Epione

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February 24, 2022 Quantum Surgical SAS % Elise Lagacherie Ouality Assurance and Regulatory Affairs Director ZAC Eureka 1000 rue du Mas de Verchant Montpellier, 34000 FRANCE Re: K211645 Trade/Device Name: Epione Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: January 19, 2022 Received: January 21, 2022 Dear Elise Lagacherie: 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). 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Sincerely, Laurel Burk Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K211645 Device Name EPIONE #### Indications for Use (Describe) The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data. The device is indicated for use in liver ablation procedures under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G by physicians trained for CT procedures. | 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. 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The logo appears to be for a medical or technology company. # K211645 510(k) SUMMARY Date prepared: 23, February 2022 #### Submitter ## Quantum Surgical SAS 1000 rue du mas de Verchant 34000 Montpellier France ## Contact Person: Elise Lagacherie, Quality & Requlatory Affairs Director e.lagacherie@quantumsurgical.com #### Device: Name of Device: EPIONE™ Common or Usual Name: Computer assisted Surgical System. Classification Name: Computed tomography X-ray system (21 CFR 892.1750) Requlatory Class: II Product Code: JAK #### Predicate Device MAXIO (JAK, K132108), Perfint Healthcare Pvt. Ltd., #### Reference Device: CAS-One IR (JAK, K152473), CAScination AG #### Device Description The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning phase, the desired instrument placement and performance is defined relative to the tarqet anatomy. During the quidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data. The device is indicated for use in liver ablation procedures under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G by physicians trained for CT procedures. The EPIONE device consists in the following components: | Robot cart | This mobile equipment can be moved in and out of the intervention room and is positioned next to the patient. The cart carries a robotic arm including a force sensor assembly allowing handguiding of the robotic arm by the user. The robotic arm movements are enabled by the user using a footswitch. The robot cart also embeds the electronic systems required to power and operate the robot arm. | |------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Quantum Surgical. The logo consists of an orange geometric shape on the left and the words "QUANTUM surgical" on the right. The word "QUANTUM" is in orange, and the word "surgical" is in gray. | Display cart | This mobile equipment can be moved in and out of the intervention room and is positioned next to the operator. The cart carries a touchscreen to operate the system. | |--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Navigation cart | This mobile equipment can be moved in and out of the intervention room and is positioned next to the table. The cart carries a navigation camera. | | EPIONET™ software | A software provides the step-by-step workflow assistance for intervention planning and intraoperative positioning of the robotic arm for instruments placement and post-operative assessment. | | EPIONE instruments | Needle guide<br>Patient reference<br>Navigation probe | #### Indications for Use The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data. The device is indicated for use in liver ablation procedures under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G by physicians trained for CT procedures. | | EPIONE | MAXIO<br>predicate device | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use /<br>Indication for Use | The EPIONE device is a user controlled,<br>stereotactic accessory intended to assist in the<br>planning and manual advancement of one or<br>more instruments, as well as in verification of<br>instrument position during Computed<br>Tomography (CT) guided percutaneous<br>procedures.<br>During the planning phase, the desired<br>instrument placement and performance is<br>defined relative to the target anatomy. During<br>the guidance phase, the device enables to<br>monitor respiratory levels and verify patient<br>position prior to instrument advancement.<br>During the assessment phase, the achieved<br>instrument placement and performance are<br>displayed relative to the previously defined plan<br>through an overlay of the pre- and post-<br>treatment image data.<br>The device is indicated for use in liver ablation<br>procedures under general anesthesia with rigid<br>straight instruments such as needles and probes<br>of diameters ranging from 11G to 19G by<br>physicians trained for CT procedures. | MAXIO is a user controlled, stereotactic<br>accessory intended to assist in the planning and<br>manual advancement of one or more<br>instruments during Computed Tomography (CT)<br>guided percutaneous procedures.<br>MAXIO permits physician verification of patient<br>position prior to needle advancement and<br>monitoring of respiratory levels during the<br>procedure.<br>Image registration and overlay tools available in<br>MAXIO are intended to provide guidance to the<br>user during planning and instrument placement.