(24 days)
No
The summary describes software updates that add features (Q-Spine, 3D Viewer, E-MRI viewer eXP) that have been previously cleared by the FDA and do not mention any AI or ML capabilities. The focus is on image acquisition and viewing, not algorithmic interpretation or analysis using AI/ML.
No
The device is an MR system primarily used for imaging and providing diagnostic information, not for treatment.
Yes
The G-scan Brio produces images intended to provide "diagnostically useful information" when interpreted by a medical expert.
No
The device is described as a Magnetic Resonance (MR) system, which is a hardware device. The submission details software upgrades to this existing hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a Magnetic Resonance (MR) system that produces images of various anatomical structures. It is used to provide diagnostically useful information when interpreted by a medical expert. This is a diagnostic imaging device, not a device that performs tests on biological samples in vitro.
- Device Description: The description focuses on the hardware and software components of the MR system, including image processing features. There is no mention of analyzing biological samples or performing tests on them.
- Lack of IVD Characteristics: IVD devices typically involve reagents, calibrators, controls, and procedures for analyzing biological specimens (like blood, urine, tissue). None of these are mentioned in the provided text.
The device is a medical imaging system used for diagnostic purposes in vivo (within the living body), not in vitro (outside the living body).
N/A
Intended Use / Indications for Use
G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the head, limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column.
G-scan Brio images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.
Product codes
LNH
Device Description
The changes performed on the modified G-scan Brio, with respect to the cleared version – G-scan Brio K161973 – are due to the upgrade of the software system. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:
- A new Software version (EVO'17) including the following features:
- o New software feature Q-Spine (Quantitative Spine)
- o New software feature 3D Viewer
- o The availability of the E-MRI viewer eXP, the software used as an extension on PC.
Esaote has decided to develop and release an upgrade for software EVO. The EVO'17 includes two new features Q-Spine and 3D Viewer. The function Q-Spine has been already cleared by FDA under the name OrthoCAD System via K120288. The function 3D Viewer has been already cleared by FDA under the name 3Viseon/Surgery via K072653. E-MRI viewer eXP, the software used as an extension on PC, is equivalent to E-MRI Brio Viewer, which is currently available on the G-Scan Brio MRI systems, cleared via K161973.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
head, limbs, joints, spinal column, hand, wrist, forearm, elbow, arm, shoulder, foot, ankle, calf, knee, thigh, hip, temporomandibular joint, cervical, thoracic, lumbosacral sections.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical expert trained in use of MR equipment.
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 Tests:
The G-scan Brio has been evaluated to demonstrate substantial equivalence related to medical electrical equipment, risk management, and software verification and has been found to conform to the following medical device safety standards:
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-1-6
- IEC 60601-2-33
- ISO 14971
- ISO 62304
- IEC 62366
- NEMA MS-1
- NEMA MS-3
Clinical Tests:
No clinical tests are included within this submission.
Conclusion:
The non-clinical testing demonstrates that the G-scan Brio is as safe, as effective, and performs as well as or better than the predicate. G-scan Brio is substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards.
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
Indications for Use
510(k) Number (if known)
K180592
Device Name G-Scan Brio
Indications for Use (Describe)
G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique crosssection images of the head, limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column.
G-scan Brio images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.
| 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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1
510(k) Summary G-scan Brio Esaote S.p.A.
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
Submitter Information
Esaote, S.p.A. Via E. Melen 77 Genova 16152 Italy
Contact Person: Allison Scott, RAC P: 317.272.5419 Allison.Scott@navigant.com
Date: March 2, 2018
- Trade Name: G-scan Brio
Classification Panel: Radiology
Classification Name(s): Magnetic Resonance Diagnostic Device
Classification Number: 90LNH
Predicate Device(s)
| Trade Name | Common name | Class | Product
code | Manufacturer | K
number |
|-------------|-----------------------------------------------|-------|-----------------|---------------|-------------|
| G-scan Brio | System, nuclear magnetic
resonance imaging | II | LNH | ESAOTE S.P.A. | K161973 |
Reference Device(s)
| Trade Name | Common name | Class | Product
code | Manufacturer | K
number |
|---------------------|--------------------------------------------|-------|-----------------|----------------------------------|-------------|
| OrthoCAD
System | System, Image Processing,
Radiological | II | LLZ | ESAOTE S.P.A. | K120288 |
| 3Viseon/
Surgery | Picture Archiving
Communications System | II | LLZ | 3MENSIO
MEDICAL
IMAGING BV | K072653 |
2
510(k) Summary G-scan Brio Esaote S.p.A.
Device Description
The changes performed on the modified G-scan Brio, with respect to the cleared version – G-scan Brio K161973 – are due to the upgrade of the software system. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:
- A new Software version (EVO'17) including the following features:
- o New software feature Q-Spine (Quantitative Spine)
- o New software feature 3D Viewer
- o The availability of the E-MRI viewer eXP, the software used as an extension on PC.
Esaote has decided to develop and release an upgrade for software EVO. The EVO'17 includes two new features Q-Spine and 3D Viewer. The function Q-Spine has been already cleared by FDA under the name OrthoCAD System via K120288. The function 3D Viewer has been already cleared by FDA under the name 3Viseon/Surgery via K072653. E-MRI viewer eXP, the software used as an extension on PC, is equivalent to E-MRI Brio Viewer, which is currently available on the G-Scan Brio MRI systems, cleared via K161973.
Intended Use(s)
G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the head, limbs, joints and spinal column. It is intended for imaging the head, imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column.
G-scan Brio images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.
Technological Characteristics
The technological characteristics of the G-scan Brio systems with the addition of Q-Spine, 3D Viewer, and availability of E-MRI viewer eXP, reflected in this 510(k), do not alter the scientific technology of the G-scan Brio systems and are substantially equivalent to those of the predicate devices. The modification are implemented in order to improve display, analysis and comparison of Magnetic Resonance images.
Summary of Non-Clinical Tests
The G-scan Brio has been evaluated to demonstrate substantial equivalence related to medical electrical equipment, risk management, and software verification and has been found to conform to the following medical device safety standards:
- IEC 60601-1
- IEC 60601-1-2 .
- IEC 60601-1-6
3
510(k) Summary G-scan Brio Esaote S.p.A.
- IEC 60601-2-33
- . ISO 14971
- ISO 62304 ●
- . IEC 62366
- NEMA MS-1
- NEMA MS-3
Summary of Clinical Tests
No clinical tests are included within this submission.
Conclusion
The non-clinical testing demonstrates that the G-scan Brio is as safe, as effective, and performs as well as or better than the predicate. G-scan Brio is substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards.
4
Esaote S.p.A % Allison Scott Associate Director Navigant Consulting, Inc 9100 Keystone Crossing Suite 500 Indianapolis, Indiana 46240
Re: K180592
Trade/Device Name: G-scan Brio Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: March 2, 2018 Received: March 6, 2018
Dear Allison Scott:
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. 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
March 30, 2018
5
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure