(272 days)
CAS-One IR (JAK, K152473)
No
The summary describes a robotic stereotactic system for CT-guided procedures with image registration and navigation capabilities, but it does not mention the use of AI or ML algorithms for any of its functions.
No.
The EPIONE device is a stereotactic accessory intended to assist in planning, manual advancement of instruments, and verification of instrument position during CT-guided percutaneous procedures, specifically for liver ablation. It is used in conjunction with instruments like needles and probes, but it does not directly perform a therapeutic action itself; it aids the physician in carrying out the therapeutic procedure.
No
The EPIONE device is described as a "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," and for "intraoperative positioning of the robotic arm for instruments placement and post-operative assessment." Its primary function is to guide interventional procedures, not to diagnose a disease or condition. While it uses CT imaging and provides "assessment" of instrument placement, this assessment is in the context of verifying the success of an intervention, not for initial diagnosis.
No
The device description explicitly lists multiple hardware components including a robot cart, display cart, navigation cart, and EPIONE instruments (needle guide, patient reference, navigation probe), in addition to the software.
Based on the provided information, the EPIONE device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The EPIONE device is a surgical accessory that assists in placing instruments into the human body for procedures like liver ablation. It works with imaging data (CT scans) of the patient's anatomy, not with biological samples like blood, urine, or tissue that are analyzed outside the body.
- The intended use is procedural guidance and assistance. The device's purpose is to aid physicians in planning, guiding, and verifying the placement of instruments during CT-guided percutaneous procedures. This is a procedural function, not a diagnostic one based on analyzing biological samples.
- The device description focuses on hardware and software for surgical assistance. The components (robot cart, display cart, navigation cart, software, instruments) are all designed to facilitate the physical process of instrument placement and navigation within the body.
- The performance studies evaluate accuracy of instrument placement and safety during the procedure. The studies described (accuracy tests, animal studies, clinical studies) focus on the device's ability to accurately guide instruments and its safety during the surgical procedure, not on the accuracy of a diagnostic test performed on a sample.
In summary, the EPIONE device is a surgical guidance system, not a device used to perform diagnostic tests on samples taken from the body. Therefore, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
JAK
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 target anatomy. During the guidance 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.
- 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.
- EPIONE™ 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, Patient reference, Navigation probe
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Liver (for ablation procedures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians trained for CT procedures, under general anesthesia conditions in an intervention room.
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)
Non-Clinical Performance Data:
- 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.
- Preclinical animal study: 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.
- Software design and validation testing: 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".
Clinical study:
- Study type: A multi-center, prospective and interventional clinical study
- Sample size: 21 patients
- Study results: The results of this study show that the EPIONE device is safe and effective for CT-guided percutaneous procedures for liver ablations under general anesthesia conditions with no adverse events reported for any of the subjects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MAXIO (JAK, K132108)
Reference Device(s)
CAS-One IR (JAK, K152473)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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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). 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.
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
1
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 (QS) 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,
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
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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)
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Image /page/3/Picture/0 description: The image shows the logo for Quantum Surgical. The logo consists of an orange geometric shape on the left, resembling a stylized letter "Q". To the right of the shape, the words "QUANTUM" and "surgical" are written in gray, with "QUANTUM" on top of "surgical". 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. |
|---|---|
| ------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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 |
| Patient reference | |
| 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
predicate device |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use /
Indication 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. | MAXIO is a user controlled, stereotactic
accessory intended to assist in the planning and
manual advancement of one or more
instruments during Computed Tomography (CT)
guided percutaneous procedures.
MAXIO permits physician verification of patient
position prior to needle advancement and
monitoring of respiratory levels during the
procedure.
Image registration and overlay tools available in
MAXIO are intended to provide guidance to the
user during planning and instrument placement.
MAXIO is indicated for use with rigid straight
instruments such as needles and probes used in
Computed Tomography (CT) guided
percutaneous interventional procedures
performed by physicians trained for CT
procedures on organs and anatomical structures
in the thorax, abdomen and pelvis. |
| Patient Anesthesia
Conditions | For use under general anesthesia conditions | For use under local to general anesthesia
conditions |
| | EPIONE | MAXIO |
| | | predicate device |
| Intra-interventional
Planning | Physician defines trajectory per an entry point
and a target point on CT images. | Physician defines trajectory per an entry point
and a target point on CT images. |
| Interventional
instruments | Rigid straight interventional instruments such as
needles and probes for ablation from 11G to
19G. | Rigid straight interventional instruments such as
needles, probes for biopsy, ablation and
drainage from 11G to 21G. |
| Needle
configuration and
performance | • Needle selection among a list of predefined
needles
• Manufacturer defined performances (e.g.
ablation zones). | • Needle selection among a list of predefined
needles
• Manufacturer defined performances (e.g.
ablation zones).
• User-defined performances (e.g. ablation
zones). |
| Needle guidance | • Robotic arm with needle guide is positioned
on the desired trajectory as was planned on
the intra-interventional CT images.
• Instrument (e.g. needle) is then manually
advanced through the guide on the planned
trajectory. | • Robotic arm with needle guide instrument is
positioned on the desired trajectory as was
planned on the intra-interventional CT images.
• Instrument (e.g. needle) is then manually
advanced through the guide on the planned
trajectory. |
| Patient registration | Automatic patient location to image registration
per array of markers on a patient reference
instrument placed on the patient's skin and
included in the CT-scan images and which are
located using an optical tracking system. | The location of the robotic workstation is located
to a fixed established reference position relative
to the C-arm and bed per the use of a docking
mat and calibration process performed during
the initial workstation installation. |
| Patient
Registration
verification | The navigation probe is pointed to pre-identified
points on the patient (skin markers) to verify
their relative locations. | Skin markers are placed on the patient and
included in the CT-scan and located when
planning. Then before needle placement, it is
verified using a laser system that the patient has
not moved by verifying that the locations of the
skin markers are still in the same location as
when scanned. In addition, table markers on the
C-arm are also used to verify also per a laser
cross-hairs that the relative locations of the C-
arm and robot workstation have not changed
from the original installation. |
| Respiratory Motion
Management | Respiratory motion control using breath-hold
Measurement of apnea reference level during
the intra-interventional planning CT imaging.
Live display of respiratory level using the markers
/ patient reference placed on the patient and
visual comparison with the reference level
during needle guidance. | Respiratory motion control using breath-hold.
Measurement of apnea reference level during
the intra-interventional planning CT imaging.
Live display of respiratory level using a
respiratory belt mounted on the patient
(Medspira Breath-Hold for Interventional
Radiology) and visual comparison with the
reference level during needle guidance. |
| Intra-interventional
verification | Verification CT Image registration with planning
CT to compare achieved needle position to
planned needle trajectory. | Verification CT Image registration with planning
CT to compare achieved needle position to
planned needle trajectory. |
| Post-procedure
verification | Register intra-interventional CT series with post
procedure CT series to display planned target
position on Post-procedure CT image. | Register intra-interventional CT series with post
procedure CT series to display planned target
position on Post-procedure CT image. |
Comparison of Technological Characteristics with the predicate device
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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.
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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.
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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.