G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the 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 spine and the lumbar spine 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 the use of MR equipment, the images can provide diagnostically useful information.

Device Description

The changes performed on the modified G-scan device (G-scan Brio), with respect to the cleared version - G-scan K111803 - are due to the improvement of the system performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

1. A new patient table that can be moved manually in the inner/outer direction of the gantry.
1. A new footboard and seat for vertical examinations.
1. A patient table extension.
1. A back support.
1. A new step for patient positioning.
1. A new control panel on the front of the magnet.
1. Upgrading of the hydraulic circuit.
1. Upgrading of the electronics.
1. 4-channels Lumbar spine coils N.17 and 18 introduction, cleared via K110802.
1. A new software release.

AI/ML Overview

The G-scan Brio is a Magnetic Resonance (MR) system.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Study Type
Safety and Performance Standards Adherence	Met all listed industry performance and safety standards, and demonstrated to be as safe and effective as predicate devices.	Non-clinical testing
IEC 60601-1:1988 (Medical Electrical Equipment - General Safety)	Met	Non-clinical testing
IEC 60601-1-1:2000 (Medical Electrical Equip - Safety for Medical Electrical Systems)	Met	Non-clinical testing
IEC 60601-1-2:2001 (General safety - Electromagnetic compatibility)	Met	Non-clinical testing
IEC 60601-1-4:2000 (Programmable electrical medical systems)	Met	Non-clinical testing
IEC 60601-2-33 (2008) (Safety of magnetic resonance equipment)	Met	Non-clinical testing
IEC 62304:2006 (Medical device software)	Met	Non-clinical testing
ISO 10993-1:2003 (Biological evaluation of medical devices)	Met	Non-clinical testing
ISO 14971:2007 (Application of risk management to medical devices)	Met	Non-clinical testing
NEMA MS-1-2008 (SNR in Diagnostic MRI)	Met	Non-clinical testing
NEMA MS 2-2008 (Geometric Distortion in Diagnostic MRI)	Met	Non-clinical testing
NEMA MS 3-2008 (Image Uniformity in Diagnostic MRI)	Met	Non-clinical testing
NEMA MS 5-2010 (Slice Thickness in Diagnostic MRI)	Met	Non-clinical testing
Maintenance of Intended Use	Demonstrated that modifications did not affect the intended use or alter the fundamental scientific technology.	Non-clinical testing
Image Quality (Implied)	The device is intended to produce diagnostically useful images when interpreted by a medical expert. Conformance to NEMA MS standards (SNR, Geometric Distortion, Image Uniformity, Slice Thickness) directly relates to image quality.	Non-clinical testing

2. Sample size used for the test set and the data provenance:

The provided document describes non-clinical testing focused on engineering and performance standards, not a clinical study involving human subjects or patient data. Therefore, there is no "test set" in the sense of a dataset of patient images with associated ground truth for evaluating diagnostic accuracy or a similar clinical performance endpoint. The testing involved the device in a laboratory setting to verify its adherence to technical specifications and safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As explained above, this was a non-clinical engineering and performance study. There was no "ground truth" related to medical diagnoses established by experts for a test set of images. The "ground truth" was the technical specifications and standards (e.g., specific SNR values, distortion limits).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No human interpretation of images for diagnosis or "adjudication" was performed as part of this non-clinical performance data. The device's performance was measured against established technical standards.

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 comparative effectiveness study was not done. The G-scan Brio is an MRI hardware system, and the filing focuses on technical and safety performance, not the diagnostic performance of a read by a human expert with or without AI assistance. The document predates widespread AI integration in MR system hardware.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not done. The G-scan Brio is an MRI system that requires interpretation by a human expert. The "performance data" refers to the system's compliance with technical and safety standards, not the performance of an independent algorithm for diagnostic interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this performance data was primarily technical specifications and established industry standards (e.g., NEMA standards for SNR, geometric distortion, image uniformity, slice thickness). The verification involved confirming the physical and technical parameters of the device met these engineering and safety benchmarks.

8. The sample size for the training set:

Not applicable. This document describes the performance of an MR imaging system (hardware and associated software), not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As this is not an AI algorithm, there was no training set or associated ground truth establishment process for a training set.

Summary

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510(k) Summary	K122006
G-scan Brio
Esaote S.p.A.
510(k) Summary
	AUG 6 2012

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).

Submitter Information

Donatella Ragghianti Esaote, S.p.A. Via Siffredi 58 Genova 16153 Italy

Contact Person: Allison Scott, RAC P: 317.569.9500 x106 F: 317.569.9520 ascott@ansongroup.com

July 6, 2012 Date:

Trade Name: G-scan Brio

Common Name: System, Nuclear Magnetic Resonance Imaging

Classification Name(s): Magnetic Resonance Diagnostic Device

Classification Number: аогин

Predicate Device(s)

Trade Name	Common name	Class	Product code	Manufacturer	K number
G-scan	System, nuclear magneticresonance imaging	II	LNH	ESAOTE S.P.A.	K111803

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510(k) Summary G-scan Brio Esaote S.p.A. - - - - < - *

Device Description

1. A new patient table that can be moved manually in the inner/outer direction of the gantry.
1. A new footboard and seat for vertical examinations.
1. A patient table extension.
1. A back support.
1. A new step for patient positioning.
1. A new control panel on the front of the magnet.
1. Upgrading of the hydraulic circuit.
1. Upgrading of the electronics.
1. 4-channels Lumbar spine coils N.17 and 18 introduction, cleared via K110802.
1. A new software release.

Intended Use(s)

Technological Characteristics

The modifications reflected in this Special 510(k) for the G-scan Brio system are to improve system performance. The modifications have not altered the fundamental scientific technology of the unmodified version, G-scan K111803.

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510(k) Summary G-scan Brio Esaote S.p.A.

Performance Data

Design controls and risk analysis measures were applied to the development of the G-Scan Brio system, along with the following industry performance and safety standards:

. IEC 60601-1:1988 Medical Electrical Equipment - Part 1: General Requirements for Safety
. IEC 60601-1-1:2000, Medical Electrical Equip - Part 1: General Requirements for Safety; Safety Requirements for Medical Electrical Systems
. IEC 60601-1-2:2001, General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and Tests
. IEC 60601-1-4:2000, Medical electrical equipment - Collateral standard: Programmable electrical medical systems
. IEC 60601-2-33 (2008), Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
. IEC 62304:2006 Medical device software - Software life cycle processes
. ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
. ISO 14971:2007 Medical devices - Application of risk management to medical devices
. NEMA MS-1-2008, Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
. NEMA MS 2-2008 Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
. NEMA MS 3-2008 Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
. NEMA MS 5-2010 Determination of Slice Thickness in Diagnostic Magnetic Resonance Images

Non-clinical testing of the G-scan Brio system demonstrated that it met performance requirements and is as safe and effective as the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Esaote, S.p.A % Allison Driskell Scott, RAC Regulatory Associate Anson Group, LLC 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268

Re: K122006

Trade/Device Name: G-scan Brio Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device · Regulatory Class: II Product Code: LNH, LLZ and MOS Dated: July 6, 2012 Received: July 9, 2012

Dear Ms. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

AUG 6 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: G-scan Brio

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Regulation Number and Section

§ 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.