VERASENSE for Zimmer Biomet Persona
Device Facts
| Record ID | K180459 |
|---|---|
| Device Name | VERASENSE for Zimmer Biomet Persona |
| Applicant | Orthosensor, Inc. |
| Product Code | ONN · Neurology |
| Decision Date | Jun 7, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
The VERASENSE 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 implant to reduce instability from flexion gap asymmetry. The VERASENSE is sterile, for single patient use.
Device Story
VERASENSE is an intelligent disposable tibial insert for intraoperative knee balancing during TKA. It uses capacitive sensors to measure dynamic loads in medial and lateral knee compartments. Data is transmitted wirelessly to a LinkStation MINI or Evaluation Kit running the VERASENSE Software Application (VSA). The VSA displays real-time graphical and numerical load data and center of load (COL) location to the surgeon. Used in hospital operating rooms by surgeons to guide implant adjustment, reducing flexion gap asymmetry and improving joint stability. The device is sterile, single-use, and implant-system specific.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1), electrical safety, EMC, software verification/validation, and performance testing (usability, sterilization, packaging, shelf life).
Technological Characteristics
Disposable tibial insert with capacitive sensors. Materials: PEEK (VITREX 381G) and stainless steel. Power: Two 3V Lithium batteries (parallel). Wireless: 2402–2480 MHz Bluetooth. Sterilization: Ethylene Oxide (10^-6 SAL). Software: VSA running on Windows 10 tablet. Connectivity: Bluetooth/USB. Electrical safety: AAMI ANSI ES60601-1. EMC: IEC 60601-1-2.
Indications for Use
Indicated for patients undergoing primary or revision Total Knee Arthroplasty (TKA) requiring adjustment of the femoral implant to reduce instability from flexion gap asymmetry.
Regulatory Classification
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.
Predicate Devices
- VERASENSE Knee System (K150372)
Submission Summary (Full Text)
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June 7, 2018
OrthoSensor, Inc. Deborah Johnson Senior Manager Regulatory Affairs 1855 Griffin Road, Suite A-310 Dania Beach, Florida 33004
Re: K180459
Trade/Device Name: VERASENSE for Zimmer Biomet Persona Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: ONN Dated: May 16, 2018 Received: May 17, 2018
Dear Deborah 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 Part 801); medical device 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Katherine D. Kavlock -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K180459
Device Name VERASENSE for Zimmer Biomet Persona
### Indications for Use (Describe)
The VERASENSE 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 implant to reduce instability from flexion gap asymmetry. The VERASENSE is sterile, for single patient use.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 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 dark blue, one in light blue, and one in gray. The company name is written in a simple, sans-serif font, with the "ORTHO" portion in gray and the "SENSOR" portion in blue.
K180459
### 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
#### I. SUBMITTER
OrthoSensor, Inc. 1855 Griffin Road, Suite A-310 Dania Beach, FL 33004 Establishment Registration Number: 3008592715
Phone: (954) 577-7770 Fax: (954) 337-9222
Contact Person: Deborah Johnson, Senior Manager Regulatory Affairs
Date Prepared: May 15, 2018
#### II. DEVICE
Name of Device: VERASENSE for Zimmer Biomet Persona Common or Usual Name: Intraoperative Orthopedic Joint Assessment Aid Classification Name: Stereotaxic instrument Regulatory Class: II Regulation Number: 21 CFR 882.4560 Product Code: ONN
#### III. PREDICATE DEVICE
VERASENSE Knee System, K150372
#### IV. DEVICE DESCRIPTION
VERASENSE provides a means to dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA).
The VERASENSE consists of a knee sensor device and the following required accessories: LinkStation MINI or LinkStation Evaluation Kit and VERASENSE Software Application (VSA). The required accessories are intended to support the performance of the VERASENSE parent device. The LinkStation MINI / LinkStation MINI Evaluation Kit is capable of running the VSA and communicating wirelessly with the VERASENSE from outside the sterile field in the operating room. Individual VERASENSE devices are packaged sterile,
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Image /page/4/Picture/1 description: The image shows the logo for Orthosensor. The logo consists of a stylized symbol above the word "ORTHOSENSOR". The symbol is made up of three curved shapes, two in blue and one in gray, arranged in a triangular formation. The word "ORTHOSENSOR" is written in a simple, sans-serif font, with the letters in gray.
for single patient use with a Shim Set for thickness adjustments. The required accessories are not packaged sterile and are reusable.
