(172 days)
No
The description focuses on measuring and displaying load data, not on using algorithms to interpret or predict based on that data. There is no mention of AI, ML, training, or testing sets.
No
The device is described as a tool for measuring load magnitude and displaying the center of the humeral component on the glenosphere component during reverse Total Shoulder Arthroplasty (rTSA). It is explicitly stated that "The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement." While it provides information to a surgeon, it does not directly treat or prevent a medical condition, which are characteristics of a therapeutic device.
No
The "Intended Use / Indications for Use" section explicitly states, "The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement." Instead, it is described as "a tool for measuring load magnitude and displaying center of the humeral component on the glenosphere component."
No
The device description explicitly states it is an "intelligent disposable humeral insert trial" which is a hardware component that measures and transmits data. The software component (VSA-S) is used to display this data, but the core measurement function is performed by the hardware insert.
Based on the provided information, the VERASENSE for Exactech Equinoxe is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- VERASENSE Function: The VERASENSE device is a surgical tool used during a reverse Total Shoulder Arthroplasty procedure. It measures mechanical loads and the center of load within the joint components.
- Intended Use: The intended use clearly states it's a "tool for measuring load magnitude and displaying center of the humeral component on the glenosphere component." It explicitly states it "does not make a diagnosis."
- Device Description: The description reinforces its function as an "intelligent disposable humeral insert trial" that measures "dynamic loads on the humeral insert."
The device is used in vivo (within the body during surgery) to provide real-time feedback to the surgeon about the mechanical forces and alignment of the implanted components, not to diagnose a condition from a sample taken from the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ONN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humeral component on the glenosphere component (shoulder)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgeons / Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing: The biocompatibility evaluation for the VERASENSE for Exactech Equinoxe was conducted in accordance with Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff, Issued 06-16-2016. The biocompatibility tests conducted were:
- Cytotoxicity
- Sensitization
- Irritation
- Acute systemic toxicity
- Material mediated pyrogenicity
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the VERASENSE for Exactech Equinoxe and required accessories. The subject device and required accessories comply with the IEC 60601-1 standard for electrical safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing: Verification and validation testing was conducted on the sensor firmware and software application accessory and the documentation provided is as recommended in the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The sensor firmware and software accessory for this device were considered as a "minor" level of concern, since the deice is used as a tool and does not directly drive a decision regarding treatment or therapy.
Performance Testing Bench: The safety performance of the VERASENSE for Exactech Equinoxe has been verified according to OrthoSensor, Inc's procedures for product design and development to ensure that it meets its intended use, including:
- Usability
- Sterilization
- Packaging Integrity
- Shelf life
- Biocompatibility Assessment
- Electrical Safety Testing IEC 60601-1
- Validation Software Verification and Validation
- Electromagnetic Compatibility (EMC) IEC 60601-1-2
- Design Verification and Performance Testing
Performance Testing Animal: This submission does not include any animal performance testing.
Performance Testing Clinical: This submission does not include any clinical performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
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)
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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
- Labeling 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 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 (