(139 days)
No
The summary does not mention AI, ML, or related terms, and the described functionalities (planning, guidance, assessment, multi-needle planning, ablated zone measurement) are consistent with traditional image processing and navigation techniques.
No.
The device is described as a "stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments," which implies it is a tool used in a therapeutic procedure rather than performing the therapy itself. It is a guidance and planning system, not an instrument that directly applies a therapeutic effect.
No
The document describes the EPIONE device as a user-controlled, stereotactic accessory intended to assist in the planning, manual advancement, and verification of instrument position during CT-guided percutaneous ablation procedures. Its primary function is to guide interventional procedures, not to diagnose a condition or disease.
No
The device description explicitly lists hardware components: Robot cart, Display cart, Navigation cart, EPIONE instruments (Needle guide, Patient reference, Short Navigation probe). While it includes software, it is not solely software.
Based on the provided text, the EPIONE device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- EPIONE's Function: The EPIONE device is described as 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 ablation procedures". It is used during a medical procedure to guide instruments within the body, not to analyze samples taken from the body.
- No Mention of Sample Analysis: The description focuses on image-guided navigation, instrument placement, and monitoring of patient position and respiratory levels. There is no mention of analyzing biological samples.
Therefore, the EPIONE device falls under the category of a surgical accessory or navigation system, not an in vitro diagnostic device.
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 ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G. During the planning phase, the desired instrument and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory 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.
Product codes
JAK
Device Description
The proposed Epione v1.0.2 is a modified version of the Epione predicate device as was cleared under 510(k) K211645. Aside from the modifications that are summarized further below, the Epione v1.0.2 is the same as the predicate as follows.
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device 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) quided 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 with rigid straight instruments such as needles, and applicators (cryoprobes, electrodes, and antennas), used in CT-guided interventional procedures performed by physicians trained for CT procedures on organs and anatomical structures in the abdomen.
The EPIONE device v1.0.2 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, Short Navigation probe
The modifications include :
- expanding its ablation procedure indications to organs in the abdomen as compared to ablation procedures only on the liver in the Epione predicate,
- the addition of a new software functionalities to facilitate multi-needle planning that include configurable multiple needle array configurations for simultaneous needle group planning as compared to the planning of one needle at a time in a sequential manner in the Epione predicate,
- the addition of post-procedure imaging software tools to measure the post-procedure ablated zones as compared to only visual assessment in the Epione predicate, and
- the addition of an alternate shortened version of the navigation probe as compared to original longer version in the Epione predicate. This short navigation probe replaces the longer original navigation probe.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians trained for CT procedures; performed under general anesthesia
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 were repeated from the EPIONE predicate.
- Respiratory Monitoring Effectiveness Tests were repeated from the EPIONE predicate.
- Positional accuracy testing was re-performed in accordance with the ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems to re-verify that the static positioning accuracy of the device when using the new shorter navigation probe was maintained as in the Epione predicate with the longer navigation probe.
- Usability Testing, in accordance to IEC 62366-1:2015 and the FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices was re-performed.
- Software design and verification and validation testing was completed in compliance to the FDA guidance "Content of Premarket Submissions for Software Contained in Medical Devices", the new draft guidance "Content of Premarket Submissions for Device Software Functions", the IEC 62304 Standard "Medical Device Software – Life Cycle Process", as well as FDA cybersecurity premarket quidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
Clinical study:
- Study Type: non-interventional study
- Sample Size: first 33 patients (interim data from an ongoing clinical study)
- Key Results: The interim results demonstrate the in-vivo equivalence in safety and effectiveness of the EPIONE v1.0.2 for procedures in the abdomen as compared to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EPIONE (JAK, K211645), MAXIO (JAK, K132108)
Reference Device(s)
Not Found
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.
0
May 3, 2023
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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Quantum Surgical SAS % Elise Lagacherie Quality Assurance & Regulatory Affairs Director ZAC Eureka 1000 Rue du Mas de Verchant 34000 Montpellier FRANCE
Re: K223758
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: March 31, 2023 Received: April 3, 2023
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 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
1
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 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-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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223758
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 ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G. During the planning phase, the desired instrument and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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 and the words "QUANTUM surgical" on the right. The word "QUANTUM" is in orange, and the word "surgical" is in gray.
