(27 days)
The InVision 1.5 Surgical Theatre is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and that displays the internal structure and/or function of the head, body or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The InVision 1.5 Surgical Theatre may also be used for imaging during intraoperative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.
The InVision 1.5 Surgical Theatre may also be used for imaging in a multi-room suite.
The proposed InVision™ 1.5 Surgical Theatre is a traditional Magnetic Resonance Imaging (MRI) scanner that is suspended on an overhead rail system. It is designed to operate inside a Radio Frequency (RF) shielded room to facilitate intraoperative and multi-room use. The InVision 1.5 Surgical Theatre uses a scanner, the Siemens MAGNETOM Sola (K203443, reference device), to produce images of the internal structures of the head as well as the whole body. The Siemens 1.5T MAGNETOM Sola MRI scanner is an actively shielded magnet with a magnetic field strength of 1.5 Tesla.
The InVision 1.5 Surgical Theatre provides surgeons with access to magnetic resonance (MR) images while in the surgical field without changing the surgical/clinical workflow. When images are requested in the operating room (OR), the magnet is moved from the diagnostic room (DR) to the OR on a pair of overhead rails while the patient remains stationary during the procedure. Imaging is performed and once complete the magnet is moved out of the OR to the DR. The magnet can be moved in and out of the surgical field multiple times, as required, throughout the course of the surgical procedure. When the Siemens MAGNETOM Sola MRI scanner is in the DR, the OR may be used as a standard OR, utilizing standard surgical instruments and equipment during surgery. When not required in the OR, the scanner is available for use in the DR as a standard diagnostic MRI.
This document primarily focuses on the substantial equivalence of a new medical device, the InVision™ 1.5 Surgical Theatre, to a previously cleared predicate device, the IMRIS iMRI 3T V. The information provided is characteristic of a 510(k) premarket notification to the FDA, which aims to demonstrate that a new device is as safe and effective as an already legally marketed device, and not a study proving the device meets specific acceptance criteria typical of an AI/ML software performance study.
Therefore, many of the specific details requested in the prompt, such as acceptance criteria in terms of AI model performance metrics (e.g., sensitivity, specificity, AUC), sample size for test sets directly related to AI performance, expert adjudication methods for ground truth, MRMC studies, or standalone algorithm performance, are not applicable or present in this document. This submission is for a physical medical device (an MRI scanner system with a moving gantry), not an AI/ML software.
However, I can extract information related to the device's validation and comparison to its predicate:
Acceptance Criteria and Device Performance (as per 510(k) for a physical device):
The "acceptance criteria" in this context are related to demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The performance is assessed through non-clinical testing to ensure it meets safety and functional standards, and maintains clinically acceptable imaging performance.
1. Table of acceptance criteria and the reported device performance:
Since this is a physical device and not an AI/ML software, the "acceptance criteria" are not reported as specific performance metrics like sensitivity/specificity for an algorithm. Instead, they relate to regulatory and functional compliance.
