(30 days)
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.
VERASENSE is sterile, for single patient use.
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.
This document describes a 510(k) premarket notification for the VERASENSE for Stryker Triathlon device. It is a re-submission for a device that has previously been cleared for other implant systems (VERASENSE for Zimmer Biomet Persona, K180459). Therefore, the provided text focuses on demonstrating substantial equivalence to existing predicate devices, rather than a full de novo acceptance criteria and performance study for a novel device.
As a result, many of the typical elements of an acceptance criteria and performance study (like specific performance metrics from a clinical study, sample size for testing, expert validation process, MRMC studies) are not present in this document, as the primary goal is to show that the modified device functions similarly and safely to already-cleared devices.
However, I can extract the information that is present and highlight what is not available based on the request.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The acceptance criteria for this 510(k) submission are not expressed as specific performance thresholds for a new clinical trial, but rather as demonstrating substantial equivalence to predicate devices. The "performance" is demonstrated by showing that the subject device meets the same specifications and standards as the predicate devices, despite minor technological differences.
Table of Acceptance Criteria (vs. Predicate Device) and Reported Device Performance:
| Feature/Criteria | Predicate Device (K180459) | Subject Device (VERASENSE for Stryker Triathlon) | Reported Performance / Substantial Equivalence |
|---|---|---|---|
| Classification | 21 CFR 882.4560 (Class II, Stereotaxic Instrument) | 21 CFR 882.4560 (Class II, Stereotaxic Instrument) | Substantially Equivalent |
| Product Code | ONN | ONN | Substantially Equivalent |
| Intended Use | Dynamic knee balancing during TKA | Dynamic knee balancing during TKA | Substantially Equivalent (VERASENSE provides a means for orthopedic surgeons to dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA)). |
| Indications for Use | Same as Subject Device. | Indicated for any medical condition in which primary or revision TKA would be indicated, as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. Sterile, single patient use. | Substantially Equivalent |
| 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 |
| Load Range and Accuracy | 5-40 lbf <= 3.5 lbf; 41-70 lbf for reference only | 5-40 lbf <= 3.5 lbf; 41-70 lbf for reference only | Substantially Equivalent |
| Maximum Safe Load | 70 lbf | 70 lbf | Substantially Equivalent |
| Battery Life | 40 min | 40 min | Substantially Equivalent |
| Wireless Communication Protocol | Bluetooth Low Energy (BLE) 4.2 | Bluetooth Low Energy (BLE) 4.2 | Substantially Equivalent |
| Operating Conditions (Sensor/HW) | Temperature 15-37°C, RH 30-100% submersion | Temperature 15-37°C, RH 30-100% submersion | Substantially Equivalent |
| Storage Conditions (Sensor/HW) | Temperature 0-50°C, RH 10-80% non-condensing | Temperature 0-50°C, RH 10-80% non-condensing | Substantially Equivalent |
| Sterilization Method | Ethylene Oxide 10-6 SAL | Ethylene Oxide 10-6 SAL | Substantially Equivalent |
| Shelf Life (Sensor) | 24 months | 24 months | Substantially Equivalent |
| Packaging | Sterile, Double Tyvek/Film pouches, chipboard box | Sterile, Double Tyvek/Film pouches, chipboard box | Substantially Equivalent |
| Software Operating Principle | VSA calculates force vectors and positional data, displays numerically and pictorially load data vs. position. | VSA calculates force vectors and positional data, displays numerically and pictorially load data vs. position. | Substantially Equivalent |
| Software Programming Language | C# | C# | Substantially Equivalent |
| Software Operating System Compatibility | Microsoft Windows | Microsoft Windows | Substantially Equivalent |
| Software Level of Concern | Minor | Minor | Substantially Equivalent |
| Hardware Accessory Operating Principle | Receives and processes GFSK modulated data. Transportable. | Receives and processes GFSK modulated data. Transportable. | Substantially Equivalent |
Identified Technological Differences (and justification for substantial equivalence):
| Feature | Predicate Device (K180459) | Subject Device | Substantially Equivalent or Difference | Justification for Substantial Equivalence |
|---|---|---|---|---|
| Labeling | Specific to Zimmer Biomet Persona | Specific to Stryker Triathlon | Technological Difference #1 | Addressed through V&V activities. |
| Dimensions | Specific to Zimmer Biomet Persona | Same as Reference Device (K150372) | Technological Difference #2 | Subject device housing dimensions are the same as the reference device (K150372). V&V supports this. |
| Battery Type | Lithium Ion coin cell | Silver Oxide coin cell | Technological Difference #3 | Subject device battery is the same as the reference device (K150372). V&V supports this. |
