(172 days)
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.
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.
The provided text describes the VERASENSE for Exactech Equinoxe device, but it does not contain information about a study proving the device meets acceptance criteria related to an AI/ML algorithm's performance.
Instead, the document primarily focuses on demonstrating the substantial equivalence of the VERASENSE for Exactech Equinoxe to a predicate device (VERASENSE for Zimmer Biomet Persona) for regulatory clearance. This involves a comparison of technological characteristics, mechanical and functional features, electrical properties, environmental conditions, and materials.
The performance data section mentions:
- Biocompatibility testing: Conducted according to ISO 10993-1.
- Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1 and IEC 60601-1-2.
- Software Verification and Validation Testing: For sensor firmware and software application accessory, categorized as "minor" level of concern.
- Performance Testing (Bench): Covering usability, sterilization, packaging integrity, shelf life, biocompatibility, electrical safety, software V&V, and EMC.
Crucially, it explicitly states:
- Performance Testing Animal: "This submission does not include any animal performance testing. We determined that no such testing was required to demonstrate substantial equivalence."
- Performance Testing Clinical: "This submission does not include any clinical performance testing. We determined that no such testing was required to demonstrate substantial equivalence."
Therefore, based on the provided text, I cannot describe acceptance criteria and a study that proves the device meets those criteria for an AI/ML algorithm's performance, as no such study is detailed.
The device, VERASENSE for Exactech Equinoxe, is described as a tool for "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)." This describes a sensor-based measurement device rather than an AI/ML diagnostic or assistive algorithm.
The closest information available regarding "performance" that could be interpreted as "acceptance criteria" related to the device's core function (load and COL measurement) is in the comparison table:
Table of Acceptance Criteria and Reported Device Performance (as inferred from comparison with predicate and functional specifications)
| Acceptance Criteria (from Subject Device K200587 specifications) | Reported Device Performance (from Subject Device K200587 specifications) |
|---|---|
| Load Range and Accuracy: | |
| 5 - 40 lbf | $\le 3.5 \text{ lbf}$ |
| 41 - 70 lbf | $\le 15%$ |
| Maximum Safe Load | 70 lbf |
| Center of Load (COL) Location Accuracy: | $\le 3\text{mm}$ |
| Mechanical Dimensions: | Equal to the dimensions of the implant humeral liner $\pm 0.50\text{ mm}$ under all operating conditions |
| Battery Life: | 40 min |
None of the other requested information (sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) is present in the provided document, as it pertains to AI/ML algorithm validation, which is not described for this device.
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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.
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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
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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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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.
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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 DeviceK180459 | Subject DeviceK200587 | ||
|---|---|---|---|
| Sensor and required accessories | |||
| Classification | 21 CFR 882.4560 | 21 CFR 882.4560 | |
| Product Code | ONN | ONN | |
| Intended Use | VERASENSE provides a means fororthopedic surgeons to dynamicallybalance the knee during primary or revisionTotal Knee Arthroplasty (TKA). | VERASENSE for Exactech Equinoxe providesorthopedic surgeons a tool for a measuring loadmagnitude and displaying center of load (COL)location (weighted average) of the humeralcomponent on the glenosphere component during areverse total shoulder arthroplasty (rTSA). | |
| Indications for Use | The VERASENSE is indicated for anymedical condition in which primary orrevision Total Knee Arthroplasty (TKA)would be indicated.For use as a tool for adjustment of thefemoral knee implant to reduce instabilityfrom flexion gap asymmetry. TheVERASENSE is sterile, for single patient use. | The VERASENSE for Exactech Equinoxe is indicatedfor any medical condition in which primary reverseTotal Shoulder Arthroplasty (rTSA) would beindicated.For use as a tool for measuring load magnitude anddisplaying center of load location of the humeralcomponent on the glenosphere component. Thedevice does not make a diagnosis and is notintended to replace a surgeon's clinical judgement.The VERASENSE for Exactech Equinoxe is sterile, forsingle patient use. | |
| Environment | Hospital | Hospital | |
| Electrical Safety* | ANSI AAMI ES60601-1:2005/(R)2012and A1:2012, | ANSI AAMI ES60601-1:2005/(R)2012 andA1:2012, | |
| ElectromagneticCompatibility(EMC)* | IEC 60601-1-2:2014 | IEC 60601-1-2:2014 | |
| Usability* | 62304:2006/A1:2016 | 62304:2006/A1:2016 | |
| Labeling | VERASENSE for Zimmer BiometPersona product label, VERASENSEknee sensor IFU, and VERASENSE kneesensor and accessories user guide. | VERASENSE for Exactech Equinoxe productlabel, VERASENSE shoulder sensor IFU, andVERASENSE shoulder sensor and accessoriesuser guide. | |
| Predicate DeviceK180459 | Subject DeviceK200587 | ||
| SENSOR (parent device) | |||
| Mechanical | Dimensions | Equal to the dimensions of the implant trial orfinal liner ± 0.50 mm under all operatingconditions | Equal to the dimensions of the implant humeral liner ±0.50 mm under all operating conditions |
| Functional | OperatingPrinciple | Capacitive sensors on the device measure thepressure exerted by the femoral component ofthe implant on the sensor (two compartments,three pressure sensors in each compartment) | Capacitive sensors on the device measure the pressureexerted by the humeral component of the implant onthe sensor (one compartment, three pressure sensorsin the compartment) |
| Load RangeandAccuracy | $5-40 \text{ lbf } \le 3.5 \text{ lbf}$ | $5-40 \text{ lbf } \le 3.5 \text{ lbf}$ | |
| 41-70 lbf for reference only | 41-70 lbf ≤ 15% | ||
| MaximumSafe Load | 70 lbf | 70 lbf | |
| Center of Load(COL) Location | For Reference Only | ≤ 3mm | |
| Communication | Transmission of data from sensor to theLinkStation MINI or LinkStation MINI EvaluationKit. | Transmission of data from sensor to the LinkStation MINIor LinkStation MINI Evaluation Kit. | |
| Battery | 40 min | 40 min |
*when sensor and accessories tested together
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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 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.
