(149 days)
The Quadsense is indicated for use in primary Total Knee Arthroplasty (TKA), where the patella is resurfaced.
For use as a comparative tool to measure patellofemoral joint force. Quadsense sensor is sterile, for single patient use.
The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement.
The QUADSENSE system has been designed to allow surgeons to compare forces in the patellofemoral joint during total knee surgery.
The QUADSENSE system includes a sensor that attaches to the patella, adjustment shims that attach to the sensor, a control puck, and a touchscreen Panel PC with QUADSENSE software. The patella sensor can take readings of Medial, Lateral, Superior, and Inferior loads during range of motion trials. The sensor records data that is displayed on the Panel PC in real time. The Panel PC remains outside of the sterile field, and the software workflow can be controlled by the surgeon using the control puck, within the sterile field. The Panel PC collects and temporarily stores sensor reading data so the surgeon can view the sensor readings of force through the patellofemoral joint during different stages of the surgical procedure.
The sensor has been designed to attach to the patella at the start of the surgical procedure, following a conservative resection of the patella. This allows the surgeon to take a sensor reading of the patient's force through the patellofemoral joint during range of motion trials, prior to the resurfacing of the femur and the tibia. The surgeon can then take a reading of the force through the patellofemoral joint with the trial femoral and tibial components in situ. This allows the surgeon to assess how the new position of the femoral and tibial components has impacted the patient's force through the patellofemoral joint by comparing the reference reading taken prior to resurfacing to the reading(s) taken following trial implant insertion.
The sensor is supplied with several shims with different thicknesses and angles. By changing the thickness, rotation angulation parameters of the shim attached to the surgical procedure the surgeon can assess how change in patella thickness or angulation will impact the force through the patellofemoral joint.
The provided text describes the regulatory clearance for the QUADSENSE device and includes some performance data, but it does not contain the specific information requested in your prompt regarding detailed acceptance criteria, the study proving the device meets those criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, or training set details.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (VERASENSE for Zimmer Biomet Persona) for FDA clearance (K241298). It mentions several types of testing performed to ensure safety and performance, but these are general categories rather than specific performance studies with detailed outcomes against acceptance criteria.
Here's an breakdown of the information that is available and what is missing based on your request:
Information available in the document:
-
1. A table of acceptance criteria and the reported device performance: A direct table is not provided. However, some performance aspects are mentioned:
- Applied Force of Load Sensing - Load Range and Accuracy:
- Predicate (VERASENSE): 5-40 lbf ≤ 3.5 lbf; 41-70 lbf for reference only
- Subject Device (QUADSENSE): Sensor is calibrated at 70 Newtons (15.7 lbf) with 10% error
- Maximum Safe Load:
- Predicate (VERASENSE): 70 lbf
- Subject Device (QUADSENSE): 16.8kg (37.0 lbf)
- Biocompatibility: Meets requirements of ISO 10993-1:2018 (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Material mediated pyrogenicity).
- Electrical Safety: Complies with IEC 60601-1.
- Electromagnetic Compatibility (EMC): Complies with IEC 60601-1-2.
- Software Verification and Validation: Conducted, documentation provided as per FDA guidance.
- Cybersecurity: Threat modeling, risk management, and mitigation measures performed.
- Applied Force of Load Sensing - Load Range and Accuracy:
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states, "The QUADSENSE software application does not directly drive a decision regarding treatment or therapy." It's a "comparative tool to measure patellofemoral joint force." This implies a standalone measurement capability to provide data to the surgeon, so in that sense, its basic functionality is standalone.
-
7. The type of ground truth used: Not explicitly stated for performance validation beyond compliance with standards (e.g., electrical safety, biocompatibility). For force measurement, the "ground truth" would implicitly be the calibrated reference loads used during testing.
Information NOT available in the document:
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No details on sample sizes for any performance testing, nor on data provenance (country, retrospective/prospective).
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable or not specified, as the device doesn't make a diagnosis but rather measures force. The "experts" would be the engineers validating the force measurement.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable based on the nature of the device (a measurement tool, not a diagnostic imaging AI).
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical tool that measures force, not an AI for interpreting medical images by human readers.
- 8. The sample size for the training set: The document does not describe any machine learning/AI training sets for the device.
- 9. How the ground truth for the training set was established: Not applicable, as no training set is described.