| Patient Contacting Materials (Top Housing/Shims) | Colorless Polycarbonate Resin (top); VITREX PEEK/stainless-steel (shims) | Colored Polycarbonate Resin (top); Colored Polycarbonate Resin (shims) | Technological Difference #4 | Subject device materials are the same as predicate and reference devices. Different colors are for sizing. V&V indicates these are safe. |
| Firmware Version | 2.2.2 | 3.1.24 | Technological Difference #5 | Addressed and deemed acceptable through V&V activities. |
| Software Version | ≥5.1.0.17 | ≥5.3.0.64 | Technological Difference #6 | Addressed and deemed acceptable through V&V activities. |
Study Details (Based on Substantial Equivalence Demonstration Documentation)
Given this is a 510(k) submission for substantial equivalence based on prior clearances and design modifications, the "study" is primarily a verification and validation (V&V) assessment of the changes, rather than a prospective clinical trial proving de novo performance.
-
Sample size used for the test set and the data provenance:
- The document does not specify a sample size in terms of clinical cases or patients for a test set. The "test set" here refers to engineering and bench testing to verify the changes and demonstrate that the device still meets its specifications, rather than a clinical dataset.
- Data Provenance: Not explicitly stated as "country of origin" for data, but the V&V activities align with FDA regulations for device modification. The studies mentioned are verification and validation activities for compliance with 21 CFR 820.30 design controls. These would typically be internal testing data (bench, pre-clinical if necessary) to support the safety and effectiveness of the modified device. These are retrospective in the sense that they are conducted on the modified device to confirm its performance against established specifications, not prospective in gathering new clinical outcome data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. Ground truth, in the context of device performance for substantial equivalence, relies on the device meeting its established technical specifications (e.g., load accuracy, battery life, communication range) rather than expert interpretation of clinical outcomes for a new clinical efficacy claim.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable/provided. Adjudication methods are typically for clinical studies involving human interpretation (e.g., image reading), which is not the primary focus of this type of 510(k) submission for substantial equivalence based on technical specifications. The V&V activities would involve engineering and quality assurance reviews against defined acceptance criteria.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is an intraoperative mechanical assessment tool, not an AI-assisted diagnostic imaging device requiring human reader improvement studies. Its function is to provide force and load data to a surgeon, not to interpret images or assist in diagnosis.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself provides objective measurements (load data). The algorithm in the software (VSA) processes this data to display force vectors and positional data. The document states that the Load Range and Accuracy is 5-40 lbf $\leq$ 3.5 lbf, demonstrating a standalone performance metric for the sensor and its associated processing. However, a dedicated "standalone performance study" as would be defined for an AI diagnostic algorithm is not described, as the device's role is to provide real-time data during surgery for human decision-making, not to replace it.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for demonstrating substantial equivalence and device performance in this context is primarily derived from engineering specifications, bench testing, and conformity to recognized standards (e.g., IEC standards). For mechanical and functional aspects, this would involve validated measurement equipment and calibration standards. For software, it would involve software verification and validation against requirements and design specifications. There is no mention of clinical outcomes data, expert consensus, or pathology as a ground truth, as the submission is for substantial equivalence of modifications, not a de novo clinical claim.
-
The sample size for the training set:
- This information is not applicable and not provided. This device is not an AI/ML algorithm that is "trained" on data in the traditional sense. It is a sensor-based device with a fixed algorithm for processing sensor data.
-
How the ground truth for the training set was established:
- This information is not applicable and not provided for the same reason as point 7.
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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
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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
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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."
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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.