The VERASENSE device is an intelligent disposable tibial insert that measures dynamic loads in the medial and lateral compartments of the knee and wirelessly transmits the measured load data to the LinkStation MINI or LinkStation MINI Evaluation Kit. The VSA provides the surgeon with a graphical and numerical presentation of the loads in both the medial and lateral compartments of the knee. The VSA also provides location of the center of load (COL) from the femoral to the tibial component in each of the medial and lateral compartments for reference only.
VERASENSE devices are implant system specific due to variations in implant design. VERASENSE is compatible with the following implant systems:
- VERASENSE for Biomet Vanguard ●
- VERASENSE for Stryker Triathlon ●
- VERASENSE for Zimmer NexGen ●
- VERASENSE for Smith & Nephew Legion ●
- VERASENSE for Smith & Nephew Journey II ●
- . VERASENSE for Zimmer Biomet Persona
#### INDICATIONS FOR USE V.
The VERASENSE 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 is sterile, for single patient use.
### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
At a high level, the subject and predicate devices are based on the following same technological elements:
- Capacitive sensors on the device measure the pressure exerted by the ● femoral component of the implant on the sensor.
- Required accessories intended to support the performance of the VERASENSE parent device are the LinkStation MINI or LinkStation MINI Evaluation Kit and VERASENSE Software Application (VSA)
- Patient contacting material of the top and bottom housings
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Image /page/5/Picture/1 description: The image shows the logo for Orthosensor. The logo consists of a stylized symbol above the word "ORTHOSENSOR". The symbol is made up of three curved shapes, two in blue and one in gray, arranged in a triangular formation. The word "ORTHOSENSOR" is written in a simple, sans-serif font, with each letter in gray.
The following technological differences exist between the subject and predicate devices:
- the geometry / dimensions of the Zimmer Biomet Persona implant . system
- Articular surface is on shims, detached from the electronics ●
- Electronics module is reversible ●
- Patient contacting shim material changed to PolyEtherEtherKetone ● (PEEK) and stainless steel
- . Sensor wireless communication frequency changed to 2402 – 2480 MHz Bluetooth
- . New wireless connection mode for the LinkStation MINI / LinkStation MINI Evaluation Kit via tablet component integrated Bluetooth
- New version of the VSA with the addition of the VERASENSE for Zimmer Biomet Persona to the scope of the software application
- . Updated labeling to include compatibility with VERASENSE for Zimmer Biomet Persona variant and instructions for new wireless connection mode
| | Predicate Device K150372 | Subject Device |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 882.4560 | 21 CFR 882.4560 |
| Product Code | ONN | ONN |
| Indications for Use | The VERASENSE is indicated for any<br>medical condition in which primary or<br>revision Total Knee Arthroplasty (TKA)<br>would be indicated.<br>For use as a tool for adjustment of the<br>femoral knee implant to reduce<br>instability from flexion gap asymmetry.<br>The VERASENSE is sterile, for single<br>patient use. | The VERASENSE is indicated for any<br>medical condition in which primary or<br>revision Total Knee Arthroplasty (TKA)<br>would be indicated.<br>For use as a tool for adjustment of the<br>femoral knee implant to reduce<br>instability from flexion gap asymmetry.<br>The VERASENSE is sterile, for single<br>patient use. |
| Environment | Hospital | Hospital |