In summary, the document demonstrates that QUADSENSE has undergone various engineering and safety tests to meet medical device standards and establish substantial equivalence. However, it does not detail a clinical performance study with defined acceptance criteria for diagnostic accuracy, nor does it describe an AI component with associated training or test data specifics as often found for AI/ML-based diagnostic devices.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 4, 2024
Eventum Orthopaedics Ltd % Kelliann Payne Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103
Re: K241298
Trade/Device Name: QUADSENSE Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: ONN Dated: May 8, 2024 Received: September 4, 2024
Dear Kelliann Payne:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-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).
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Sincerely,
Tejen D. Soni -S
For
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241298
Device Name QUADSENSE
Indications for Use (Describe)
The Quadsense is indicated for use in primary Total Knee Arthroplasty (TKA), where the patella is resurfaced.
For use as a comparative tool to measure patellofemoral joint force. Quadsense sensor is sterile, for single patient use.
The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement.
| Type of Use (Select one or both, as applicable) |
|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/1 description: The image shows the logo for Eventum Orthopaedics. The logo consists of a stylized "E" symbol in pink and blue, followed by the word "eventum" in pink. Below the word "eventum" is the word "orthopaedics" in blue.
Traditional 510(k) Summary - QUADSENSE
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
1 Submitter
| Eventum Orthopaedics Ltd |
|---|
| Richmond House |
| Lawnswood Business Park |
| Redvers Close |
| Leeds |
| LS16 6QY |
| United Kingdom |
Primary Contact / Person: John Naybour, CEO
Phone: +44 7309993335
Date Prepared: October 4, 2024
2 Device
| Trade/Proprietary Name: | QUADSENSE |
|---|---|
| Common or Usual Name: | Intraoperative Orthopaedic Joint Assessment Aid |
| Regulation Number: | 21 CFR 882.4560 |
| Regulation Name: | Stereotaxic Instrument |
| Regulatory Class: | Class II |
| Classification Panel: | Neurological Devices |
| Product Code: | ONN |
3 Predicate Device
K180459 VERASENSE for Zimmer Biomet Persona
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Image /page/5/Picture/1 description: The image shows the logo for Eventum Orthopaedics. The logo consists of a stylized "E" symbol on the left, with the word "eventum" in pink to the right of the symbol. Below the word "eventum" is the word "orthopaedics" in a smaller, darker blue font. The "E" symbol is made up of two semi-circles, one pink and one blue, with a horizontal line in the middle.
Device Description ব
The QUADSENSE system has been designed to allow surgeons to compare forces in the patellofemoral joint during total knee surgery.
The QUADSENSE system includes a sensor that attaches to the patella, adjustment shims that attach to the sensor, a control puck, and a touchscreen Panel PC with QUADSENSE software. The patella sensor can take readings of Medial, Lateral, Superior, and Inferior loads during range of motion trials. The sensor records data that is displayed on the Panel PC in real time. The Panel PC remains outside of the sterile field, and the software workflow can be controlled by the surgeon using the control puck, within the sterile field. The Panel PC collects and temporarily stores sensor reading data so the surgeon can view the sensor readings of force through the patellofemoral joint during different stages of the surgical procedure.
The sensor has been designed to attach to the patella at the start of the surgical procedure, following a conservative resection of the patella. This allows the surgeon to take a sensor reading of the patient's force through the patellofemoral joint during range of motion trials, prior to the resurfacing of the femur and the tibia. The surgeon can then take a reading of the force through the patellofemoral joint with the trial femoral and tibial components in situ. This allows the surgeon to assess how the new position of the femoral and tibial components has impacted the patient's force through the patellofemoral joint by comparing the reference reading taken prior to resurfacing to the reading(s) taken following trial implant insertion.
The sensor is supplied with several shims with different thicknesses and angles. By changing the thickness, rotation angulation parameters of the shim attached to the surgical procedure the surgeon can assess how change in patella thickness or angulation will impact the force through the patellofemoral joint.
5 Indications for Use
The Quadsense is indicated for use in primary Total Knee Arthroplasty (TKA), where the patella is resurfaced.
For use as a comparative tool to measure patellofemoral joint force. Quadsense sensor is sterile, for single patient use.
The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement.
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Image /page/6/Picture/1 description: The image shows the logo for Eventum Orthopaedics. The logo consists of a stylized "E" symbol on the left, with the word "eventum" in pink to the right of the symbol. Below the word "eventum" is the word "orthopaedics" in blue. The "E" symbol is split into two colors, with the left half in pink and the right half in blue.
റ 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 on the device used to measure forces during total knee arthroplasty to ensure the correct positioning of implants.
