← Product Code [ONN](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN) · K200587 # VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder (K200587) _Orthosensor, Inc. · ONN · Aug 25, 2020 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94neurological-surgical-devices/ONN/K200587 ## Device Facts - **Applicant:** Orthosensor, Inc. - **Product Code:** [ONN](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN.md) - **Decision Date:** Aug 25, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.4560 - **Device Class:** Class 2 - **Review Panel:** Neurology ## Indications for Use The VERASENSE for Exactech Equinoxe is for any medical condition in which reverse Total Shoulder Arthroplasty (rTSA) would be indicated. For use as a tool for measuring load magnitude and displaying center of load location of the humeral component on the glenosphere component. The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement. The VERASENSE for Exactech Equinoxe is sterile, for single patient use. ## Device Story Intelligent disposable humeral insert trial; measures dynamic loads on humeral insert during reverse Total Shoulder Arthroplasty (rTSA). Capacitive sensors detect pressure; wirelessly transmits data via Bluetooth Low Energy (BLE) 4.2 to LinkStation MINI or Evaluation Kit. VSA-S software displays load magnitude and center of load (COL) location (weighted average) on screen. Used in hospital operating rooms by surgeons. Provides real-time intraoperative feedback to assist in balancing joint components; does not replace clinical judgment. Benefits include objective data for component positioning. Sterile, single-patient use. ## Clinical Evidence No clinical data provided. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability, sterilization, packaging, and shelf-life validation. ## Technological Characteristics Disposable humeral insert trial with capacitive pressure sensors. Materials: Polycarbonate resin housing, Loctite 3311/3936 adhesives. Energy: Silver oxide coin cell battery. Connectivity: BLE 4.2 (2402-2480 MHz). Sterilization: Ethylene Oxide (10^-6 SAL). Dimensions match implant trial ±0.50 mm. Software: Firmware v2.2.6. Complies with IEC 60601-1 and IEC 60601-1-2. ## Regulatory 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](/device/K180459.md)) ## Reference Devices - VERASENSE Knee System ([K150372](/device/K150372.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ August 25, 2020 Image /page/0/Picture/1 description: The image shows 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION". OrthoSensor, Inc. Deborah Escobar Johnson Director of Regulatory Affairs 1855 Griffin Road Suite A-310 Dania Beach, Florida 33004 Re: K200587 Trade/Device Name: VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: ONN Dated: July 24, 2020 Received: July 27, 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. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 (OS) 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, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200587 Device Name VERASENSE for Exactech Equinoxe ### Indications for Use (Describe) The VERASENSE for Exactech Equinoxe is for any medical condition in which reverse Total Shoulder Arthroplasty (rTSA) would be indicated. For use as a tool for measuring load magnitude and displaying center of the humeral component on the glenosphere component. The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement. The VERASENSE for Exactech Equinoxe is sterile, for single patient use. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X 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}------------------------------------------------ VERASENSE for Exactech Equinoxe Traditional 510(k) Image /page/3/Picture/2 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. The word "ORTHO" is in gray, and the word "SENSOR" is in dark blue. # Traditional 510(k) Summary # This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92 ### I. SUBMITTER OrthoSensor, Inc. 1855 Griffin Road, Suite A-310 Dania Beach, FL 33004 Establishment Registration Number: 3008592715 Phone: (954) 577-7770 Fax: (954) 337-9222 Contact Person: Deborah Johnson, Director of Regulatory Affairs Date Prepared: July 24, 2020 ### II. DEVICE Name of Device: VERASENSE for Exactech Equinoxe 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 for Exactech Equinoxe device is an intelligent disposable humeral insert trial that measures dynamic loads on the humeral insert and wirelessly transmits the measured load data to the LinkStation