| Acceptance Criteria (Conceptual for a 510(k)) | Reported Device Performance (Summary from Submission) |
|---|---|
| Same Intended Use as Predicate | The InVision™ 1.5 Surgical Theatre has the same intended use as the predicate device (IMRIS iMRI 3T V): "as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and that displays the internal structure and/or function of the head, body or extremities. ... May also be used for imaging during intraoperative and interventional procedures... and in a multi-room suite." |
| Similar Technological Characteristics to Predicate (differences do not raise new safety/effectiveness concerns) | Similarities: Regulation number, name, product code, classification, panel, intended use, type of magnet (superconducting, actively shielded), where used (hospital OR/DR), IMRIS Surgical Theatre room configurations, Siemens diagnostic RF coils, rail system, magnet mover material, mounting mechanism, turret assembly, side carriages, quench management/manifold, cable management, collision detection system, manual backup, magnet mover/intermediate covers, intraoperative RF coil connectors, RF switch, table emulator system, gradient cable, mounted side display, drive mechanism, position control, software (magnet mover software), surgical table, head fixation device, horseshoe headrest, biocompatibility, sterilization. Differences and Rationale: - Siemens MRI System: Proposed uses Siemens 1.5T MAGNETOM Sola (K203443) vs. Predicate's Siemens 3T MAGNETOM Vida (K192924). - Static Field Strength: Proposed 1.5 Tesla vs. Predicate 3 Tesla. - IMRIS Intraoperative Imaging Coils: HC150 Coil and InSitu Coil 1.5T vs. HC300 Coil and InSitu Coil 3T. These differences are assessed through non-clinical testing (functional, imaging performance, integration, software verification, acoustic energy analysis, heating verification) to ensure equivalent safety and performance. |
| Compliance with Recognized Consensus Standards | All listed FDA recognized consensus standards (Table 2 on page 10-11) were conformed to. This includes standards for medical electrical equipment (safety, EMC), risk management, usability engineering, software life cycle processes, acoustic noise measurement, characterization of phased array coils, SNR/image uniformity, biocompatibility, and sterilization. |
| Clinically Acceptable MR Imaging Performance | "Successful completion of the standard Siemens OA tests and expert review of sample clinical images demonstrates that the InVision 1.5 Surgical Theatre maintains clinically acceptable MR imaging performance within both the DR and OR(s)." |
| Safety and Performance Profile Equivalent to Predicate | "The verification and validation testing of the InVision 1.5 Surgical Theatre support a determination of substantial equivalence." "The InVision 1.5 Surgical Theatre technological characteristics do not raise different questions of safety and effectiveness." |
2. Sample sized used for the test set and the data provenance:
- Test Set (Non-Clinical): The document refers to "Performance Testing" on the "InVision 1.5 Surgical Theatre (finished device) and applicable components and hardware" (Table 3, page 12). This indicates the testing was performed on the actual device hardware.
- Sample Clinical Images: "Sample Clinical Images in DR and OR" were assessed, as required by the guidance for Magnetic Resonance Diagnostic Devices. The number of images or patient cases is not specified.
- Data Provenance: Not explicitly stated, but given it's a medical device for US market clearance, typically such testing involves internal data or data collected under controlled conditions to demonstrate device functionality and safety. It's safe to assume it's retrospective, as it involves "sample clinical images" for assessment rather than a prospective clinical trial. Country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions "expert review of sample clinical images." The number of experts and their specific qualifications (e.g., years of experience) are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No specific adjudication method is described for the "expert review of sample clinical images."
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:
- No, an MRMC study was not done. This submission is for a physical MRI device, not an AI-assisted diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This isn't an AI algorithm. The performance being assessed is the image acquisition capability of the MRI system, which a human clinician interprets.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the "sample clinical images" assessed, the "ground truth" for image quality and clinical acceptability was based on expert review. This is typical for demonstrating image quality of a diagnostic device. Since it's an MRI system, the "truth" is whether the images accurately represent the internal structure and/or function for diagnosis, as interpreted by a trained physician. It's not about diagnosing specific diseases with a "pathology" ground truth, but rather about the diagnostic quality of the images produced.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As stated above, there is no AI/ML training set in this context.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Feburary 15, 2024
Deerfield Imaging, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k Saint Paul, Minnesota 55114
Re: K240157
Trade/Device Name: InVision™ 1.5 Surgical Theatre Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: January 19, 2024 Received: January 19, 2024
Dear Prithul Bom:
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" (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).
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2
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 (QS) 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.
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-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,
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of 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) K240157
Device Name InVision™ 1.5 Surgical Theatre
Indications for Use (Describe)
The InVision 1.5 Surgical Theatre is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and that displays the internal structure and/or function of the head, body or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The InVision 1.5 Surgical Theatre may also be used for imaging during intraoperative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.
The InVision 1.5 Surgical Theatre may also be used for imaging in a multi-room suite.