- Required accessories intended to support the performance of the parent devices are ● connection to a visual display and software application to provide measurement data (text and graphical) in real time.
- Both QUADSENSE and VERASENSE use attachable shims to modify the geometry of the sensor to assess the effect of different cuts.
- . Patient contacting materials have electronic components that are temporarily implanted in the patient for limited duration contact (<24 hours).
- Systems are provided EtO sterilised for single use. .
The following technological differences exist between the subject and predicate devices:
- The capacitive sensors are placed in different parts of the knee
- Patient contacting shim material differs, VERASENSE: PolyEtherEtherKetone (PEEK) and ● stainless steel and QUADSENSE: MAGNUM™ 8391 MED ABS Resin
- Transfer of data to the dedicated computer differs, VERASENSE: Wireless and QUADSENSE: Wired communication.
- Shelf life of QUADSENSE is 12 months.
- IP rating of QUADSENSE is IP55.
Technological differences between the subject device and predicate device have been assessed which has demonstrated that no new questions of safety and effectiveness are raised as a result of these technological differences.
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Image /page/7/Picture/1 description: The image shows the logo for Eventum Orthopaedics. The logo consists of a stylized "E" symbol on the left, with the word "eventum" in pink text to the right of the symbol. Below the word "eventum" is the word "orthopaedics" in a dark blue font. The "E" symbol is made up of a pink semi-circle on the left and a dark blue semi-circle on the right, with a horizontal line in the middle of the pink semi-circle.
| Attribute | VERASENSE[Predicate]forZimmer Biomet Persona(K180459) | QUADSENSESubject Device |
|---|---|---|
| Classification | 21 CFR 882.4560 | 21 CFR 882.4560 |
| Product Code | ONN | ONN |
| Intended Use | VERASENSE providesorthopedic surgeons a tool foradjustment of the femoralknee implant during primary orrevision Total KneeArthroplasty (TKA). | QUADSENSE providesorthopedic surgeons a toolfor adjustment of the patellaimplant during primary TotalKnee Arthroplasty (TKA). |
| Indications for Use | The VERASENSE is indicated forany medical condition in whichprimary or revision Total KneeArthroplasty (TKA) would beindicated.For use as a tool foradjustment of the femoralknee implant to reduceinstability from flexion gapasymmetry. The VERASENSE issterile, for single patient use. | QUADSENSE is indicated forany medical condition inwhich primary Total KneeArthroplasty (TKA) would beindicated, and the patella isresurfaced.For use as a comparative toolto measure patellofemoraljoint force.Quadsense sensor is sterile,for single patient use. |
| Environment | Hospital | Hospital |
| Electrical Safety | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012. | IEC 60601-1:2005+AMD1:2012+AMD2:2020 |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 | IEC 60601-1-2:2014/AMD1:2020 |
| Usability | Usability evaluation performed | Usability evaluationperformed according to IEC62366-1:2015+A1:2020 |
| Labelling | VERASENSE for Zimmer BiometPersona product label | Product labelling, IFU,QUADSENSE Surgical |
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Image /page/8/Picture/1 description: The image shows the logo for Eventum Orthopaedics. The logo consists of a stylized letter "E" formed by two semi-circles in pink and blue, with a horizontal line in the middle of the pink semi-circle. To the right of the symbol is the word "eventum" in pink, and below that is the word "orthopaedics" in blue.