<br>MAXIO is indicated for use with rigid straight<br>instruments such as needles and probes used in<br>Computed Tomography (CT) guided<br>percutaneous interventional procedures<br>performed by physicians trained for CT<br>procedures on organs and anatomical structures<br>in the thorax, abdomen and pelvis. | | Patient Anesthesia<br>Conditions | For use under general anesthesia conditions | For use under local to general anesthesia<br>conditions | | | EPIONE | MAXIO | | | | predicate device | | Intra-interventional<br>Planning | Physician defines trajectory per an entry point<br>and a target point on CT images. | Physician defines trajectory per an entry point<br>and a target point on CT images. | | Interventional<br>instruments | Rigid straight interventional instruments such as<br>needles and probes for ablation from 11G to<br>19G. | Rigid straight interventional instruments such as<br>needles, probes for biopsy, ablation and<br>drainage from 11G to 21G. | | Needle<br>configuration and<br>performance | • Needle selection among a list of predefined<br>needles<br>• Manufacturer defined performances (e.g.<br>ablation zones). | • Needle selection among a list of predefined<br>needles<br>• Manufacturer defined performances (e.g.<br>ablation zones).<br>• User-defined performances (e.g. ablation<br>zones). | | Needle guidance | • Robotic arm with needle guide is positioned<br>on the desired trajectory as was planned on<br>the intra-interventional CT images.<br>• Instrument (e.g. needle) is then manually<br>advanced through the guide on the planned<br>trajectory. | • Robotic arm with needle guide instrument is<br>positioned on the desired trajectory as was<br>planned on the intra-interventional CT images.<br>• Instrument (e.g. needle) is then manually<br>advanced through the guide on the planned<br>trajectory. | | Patient registration | Automatic patient location to image registration<br>per array of markers on a patient reference<br>instrument placed on the patient's skin and<br>included in the CT-scan images and which are<br>located using an optical tracking system. | The location of the robotic workstation is located<br>to a fixed established reference position relative<br>to the C-arm and bed per the use of a docking<br>mat and calibration process performed during<br>the initial workstation installation. | | Patient<br>Registration<br>verification | The navigation probe is pointed to pre-identified<br>points on the patient (skin markers) to verify<br>their relative locations. | Skin markers are placed on the patient and<br>included in the CT-scan and located when<br>planning. Then before needle placement, it is<br>verified using a laser system that the patient has<br>not moved by verifying that the locations of the<br>skin markers are still in the same location as<br>when scanned. In addition, table markers on the<br>C-arm are also used to verify also per a laser<br>cross-hairs that the relative locations of the C-<br>arm and robot workstation have not changed<br>from the original installation. | | Respiratory Motion<br>Management | Respiratory motion control using breath-hold<br>Measurement of apnea reference level during<br>the intra-interventional planning CT imaging.<br>Live display of respiratory level using the markers<br>/ patient reference placed on the patient and<br>visual comparison with the reference level<br>during needle guidance. | Respiratory motion control using breath-hold.<br>Measurement of apnea reference level during<br>the intra-interventional planning CT imaging.<br>Live display of respiratory level using a<br>respiratory belt mounted on the patient<br>(Medspira Breath-Hold for Interventional<br>Radiology) and visual comparison with the<br>reference level during needle guidance. | | Intra-interventional<br>verification | Verification CT Image registration with planning<br>CT to compare achieved needle position to<br>planned needle trajectory. | Verification CT Image registration with planning<br>CT to compare achieved needle position to<br>planned needle trajectory. | | Post-procedure<br>verification | Register intra-interventional CT series with post<br>procedure CT series to display planned target<br>position on Post-procedure CT image. | Register intra-interventional CT series with post<br>procedure CT series to display planned target<br>position on Post-procedure CT image. | #### Comparison of Technological Characteristics with the predicate device {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Quantum Surgical. The logo consists of an orange hexagon with a stylized "Q" shape on the left side. To the right of the hexagon is the text "QUANTUM" in a larger, bolder font, stacked above the word "surgical" in a smaller font. The comparisons between the EPIONE and the predicate determined that: - The EPIONE device has the same general intended use as the predicate. The indications for use of the EPIONE is for liver ablations as in the predicate except that the predicate has a wider indication to also include other procedures and anatomical areas. The EPIONE is therefore equivalent to the predicate in this respect within its indications for use in liver ablations. - The EPIONE device is limited for use for patients under general anesthesia as in the predicate except that the predicate allows also for local anesthesia conditions. The EPIONE device is therefore equivalent to the predicate within its use under general anesthesia conditions. