VERASENSE for Stryker Triathlon

K200665 · Orthosensor, Inc. · ONN · Apr 12, 2020 · Neurology

Device Facts

• Record ID: K200665
• Device Name: VERASENSE for Stryker Triathlon
• Applicant: Orthosensor, Inc.
• Product Code: ONN · Neurology
• Decision Date: Apr 12, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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 asymmetry. VERASENSE is sterile, for single patient use.

Device Story

VERASENSE is a disposable, intelligent tibial insert trial for TKA. It features capacitive sensors measuring pressure in medial/lateral knee compartments. It wirelessly transmits load data via Bluetooth Low Energy (BLE) 4.2 to a LinkStation MINI and VERASENSE Software Application (VSA). Used in hospital operating rooms by surgeons. VSA displays load magnitude and center of load (COL) location numerically and graphically. Surgeons use this real-time feedback to adjust femoral implant positioning, aiming to reduce flexion gap asymmetry and improve joint stability. Device is sterile, single-patient use, and implant-specific (Stryker Triathlon).

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including verification and validation activities for design modifications, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and usability (IEC 62366).

Technological Characteristics

Disposable tibial insert trial with capacitive pressure sensors. Materials: Polycarbonate resin (housing), Loctite 3936 (adhesive). Connectivity: BLE 4.2 (2402–2480 MHz). Power: Silver oxide coin cell batteries. Sterilization: Ethylene oxide (10^-6 SAL). Software: VSA application (C#). Dimensions match implant trial/liner ± 0.50 mm. IPX4 rated.

Indications for Use

Indicated for patients undergoing primary or revision Total Knee Arthroplasty (TKA). Used as a tool for adjusting femoral knee implants 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 for Zimmer Biomet Persona (K180459)

Reference Devices

• VERASENSE Knee System (K150372)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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)

| <div> <span> <b> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> </div> |
|---------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> Over-The-Counter Use (21 CFR 801 Subpart C) </b> </span> </div> |

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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:

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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: [phone] Fax: [phone]