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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 DeviceK180459 | Subject DeviceK200587 | |||
|---|---|---|---|---|
| Battery | Type | Lithium Ioncoin cell | Silver Oxidecoin cell | |
| OperatingVoltage andcurrent | 3.1 V DC30mAh | 1.55V27mAh | ||
| ConnectionType | Two batteries in parallel | Two batteries in series | ||
| Electrical | IEC 60601-1 Medical Electrical Equipment Classification | ProtectionAgainst ElectricShock | Internally powered | Internally powered |
| Installationand Use | Hand held | Hand held | ||
| Applied Part | Type BF | Type BF | ||
| Protectionagainstharmfulingress ofwater orparticulatematter | IPX4 | IPX4 | ||
| Mode ofOperation | Continuous | Continuous | ||
| Suitability inan oxygen richenvironment | No | No | ||
| Wireless Communication | Technology | Radio Frequency | Radio Frequency | |
| FrequencyBand | 2402 - 2480 MHz | 2402 - 2480 MHz | ||
| CommunicationProtocol | Bluetooth LowEnergy (BLE) 4.2 | Bluetooth LowEnergy (BLE) 4.2 | ||
| Range | 2 m | 2 m | ||
| ElectromagneticInterference (EMI) | Sensor will tolerate typical levels ofelectromagnetic interface experience in theoperating room environment. | Sensor will tolerate typical levels of electromagneticinterface experience in the operating roomenvironment. | ||
| ElectrostaticDischarge (ESD) | 8kV contact discharge15 kV air discharge | 8kV contact discharge15 kV air discharge | ||
| Predicate DeviceK180459 | Subject DeviceK200587 | |||
| EnvironmentalOperatingConditions | Storagetemperature | 15 - 37 °C | 15 - 37 °C | |
| Relativehumidity | 30 - 100% | 30 - 100% | ||
| submersion | submersion | submersion | ||
| EnvironmentalStorageConditions | Storagetemperature | 0 - 50 °C | 0 - 50 °C | |
| Relativehumidity | 10 - 80%non-condensing | 10 - 80%non-condensing | ||
| Atmosphericpressure | 36 – 106 kPa | 36 – 106 kPa | ||
| Type of Contact | with tissue/bone | with tissue/bone | ||
| Duration ofContact | limited duration contact (<24 hours) | limited duration contact (<24 hours) | ||
| Materials (patient contacting) | Housing | Top | Colorless Polycarbonate Resin | Colored Polycarbonate Resin (38 mm Blue550680,42 mm Yellow 150210) |
| Bottom | Colorless Polycarbonate Resin | Colorless Polycarbonate Resin | ||
| Adhesive | Betweentop andbottomhousing | Loctite 3936 | Loctite 3311 | |
| For venthole | Loctite 3936 | Loctite 3936 | ||
| Shims | 10, 11, 12, 13 mmVITREX PolyEtherEtherKetone (PEEK)381G & stainless-steel metal plates | 0, 2.5 mmColorless Polycarbonate Resin | ||
| 14 and 16 mmVITREX PolyEtherEtherKetone (PEEK)381G | ||||
| SterilizationMethod | 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 firmwareversion 2.2.2 which includescommunication modes and calibrationcoefficient. | VERASENSE shoulder sensor firmware version2.2.6 which includes communication modesand calibration coefficient. |
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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.