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Quantum Surgical. The logo consists of an orange geometric shape resembling a stylized "q" on the left, followed by the words "QUANTUM" in orange and "surgical" in gray on the right. The geometric shape is made up of connected lines and angles, creating a modern and abstract design. - The EPIONE device is compatible for use with interventional instruments with diameters ranging from 11G to 19G as compared to the predicate with a wider range of 11G to 21G. Given that the proposed EPIONE range is within that of the predicate, the EPIONE device is therefore equivalent to the predicate within its narrower range. - · The EPIONE device was shown to have equivalent technological characteristics to the predicate including a robotic arm to position the needle guide per the planned trajectory. An important difference is that the EPIONE additionally implements an optical tracking system to both register and track the patient location and instrumentation to ensure correct placement of the needle relative to the CT based planned trajectory. The predicate alternately utilizes a locating mat and location calibration process at installation to provide for a fixed known location of the C-arm, and a laser system to thereafter ensure that the patient location has not changed. However, this different technological approach in the EPIONE is, along with other related differences in instrumentation for use with the tracking system, is supported by an equivalent implementation of an optical tracking system in the reference device, the CAS-One IR, for the same purposes and the same intended use as the EPIONE. This should then not raise any new questions of safety or effectiveness. #### Summary of Non-Clinical Performance Data: The following nonclinical performance testing was conducted to establish substantial equivalence and to verify that the EPIONE device will perform safely and effectively per its intended use: - . Overall System Accuracy Tests - . Respiratory Monitoring Effectiveness Tests - . Needle Bending Test Study - Positional accuracy testing in accordance with the ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems - Electrical Safety Tests, in accordance with IEC 60601-1 - . Electromagnetic Compatibility Tests, in accordance with IEC 60601-1-2 - . Biocompatibility Tests, in accordance with standard ISO 10993 for patient contacting components - Cleaning and Sterilization Validation Tests, for the instrument reprocessing - . Usability Testing, in accordance with IEC 62366-1:2015 and the FDA quidance document Applying Human Factors and Usability Engineering to Medical Devices. A preclinical animal study on the liver was conducted on porcine models using the EPIONE device to demonstrate safety and effectiveness of the device. The study evaluated the accuracy, safety, and feasibility of robotically assisted CT-guided needle placement in the liver of an in-vivo model (with breathing movements) with the EPIONE device. A total of 36 needle placements were performed in the liver. The average accuracy of the system demonstrates that the EPIONE device is safe and effective for CT-guided needle placement in the liver. Additionally, Software design and velidation testing was completed in completed in compliance with the FDA guidance "Content of Premarket Submissions for Software Contained in Medical Devices", the IEC 62304 Standard "Medical Device Software - Life Cycle Process", as well as FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The performance testing of the EPIONE device demonstrated that it should be as safe and as effective as the predicate device. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for Quantum Surgical. The logo consists of an orange hexagon with a stylized "q" shape on the left side. To the right of the hexagon, the words "QUANTUM" are written in orange, and below that, the word "surgical" is written in gray. ## Clinical study A multi-center, prospective and interventional clinical study, was performed using the EPIONE™ device for liver ablations on 21 patients under general anesthesia to supplement the bench and preclinical animal testing and confirm the safety and performance of the results of this study show that the EPIONE™ device is safe and effective for CT-quided percutaneous procedures for liver ablations under general anesthesia conditions with no adverse events reported for any of the subjects. ## Conclusions Compared to the predicate, the EPIONE device has the same intended use, indications for use within that of the predicate, patient anesthesia condition within that of the predicate, and equivalent technological characteristics. The differences between the EPIONE device and the predicate do not raise different questions of safety and effectiveness. The testing including bench testing, animal, and clinical testing demonstrated that the device should be as safe and effective in achieving its intended use as in the predicate. The EPIONE™ device is therefore substantially equivalent to the identified predicate device.