K223758
510(k) SUMMARY
Date prepared: 02, May 2023
Submitter
Quantum Surgical SAS
1000 rue du mas de Verchant 34000 Montpellier France
Contact Person:
Elise Lagacherie, Quality & Regulatory 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
Primary Predicate Device
EPIONE® (JAK, K211645), Quantum Surgical SAS
Secondary Predicate Device
MAXIO (JAK, K132108), Perfint Healthcare Pvt. Ltd.
Note : This proposed new version for EPIONE, will be referred to as "EPIONE v1.0.2" to differentiate it from the original EPIONE predicate.
Device Description
The proposed Epione v1.0.2 is a modified version of the Epione predicate device as was cleared under 510(k) K211645. Aside from the modifications that are summarized further below, the Epione v1.0.2 is the same as the predicate as follows.
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device 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) quided 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 with rigid straight instruments such as needles, and applicators (cryoprobes, electrodes, and antennas), used in CT-guided interventional procedures performed by physicians trained for CT procedures on organs and anatomical structures in the abdomen.
The EPIONE device v1.0.2 consists in the following components:
4
Image /page/4/Picture/0 description: The image contains the logo for Quantum Surgical. The logo consists of an orange hexagon with a stylized "Q" shape formed by a thick orange line wrapping around the hexagon. To the right of the hexagon is the text "QUANTUM" in orange, stacked above the word "surgical" in gray. The logo appears to be for a medical or surgical company.
| 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 | |
| Short Navigation probe |
The modifications include :
- expanding its ablation procedure indications to organs in the abdomen as compared to ablation procedures only on the liver in the Epione predicate,
- the addition of a new software functionalities to facilitate multi-needle planning that include configurable multiple needle array configurations for simultaneous needle group planning as compared to the planning of one needle at a time in a sequential manner in the Epione predicate,
- the addition of post-procedure imaging software tools to measure the post-procedure ablated zones as compared to only visual assessment in the Epione predicate, and
- the addition of an alternate shortened version of the navigation probe as compared to original longer version in the Epione predicate. This short navigation probe replaces the longer original navigation probe.
EPIONE v1.0.2 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 ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G.
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.
5
Image /page/5/Picture/0 description: The image shows 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.
Comparison with the primary and secondary predicate devices
| EPIONE v1.0.2 | EPIONE | MAXIO | |
|---|---|---|---|
| Proposed device | Primary Predicate device | Secondary 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 | |||
| ablation procedures in the abdomen, | |||
| performed by physicians trained for CT | |||
| procedures and performed under general | |||
| anesthesia with rigid straight instruments | |||
| such as needles and probes of diameters | |||
| ranging from 11G to 19G. | |||
| 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 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 general anesthesia conditions | For use under local and general anesthesia
conditions |
| Intra-
interventional
Planning | Physician defines trajectories 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. | Physician defines trajectory per an entry point
and a target point on CT images. |
| Interventional
instruments | Rigid straight interventional instruments such as
needles, probes for biopsy, ablation and drainage
from 11G to 19G | Rigid straight interventional instruments such as
needles, probes for biopsy, ablation and drainage
from 11G to 19G | Rigid straight interventional instruments such as
needles, probes for biopsy, ablation and drainage
from 11G to 21G |
| | EPIONE v1.0.2
Proposed device | EPIONE
Primary Predicate device | MAXIO
Secondary Predicate device |
| Needle
configuration and
performance | • Needle selection amongst a list of predefined
needles
• Manufacturer defined performances (e.g.
ablation zones)
• User-defined performances (tools for
assessment of ablation zones) | • Needle selection among a list of predefined
needles
• Manufacturer defined performances (e.g.
ablation zones) | • Needle selection amongst a list of predefined
needles
• Manufacturer defined performances (e.g.
ablation zones).