| VERASENSE (sensor) | | |
| Operating Principle | Capacitive sensors on the device<br>measure the pressure exerted by the<br>femoral component of the implant<br>on the sensor. | Capacitive sensors on the device<br>measure the pressure exerted by the<br>femoral component of the implant<br>on the sensor. |
| Power Requirements | Internally powered<br>Two 1.55V, 27mAh Silver Oxide<br>batteries (in series) | Internally powered<br>Two 3V, 30mAh Lithium batteries<br>(in parallel) |
| | Predicate Device K150372 | Subject Device |
| Form of Wireless technology | Radio Frequency | Radio Frequency |
| RF<br>Frequencies | VERASENSE<br>for Stryker<br>Triathlon<br>402.0 – 405.0 MHz | 2402 – 2480 MHz<br>Bluetooth |
| | VERASENSE<br>for Biomet<br>Vanguard | |
| | VERASENSE<br>for Zimmer<br>NexGen | |
| | VERASENSE<br>for Smith &<br>Nephew<br>Legion<br>404.3 MHz | |
| | VERASENSE<br>for Smith &<br>Nephew<br>Journey II | |
| | VERASENSE<br>for Zimmer<br>Biomet<br>Persona | |
| | | |
| Range | 2 m | 2 m |
| Packaging | Sterile, Double Tyvek /Film pouches,<br>chipboard box | Sterile, Double Tyvek /Film pouches,<br>chipboard box |
| Sterilization Method<br>(sensor only) | Ethylene Oxide 10-6 SAL | Ethylene Oxide 10-6 SAL |
| Materials<br>(patient<br>contacting) | Top<br>housing<br>Colored Polycarbonate Resin | Colorless Polycarbonate Resin |
| | Bottom<br>housing<br>Colorless Polycarbonate Resin | Colorless Polycarbonate Resin |
| | Adhesive<br>between<br>top and<br>bottom<br>housing<br>Loctite | Loctite |
| | Shims<br>Colored Polycarbonate Resin | 10, 11, 12, 13 mm<br>VITREX PolyEtherEtherKetone (PEEK)<br>381G & stainless steel metal plates<br><br>14 and 16 mm<br>VITREX PolyEtherEtherKetone (PEEK)<br>381G |
| Shelf Life | 24 months | 3 months |
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Image /page/6/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, two in blue and one in gray, arranged in a triangular formation. The text "ORTHOSENSOR" is written in a serif font, with the "S" in "SENSOR" being slightly larger and a different shade of blue than the rest of the letters.
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Image /page/7/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 lines, with the top line being blue, the middle line being gray, and the bottom line being blue. The company name is written in a sans-serif font, with the letters being gray.
| Predicate Device K150372 | | Subject Device | | |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Required Accessories (intended to support the performance of the VERASENSE parent device) | | | | |
| | VERASENSE Software Application (VSA) | | | |
| | VSA for Mac<br>OX | VSA for Microsoft<br>Windows | VSA for Microsoft Windows | |
| Operating Principle | The VERASENSE<br>Software<br>Application<br>calculates force<br>vectors and<br>positional data,<br>display both<br>numerically and<br>pictorially load<br>data versus<br>position,<br>according to the<br>description and<br>specifications. | The VERASENSE Software<br>Application calculates force<br>vectors and positional data,<br>display both numerically and<br>pictorially load data versus<br>position, according to the<br>description and<br>specifications. | The VERASENSE Software Application calculates<br>force vectors and positional data, display both<br>numerically and pictorially load data versus<br>position, according to the description and<br>specifications. | |
| Operating System<br>Compatibility | Mac OSX | Microsoft Windows | Microsoft Windows | |
| VSA version number(s) | 3.7 - 3.9.4.2 | 4.0.31.0 - 5.0.0.0 | 5.1.0.17 | |
| | | LinkStation | | |
| | | LinkStation | LinkStation<br>MINI | LinkStation MINI<br>Evaluation Kit |
