVE" on the device.
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- Performance testing: Bench tests were performed. Bench testing included mechanical testing, force testing, electrical safety, EMC, and sterility testing, including EO residues. Software validation and risk analysis was conducted. The results were satisfactory and revealed no concerns over safety and effectiveness as compared to our predicate device. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.
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- Conclusion: The indications for use has not changed from our predicate, and the technical changes involve only integrating the formerly wireless display into the force sensing unit. Therefore the modified device is as safe and effective as our predicate device and is substantially equivalent to that device.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2014
Synvasive Technology Incorporated % Mr. Danel Kamın. P.E. Principal Engineer 8870 Ravello Court Naples, Florida 34114
Re: K132104
Trade/Device Name: eLibra Soft Tissue Force Sensor Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: ONN Dated: September 4, 2013 Received: February 26. 2014
Dear Mr. Kamm:
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 complics 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
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Page 2 - Mr. Daniel Kamm, P.E.
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
4
Indications for Use
510(k) Number (if known): K132104
Device Name: eLibra Soft Tissue Force 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.
Prescription Usc X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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.
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Division