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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510(k) Summary
I. SUBMITTER
| Establishment: | Deerfield Imaging, Inc.1230 Chaska Creek Way, Suite 100Chaska, MN 55318 USA |
|---|---|
| Date Prepared: | December 21, 2023 |
| Contact Person: | Liz Ashworth |
| Phone: | 218-256-7150 |
II. DEVICE
| Device Name: | InVision™ 1.5 Surgical Theatre |
|---|---|
| Common Name: | MRDD (Magnetic Resonance Diagnostic Device) |
| Classification Name: | System, Nuclear Magnetic Resonance Imaging (21 CFR 892.1000) |
| Regulatory Class: | II |
| Product Code: | Primary: LNHSecondary: LNI, MOS |
III. PREDICATE DEVICE
| Device Name: | IMRIS iMRI 3T V |
|---|---|
| 510(k) Number: | K212367 |
| Common Name: | MRDD (Magnetic Resonance Diagnostic Device) |
| Classification Name: | System, Nuclear Magnetic Resonance Imaging (21 CFR 892.1000) |
| Regulatory Class | II |
| Product Code: | Primary: LNHSecondary: LNI, MOS |
The reference device used in the submission is the K203443 Siemens MAGNETOM Sola.
IV. DEVICE DESCRIPTION
The proposed InVision™ 1.5 Surgical Theatre is a traditional Magnetic Resonance Imaging (MRI) scanner that is suspended on an overhead rail system. It is designed to operate inside a Radio Frequency (RF) shielded room to facilitate intraoperative and multi-room use. The InVision 1.5 Surgical Theatre uses a scanner, the Siemens MAGNETOM Sola (K203443, reference device), to produce images of the internal structures of the head as well as the whole body. The Siemens 1.5T MAGNETOM Sola MRI scanner is an actively shielded magnet with a magnetic field strength of 1.5 Tesla.
The InVision 1.5 Surgical Theatre provides surgeons with access to magnetic resonance (MR) images while in the surgical field without changing the surgical/clinical workflow. When images are requested in the operating room (OR), the magnet is moved from the diagnostic room (DR) to the OR on a pair of overhead rails while the patient remains stationary during the procedure.
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SIMPIS
Imaging is performed and once complete the magnet is moved out of the OR to the DR. The magnet can be moved in and out of the surgical field multiple times, as required, throughout the course of the surgical procedure. When the Siemens MAGNETOM Sola MRI scanner is in the DR, the OR may be used as a standard OR, utilizing standard surgical instruments and equipment during surgery. When not required in the OR, the scanner is available for use in the DR as a standard diagnostic MRI.
V. INDICATIONS FOR USE
The InVision 1.5 Surgical Theatre is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The InVision 1.5 Surgical Theatre may also be used for imaging during intraoperative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.
The InVision 1.5 Surgical Theatre may also be used for imaging in a multi-room suite.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The proposed InVision 1.5 Surgical Theatre is shown to be substantially equivalent to the predicate device IMRIS iMRI 3T V (K212367) by comparing the indications for use, principles of operation, technological characteristics, and performance testing similarities and differences. The imaging functionality and software in the Siemens MAGNETOM Sola MRI is not modified from the standard floor-based Siemens MAGNETOM Sola (K203443. reference device). The accessories used in the InVision 1.5 Surgical Theatre, including the Intraoperative Imaging Coils, VISIUSmatrix, ORT400 Operating Room Table, Head Fixation Device (HFD100), Horseshoe Headrest, and IMRISeye, are substantially equivalent to the predicate IMRIS iMRI 3T V accessories. The technological characteristic difference between the proposed InVision 1.5 Surgical Theatre and the IMRIS iMRI 3T V predicate device is that the predicate device includes the Siemens MAGNETOM Vida scanner while the proposed device uses the Siemens MAGNETOM Sola scanner. Due to the difference in Siemens MRI scanner, the proposed device incorporates changes to magnet mover components and updates to the modifications made to the Siemens scanner when it is integrated with the InVision 1.5 Surgical Theatre (see Table 1). The technological characteristic difference rationale demonstrates that the proposed device is safe and effective as a legally marketed predicate device and does not raise different questions of safety and effectiveness.