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 Device<br>K180459 | Subject Device | Substantially<br>Equivalent or<br>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<br>means for orthopedic<br>surgeons to dynamically<br>balance the knee during<br>primary or revision Total<br>Knee Arthroplasty (TKA). | VERASENSE provides a<br>means for orthopedic<br>surgeons to dynamically<br>balance the knee during<br>primary or revision Total<br>Knee Arthroplasty (TKA). | Substantially Equivalent |
| Indications for<br>Use | The VERASENSE is<br>indicated for any medical<br>condition in which primary<br>or revision Total Knee<br>Arthroplasty (TKA) would<br>be indicated.<br>For use as a tool for<br>adjustment of the femoral<br>knee implant to reduce<br>instability from flexion gap<br>asymmetry. The<br>VERASENSE is sterile, for<br>single patient use. | The VERASENSE is<br>indicated for any medical<br>condition in which primary<br>or revision Total Knee<br>Arthroplasty (TKA) would<br>be indicated.<br>For use as a tool for<br>adjustment of the femoral<br>knee implant to reduce<br>instability from flexion gap<br>asymmetry. The<br>VERASENSE is sterile, for<br>single 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 Device<br>K180459 | Subject Device | Substantially<br>Equivalent or<br>Difference |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Environment | Hospital | Hospital | Substantially Equivalent |
| Electrical Safety* | IEC 60601-1 | IEC 60601-1 | Substantially Equivalent |
| Electromagnetic<br>Compatibility<br>(EMC)* | IEC 60601-1-2 | IEC 60601-1-2 | Substantially Equivalent |
| Usability* | IEC 62366 | IEC 62366 | Substantially Equivalent |
| Labeling | VERASENSE for Zimmer<br>Biomet Persona product<br>label, VERASENSE knee<br>sensor IFU, and<br>VERASENSE knee sensor<br>and accessories user<br>guide. | VERASENSE for Stryker<br>Triathlon product label,<br>VERASENSE knee sensor<br>IFU, and VERASENSE<br>knee sensor and<br>accessories user guide. | Technological<br>Difference #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 Device<br>K180459 | Subject Device | Substantially<br>Equivalent or<br>Difference |
|------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| | SENSOR (parent device) | | | | |
| Mechanical | | Dimensions | VERASENSE for Zimmer Biomet<br>Persona sensor is equal to the<br>dimensions of the implant trial<br>or final liner ± 0.50 mm under<br>all operating conditions | VERASENSE for Stryker<br>Triathlon sensor is equal to the<br>dimensions of the implant trial<br>or final liner ± 0.50 mm under<br>all operating conditions | Technological<br>Difference #2<br>Subject device housing<br>dimensions are the same as the<br>reference device. |
| Functional<br>Applied Force of Load<br>Sensing | Operating<br>Principle | | Capacitive sensors on the<br>device measure the pressure<br>exerted by the femoral<br>component of the implant on<br>the sensor (two compartments,<br>three pressure sensors in each<br>compartment) | Capacitive sensors on the<br>device measure the pressure<br>exerted by the femoral<br>component of the implant on<br>the sensor (two compartments,<br>three pressure sensors in each<br>compartment) | Substantially Equivalent |
| | | Load<br>Range and<br>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<br>Safe Load | 70 lbf | 70 lbf | Substantially Equivalent |
| | | Center of Load<br>(COL) Location | | For Reference Only | For Reference Only |
| | | Communication | | Transmission of data from<br>sensor to the LinkStation MINI<br>or LinkStation MINI Evaluation<br>Kit. | Transmission of data from sensor<br>to the LinkStation MINI or<br>LinkStation MINI Evaluation Kit. |
| | Battery | | 40 min | 40 min | Substantially Equivalent |
| | | | Predicate Device<br>K180459 | Subject Device | Substantially<br>Equivalent or<br>Difference |
| | Battery | Type | Lithium Ion<br>coin cell | Silver Oxide<br>coin cell | Technological<br>Difference #3<br>Subject device battery is the<br>same battery as the reference<br>device |
| | | Operating<br>Voltage<br>and<br>current | 3.1 V DC<br>30 mAh | 1.55V<br>27 mAh | |
| | | Connection<br>Type | Two batteries in parallel | Two batteries in series | |
| | Electrical<br>IEC 60601-1 Medical Electrical Equipment Classification | Protection<br>Against Electric<br>Shock | Internally powered | Internally powered | Substantially Equivalent |