| Attribute | [Predicate] VERASENSE forZimmer Biomet Persona(K180459) | QUADSENSESubject Device | ||
|---|---|---|---|---|
| VERASENSE knee sensor IFU, and VERASENSE knee sensor and accessories user guide. | Technique User Guide | |||
| Sensor | ||||
| Mechanical | Dimensions | Equal to the dimensions of the implant trial or final liner ± 0.50 mm under all operating conditions. | Diameter of 40mm.Minimum construct thickness of 6mm but shape and thickness can be adjusted by attachments of shims. | |
| 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 record comparative pressure exerted on the patella. Four sensors positioned superiorly, medially, laterally and inferiorly in relation to the anatomy. Sensors record pressure and device acts as a comparator to baseline loads. | ||
| Functional | Applied Force of Load Sensing | Load Range and Accuracy | 5-40 lbf ≤ 3.5 lbf41-70 lbf for reference only | Sensor is calibrated at 70 Newtons (15.7 lbf) with 10% error |
| Maximum Safe Load | 70 lbf | 16.8kg (37.0 lbf) | ||
| Center of Load (COL) Location | For Reference Only | Measurement is not applicable | ||
| Attribute | [Predicate] VERASENSE for Zimmer Biomet Persona (K180459) | QUADSENSE Subject Device | ||
| Communication | Transmission of data from sensor to the LinkStation MINI or LinkStation MINI Evaluation Kit. | Transmission of data from sensor by Analog cable, analog to digital converter, digital cable. | ||
| Battery | 40 min, Battery integrated into wireless sensor device. | QUADSENSE has a minimum operational time of 60 minutes on Panel PC battery power under normal use conditions.QUADSENSE sensor does not include a battery and is powered by the Panel PC. | ||
| ElectricalIEC 60601-1 Medical ElectricalEquipment Classification | Power | Type | Electrically powered via Lithium Ion coin cell | Electrically powered via Panel PC USB 2.0 port, not connected to mains. |
| Operating Voltage and current | 3.1 V DC 30mAH | 5 Vdc, 300 mAdc, 1.5 W MAX | ||
| Protection Against Electric Shock | Internally powered | Electrical insulation | ||
| Installation and Use | Hand held | Portable | ||
| Applied Part | Type BF | Type BF | ||
| Protection against harmful ingress of water of particulate | IPX4 | IP55 | ||
| Attribute | [Predicate]VERASENSE forZimmer Biomet Persona(K180459) | QUADSENSESubject Device | ||
| Wireless Communication | matter | |||
| Mode of Operation | Continuous | Continuous | ||
| Suitability in an oxygen rich environment | No | No | ||
| Purpose | Sensor communicates with Panel PC via wireless connection | Sensor communicates with Panel PC via wired connection. No wireless communication capability is present between the sensor and the Panel PC. | ||
| Technology | Radio Frequency | |||
| Frequency Band | 2402-2480 MHz | |||
| Communication Protocol | Bluetooth Low Energy (BLE) 4.2 | |||
| Range | 2m | |||
| Electromagnetic Interference (EMI) | Sensor will tolerate typical levels of electromagnetic interface experience in the operating room environment. | QUADSENSE will tolerate typical levels of electromagnetic interface experience in the operating room environment. | ||
| Electrostatic Discharge (ESD) | 8kV contact discharge15 kV air discharge | 8kV contact discharge15 kV air discharge | ||
| Environmental | Operating Conditions | Operating temperature | 15 – 37°C | 10 – 35°C |
| Relative humidity | 30 – 100% submersion | 30 – 70% | ||
| Atmospheric | Undisclosed | 70 kPa – 106 kPa | ||
| Attribute | [Predicate] VERASENSE forZimmer Biomet Persona(K180459) | QUADSENSESubject Device | ||
| Storage Conditions | pressure | |||
| MaximumAltitude | Undisclosed | 2000m above sea level. | ||
| Storagetemperature | 0 – 50°C | 10 – 35°C | ||
| Relativehumidity | 10 – 80% non-condensing | 15 – 80% non-condensing | ||
| Atmosphericpressure | 36 kPa – 106 kPa | 70 kPa – 106 kPa | ||
| Materials (patient contacting) | Type of Contact | With tissue/bone | With tissue/bone | |
| Duration of Contact | Limited duration contact (<24hours) | Limited duration contact(<24 hours) | ||
| Housing | Top | Colorless Polycarbonate Resin | MAGNUMTM 8391 MED ABSResin | |
| Bottom | Colorless Polycarbonate Resin | MAGNUMTM 8391 MED ABSResin | ||
| Attachment mechanism | Attached directly to the trialimplants | Attached to the patella using316L Stainless steel pins | ||
| Shims | VITREX PolyEtherEtherKetone(PEEK) 381G & stainless-steelmetal plates | MAGNUMTM 8391 MED ABSResin | ||
| Sterilization Method | Ethylene Oxide 10-6 SAL | Ethylene Oxide 10-6 SAL | ||
| Shelf Life | 14 months | 12 months | ||
| Packaging | Sterile, Double Tyvek / Filmpouches, chipboard box | Sterile, Double Paper, PET/PEFilm pouches, cardboard box |
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Image /page/9/Picture/1 description: The image shows the logo for Eventum Orthopaedics. The logo consists of a stylized "E" symbol, with the left half in pink and the right half in blue. To the right of the symbol is the word "eventum" in pink, with the word "orthopaedics" in blue underneath.
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Image /page/10/Picture/1 description: The image shows the logo for Eventum Orthopaedics. The logo consists of a stylized letter "E" on the left, with the top half in pink and the bottom half in navy blue. To the right of the "E" is the word "eventum" in pink, and below that is the word "orthopaedics" in navy blue.