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| Characteristic | Predicate DeviceiMRI 3T VK212367 | Proposed DeviceInVision 1.5 SurgicalTheatre | EquivalenceComparison |
|---|---|---|---|
| RegulationNumber | 21 CFR 892.1000 | 21 CFR 892.1000 | Same |
| Regulation Name | Magnetic resonancediagnostic device | Magnetic resonancediagnostic device | Same |
| Product Code | Primary: LNHSecondary: LNI, MOS | Primary: LNHSecondary: LNI, MOS | Same |
| Classification | Class II | Class II | Same |
| Panel | Radiology | Radiology | Same |
| IntendedUse/Indicationsfor Use | The IMRIS iMRI 3T V isindicated for use as amagnetic resonancediagnostic device (MRDD)that produces transverse,sagittal, coronal and obliquecross sectional images,spectroscopic images and/orspectra, and that displays theinternal structure and/orfunction of the head, body orextremities.Other physical parametersderived from the imagesand/or spectra may also beproduced. Depending on theregion of interest, contrastagents may be used. Theseimages and/or spectra and thephysical parameters derivedfrom the images and/orspectra when interpreted by atrained physician yieldinformation that may assist indiagnosis.The IMRIS iMRI 3T Vsystem may also be used forimaging during intra-operative | The InVision 1.5 SurgicalTheatre is indicated for use asa magnetic resonancediagnostic device (MRDD)that produces transverse,sagittal, coronal and obliquecross sectional images,spectroscopic images and/orspectra, and that displays theinternal structure and/orfunction of the head, body orextremities.Other physical parametersderived from the imagesand/or spectra may also beproduced. Depending on theregion of interest, contrastagents may be used. Theseimages and/or spectra and thephysical parameters derivedfrom the images and/orspectra when interpreted by atrained physician yieldinformation that may assist indiagnosis.The InVision 1.5 SurgicalTheatre may also be used forimaging during intra-operative | Same |
| Characteristic | Predicate DeviceiMRI 3T VK212367 | Proposed DeviceInVision 1.5 SurgicalTheatre | EquivalenceComparison |
| and interventional procedureswhen performed with MR safedevices or MR conditionaldevices approved for use withthe MR scanner. | and interventional procedureswhen performed with MR safedevices or MR conditionaldevices approved for use withthe MR scanner. | ||
| The IMRIS iMRI 3T V MRIsystems may also be used forimaging in a multi-room suite. | The InVision 1.5 SurgicalTheatre may also be used forimaging in a multi-room suite. | ||
| SiemensMAGNETOMMRI System | Siemens 3T MAGNETOMVida (K192924) | Siemens 1.5T MAGNETOMSola (K203443) | Different |
| Static fieldstrength ofmagnet | 3 Tesla | 1.5 Tesla | Different |
| Type of magnet | Superconducting, ActivelyShielded | Superconducting, ActivelyShielded | Same |
| Where used | Hospital operating room anddiagnostic room | Hospital operating room anddiagnostic room | Same |
| IMRIS SurgicalTheatre roomconfigurations | • OR1-DR• DR-OR2• OR1-DR90T• OR1-DR90• DR90-OR2• OR1-DR-OR2• OR1-DR90-OR2• OR1-DR90T-OR2• OR1-DR CB• OR1-DR90 CB• OR1-DR90T CB• CB DR-OR2• CB DR90-OR2 | • OR1-DR• DR-OR2• OR1-DR90T• OR1-DR90• DR90-OR2• OR1-DR-OR2• OR1-DR90-OR2• OR1-DR90T-OR2• OR1-DR CB• OR1-DR90 CB• OR1-DR90T CB• CB DR-OR2• CB DR90-OR2 | Same |
| Siemensdiagnostic RFcoils | Siemens standard RF coils | Siemens standard RF coils | Same |
| IMRISIntraoperativeImaging Coils | HC300 Coil(K103506) | HC150 Coil(K103506) | Similar |
| Characteristic | Predicate DeviceiMRI 3T VK212367 | Proposed DeviceInVision 1.5 SurgicalTheatre | EquivalenceComparison |
| and coil interfacecables | InSitu Coil 3T(K123091)3T coil interface cables toconnect and use Siemens RFcoils in intraoperativesettings | InSitu Coil 1.5T(K123091)1.5T coil interface cables toconnect and use Siemens RFcoils in intraoperative settings | Similar |