| | | Installation<br>and Use | Hand held | Hand held | Substantially Equivalent |
| | | Applied Part | Type BF | Type BF | Substantially Equivalent |
| | | Protection<br>against<br>harmful<br>ingress of<br>water or<br>particulate<br>matter | IPX4 | IPX4 | Substantially Equivalent |
| | | Mode of<br>Operation | Continuous | Continuous | Substantially Equivalent |
| | | Suitability in<br>an oxygen<br>rich<br>environment | No | No | Substantially Equivalent |
| | | | Technology | Radio Frequency | Radio Frequency |
| | | | Frequency<br>Band | 2402 – 2480 MHz | 2402 – 2480 MHz |
| | Wireless Communication | | Communicati<br>on Protocol | Bluetooth Low<br>Energy (BLE) 4.2 | Bluetooth Low<br>Energy (BLE) 4.2 |
| | | | Range | 2 m | 2 m |
| | | Electromagnetic<br>Interference (EMI) | | Sensor will tolerate typical<br>levels of electromagnetic<br>interface experience in the<br>operating room environment. | Sensor will tolerate typical<br>levels of electromagnetic<br>interface experience in the<br>operating room environment. |
| | | Electrostatic<br>Discharge (ESD) | | 8kV contact discharge<br>15 kV air discharge | 8kV contact discharge<br>15 kV air discharge |
| | | | Predicate Device<br>K180459 | Subject Device | Substantially<br>Equivalent or<br>Difference |
| Environmental | Operating<br>Conditions | Storage<br>temperature | 15 - 37 °C | 15 - 37 °C | Substantially Equivalent |
| | | Relative<br>humidity | 30 - 100%<br>submersion | 30 - 100%<br>submersion | Substantially Equivalent |
| | Storage<br>Conditions | Storage<br>temperature | 0 - 50 °C | 0 - 50 °C | Substantially Equivalent |
| | | Relative<br>humidity | 10 - 80%<br>non-condensing | 10 - 80%<br>non-condensing | Substantially Equivalent |
| | Atmospheric<br>pressure | | 36 - 106 kPa | 36 - 106 kPa | Substantially Equivalent |
| | Type of Contact | | with tissue/bone | with tissue/bone | Substantially Equivalent |
| | Duration of<br>Contact | | limited duration contact<br>(<24 hours) | limited duration contact<br>(<24 hours) | Substantially Equivalent |
| Materials (patient contacting) | Housing | Top | Colorless Polycarbonate<br>Resin | Colored Polycarbonate<br>Resin (Size 2 black, Size 3<br>brown, Size 4 green, Size<br>5 blue, Size 6 yellow, Size<br>7 burnt orange) | Technological<br>Difference #4<br><br>Subject device materials are<br>the same as the predicate and<br>reference devices |
| | | Bottom | Colorless Polycarbonate<br>Resin | Colorless Polycarbonate<br>Resin | |
| | Adhesive | Between<br>top and<br>bottom<br>housing | Loctite 3936 | Loctite 3936 | |
| | | For vent<br>hole | Loctite 3936 | Loctite 3936 | |
| | Shims | | 10, 11, 12, 13 mm<br>VITREX<br>PolyEtherEtherKetone<br>(PEEK) 381G & stainless-<br>steel metal plates<br><br>14 and 16 mm<br>VITREX<br>PolyEtherEtherKetone<br>(PEEK) 381G | Sizes 9, 10, 11, 12, 13, 16<br>mm<br>Colored Polycarbonate<br>Resin (Size 2 black, Size 3<br>brown, Size 4 green, Size<br>5 blue, Size 6 yellow, Size<br>7 burnt orange) | |
| Sterilization<br>Method | | | Ethylene Oxide 10-6 SAL | Ethylene Oxide 10-6 SAL | Substantially Equivalent |
| Shelf Life | | | 24 months | 24 months | Substantially Equivalent |
| Packaging | | | Sterile, Double Tyvek<br>/Film pouches,<br>chipboard box | Sterile, Double Tyvek<br>/Film pouches,<br>chipboard box | Substantially Equivalent |
| Firmware<br>version | | | VERASENSE knee sensor<br>firmware version 2.2.2<br>which includes<br>communication modes<br>and calibration coefficient. | VERASENSE knee sensor<br>firmware version 3.1.24<br>which includes<br>communication modes<br>and calibration coefficient. | Technological<br>Difference #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 Device<br>K180459 | Subject Device | Substantially Equivalent or Difference |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| | Required Accessories (Intended to support the performance of the VERASENSE sensor parent device) | | |
| | SOFTWARE ACCESSORY | | |
| Operating<br>Principle | The VERASENSE<br>Software Application<br>(VSA) calculates force<br>vectors and positional<br>data, display both<br>numerically and<br>pictorially load data<br>versus position. | The VERASENSE<br>Software Application<br>(VSA) calculates force<br>vectors and positional<br>data, display both<br>numerically and<br>pictorially load data<br>versus position. | Substantially Equivalent |
