(30 days)
No
The description focuses on direct measurement and transmission of load data, with the software providing a graphical and numerical presentation of this data. There is no mention of algorithms that learn from data or make predictions, which are characteristic of AI/ML.
No
The device is described as a "tool for adjustment of the femoral knee implant" and measures dynamic loads. It does not exert therapeutic action on the patient but provides data to aid the surgeon during a procedure.
No
The device is described as a "tool for adjustment" during knee arthroplasty, providing intraoperative measurements of loads to guide the surgeon. While it provides "data" for "reference only," it does not make a diagnosis of a disease or condition. Its purpose is to facilitate the surgical procedure.
No
The device description clearly states that VERASENSE is a "disposable tibial insert trial" that measures dynamic loads and wirelessly transmits data. This indicates a physical hardware component (the insert trial) is integral to the device's function, not just software.
Based on the provided information, the VERASENSE device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a tool for adjusting a femoral knee implant during Total Knee Arthroplasty (TKA). This is an in vivo procedure (performed within the living body).
- Device Description: The description details a disposable tibial insert trial that measures dynamic loads in the knee and transmits data wirelessly. This is also an in vivo measurement.
- Anatomical Site: The anatomical site is the knee, which is part of the living body.
- Lack of IVD Characteristics: There is no mention of analyzing samples outside the body (in vitro), such as blood, urine, tissue, etc., which is the defining characteristic of an IVD.
The device is a surgical tool used during a surgical procedure to aid the surgeon in achieving proper balance and stability of the knee implant.
N/A
Intended Use / Indications for Use
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 asymmerry.
VERASENSE is sterile, for single patient use.
Product codes (comma separated list FDA assigned to the subject device)
ONN
Device Description
The VERASENSE device is an intelligent disposable tibial insert trial that measures dynamic loads in the medical and lateral compartments of the knee and wirelessly transmits the measured load data to the LinkStation MINI and LinkStation MINI Evaluation Kit with VERASENSE Software Application (VSA). The VSA provides the surgeon with a graphical and numerical presentation of the load magnitude and center of load (COL) location (weighted average) of the femoral to the tibial component in each of the medial and lateral compartments of the knee for reference only. Individual VERASENSE devices are packaged sterile, for single patient use with a shim set for thickness adjustments.
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
Hospital
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 risk analysis method used to assess the impact of the modifications to the device was Failure Modes and Effects Analysis (FMEA) described in the FDArecognized version of ISO 14971. The verification and validation (V&V) activities for the device modifications were executed for compliance with 21 CFR 820.30 design controls and were found acceptable in the predicate submission K180459 and reference submission K150372. The results of V&V support substantial equivalence to the predicate device.
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.
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
April 12, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
OrthoSensor, Inc. Deborah Escobar Johnson Director of Regulatory Affairs 1855 Griffin Road Suite A-310 Dania Beach, Florida 33004
Re: K200665
Trade/Device Name: VERASENSE for Stryker Triathlon Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: ONN Dated: March 11, 2020 Received: March 13, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
gencies. You must comply with all the Act's
Page 2
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K200665
Device Name VERASENSE for Stryker Triathlon
Indications for Use (Describe)
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 asymmerry.
VERASENSE 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/1 description: The image shows the logo for Orthosensor. The logo consists of three curved lines in the shape of a triangle, with the top line being blue, the middle line being gray, and the bottom line being dark blue. Below the triangle is the word "ORTHOSENSOR" in a serif font, with "ORTHO" in gray and "SENSOR" in dark blue.
Special 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, Director of Regulatory Affairs Date Prepared: March 11, 2020
II. DEVICE
Name of Device: VERASENSE for Stryker Triathlon 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
Primary: VERASENSE for Zimmer Biomet Persona, K180459 Reference: VERASENSE Knee System, K150372
IV. DEVICE DESCRIPTION
The VERASENSE device is an intelligent disposable tibial insert trial that measures dynamic loads in the medical and lateral compartments of the knee and wirelessly transmits the measured load data to the LinkStation MINI and LinkStation MINI Evaluation Kit with VERASENSE Software Application (VSA). The VSA provides the surgeon with a graphical and numerical presentation of the load magnitude and center of load (COL) location (weighted average) of the femoral to the tibial component in each of the medial and lateral compartments of the knee for reference only. Individual VERASENSE devices are packaged sterile, for single patient use with a shim set for thickness adjustments.