| Rail system(2 room and 3room) | Stainless steel rails Rail covers Mounting clamp blockassembly Rail accessories Striker bar End stops Limit switches | Stainless steel rails Rail covers Mounting clamp blockassembly Rail accessories Striker bar End stops Limit switches | Same |
| Magnet movermaterial | Steel and stainless steel | Steel and stainless steel | Same |
| Mountingmechanism | Overhead rail beam andcarriage with acetal rollers | Overhead rail beam andcarriage with acetal rollers | Same |
| Cable guards | Mechanical guards to protectcabling from magnet moverturret and hangers. | Mechanical guards to protectcabling from magnet moverturret. | Similar |
| Hangers,stabilizers | Mechanical interfaces toconnect the magnet moverstructure. | Mechanical interfaces toconnect the magnet moverstructure. | Similar |
| Turret assembly | Mechanical assembly thatallows the magnet to rotatebetween 0° and 180°. | Mechanical assembly thatallows the magnet to rotatebetween 0° and 180°. | Same |
| Side carriages | Mechanical interface toconnect the mover assemblyto the ceiling mounted rails. | Mechanical interface toconnect the mover assemblyto the ceiling mounted rails. | Same |
| Quenchmanagement | Flexible stainless steelquench line | Flexible stainless steel quenchline | Same |
| Quench manifold | Mechanical interface toconnect the quench line. | Mechanical interface toconnect the quench line. | Similar |
| Cablemanagement | Flexible cable carrier | Flexible cable carrier | Same |
| Collisiondetection system | Integrated Pressure ActivatedCollision-detection System(IPACS) | Integrated Pressure ActivatedCollision-detection System(IPACS) | Similar |
| Manual backup | Manual crank | Manual crank | Same |
| Characteristic | Predicate DeviceiMRI 3T VK212367 | Proposed DeviceInVision 1.5 SurgicalTheatre | EquivalenceComparison |
| Magnet movercovers | Cover components that wrapthe magnet mover and arestationary with respect to themover. | Cover components that wrapthe magnet mover and arestationary with respect to themover. | Same |
| Magnet covers | Customized by IMRIS toaccommodate the magnetmover, mounted side display,RF/air cover, collisiondetection system, andmounted docking station. | Customized by IMRIS toaccommodate the magnetmover, mounted side display,RF/air cover, collisiondetection system, andmounted docking station. | Similar |
| Intermediatecovers | Cover the gap between themagnet covers and themagnet mover covers. | Cover the gap between themagnet covers and the magnetmover covers. | Similar |
| Rampconnectionassembly | Provides electricalconnections and supportingmechanical bracketry to rampthe magnet, customplacement for IMRISsystems. | Provides electricalconnections and supportingmechanical bracketry to rampthe magnet, custom placementfor IMRIS systems. | Similar |
| IntraoperativeRF coilconnectors | Front of magnet | Front of magnet | Same |
| RF switch | Multi-channel double-throwelectronic switch, locatedbetween the RF slideconnectors and the Siemensdigital receiver. | Multi-channel double-throwelectronic switch, locatedbetween the RF slideconnectors and the Siemensdigital receiver. | Same |
| RF/air cover | Connection interface for userinteracting components (RFcoils, patient headphones,and panic squeeze ball) onthe front of the magnet. | Connection interface for userinteracting components (RFcoils, patient headphones, andpanic squeeze ball) on thefront of the magnet. | Similar |
| Table emulatorsystem | Mounted docking stationTable emulator | Mounted docking stationTable emulator | SimilarSame |
| Gradient cable | 16.5 meters | 16.5 meters | Same |
| Mounted sidedisplay | Handheld pendant and sidecontrol panel | Handheld pendant and sidecontrol panel | Similar |
| Characteristic | Predicate DeviceiMRI 3T VK212367 | Proposed DeviceInVision 1.5 SurgicalTheatre | EquivalenceComparison |
