(27 days)
No
The summary describes a traditional MRI system with a unique mechanical design for intraoperative use. There is no mention of AI/ML in the intended use, device description, or performance studies.
No
Explanation: The device is described as an MRI scanner used to produce images and spectra for diagnostic purposes, not for treating any condition. Its intended use is to "assist in diagnosis."
Yes
The device produces images and spectra that, when interpreted by a trained physician, yield information that may assist in diagnosis. It can also be used as a standard diagnostic MRI when not in the operating room.
No
The device description explicitly states it is a "traditional Magnetic Resonance Imaging (MRI) scanner" and details hardware components like a magnet, overhead rail system, and integration with a Siemens MAGNETOM Sola scanner. The performance studies also mention testing of hardware components.
Based on the provided information, the InVision 1.5 Surgical Theatre is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- InVision 1.5 Surgical Theatre Function: The InVision 1.5 Surgical Theatre is a Magnetic Resonance Imaging (MRI) scanner. It produces images of the internal structure and/or function of the head, body, or extremities directly from the patient, not from a specimen taken from the patient.
- Intended Use: The intended use clearly states it produces images and spectroscopic images of the internal structure and/or function of the head, body, or extremities. This is consistent with in vivo imaging, not in vitro testing.
- Device Description: The description confirms it's a traditional MRI scanner used to produce images of internal structures.
Therefore, the InVision 1.5 Surgical Theatre falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LNH, LNI, MOS
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Head, body or extremities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician in a hospital operating room and diagnostic 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)
Performance Testing:
- Study Type: Non-clinical testing, 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.
- Sample Size: Not specified, but includes the InVision 1.5 Surgical Theatre (finished device) and applicable components and hardware.
- AUC: Not Found
- MRMC: Not Found
- Standalone Performance: Not Found
- Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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).
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
I. SUBMITTER
| Establishment: | Deerfield Imaging, Inc.
1230 Chaska Creek Way, Suite 100
Chaska, 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: LNH |
| Secondary: 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: LNH |
| Secondary: 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.
4
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.
5
| Characteristic | Predicate Device
iMRI 3T V
K212367 | Proposed Device
InVision 1.5 Surgical
Theatre | Equivalence
Comparison |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Regulation
Number | 21 CFR 892.1000 | 21 CFR 892.1000 | Same |
| Regulation Name | Magnetic resonance
diagnostic device | Magnetic resonance
diagnostic device | Same |
| Product Code | Primary: LNH
Secondary: LNI, MOS | Primary: LNH
Secondary: LNI, MOS | Same |
| Classification | Class II | Class II | Same |
| Panel | Radiology | Radiology | Same |
| Intended
Use/Indications
for Use | The IMRIS iMRI 3T V 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 IMRIS iMRI 3T V
system may also be used for
imaging during intra-operative | 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 intra-operative | Same |
| Characteristic | Predicate Device
iMRI 3T V
K212367 | Proposed Device
InVision 1.5 Surgical
Theatre | Equivalence
Comparison |
| | and interventional procedures
when performed with MR safe
devices or MR conditional
devices approved for use with
the MR scanner. | and interventional procedures
when performed with MR safe
devices or MR conditional
devices approved for use with
the MR scanner. | |
| | The IMRIS iMRI 3T V MRI
systems may also be used for
imaging in a multi-room suite. | The InVision 1.5 Surgical
Theatre may also be used for
imaging in a multi-room suite. | |
| Siemens
MAGNETOM
MRI System | Siemens 3T MAGNETOM
Vida (K192924) | Siemens 1.5T MAGNETOM
Sola (K203443) | Different |
| Static field
strength of
magnet | 3 Tesla | 1.5 Tesla | Different |
| Type of magnet | Superconducting, Actively
Shielded | Superconducting, Actively
Shielded | Same |
| Where used | Hospital operating room and
diagnostic room | Hospital operating room and
diagnostic room | Same |
| IMRIS Surgical
Theatre room
configurations | • 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 |
| Siemens
diagnostic RF
coils | Siemens standard RF coils | Siemens standard RF coils | Same |
| IMRIS
Intraoperative
Imaging Coils | HC300 Coil
(K103506) | HC150 Coil
(K103506) | Similar |
| Characteristic | Predicate Device
iMRI 3T V
K212367 | Proposed Device
InVision 1.5 Surgical
Theatre | Equivalence
Comparison |
| and coil interface
cables | InSitu Coil 3T
(K123091)
3T coil interface cables to
connect and use Siemens RF
coils in intraoperative
settings | InSitu Coil 1.5T
(K123091)
1.5T coil interface cables to