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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 DeviceK180459 | Subject DeviceK200587 | |||||
|---|---|---|---|---|---|---|
| Required Accessories (Intended to support the performance of the VERASENSE sensor parent device) | ||||||
| HARDWARE ACCESSORY | ||||||
| Operating Principle | The LinkStation MINI and LinkStation MINIEvaluation Kit receives and processes processGaussian Frequency-Shift Keying (GFSK)modulated data from the sensors. TheLinkStation MINI can be transported fromstorage location to and from placementpositioning of the system within the operatingroom without causing delay to surgical flow.The LinkStation MINI Evaluation Kit can betransported from case to case and be robust forassembly and break down in surgicalenvironments with repeated use. | The LinkStation MINI and LinkStation MINI EvaluationKit receives and processes process Gaussian Frequency-Shift Keying (GFSK) modulated data from the sensors.The LinkStation MINI can be transported from storagelocation to and from placement positioning of thesystem within the operating room without causingdelay to surgical flow.The LinkStation MINI Evaluation Kit can be transportedfrom case to case and be robust for assembly andbreak down in surgical environments with repeateduse. | ||||
| Stand Component | Roll Stand withutility basket andlockable casters | Tablet Kickstand | Roll Stand with utilitybasket and lockablecasters | Tablet Kickstand | ||
| MagnetComponent | Neodymium magnet with a magnet to steel discpull of greater than 2.75 lbs | Neodymium magnet with a magnet to steel disc pull ofgreater than 2.75 lbs | ||||
| Display UnitMount | Connects to standwith tilt and rotation | Kickstand that holdstablet on tabletop | Connects to standwith tilt and rotation | Kickstand that holds tableton tabletop | ||
| USB Cable | USB 2.0 down angleA male to up angleMINI-B male 10"(25.4cm) | USB 2.0 down angle Amale to up angleMINI-B male 48"(122cm) | USB 2.0 down angle Amale to up angleMINI-B male 10"(25.4cm) | USB 2.0 down angle A maleto up angle MINI-B male48" (122cm) | ||
| Environmental | OperatingConditions | Storagetemperature | -10 - 60 °C | -10 - 60 °C | ||
| Relativehumidity | 5 - 95% | 5 - 95% | ||||
| non-condensing | non-condensing | |||||
| StorageConditions | Storagetemperature | 0 - 50 °C | 0 - 50 °C | |||
| Relativehumidity | 5 - 95% | 5 - 95% | ||||
| non-condensing | non-condensing |
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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 DeviceK180459 | Subject DeviceK200587 | |||||
|---|---|---|---|---|---|---|
| Transceiver Mount | Mounted on roll stand | Mounted on tripod | Mounted on roll stand | Mounted on tripod | ||
| Power | USB powered and intended to be connectedto the USB port of the LinkStation MINIdisplay unit (5 V dc) | USB powered and intended to be connectedto 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 wateror 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.
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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 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 simple, sans-serif font, with the letters in gray.
PERFORMANCE DATA VII.
The following performance data were provided in support of the substantial equivalence determination.
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 ●
The VERASENSE for Exactech Equinoxe is an implant device with limited duration contact (<24 hours) with tissue/bone.
Based on the results of the biocompatibility testing performed on the final VERASENSE for Exactech Equinoxe, in addition to the biocompatibility testing results of the raw materials, the VERASENSE for Exactech Equinoxe meets the requirements outlined in EN ISO 10993-1:2009/AC:2010.
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.
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VERASENSE for Exactech Equinoxe Traditional 510(k)
Image /page/12/Picture/2 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 lines, two in blue and one in gray, that converge at a central point. The text "ORTHOSENSOR" is written in a simple, sans-serif font, with the "ORTHO" portion in a lighter gray color and the "SENSOR" portion in a darker blue.
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
60601-1-2
Compatibility (EMC) IEC
Design Verification and
Performance Testing Animal
This submission does not include any animal performance testing. We determined that no such testing was required to demonstrate substantial equivalence.
Performance Testing Clinical
This submission does not include any clinical performance testing. We determined that no such testing was required to demonstrate substantial equivalence.
CONCLUSION VIII.
The subject device has the same general intended use, use environment, operating principle, load accuracy for 5- 40 lbf, maximum safe load, wireless communication protocol, operating conditions, storage conditions, sterilization method, packaging, hardware accessory and meets the same electrical safety, electromagnetic compatibility, usability standards as the predicate device VERASENSE for Zimmer Biomet Persona.
The difference in the indications for use, labeling, dimensions, 41-70 lbf load accuracy, COL location accuracy, battery, patient contacting materials, shelf life, firmware, and software accessory between the predicate and subject have been identified. Substantial equivalence has been demonstrated through verification and validation activities. It can be concluded that all clinical and 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).