| System status screen displaysto assist the operator withApplication Platforminterface | System status screen displaysto assist the operator withApplication Platform interface | Same | |
| Drivemechanism | Friction based, belt drivendrive rollers | Friction based, belt drivendrive rollers | Same |
| Position control | Safety limit switches | Safety limit switches | Same |
| Software | Magnet mover software | Magnet mover software | Same |
| Surgical table inthe OR | ORT400 (Baxter TruSystem7500) | ORT400 (Baxter TruSystem7500) | Same |
| Head FixationDevice | HFD100 | HFD100 | Same |
| HorseshoeHeadrest | Horseshoe Headrest | Horseshoe Headrest | Same |
| Patient alignmenttool | IMRISeye | IMRISeye | Similar |
| Tissue-contactingcomponents andmaterials | • Siemens MAGNETOMBioMatrix patient table• Siemens Nexaris table• Siemens BioMatrixdiagnostic RF coils• HC300 Coil• InSitu Coil 3T• HFD100• ORT400 table• Horseshoe Headrest | • Siemens MAGNETOMBioMatrix patient table• Siemens Nexaris table• Siemens BioMatrixdiagnostic RF coils• HC150 Coil• InSitu Coil 1.5T• HFD100• ORT400 table• Horseshoe Headrest | Same |
| Biocompatibility | Compliant to ISO 10993 | Compliant to ISO 10993 | Same |
| Sterilization | Compliant to ISO 11135 | Compliant to ISO 11135 | Same |
Table 1 – Substantial Equivalence
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The InVision 1.5 Surgical Theatre conforms to the FDA recognized consensus standards listed in Table 2.
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்பாட்ட
| RecognitionNumber | Product Area | ReferenceNumber andDate | Title of Standard | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 19-46 | General II (ES/EMC) | ANSI AAMIES60601-1:2005/(R)2012 &A1:2012,C1:2009/(R)2012& A2:2010/(R)2012 (Cons.Text) [Incl.AMD2:2021] | Medical electricalequipment - Part 1:General requirementsfor basic safety andessential performance(IEC 60601-1:2005,MOD) [IncludingAmendment 2 (2021)] | ANSI AAMI |
| 19-36 | General II (ES/EMC) | IEC 60601-1-2Edition 4.1 2020-09CONSOLIDATEDVERSION | Medical electricalequipment - Part 1-2:General requirementsfor basic safety andessential performance -Collateral Standard:Electromagneticdisturbances -Requirements and tests | IEC |
| 5-125 | General I (QS/RM) | ISO 14971 ThirdEdition 2019-12 | Medical devices -Application of riskmanagement to medicaldevices | ISO |
| 5-129 | General I (QS/RM) | IEC 62366-1Edition 1.1 2020-06CONSOLIDATEDVERSION | Medical devices - Part 1:Application of usabilityengineering to medicaldevices | IEC |
| 13-79 | Software/Informatics | IEC 62304 Edition1.1 2015-06CONSOLIDATEDVERSION | Medical device software- Software life cycleprocesses | IEC |
| 12-232 | Radiology | NEMA MS 4-2010 | Acoustic NoiseMeasurement Procedurefor Diagnosing MagneticResonance ImagingDevices | NEMA |
| 12-288 | Radiology | NEMA MS 9-2008(R2020) | Standards PublicationCharacterization ofPhased Array Coils forDiagnostic Magnetic | NEMA |
| RecognitionNumber | Product Area | ReferenceNumber andDate | Title of Standard | StandardsDevelopmentOrganization |
| 12-195 | Radiology | NEMA MS 6-2008(R2014, R2020) | Resonance ImagesDetermination ofSignal-to-Noise Ratioand Image Uniformityfor Single-Channel Non-Volume Coils inDiagnostic MR Imaging | NEMA |
| 2-258 | Biocompatibility | ISO 10993-1 Fifthedition 2018-08 | Biological evaluation ofmedical devices - Part 1:evaluation andtesting within a riskmanagement process | ISO |
| 14-529 | Sterility | ISO 11135 Secondedition 2014-07-15 | Sterilization of health-care products - Ethyleneoxide - Requirements forthe development,validation and routinecontrol of a sterilizationprocess for medicaldevices [Including:Amendment 1 (2018)] | ISO |
| 14-530 | Sterility | ISO 11607-1Second edition2019-02 | Packaging for terminallysterilized medical devices- Part 1: Requirementsfor materials, sterilebarrier systems andpackaging systems | ISO |