MINI and LinkStation MINI Evaluation Kit with VERASENSE Software Application for Shoulder (VSA-S). The VSA-S provides the surgeon with a graphical and numerical presentation of the glenohumeral load magnitude and center of load (COL) location (weighted average) from the humeral to glenoid components. Individual VERASENSE for Exactech Equinoxe 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 text "VERASENSE for Exactech Equinoxe Traditional 510(k)". The text is in black font and is centered in the image. The text appears to be a product name or a description of a medical device. Image /page/4/Picture/2 description: The image shows the logo for Orthosensor. The logo consists of a stylized symbol above the company name. The symbol is made up of three curved lines, two in blue and one in gray, arranged in a triangular shape. The company name, "ORTHOSENSOR," is written in a combination of gray and blue letters. ### INDICATIONS FOR USE V. The VERASENSE for Exactech Equinoxe is for any medical condition in which Reverse Total Shoulder Arthroplasty (rTSA) would be indicated. For use as a tool for measuring load magnitude and displaying center of load location of the humeral component on the glenosphere component. The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement. The VERASENSE for Exactech Equinoxe 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 accessories intended to support the performance of the parent device are the LinkStation MINI or LinkStation MINI Evaluation Kit - Patient contacting material used for the bottom housing and adhesive in ● the vent hole - Load operating range and accuracy for 5 40 lbf ● The following clinical and technological differences exist between the subject and predicate devices: - Clinical - o Intended Use - o Indications for use - Technological ● - Labeling O - Dimensions o - Load operating range and accuracy for 41 70 lbf ≤ 15% O - Center of Load location accuracy O - Battery O - Patient contacting materials (Top housing colorant material, O adhesive between top and bottom housing, shims) - Shelf life O - Firmware O - Software application accessory 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 lines, two in blue and one in gray, that converge at a central point. The company name "ORTHOSENSOR" is written in a serif font, with "ORTHO" in gray and "SENSOR" in blue. | | Predicate Device
K180459 | Subject Device
K200587 | | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Sensor and required accessories | | | | Classification | 21 CFR 882.4560 | 21 CFR 882.4560 | | | Product Code | ONN | ONN | | | Intended Use | VERASENSE provides a means for
orthopedic surgeons to dynamically
balance the knee during primary or revision
Total Knee Arthroplasty (TKA). | VERASENSE for Exactech Equinoxe provides
orthopedic surgeons a tool for a measuring load
magnitude and displaying center of load (COL)
location (weighted average) of the humeral
component on the glenosphere component during a
reverse total shoulder arthroplasty (rTSA). | | | 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 for Exactech Equinoxe is indicated
for any medical condition in which primary reverse
Total Shoulder Arthroplasty (rTSA) would be
indicated.

For use as a tool for measuring load magnitude and
displaying center of load location of the humeral
component on the glenosphere component. The
device does not make a diagnosis and is not
intended to replace a surgeon's clinical judgement.

The VERASENSE for Exactech Equinoxe is sterile, for
single patient use. | | | Environment | Hospital | Hospital | | | Electrical Safety* | ANSI AAMI ES60601-1:2005/(R)2012
and A1:2012, | ANSI AAMI ES60601-1:2005/(R)2012 and
A1:2012, | | | Electromagnetic
Compatibility
(EMC)* | IEC 60601-1-2:2014 | IEC 60601-1-2:2014 | | | Usability* | 62304:2006/A1:2016 | 62304:2006/A1:2016 | | | Labeling | VERASENSE for Zimmer Biomet
Persona product label, VERASENSE
knee sensor IFU, and VERASENSE knee
sensor and accessories user guide. | VERASENSE for Exactech Equinoxe product
label, VERASENSE shoulder sensor IFU, and
VERASENSE shoulder sensor and accessories
user guide. | | | | Predicate Device
K180459 | Subject Device
K200587 | | | | SENSOR (parent device) | | | | Mechanical | Dimensions | Equal to the dimensions of the implant trial or
final liner ± 0.50 mm under all operating
conditions | Equal to the dimensions of the implant humeral liner ±
0.50 mm under all operating conditions | | Functional | 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 humeral component of the implant on