| Programming<br>Language | C# | C# | Substantially Equivalent |
| Operating<br>System<br>Compatibility | Microsoft Windows | Microsoft Windows | Substantially Equivalent |
| Level of Concern | Minor | Minor | Substantially Equivalent |
| Version | ≥5.1.0.17 | ≥5.3.0.64 | Technological<br>Difference #6 |
| | HARDWARE ACCESSORY | | |
| Operating<br>Principle | The LinkStation MINI and<br>LinkStation MINI Evaluation Kit<br>receives and processes process<br>Gaussian Frequency-Shift<br>Keying (GFSK) modulated data<br>from the sensors. The<br>LinkStation MINI can be<br>transported from storage<br>location to and from placement<br>positioning of the system<br>within the operating room<br>without causing delay to<br>surgical flow.<br>The LinkStation MINI<br>Evaluation Kit can be<br>transported from case to case<br>and be robust for assembly and<br>break down in surgical<br>environments with repeated<br>use. | The LinkStation MINI and<br>LinkStation MINI Evaluation Kit<br>receives and processes process<br>Gaussian Frequency-Shift<br>Keying (GFSK) modulated data<br>from the sensors. The<br>LinkStation MINI can be<br>transported from storage<br>location to and from placement<br>positioning of the system<br>within the operating room<br>without causing delay to<br>surgical flow.<br>The LinkStation MINI<br>Evaluation Kit can be<br>transported from case to case<br>and be robust for assembly and<br>break down in surgical<br>environments with repeated<br>use. | Substantially Equivalent |
| Stand<br>Component | Roll Stand<br>with utility<br>basket and<br>lockable<br>casters | Roll Stand<br>with utility<br>basket and<br>lockable<br>casters<br><br>Tablet<br>Kickstand | Tablet<br>Kickstand<br><br>Substantially Equivalent |
| Magnet<br>Component | Neodymium magnet with a<br>magnet to steel disc pull of<br>greater than 2.75 lbs | Neodymium magnet with a<br>magnet to steel disc pull of<br>greater 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 Unit<br>Mount | | | Connects to<br>stand with<br>tilt and<br>rotation | Kickstand<br>that holds<br>tablet on<br>tabletop | Connects to<br>stand with<br>tilt and<br>rotation | Kickstand<br>that holds<br>tablet on<br>tabletop | Substantially Equivalent | |
|-----------------------|-------------------------------------------|--------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------|--------------------------|
| | | | Predicate Device<br>K180459 | | Subject Device | | Substantially<br>Equivalent or<br>Difference | |
| USB Cable | | | USB 2.0<br>down angle<br>A male to up<br>angle MINI-B<br>male 10"<br>(25.4cm) | USB 2.0<br>down angle<br>A male to up<br>angle MINI-B<br>male 48"<br>(122cm) | USB 2.0<br>down angle<br>A male to up<br>angle MINI-B<br>male 10"<br>(25.4cm) | USB 2.0<br>down angle<br>A male to up<br>angle MINI-B<br>male 48"<br>(122cm) | Substantially Equivalent | |
| Environmental | Operating<br>Conditions | Storage<br>temperature | -10 - 60 °C | | -10 - 60 °C | | Substantially Equivalent | |
| | | Relative<br>humidity | 5 - 95%<br>non-condensing | | 5 - 95%<br>non-condensing | | Substantially Equivalent | |
| | Storage<br>Conditions | Storage<br>temperature | 0 - 50 °C | | 0 - 50 °C | | Substantially Equivalent | |
| | | Relative<br>humidity | 5 - 95%<br>non-condensing | | 5 - 95%<br>non-condensing | | Substantially Equivalent | |
| | Type | | | Tablet PC 12.5 in (31.8<br>cm) diagonal<br>touchscreen 256 color<br>display | | Tablet PC 12.5 in (31.8<br>cm) diagonal<br>touchscreen 256 color<br>display | | 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 | Electrical<br>Equipment<br>Classification | Protection<br>Against<br>Electric<br>Shock | | Class I | | Class I | | Substantially Equivalent |
| | | Installation<br>and Use | | Transportable | | Transportable | | Substantially Equivalent |
| | | Applied<br>Part | | No Applied Parts<br>(does contact patient) | | No Applied Parts<br>(does contact patient) | | Substantially Equivalent |
| | | IEC 60601-1<br>Medical<br>Electrical | Protection<br>against<br>harmful<br>ingress of<br>water or<br>particulate<br>matter | | IP54 | | IP54 | |
| | | | Mode of<br>Operation | | Continuous | | Continuous | |
| | | | Suitability<br>in an oxygen<br>rich<br>environment |…