| Operating Principle | Transceiver is connected to<br>LinkStation via a USB cable. Data<br>from the VERASENSE is wirelessly<br>received by the transceiver at a<br>frequency of 401.05-405.55 MHz.<br>The transceiver processes Gaussian<br>Frequency-Shift Keying (GFSK)<br>modulated data | | The transceiver<br>component of the<br>LinkStation<br>MINI/LinkStation MINI<br>Evaluation Kit can<br>receive and process<br>simultaneously 2<br>channels and the<br>carrier frequency band<br>for the wireless<br>communication is<br>401.05 - 405.55 MHz.<br>The integrated<br>Bluetooth transceiver<br>in the tablet computer<br>component of the<br>LinkStation<br>MINI/LinkStation MINI<br>Evaluation Kit carrier<br>frequency band for the<br>wireless<br>communication is 2402<br>– 2480 MHz Bluetooth<br>4.0 compatible. The<br>transceivers processes<br>Gaussian Frequency-<br>Shift Keying (GFSK)<br>modulated data. | The transceiver<br>component of the<br>LinkStation<br>MINI/LinkStation MINI<br>Evaluation Kit can<br>receive and process<br>simultaneously 2<br>channels and the carrier<br>frequency band for the<br>wireless communication<br>is 401.05 - 405.55 MHz.<br>The integrated Bluetooth<br>transceiver in the tablet<br>computer component of<br>the LinkStation<br>MINI/LinkStation MINI<br>Evaluation Kit carrier<br>frequency band for the<br>wireless communication<br>is 2402 — 2480 MHz<br>Bluetooth 4.0<br>compatible. The<br>transceivers processes<br>Gaussian Frequency-Shift<br>Keying (GFSK) modulated<br>data. |
| | | Predicate Device K150372 | Subject Device | |
| Sensor Compatibility | | VERASENSE for Stryker Triathlon | VERASENSE for Stryker Triathlon | VERASENSE for Stryker Triathlon |
| | | VERASENSE for Biomet Vanguard | VERASENSE for Biomet Vanguard | VERASENSE for Biomet Vanguard |
| | | VERASENSE for Zimmer NexGen | VERASENSE for Zimmer NexGen | VERASENSE for Zimmer NexGen |
| | | VERASENSE for Smith & Nephew Legion | VERASENSE for Smith & Nephew Legion | VERASENSE for Smith & Nephew Legion |
| | | VERASENSE for Smith & Nephew Journey II | VERASENSE for Smith & Nephew Journey II | VERASENSE for Smith & Nephew Journey II |
| Display Unit | | Apple iMac 27" | Tablet PC 12.5" | VERASENSE for Zimmer Biomet Persona<br>Tablet PC 12.5" |
| | Display Unit Connection Modes | WIFI connectivity, Bluetooth connectivity, USB ports, Ethernet, Thunderbolt, and FireWire | WIFI connectivity, Bluetooth connectivity, and a USB port | WIFI connectivity, Bluetooth connectivity, and a USB port |
| | Display Unit Power Requirements | 310W universal 3-pin jack, 100-240V, 50-60Hz | 65W universal 3-pin jack, 100-240V, 1.5A, 50-60Hz | 65W universal 3-pin jack, 100-240V, 1.5A, 50-60Hz |
| | Display Unit Operating System | Mac OSX | Windows 10 | Windows 10 |
| Stand Component | | Ergotron Neo-Flex Stand | Roll Stand | Tablet Kickstand |
| Magnet | | Neodymium magnet with a magnet to steel disc pull of greater than 2.75 lbs | Neodymium magnet with a magnet to steel disc pull of greater than 2.75 lbs | Neodymium magnet with a magnet to steel disc pull of greater than 2.75 lbs |
| Mount | | Mounted on roll stand | Mounted on roll stand | Mounted on tripod |
| Transceiver Component | Power requirements | USB powered and intended to be connected to the USB port of the LinkStation MINI display unit (5 V dc) | USB powered and intended to be connected to the USB port of the LinkStation MINI display unit (5 V dc) | USB powered and intended to be connected to the USB port of the LinkStation MINI display unit (5 V dc) |
| | Form of Wireless technology | Radio Frequency | Radio Frequency | Radio Frequency |
| | RF Frequencies | 401.05 - 405.55MHz | 401.05 – 405.55MHz | 401.05 – 405.55MHz |
| | Range | 2 m | 2 m | 2 m…