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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 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
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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 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 DeviceK180459 | Subject Device | SubstantiallyEquivalent orDifference | |
|---|---|---|---|
| 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 ameans for orthopedicsurgeons to dynamicallybalance the knee duringprimary or revision TotalKnee Arthroplasty (TKA). | VERASENSE provides ameans for orthopedicsurgeons to dynamicallybalance the knee duringprimary or revision TotalKnee Arthroplasty (TKA). | Substantially Equivalent |
| Indications forUse | The VERASENSE isindicated for any medicalcondition in which primaryor revision Total KneeArthroplasty (TKA) wouldbe indicated.For use as a tool foradjustment of the femoralknee implant to reduceinstability from flexion gapasymmetry. TheVERASENSE is sterile, forsingle patient use. | The VERASENSE isindicated for any medicalcondition in which primaryor revision Total KneeArthroplasty (TKA) wouldbe indicated.For use as a tool foradjustment of the femoralknee implant to reduceinstability from flexion gapasymmetry. TheVERASENSE is sterile, forsingle patient use. | Substantially Equivalent |
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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 DeviceK180459 | Subject Device | SubstantiallyEquivalent orDifference | |
|---|---|---|---|
| Environment | Hospital | Hospital | Substantially Equivalent |
| Electrical Safety* | IEC 60601-1 | IEC 60601-1 | Substantially Equivalent |
| ElectromagneticCompatibility(EMC)* | IEC 60601-1-2 | IEC 60601-1-2 | Substantially Equivalent |
| Usability* | IEC 62366 | IEC 62366 | Substantially Equivalent |
| Labeling | VERASENSE for ZimmerBiomet Persona productlabel, VERASENSE kneesensor IFU, andVERASENSE knee sensorand accessories userguide. | VERASENSE for StrykerTriathlon product label,VERASENSE knee sensorIFU, and VERASENSEknee sensor andaccessories user guide. | TechnologicalDifference #1 |
*when sensor and accessories tested together
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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 DeviceK180459 | Subject Device | SubstantiallyEquivalent orDifference | |||
|---|---|---|---|---|---|
| SENSOR (parent device) | |||||
| Mechanical | Dimensions | VERASENSE for Zimmer BiometPersona sensor is equal to thedimensions of the implant trialor final liner ± 0.50 mm underall operating conditions | VERASENSE for StrykerTriathlon sensor is equal to thedimensions of the implant trialor final liner ± 0.50 mm underall operating conditions | TechnologicalDifference #2Subject device housingdimensions are the same as thereference device. | |
| FunctionalApplied Force of LoadSensing | OperatingPrinciple | Capacitive sensors on thedevice measure the pressureexerted by the femoralcomponent of the implant onthe sensor (two compartments,three pressure sensors in eachcompartment) | Capacitive sensors on thedevice measure the pressureexerted by the femoralcomponent of the implant onthe sensor (two compartments,three pressure sensors in eachcompartment) | Substantially Equivalent | |
| LoadRange andAccuracy | $5-40 \text{ lbf } \le 3.5 \text{ lbf}$ | $5-40 \text{ lbf } \le 3.5 \text{ lbf}$ | Substantially Equivalent | ||
| 41-70 lbf for reference only | 41-70 lbf for reference only | Substantially Equivalent | |||
| MaximumSafe Load | 70 lbf | 70 lbf | Substantially Equivalent | ||
| Center of Load(COL) Location | For Reference Only | For Reference Only | |||
| Communication | Transmission of data fromsensor to the LinkStation MINIor LinkStation MINI EvaluationKit. | Transmission of data from sensorto the LinkStation MINI orLinkStation MINI Evaluation Kit. | |||
| Battery | 40 min | 40 min | Substantially Equivalent | ||
| Predicate DeviceK180459 | Subject Device | SubstantiallyEquivalent orDifference | |||
| Battery | Type | Lithium Ioncoin cell | Silver Oxidecoin cell | TechnologicalDifference #3Subject device battery is thesame battery as the referencedevice | |