4
Image /page/4/Picture/1 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 lines that converge at a central point, resembling a stylized triangle or a three-pointed star. The top two lines are in shades of blue, while the bottom line is gray. The company name, "ORTHOSENSOR," is written in a serif font below the symbol, with the "S" in "SENSOR" being slightly larger and a different color than the rest of the letters.
VERASENSE devices are implant system specific due to variations in implant design and are compatible with the following knee implant systems:
- Biomet Vanguard
- Stryker Triathlon
- Zimmer NexGen ●
- Smith & Nephew Journey II
- Smith & Nephew Legion
- 0 Zimmer Biomet Persona
V. 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 femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE is sterile, for single patient use.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
At a high level, the subject and predicate devices are based on the following same technological elements:
- Capacitive sensors in the device measure the pressure exerted by the implant component on the sensor.
- Required hardware and software application accessories intended to ● support the performance of the parent device are the LinkStation MINI or LinkStation MINI Evaluation Kit and VERASENSE Software Application (VSA)
- . Patient contacting materials for the bottom housing
The following six technological differences exist between the subject and predicate devices:
- Labeling
- Dimensions (same as reference device) ●
- o Battery (same as reference device)
- Patient contacting materials (same as reference device)
- Firmware version ●
- Software application accessory version o
5
Image /page/5/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, two in blue and one in gray, arranged in a triangular formation. The company name, "ORTHOSENSOR," is written in a combination of gray and blue letters.
The subject and reference devices are based on the following same technological elements:
- . Capacitive sensors in the device measure the pressure exerted by the implant component on the sensor.
- . Required hardware and software application accessories intended to support the performance of the parent device are the LinkStation MINI or LinkStation MINI Evaluation Kit and VERASENSE Software Application (VSA)
- . Patient contacting materials for top and bottom housing components and adhesives
- Patient contacting materials for shim assemblies .
The following technological differences exist between the subject and reference devices:
- Labeling
- Firmware version ●
- Software application accessory version ●
| | Predicate Device
K180459 | Subject Device | Substantially
Equivalent or
Difference |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| | Sensor and required accessories | | |
| Classification | 21 CFR 882.4560 | 21 CFR 882.4560 | N/A |
| Product Code | ONN | ONN | N/A |
| Intended Use | VERASENSE provides a
means for orthopedic
surgeons to dynamically
balance the knee during
primary or revision Total
Knee Arthroplasty (TKA). | VERASENSE provides a
means for orthopedic
surgeons to dynamically
balance the knee during
primary or revision Total
Knee Arthroplasty (TKA). | Substantially Equivalent |
| 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 femoral
knee implant to reduce
instability from flexion gap
asymmetry. The
VERASENSE is sterile, for
single patient 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 femoral
knee implant to reduce
instability from flexion gap
asymmetry. The
VERASENSE is sterile, for
single patient use. | Substantially Equivalent |
6
Image /page/6/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 text "ORTHOSENSOR" is written in a serif font, with "ORTHO" in gray and "SENSOR" in blue.
| | Predicate Device
K180459 | Subject Device | Substantially
Equivalent or
Difference |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Environment | Hospital | Hospital | Substantially Equivalent |
| Electrical Safety* | IEC 60601-1 | IEC 60601-1 | Substantially Equivalent |
| Electromagnetic
Compatibility
(EMC)* | IEC 60601-1-2 | IEC 60601-1-2 | Substantially Equivalent |
| Usability* | IEC 62366 | IEC 62366 | Substantially Equivalent |
| Labeling | VERASENSE for Zimmer
Biomet Persona product
label, VERASENSE knee
sensor IFU, and
VERASENSE knee sensor
and accessories user
guide. | VERASENSE for Stryker
Triathlon product label,
VERASENSE knee sensor
IFU, and VERASENSE
knee sensor and
accessories user guide. | Technological
Difference #1 |
*when sensor and accessories tested together
7
Image /page/7/Picture/0 description: The image shows the logo for Orthosensor. The logo consists of a stylized triangle shape above the word "ORTHOSENSOR". The triangle shape is made up of three curved lines, one light blue, one dark blue, and one gray.