the sensor (one compartment, three pressure sensors
in the compartment) | | | Load Range
and
Accuracy | $5-40 \text{ lbf } \le 3.5 \text{ lbf}$ | $5-40 \text{ lbf } \le 3.5 \text{ lbf}$ | | | | 41-70 lbf for reference only | 41-70 lbf ≤ 15% | | | Maximum
Safe Load | 70 lbf | 70 lbf | | | Center of Load
(COL) Location | For Reference Only | ≤ 3mm | | | 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 | *when sensor and accessories tested together {6}------------------------------------------------ Image /page/6/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. {7}------------------------------------------------ Image /page/7/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 text "ORTHOSENSOR" is written in a simple, sans-serif font, with the "ORTHO" portion in gray and the "SENSOR" portion in blue. | | | | Predicate Device
K180459 | Subject Device
K200587 | |------------------------------------------|---------------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Battery | Type | | Lithium Ion
coin cell | Silver Oxide
coin cell | | | Operating
Voltage and
current | | 3.1 V DC
30mAh | 1.55V
27mAh | | | 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 | | | | Installation
and Use | Hand held | Hand held | | | | Applied Part | Type BF | Type BF | | | | Protection
against
harmful
ingress of
water or
particulate
matter | IPX4 | IPX4 | | | | Mode of
Operation | Continuous | Continuous | | | | Suitability in
an oxygen rich
environment | No | No | | | | | | | | Wireless Communication | | Technology | Radio Frequency | Radio Frequency | | | | Frequency
Band | 2402 - 2480 MHz | 2402 - 2480 MHz | | | | Communication
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
K200587 | | Environmental
Operating
Conditions | | Storage
temperature | 15 - 37 °C | 15 - 37 °C | | | | Relative
humidity | 30 - 100% | 30 - 100% | | | | submersion | submersion | submersion | | Environmental
Storage
Conditions | | Storage
temperature | 0 - 50 °C | 0 - 50 °C | | | | Relative
humidity | 10 - 80%
non-condensing | 10 - 80%
non-condensing | | | | Atmospheric
pressure | 36 – 106 kPa | 36 – 106 kPa | | | | Type of Contact | with tissue/bone | with tissue/bone | | | | Duration of
Contact | limited duration contact (<24 hours) | limited duration contact (<24 hours) | | Materials (patient contacting) | Housing | Top | Colorless Polycarbonate Resin | Colored Polycarbonate Resin (38 mm Blue
550680,
42 mm Yellow 150210) | | | | Bottom | Colorless Polycarbonate Resin | Colorless Polycarbonate Resin | | | Adhesive | Between
top and
bottom
housing | Loctite 3936 | Loctite 3311 | | | | For vent
hole | Loctite 3936 | Loctite 3936 | | | Shims | | 10, 11, 12, 13 mm
VITREX PolyEtherEtherKetone (PEEK)
381G & stainless-steel metal plates | 0, 2.5 mm
Colorless Polycarbonate Resin | | | | | 14 and 16 mm
VITREX PolyEtherEtherKetone (PEEK)
381G | | | Sterilization
Method | | | Ethylene Oxide 10-6 SAL | Ethylene Oxide 10-6 SAL | | Shelf Life | | | 14 months | 24 months | | Packaging | | | Sterile, Double Tyvek /Film pouches,
chipboard box | Sterile, Double Tyvek /Film pouches,
chipboard box | | Firmware | | | VERASENSE knee sensor firmware
version 2.2.2 which includes
communication modes and calibration
coefficient. | VERASENSE shoulder sensor firmware version
2.2.6 which includes communication modes
and calibration coefficient. | {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the Orthosensor logo. The logo consists of a stylized symbol above the word "ORTHOSENSOR". The symbol is made up of three curved shapes, two in blue and one in gray, arranged in a triangular formation. The word "ORTHOSENSOR" is written in a serif font, with "ORTHO" in gray and "SENSOR" in blue. {9}------------------------------------------------ Image /page/9/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 text "ORTHOSENSOR" is written in a serif font, with "ORTHO" in gray and "SENSOR" in blue. | | Predicate Device
K180459 | | Subject Device
K200587 | | | | |---------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--| | | Required Accessories (Intended to support the performance of the VERASENSE sensor parent device) | | | | | | | | HARDWARE ACCESSORY | | | | | | | | Operating Principle | The LinkStation MINI and LinkStation MINI
Evaluation Kit receives and processes process
Gaussian Frequency-Shift Keying (GFSK)
modulated data from the sensors. The
LinkStation MINI can be transported from
storage location to and from placement
positioning of the system within the operating
room without causing delay to surgical flow.