| OperatingVoltageandcurrent | 3.1 V DC30 mAh | 1.55V27 mAh | |||
| ConnectionType | Two batteries in parallel | Two batteries in series | |||
| ElectricalIEC 60601-1 Medical Electrical Equipment Classification | ProtectionAgainst ElectricShock | Internally powered | Internally powered | Substantially Equivalent | |
| Installationand Use | Hand held | Hand held | Substantially Equivalent | ||
| Applied Part | Type BF | Type BF | Substantially Equivalent | ||
| Protectionagainstharmfulingress ofwater orparticulatematter | IPX4 | IPX4 | Substantially Equivalent | ||
| Mode ofOperation | Continuous | Continuous | Substantially Equivalent | ||
| Suitability inan oxygenrichenvironment | No | No | Substantially Equivalent | ||
| Technology | Radio Frequency | Radio Frequency | |||
| FrequencyBand | 2402 – 2480 MHz | 2402 – 2480 MHz | |||
| Wireless Communication | Communication Protocol | Bluetooth LowEnergy (BLE) 4.2 | Bluetooth LowEnergy (BLE) 4.2 | ||
| Range | 2 m | 2 m | |||
| ElectromagneticInterference (EMI) | Sensor will tolerate typicallevels of electromagneticinterface experience in theoperating room environment. | Sensor will tolerate typicallevels of electromagneticinterface experience in theoperating room environment. | |||
| ElectrostaticDischarge (ESD) | 8kV contact discharge15 kV air discharge | 8kV contact discharge15 kV air discharge | |||
| Predicate DeviceK180459 | Subject Device | SubstantiallyEquivalent orDifference | |||
| Environmental | OperatingConditions | Storagetemperature | 15 - 37 °C | 15 - 37 °C | Substantially Equivalent |
| Relativehumidity | 30 - 100%submersion | 30 - 100%submersion | Substantially Equivalent | ||
| StorageConditions | Storagetemperature | 0 - 50 °C | 0 - 50 °C | Substantially Equivalent | |
| Relativehumidity | 10 - 80%non-condensing | 10 - 80%non-condensing | Substantially Equivalent | ||
| Atmosphericpressure | 36 - 106 kPa | 36 - 106 kPa | Substantially Equivalent | ||
| Type of Contact | with tissue/bone | with tissue/bone | Substantially Equivalent | ||
| Duration ofContact | limited duration contact(<24 hours) | limited duration contact(<24 hours) | Substantially Equivalent | ||
| Materials (patient contacting) | Housing | Top | Colorless PolycarbonateResin | Colored PolycarbonateResin (Size 2 black, Size 3brown, Size 4 green, Size5 blue, Size 6 yellow, Size7 burnt orange) | TechnologicalDifference #4Subject device materials arethe same as the predicate andreference devices |
| Bottom | Colorless PolycarbonateResin | Colorless PolycarbonateResin | |||
| Adhesive | Betweentop andbottomhousing | Loctite 3936 | Loctite 3936 | ||
| For venthole | Loctite 3936 | Loctite 3936 | |||
| Shims | 10, 11, 12, 13 mmVITREXPolyEtherEtherKetone(PEEK) 381G & stainless-steel metal plates14 and 16 mmVITREXPolyEtherEtherKetone(PEEK) 381G | Sizes 9, 10, 11, 12, 13, 16mmColored PolycarbonateResin (Size 2 black, Size 3brown, Size 4 green, Size5 blue, Size 6 yellow, Size7 burnt orange) | |||
| SterilizationMethod | Ethylene Oxide 10-6 SAL | Ethylene Oxide 10-6 SAL | Substantially Equivalent | ||
| Shelf Life | 24 months | 24 months | Substantially Equivalent | ||
| Packaging | Sterile, Double Tyvek/Film pouches,chipboard box | Sterile, Double Tyvek/Film pouches,chipboard box | Substantially Equivalent | ||
| Firmwareversion | VERASENSE knee sensorfirmware version 2.2.2which includescommunication modesand calibration coefficient. | VERASENSE knee sensorfirmware version 3.1.24which includescommunication modesand calibration coefficient. | TechnologicalDifference #5 |
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Image /page/8/Picture/1 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 in light blue, one in dark blue, and one in gray.
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Image /page/9/Picture/1 description: The image shows the logo for Orthosensor. The logo consists of three curved shapes in the top portion of the image. The top two shapes are blue, and the bottom shape is gray. The text "ORTHOSENSOR" is in a serif font below the shapes.