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Image /page/11/Picture/1 description: The image shows the logo for Eventum Orthopaedics. The logo consists of a stylized "E" symbol on the left, with the word "eventum" in pink to the right of the symbol. Below the word "eventum" is the word "orthopaedics" in a dark blue color. The "E" symbol is made up of two semi-circles, one in pink and one in dark blue, with a horizontal line in the center of the pink semi-circle.
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Image /page/12/Picture/1 description: The image shows the logo for Eventum Orthopaedics. The logo consists of a stylized "E" symbol on the left, with the word "eventum" in pink to the right of the symbol. Below "eventum" is the word "orthopaedics" in a dark blue color. The "E" symbol is made up of two semi-circles, one in pink and one in dark blue, with a horizontal line in the center.
| Attribute | [Predicate] VERASENSE forZimmer Biomet Persona(K180459) | QUADSENSESubject Device |
|---|---|---|
| Firmware | VERASENSE knee sensorfirmware version 2.2.2 whichincludes communication modesand calibration coefficient. | QUADSENSE Sensorfirmware |
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Image /page/13/Picture/1 description: The image shows the logo for Eventum Orthopaedics. The logo consists of a stylized "E" symbol on the left, with the word "eventum" in pink text to the right. Below "eventum" is the word "orthopaedics" in a smaller, blue font.
7 Performance Data
The following performance data were provided in support of the substantial equivalence determination.
7.1 Biocompatibility Testing
The biocompatibility evaluation for QUADSENSE was conducted in accordance with International Standard ISO 10993-1:2018, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". The biocompatibility tests conducted were:
- Cytotoxicity ●
- Sensitisation
- Irritation ●
- Acute systemic toxicity
- Material mediated pyrogenicity.
The QUADSENSE 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 QUADSENSE, the device meets the requirements.
7.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on QUADSENSE. The subject device complies with the IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for EMC.
7.3 Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" The software accessory for this device was determined to require a basic documentation level, since QUADSENSE software application provides data in real time to the surgeon of the amount of force applied through the patellofemoral joint. The QUADSENSE software application does not directly drive a decision regarding treatment or therapy.
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Image /page/14/Picture/1 description: The image shows the logo for Eventum Orthopaedics. The logo consists of a stylized "E" symbol on the left, with the word "eventum" in pink text to the right of the symbol. Below the word "eventum" is the word "orthopaedics" in a smaller, blue font.
7.4 Cybersecurity
Cybersecurity threat modelling was performed. Cybersecurity risk management was performed, and mitigation measures adopted to reduce cybersecurity exposure to an acceptable level. Documentation on cybersecurity measures was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
7.5 Performance Testing
The QUADSENSE has been designed and developed in accordance with Eventum Orthopaedics Standard Operating Procedures for product design and development in line with 21 CFR 820 and in line with an externally certified ISO 13485:2016 quality management system.
The safety performance of the QUADSENSE has been verified and validated to ensure that the product meets its intended use, including:
- Performance Testing (i.e., measurement of load changes due to resurfacing of the patella)
- Biocompatibility Assessment ●
- Sterilisation
- Packaging Integrity
- Shelf life
- Software Verification and Validation
- Electrical Safety IEC 60601-1 ●
- Electromagnetic Compatibility (EMC) IEC 60601-1-2 ●
- Cybersecurity
7.6 Performance Testing Animal
This submission does not include any animal performance testing. It was determined that no such testing was required to demonstrate substantial equivalence.
Performance Testing Clinical 7.7
This submission does not contain any clinical performance testing. We determined no such testing was required to demonstrate substantial equivalence.
Conclusions ၀၀
The subject device QUADSENSE and required accessories have the same intended use, indications for use, environment of use, sterilization method, operating principle, packaging, electrical safety, and electromagnetic compatibility as the predicate device VERASENSE for
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Image /page/15/Picture/1 description: The image contains the logo for Eventum Orthopaedics. The logo consists of a stylized "E" symbol on the left, with the word "eventum" in pink text to the right of the symbol. Below the word "eventum" is the word "orthopaedics" in a smaller, blue font.
Zimmer Biomet Persona and required accessories. The differences in knee location application, wireless communications, materials, IP rating and shelf life have been identified and we determined that they have no impact on safety and effectiveness. Thus, the QUADSENSE is substantially equivalent to the previously cleared K180459 VERASENSE for Zimmer Biomet Persona and required accessories.
§ 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).