connect and use Siemens RF
coils in intraoperative settings | Similar |
| Rail system
(2 room and 3
room) | Stainless steel rails Rail covers Mounting clamp block
assembly Rail accessories Striker bar End stops Limit switches | Stainless steel rails Rail covers Mounting clamp block
assembly Rail accessories Striker bar End stops Limit switches | Same |
| Magnet mover
material | Steel and stainless steel | Steel and stainless steel | Same |
| Mounting
mechanism | Overhead rail beam and
carriage with acetal rollers | Overhead rail beam and
carriage with acetal rollers | Same |
| Cable guards | Mechanical guards to protect
cabling from magnet mover
turret and hangers. | Mechanical guards to protect
cabling from magnet mover
turret. | Similar |
| Hangers,
stabilizers | Mechanical interfaces to
connect the magnet mover
structure. | Mechanical interfaces to
connect the magnet mover
structure. | Similar |
| Turret assembly | Mechanical assembly that
allows the magnet to rotate
between 0° and 180°. | Mechanical assembly that
allows the magnet to rotate
between 0° and 180°. | Same |
| Side carriages | Mechanical interface to
connect the mover assembly
to the ceiling mounted rails. | Mechanical interface to
connect the mover assembly
to the ceiling mounted rails. | Same |
| Quench
management | Flexible stainless steel
quench line | Flexible stainless steel quench
line | Same |
| Quench manifold | Mechanical interface to
connect the quench line. | Mechanical interface to
connect the quench line. | Similar |
| Cable
management | Flexible cable carrier | Flexible cable carrier | Same |
| Collision
detection system | Integrated Pressure Activated
Collision-detection System
(IPACS) | Integrated Pressure Activated
Collision-detection System
(IPACS) | Similar |
| Manual backup | Manual crank | Manual crank | Same |
| Characteristic | Predicate Device
iMRI 3T V
K212367 | Proposed Device
InVision 1.5 Surgical
Theatre | Equivalence
Comparison |
| Magnet mover
covers | Cover components that wrap
the magnet mover and are
stationary with respect to the
mover. | Cover components that wrap
the magnet mover and are
stationary with respect to the
mover. | Same |
| Magnet covers | Customized by IMRIS to
accommodate the magnet
mover, mounted side display,
RF/air cover, collision
detection system, and
mounted docking station. | Customized by IMRIS to
accommodate the magnet
mover, mounted side display,
RF/air cover, collision
detection system, and
mounted docking station. | Similar |
| Intermediate
covers | Cover the gap between the
magnet covers and the
magnet mover covers. | Cover the gap between the
magnet covers and the magnet
mover covers. | Similar |
| Ramp
connection
assembly | Provides electrical
connections and supporting
mechanical bracketry to ramp
the magnet, custom
placement for IMRIS
systems. | Provides electrical
connections and supporting
mechanical bracketry to ramp
the magnet, custom placement
for IMRIS systems. | Similar |
| Intraoperative
RF coil
connectors | Front of magnet | Front of magnet | Same |
| RF switch | Multi-channel double-throw
electronic switch, located
between the RF slide
connectors and the Siemens
digital receiver. | Multi-channel double-throw
electronic switch, located
between the RF slide
connectors and the Siemens
digital receiver. | Same |
| RF/air cover | Connection interface for user
interacting components (RF
coils, patient headphones,
and panic squeeze ball) on
the front of the magnet. | Connection interface for user
interacting components (RF
coils, patient headphones, and
panic squeeze ball) on the
front of the magnet. | Similar |
| Table emulator
system | Mounted docking station
Table emulator | Mounted docking station
Table emulator | Similar
Same |
| Gradient cable | 16.5 meters | 16.5 meters | Same |
| Mounted side
display | Handheld pendant and side
control panel | Handheld pendant and side
control panel | Similar |
| Characteristic | Predicate Device
iMRI 3T V
K212367 | Proposed Device
InVision 1.5 Surgical
Theatre | Equivalence
Comparison |
| | System status screen displays
to assist the operator with
Application Platform
interface | System status screen displays
to assist the operator with
Application Platform interface | Same |
| Drive
mechanism | Friction based, belt driven
drive rollers | Friction based, belt driven
drive rollers | Same |
| Position control | Safety limit switches | Safety limit switches | Same |
| Software | Magnet mover software | Magnet mover software | Same |
| Surgical table in
the OR | ORT400 (Baxter TruSystem
7500) | ORT400 (Baxter TruSystem
7500) | Same |
| Head Fixation
Device | HFD100 | HFD100 | Same |
| Horseshoe
Headrest | Horseshoe Headrest | Horseshoe Headrest | Same |
| Patient alignment
tool | IMRISeye | IMRISeye | Similar |
| Tissue-
contacting
components and
materials | • Siemens MAGNETOM
BioMatrix patient table
• Siemens Nexaris table
• Siemens BioMatrix
diagnostic RF coils
• HC300 Coil
• InSitu Coil 3T
• HFD100
• ORT400 table
• Horseshoe Headrest | • Siemens MAGNETOM
BioMatrix patient table
• Siemens Nexaris table
• Siemens BioMatrix
diagnostic 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
6
7
8
9
The InVision 1.5 Surgical Theatre conforms to the FDA recognized consensus standards listed in Table 2.