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Image /page/10/Picture/0 description: The image shows the logo for Orthosensor. The logo consists of the word "ORTHOSENSOR" in a sans-serif font, with the "ORTHO" portion in a lighter gray color and the "SENSOR" portion in a darker blue color. Above the text is a stylized graphic of three curved shapes arranged in a triangular formation, with two of the shapes in blue and one in gray.
| Predicate DeviceK180459 | Subject Device | Substantially Equivalent or Difference | |
|---|---|---|---|
| Required Accessories (Intended to support the performance of the VERASENSE sensor parent device) | |||
| SOFTWARE ACCESSORY | |||
| OperatingPrinciple | The VERASENSESoftware Application(VSA) calculates forcevectors and positionaldata, display bothnumerically andpictorially load dataversus position. | The VERASENSESoftware Application(VSA) calculates forcevectors and positionaldata, display bothnumerically andpictorially load dataversus position. | Substantially Equivalent |
| ProgrammingLanguage | C# | C# | Substantially Equivalent |
| OperatingSystemCompatibility | Microsoft Windows | Microsoft Windows | Substantially Equivalent |
| Level of Concern | Minor | Minor | Substantially Equivalent |
| Version | ≥5.1.0.17 | ≥5.3.0.64 | TechnologicalDifference #6 |
| HARDWARE ACCESSORY | |||
| OperatingPrinciple | The LinkStation MINI andLinkStation MINI Evaluation Kitreceives and processes processGaussian Frequency-ShiftKeying (GFSK) modulated datafrom the sensors. TheLinkStation MINI can betransported from storagelocation to and from placementpositioning of the systemwithin the operating roomwithout causing delay tosurgical flow.The LinkStation MINIEvaluation Kit can betransported from case to caseand be robust for assembly andbreak down in surgicalenvironments with repeateduse. | The LinkStation MINI andLinkStation MINI Evaluation Kitreceives and processes processGaussian Frequency-ShiftKeying (GFSK) modulated datafrom the sensors. TheLinkStation MINI can betransported from storagelocation to and from placementpositioning of the systemwithin the operating roomwithout causing delay tosurgical flow.The LinkStation MINIEvaluation Kit can betransported from case to caseand be robust for assembly andbreak down in surgicalenvironments with repeateduse. | Substantially Equivalent |
| StandComponent | Roll Standwith utilitybasket andlockablecasters | Roll Standwith utilitybasket andlockablecastersTabletKickstand | TabletKickstandSubstantially Equivalent |
| MagnetComponent | Neodymium magnet with amagnet to steel disc pull ofgreater than 2.75 lbs | Neodymium magnet with amagnet to steel disc pull ofgreater than 2.75 lbs | Substantially Equivalent |
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Image /page/11/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 serif font below the symbol.
| Display UnitMount | Connects tostand withtilt androtation | Kickstandthat holdstablet ontabletop | Connects tostand withtilt androtation | Kickstandthat holdstablet ontabletop | Substantially Equivalent | |||
|---|---|---|---|---|---|---|---|---|
| Predicate DeviceK180459 | Subject Device | SubstantiallyEquivalent orDifference | ||||||
| USB Cable | USB 2.0down angleA male to upangle MINI-Bmale 10"(25.4cm) | USB 2.0down angleA male to upangle MINI-Bmale 48"(122cm) | USB 2.0down angleA male to upangle MINI-Bmale 10"(25.4cm) | USB 2.0down angleA male to upangle MINI-Bmale 48"(122cm) | Substantially Equivalent | |||
| Environmental | OperatingConditions | Storagetemperature | -10 - 60 °C | -10 - 60 °C | Substantially Equivalent | |||
| Relativehumidity | 5 - 95%non-condensing | 5 - 95%non-condensing | Substantially Equivalent | |||||
| StorageConditions | Storagetemperature | 0 - 50 °C | 0 - 50 °C | Substantially Equivalent | ||||
| Relativehumidity | 5 - 95%non-condensing | 5 - 95%non-condensing | Substantially Equivalent | |||||
| Type | Tablet PC 12.5 in (31.8cm) diagonaltouchscreen 256 colordisplay | Tablet PC 12.5 in (31.8cm) diagonaltouchscreen 256 colordisplay | Substantially Equivalent | |||||
| Weight | 5.5 lbs (2.5 kg) | 5.5 lbs (2.5 kg) | Substantially Equivalent | |||||
| Camera | 2.0-megapixel resolution | 2.0-megapixel resolution | Substantially Equivalent | |||||
| Battery | Lithium Ion | Lithium Ion | Substantially Equivalent | |||||
| Power Supply | 19V with AC Adapter | 19V with AC Adapter | Substantially Equivalent | |||||
| USB Port | 3.0 | 3.0 | Substantially Equivalent | |||||
| play Unit | ElectricalEquipmentClassification | ProtectionAgainstElectricShock | Class I | Class I | Substantially Equivalent | |||
| Installationand Use | Transportable | Transportable | Substantially Equivalent | |||||
| AppliedPart | No Applied Parts(does contact patient) | No Applied Parts(does contact patient) | Substantially Equivalent | |||||
| IEC 60601-1MedicalElectrical | Protectionagainstharmfulingress ofwater orparticulatematter | IP54 | IP54 | |||||
| Mode ofOperation | Continuous | Continuous | ||||||
| Suitabilityin an oxygenrichenvironment | No | No | ||||||
| Technology | Radio Frequency | Radio Frequency | Substantially Equivalent |
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Image /page/12/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 shapes, two in blue and one in gray, arranged in a triangular formation. The company name, "ORTHOSENSOR," is written in a serif font, with the letters in a dark blue-gray color.