• User-defined performances (tools for
assessment of ablation zones). |
| Needle guidance | • Robotic arm with needle guide is positioned
on the desired trajectories 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 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. | 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 CT scan 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. | 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 are also
used to verify also per a laser cross-hairs that the
relative locations of the CT scan 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 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
needle guidance) |
| | EPIONE v1.0.2
Proposed device | EPIONE
Primary Predicate device | MAXIO
Secondary Predicate device |
| 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 | Radiology).and visual comparison with the reference level during needle guidance.
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. | Register intra-interventional CT series with post procedure CT series to display planned target position on Post-procedure CT image.
Also includes tools to segment ablated zone in post-ablation images, and to register pre and post ablation image, to perform a visual assessment of the ablation. |
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Image /page/6/Picture/0 description: The image contains the logo for Quantum Surgical. The logo consists of an orange icon on the left and the text "QUANTUM surgical" on the right. The icon is an abstract shape that resembles the letter "Q". The word "QUANTUM" is in orange, and the word "surgical" is in gray.
7
Image /page/7/Picture/0 description: The image contains the logo for Quantum Surgical. The logo consists of an orange stylized letter "Q" on the left, with the words "QUANTUM" in orange and "surgical" in gray to the right of the "Q". The "Q" is made up of a hexagon shape with a line extending from the bottom left corner.
The comparisons between the EPIONE v1.0.2 and EPIONE and MAXIO predicates determined that:
- The general intended use is unchanged with the proposed modifications and is equivalent to that of the EPIONE and Maxio predicates.
- · The extension of the anatomical/organ anatomy in the EPIONE v1.0.2 to include procedures on organs and structures in the abdoninal area, as compared to procedures on the live in the EPONE predicate, is within the indications of the secondary in indications was supported with clinical data showing equivalent performance to the Maxio predicate.
- · The EPIONE v1.0.2 has equivalent technological characters. The new software multi-needle and ablation assessment features and the new shorter Navigation Probe instrument include modifications without impacting the overal technology intended use, or indications for use. The added multi-needle are also similarly provided in the Maxio predicate. These changes do not raise different questions of safety or effectiveness as compared to the predicates.
8
Summary of Non-Clinical Performance Data:
To establish substantial equivalence with predicates and to verify that the EPIONE v1.0.2 will perform safely and effectively per its intended use equivalently to the EPIONE predicate:
- . The following in-vitro performance tests were repeated from the EPIONE predicate to verify that no software implementation errors were introduced:
- o Overall System Accuracy Tests,
- o Respiratory Monitoring Effectiveness Tests and
- . The positional accuracy testing was re-performed as in the Epione predicate in accordance with the ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems to re-verify that the static positioning accuracy of the device when using the new shorter navigation probe was maintained as in the Epione predicate with the longer navigation probe.
- . Usability Testing, in accordance to IEC 62366-1:2015 and the FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices was re-performed similarly as the EPIONE predicate to demonstrate that the new multi-needle feature is safe and effective for the intended users, uses and use environments.
Additionally, Software design and verification and validation testing was completed similarly as in the Epione predicate to establish the device's safety and effectiveness including verifying the correct implementation of the various software changes in compliance to the FDA guidance "Content of Premarket Submissions for Software Contained in Medical Devices", the new draft guidance "Content of Premarket Submissions for Device Software Functions", the IEC 62304 Standard "Medical Device Software – Life Cycle Process", as well as FDA cybersecurity premarket quidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
Clinical study
This includes the interim data from an ongoing clinical in France. The main objective of this noninterventional study is to investigate the performance of EPIONE v1.0.2 as used for CT-guided procedures in different organs of the abdomen. The interim results of this study with the first 33 patients demonstrate the in-vivo equivalence in safety and effectiveness of the EPIONE v1.0.2 for procedures in the abdomen as compared to the predicates.
Conclusions
The EPIONE v1.0.2 was demonstrated to have the same overall intended use as the predicates with its expanded indication from its Epione predicate being within that of the Maxio predicate. The information supports that it has equivalent technological characteristics with the predicates that do not raise different questions of safety and effectiveness. The testing includes bench testing, animal, and clinical testing demonstrating that the device should be as safe and effective in achieving its intended use as in the predicates. The EPIONE device v1.0.2 is therefore substantially equivalent to the predicates devices.