10
்பாட்ட
| Recognition
Number | Product Area | Reference
Number and
Date | Title of Standard | Standards
Development
Organization |
|-----------------------|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 19-46 | General II (ES/
EMC) | ANSI AAMI
ES60601-
1:2005/(R)2012 &
A1:2012,
C1:2009/(R)2012
& A2:2010
/(R)2012 (Cons.
Text) [Incl.
AMD2:2021] | Medical electrical
equipment - Part 1:
General requirements
for basic safety and
essential performance
(IEC 60601-1:2005,
MOD) [Including
Amendment 2 (2021)] | ANSI AAMI |
| 19-36 | General II (ES/
EMC) | IEC 60601-1-2
Edition 4.1 2020-
09
CONSOLIDATED
VERSION | Medical electrical
equipment - Part 1-2:
General requirements
for basic safety and
essential performance -
Collateral Standard:
Electromagnetic
disturbances -
Requirements and tests | IEC |
| 5-125 | General I (QS/
RM) | ISO 14971 Third
Edition 2019-12 | Medical devices -
Application of risk
management to medical
devices | ISO |
| 5-129 | General I (QS/
RM) | IEC 62366-1
Edition 1.1 2020-
06
CONSOLIDATED
VERSION | Medical devices - Part 1:
Application of usability
engineering to medical
devices | IEC |
| 13-79 | Software/
Informatics | IEC 62304 Edition
1.1 2015-06
CONSOLIDATED
VERSION | Medical device software
- Software life cycle
processes | IEC |
| 12-232 | Radiology | NEMA MS 4-2010 | Acoustic Noise
Measurement Procedure
for Diagnosing Magnetic
Resonance Imaging
Devices | NEMA |
| 12-288 | Radiology | NEMA MS 9-2008
(R2020) | Standards Publication
Characterization of
Phased Array Coils for
Diagnostic Magnetic | NEMA |
| Recognition
Number | Product Area | Reference
Number and
Date | Title of Standard | Standards
Development
Organization |
| 12-195 | Radiology | NEMA MS 6-2008
(R2014, R2020) | Resonance Images
Determination of
Signal-to-Noise Ratio
and Image Uniformity
for Single-Channel Non-
Volume Coils in
Diagnostic MR Imaging | NEMA |
| 2-258 | Biocompatibility | ISO 10993-1 Fifth
edition 2018-08 | Biological evaluation of
medical devices - Part 1:
evaluation and
testing within a risk
management process | ISO |
| 14-529 | Sterility | ISO 11135 Second
edition 2014-07-15 | Sterilization of health-
care products - Ethylene
oxide - Requirements for
the development,
validation and routine
control of a sterilization
process for medical
devices [Including:
Amendment 1 (2018)] | ISO |
| 14-530 | Sterility | ISO 11607-1
Second edition
2019-02 | Packaging for terminally
sterilized medical devices - Part 1: Requirements
for materials, sterile
barrier systems and
packaging systems | ISO |
Table 2 – FDA Recognized Consensus Standards
11
ി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
12
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) and | ||
| applicable components and | ||
| hardware | Submission of | |
| Premarket Notifications for | ||
| Magnetic Resonance Diagnostic | ||
| Devices | ||
| Sample Clinical Images in DR | ||
| and OR | InVision 1.5 Surgical Theatre | |
| (finished device) | Submission of | |
| Premarket Notifications for | ||
| Magnetic Resonance Diagnostic | ||
| Devices | ||
| 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 and | ||
| electromagnetic compatibility | InVision 1.5 Surgical Theatre | |
| (finished device) | IEC 60601-1-2 Edition 4.1 2020-09 | |
| CONSOLIDATED 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.
13
IMRIS has concluded that the InVision 1.5 Surgical Theatre is substantially equivalent to the currently marketed predicate device IMRIS iMRI 3T V.