| IntegratedCommunications | Wireless-AC 8260 Wi-FiplusBluetooth 4.2 | Wireless-AC 8260 Wi-FiplusBluetooth 4.2 | Substantially Equivalent | |||
|---|---|---|---|---|---|---|
| -- | -- | -- | ------------------------------ | ------------------------------------------------- | ------------------------------------------------- | -------------------------- |
| Predicate DeviceK180459 | Subject Device | SubstantiallyEquivalent orDifference | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| TransceiverMount | Mountedon roll stand | Mountedon tripod | Mounted onroll stand | Mounted ontripod | Substantially Equivalent | |||||
| Transceiver ComponentElectricalIEC 60601-1 Medical Electrical Equipment | Power | USB powered andintended to be connectedto the USB port of theLinkStation MINI displayunit (5 V dc) | USB powered andintended to be connectedto the USB port of theLinkStation MINI displayunit (5 V dc) | Substantially Equivalent | ||||||
| ProtectionAgainstElectric Shock | Class II | Class II | Substantially Equivalent | |||||||
| Installationand Use | Portable | Portable | Substantially Equivalent | |||||||
| Applied Part | No Applied Parts(does not contact patient) | No Applied Parts(does not contact patient) | Substantially Equivalent | |||||||
| Protectionagainst harmfulingress of wateror particulatematter | Not ingress protected | Not ingress protected | Substantially Equivalent | |||||||
| Mode ofOperation | Continuous | Continuous | Substantially Equivalent | |||||||
| Suitability inan oxygen richenvironment | No | No | Substantially Equivalent | |||||||
| Wireless | Technology | Radio Frequency | Radio Frequency | Substantially Equivalent | ||||||
| Frequency Band | 401.05 - 405.55MHz | 401.05 - 405.55MHz | Substantially Equivalent | |||||||
| CommunicationProtocol | Proprietary | Proprietary | Substantially Equivalent | |||||||
| SterilizationMethod | N/ASupplied non-sterile | N/ASupplied non-sterile | Substantially Equivalent | |||||||
| Materials (PatientContacting) | None | None | Substantially Equivalent | |||||||
| Shelf Life | 5 years | 5 years | Substantially Equivalent |
Note: The transceiver is not used for communication with the VERASENSE for Zimmer Biomet Persona or with the VERASENSE for Stryker Triathlon.
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Image /page/13/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 shapes, one in blue and two in gray, arranged in a triangular formation. The company name "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.
SUMMARY OF DESIGN CONTROLS ACTIVITIES VII.
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.
VIII. CONCLUSION
The subject device has the same intended use, indications for use, use environment, functional specifications, wireless communication protocol, operating conditions, storage conditions, sterilization method, packaging, hardware accessory, software accessory and meets the same electrical safety, electromagnetic compatibility, usability standards as the predicate device VERASENSE for Zimmer Biomet Persona. The subject device has the same dimensions, batteries, and patient contacting materials as the reference device.
The differences in the labeling, firmware version, and software application accessory version between the predicate and subject device have been identified. Substantial equivalence has been demonstrated through verification and validation activities. It can be concluded that all technological differences between predicate are safe, effective and do not pose any harm to patients.
§ 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).