The LinkStation MINI Evaluation Kit can be
transported from case to case and be robust for
assembly and break down in surgical
environments with repeated use. | | The LinkStation MINI and LinkStation MINI Evaluation
Kit receives and processes process Gaussian Frequency-
Shift Keying (GFSK) modulated data from the sensors.
The LinkStation MINI can be transported from storage
location to and from placement positioning of the
system within the operating room without causing
delay to surgical flow.
The LinkStation MINI Evaluation Kit can be transported
from case to case and be robust for assembly and
break down in surgical environments with repeated
use. | | | | | Stand Component | Roll Stand with
utility basket and
lockable casters | Tablet Kickstand | Roll Stand with utility
basket and lockable
casters | Tablet Kickstand | | | | Magnet
Component | Neodymium magnet with a magnet to steel disc
pull of greater than 2.75 lbs | | Neodymium magnet with a magnet to steel disc pull of
greater than 2.75 lbs | | | | | Display Unit
Mount | Connects to stand
with tilt and rotation | Kickstand that holds
tablet on tabletop | Connects to stand
with tilt and rotation | Kickstand that holds tablet
on tabletop | | | | USB Cable | USB 2.0 down angle
A male to up angle
MINI-B male 10"
(25.4cm) | USB 2.0 down angle A
male to up angle
MINI-B male 48"
(122cm) | USB 2.0 down angle A
male to up angle
MINI-B male 10"
(25.4cm) | USB 2.0 down angle A male
to up angle MINI-B male
48" (122cm) | | | Environmental | Operating
Conditions | Storage
temperature | -10 - 60 °C | | -10 - 60 °C | | | | | Relative
humidity | 5 - 95% | | 5 - 95% | | | | | | non-condensing | | non-condensing | | | | Storage
Conditions | Storage
temperature | 0 - 50 °C | | 0 - 50 °C | | | | | Relative
humidity | | 5 - 95% | 5 - 95% | | | | | | non-condensing | | non-condensing | | {10}------------------------------------------------ Image /page/10/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 text "ORTHOSENSOR" is written in a serif font, with "ORTHO" in a lighter shade than "SENSOR". | | | Predicate Device
K180459 | | Subject Device
K200587 | | | |--------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------|--| | Transceiver Mount | | Mounted on roll stand | Mounted on tripod | Mounted on roll stand | Mounted on tripod | | | Power | | USB powered and intended to be connected
to the USB port of the LinkStation MINI
display unit (5 V dc) | | USB powered and intended to be connected
to the USB port of the LinkStation MINI display unit (5 V dc) | | | | Transceiver Component | IEC 60601-1 Medical Electrical Equipment Classification | Protection Against Electric Shock | Class II | | Class II | | | | | Installation and Use | Portable | | Portable | | | | | Applied Part | No Applied Parts
(does not contact patient) | | No Applied Parts
(does not contact patient) | | | | | Protection against harmful ingress of water
or particulate matter | Not ingress protected | | Not ingress protected | | | | | Mode of Operation | Continuous | | Continuous | | | | | Suitability in an oxygen rich environment | No | | No | | | | Wireless | Technology | Radio Frequency | | Radio Frequency | | | | | Frequency Band | 401.05 - 405.55MHz | | 401.05 - 405.55MHz | | | | | Communication Protocol | Proprietary | | Proprietary | | | Sterilization Method | | N/A | | N/A | | | | Materials (Patient Contacting) | | Supplied non-sterile | | Supplied non-sterile | | | | Materials (Patient Contacting) | | None | | None | | | | Shelf Life | | 5 years | | 5 years | | | Note: The transceiver is not used for communication with the VERASENSE for Zimmer Biomet Persona or with the VERASENSE for Exactech Equinoxe. {11}------------------------------------------------ VERASENSE for Exactech Equinoxe Traditional 510(k) Image /page/11/Picture/2 description: The image shows the logo for Orthosensor. The logo consists of a stylized symbol above the company name. The symbol… --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94neurological-surgical-devices/ONN/K200587](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94neurological-surgical-devices/ONN/K200587) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com