Table 2 – FDA Recognized Consensus Standards
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ിന്നവട
VII. PERFORMANCE TESTING
The InVision 1.5 Surgical Theatre has been designed to provide MR imaging in an intraoperative setting in the same manner as the predicate IMRIS iMRI 3T V (K212367). IMRIS performed testing according to the applicable guidance and regulatory standards to demonstrate that the InVision 1.5 Surgical Theatre intraoperative features are substantially equivalent to the intraoperative features of the predicate IMRIS iMRI 3T V. The InVision 1.5 Surgical Theatre does not raise any new safety or effectiveness issues related to the use of a moving MRI system in an intraoperative setting.
No clinical testing was required to demonstrate substantial equivalence. Clinical images were assessed and provided as required by the guidance document Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices. The InVision 1.5 Surgical Theatre
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non-clinical testing is summarized in Table 3.
| Testing Performed | Tested Hardware | Source/ Rationale for Test |
|---|---|---|
| Performance Testing | InVision 1.5 Surgical Theatre(finished device) andapplicable components andhardware | Submission ofPremarket Notifications forMagnetic Resonance DiagnosticDevices |
| Sample Clinical Images in DRand OR | InVision 1.5 Surgical Theatre(finished device) | Submission ofPremarket Notifications forMagnetic Resonance DiagnosticDevices |
| Electrical, mechanical,structural, and related system | InVision 1.5 Surgical Theatre(finished device) | ANSI /AAMI ES60601-1:2005/(R)2012 & A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012 (Cons. Text)[Incl. AMD2:2021] |
| Electrical safety andelectromagnetic compatibility | InVision 1.5 Surgical Theatre(finished device) | IEC 60601-1-2 Edition 4.1 2020-09CONSOLIDATED VERSION |
Table 3 – Non-Clinical Testing
The InVision 1.5 Surgical Theatre underwent system functional testing, system imaging performance testing, InVision 1.5 Surgical Theatre and Sola system integration testing, software verification testing, acoustic energy analysis, and heating verification testing.
Verification testing, including functional testing, analysis, and/or inspection, was done for the components and hardware for the side display, cable carrier, covers, quench subsystem, RF switch, table emulator subsystem, magnet mover, and IMRISeye.
The InVision 1.5 Surgical Theatre has been tested and the conclusions from the verification and validation data support that the technological characteristics of the proposed device have an equivalent safety and performance profile to that of the IMRIS iMRI 3T V predicate device (K212367). Successful completion of the standard Siemens OA tests and expert review of sample clinical images demonstrates that the InVision 1.5 Surgical Theatre maintains clinically acceptable MR imaging performance within both the DR and OR(s). The InVision 1.5 Surgical Theatre technological characteristics do not raise different questions of safety and effectiveness. The verification and validation testing of the InVision 1.5 Surgical Theatre support a determination of substantial equivalence.
VIII. CONCLUSIONS
The InVision 1.5 Surgical Theatre has the same intended use and similar basic technological characteristics as the IMRIS iMRI 3T V (K212367, predicate device). While there are some differences in technological characteristics between the proposed and predicate device, the differences were tested and verification and validation data suggest that the features bear an equivalent safety and performance profile to that of the predicate device.
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IMRIS has concluded that the InVision 1.5 Surgical Theatre is substantially equivalent to the currently marketed predicate device IMRIS iMRI 3T V.
N/A