| | | | Predicate Device
K180459 | Subject Device | Substantially
Equivalent or
Difference |
|------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| | SENSOR (parent device) | | | | |
| Mechanical | | Dimensions | VERASENSE for Zimmer Biomet
Persona sensor is equal to the
dimensions of the implant trial
or final liner ± 0.50 mm under
all operating conditions | VERASENSE for Stryker
Triathlon sensor is equal to the
dimensions of the implant trial
or final liner ± 0.50 mm under
all operating conditions | Technological
Difference #2
Subject device housing
dimensions are the same as the
reference device. |
| Functional
Applied Force of Load
Sensing | Operating
Principle | | Capacitive sensors on the
device measure the pressure
exerted by the femoral
component of the implant on
the sensor (two compartments,
three pressure sensors in each
compartment) | Capacitive sensors on the
device measure the pressure
exerted by the femoral
component of the implant on
the sensor (two compartments,
three pressure sensors in each
compartment) | Substantially Equivalent |
| | | Load
Range and
Accuracy | $5-40 \text{ lbf } \le 3.5 \text{ lbf}$ | $5-40 \text{ lbf } \le 3.5 \text{ lbf}$ | Substantially Equivalent |
| | | | 41-70 lbf for reference only | 41-70 lbf for reference only | Substantially Equivalent |
| | | Maximum
Safe Load | 70 lbf | 70 lbf | Substantially Equivalent |
| | | Center of Load
(COL) Location | | For Reference Only | For Reference Only |
| | | Communication | | Transmission of data from
sensor to the LinkStation MINI
or LinkStation MINI Evaluation
Kit. | Transmission of data from sensor
to the LinkStation MINI or
LinkStation MINI Evaluation Kit. |
| | Battery | | 40 min | 40 min | Substantially Equivalent |
| | | | Predicate Device
K180459 | Subject Device | Substantially
Equivalent or
Difference |
| | Battery | Type | Lithium Ion
coin cell | Silver Oxide
coin cell | Technological
Difference #3
Subject device battery is the
same battery as the reference
device |
| | | Operating
Voltage
and
current | 3.1 V DC
30 mAh | 1.55V
27 mAh | |
| | | Connection
Type | Two batteries in parallel | Two batteries in series | |
| | Electrical
IEC 60601-1 Medical Electrical Equipment Classification | Protection
Against Electric
Shock | Internally powered | Internally powered | Substantially Equivalent |
| | | Installation
and Use | Hand held | Hand held | Substantially Equivalent |
| | | Applied Part | Type BF | Type BF | Substantially Equivalent |
| | | Protection
against
harmful
ingress of
water or
particulate
matter | IPX4 | IPX4 | Substantially Equivalent |
| | | Mode of
Operation | Continuous | Continuous | Substantially Equivalent |
| | | Suitability in
an oxygen
rich
environment | No | No | Substantially Equivalent |
| | | | Technology | Radio Frequency | Radio Frequency |
| | | | Frequency
Band | 2402 – 2480 MHz | 2402 – 2480 MHz |
| | Wireless Communication | | Communicati
on Protocol | Bluetooth Low
Energy (BLE) 4.2 | Bluetooth Low
Energy (BLE) 4.2 |
| | | | Range | 2 m | 2 m |
| | | Electromagnetic
Interference (EMI) | | Sensor will tolerate typical
levels of electromagnetic
interface experience in the
operating room environment. | Sensor will tolerate typical
levels of electromagnetic
interface experience in the
operating room environment. |
| | | Electrostatic
Discharge (ESD) | | 8kV contact discharge
15 kV air discharge | 8kV contact discharge
15 kV air discharge |
| | | | Predicate Device
K180459 | Subject Device | Substantially
Equivalent or
Difference |
| Environmental | Operating
Conditions | Storage
temperature | 15 - 37 °C | 15 - 37 °C | Substantially Equivalent |
| | | Relative
humidity | 30 - 100%
submersion | 30 - 100%
submersion | Substantially Equivalent |
| | Storage
Conditions | Storage
temperature | 0 - 50 °C | 0 - 50 °C | Substantially Equivalent |
| | | Relative
humidity | 10 - 80%
non-condensing | 10 - 80%
non-condensing | Substantially Equivalent |
| | Atmospheric
pressure | | 36 - 106 kPa | 36 - 106 kPa | Substantially Equivalent |
| | Type of Contact | | with tissue/bone | with tissue/bone | Substantially Equivalent |
| | Duration of
Contact | | limited duration contact
(