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 Brio, with respect to the cleared version - G-scan Brio K122006 - 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:

PC Unit with GPU Card and LCD monitor NEC model P242W .
A new Software version including the following features: .
- 1. 3D acquisitions: SpeedUp technique
- 1. 3D acquisitions: Elliptical filling of k-space technique
- 1. Myelographic contrast technique
A new operating system and database engine: .
- 1. Operating system Microsoft Windows VISTA Ultimate 64 bit platform
- 1. Database based on the built-in Microsoft SQL Server database Engine

AI/ML Overview

The provided 510(k) summary for the G-scan Brio device does not include explicit acceptance criteria or a study demonstrating the device meets those criteria, as it is a Special 510(k) based on modifications to a previously cleared device (G-scan K122006).

Special 510(k)s are typically submitted when changes to a legally marketed device do not alter its intended use or fundamental scientific technology. The primary focus of such submissions is to demonstrate that the modified device remains as safe and effective as the predicate device, often relying on non-clinical testing.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in a table format or report specific device performance metrics in relation to such criteria. Instead, it states that the device has been evaluated to demonstrate substantial equivalence related to medical electrical equipment, risk management, software verification, and image quality.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical tests were performed, and thus no test set of patient data was used. The evaluation primarily relied on non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical tests were performed, and therefore no ground truth was established by experts for a test set.

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

Not applicable. No clinical tests were performed, and thus no adjudication method was used for a test set.

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

Not applicable. This is not an AI/CAD device. The device is a Magnetic Resonance (MR) system. No MRMC study was conducted.

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

Not applicable. This is not an AI/CAD device. The G-scan Brio is an MR imaging system.

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

Not applicable. Since no clinical tests were performed, no ground truth from patient data was established. The evaluation focused on non-clinical tests and conformance to safety standards.

8. The sample size for the training set

Not applicable. This is not an AI/CAD device, and no training set of data was used for algorithm development or machine learning.

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

Not applicable. As there was no training set, there was no ground truth established for one.

Summary

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

KB33490
Page 1 of 3

510(k) Summary

DEC 3 0 2013

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 Allison.Scott@navigant.com
Date: November 12, 2013

Trade Name: G-scan Brio

Common Name: System, Nuclear Magnetic Resonance Imaging

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	System, nuclear magneticresonance imaging	II	LNH	ESAOTE S.P.A.	K122006

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

Device Description

PC Unit with GPU Card and LCD monitor NEC model P242W .
A new Software version including the following features: .
- 1. 3D acquisitions: SpeedUp technique
- 1. 3D acquisitions: Elliptical filling of k-space technique
- 1. Myelographic contrast technique
A new operating system and database engine: .
- 1. Operating system Microsoft Windows VISTA Ultimate 64 bit platform
- 1. Database based on the built-in Microsoft SQL Server database Engine

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 Brio K122006.

Summary of Non-Clinical Tests

The G-Scan Brio has been evaluated to demonstrate substantial equivalence related to medical electrical equipment, risk management, software verification, and image quality and has been found to conform to the following medical device safety standards:

. IEC 60601-1-1
IEC 60601-1-2 o
. ISO 14971
150 62304 o
. NEMA MS-1

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

K133490
Page 3 of 3

Summary of Clinical Tests

No clinical tests were performed.

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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The stylized symbol features three curved shapes that resemble human figures or abstract forms.

Public Health Service

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

December 30, 2013

Esaote, S.p.A. % Allison Scott, RAC Navigant Consulting, Inc. 9001 Weslevan Road. Suite 200 INDIANAPOLIS IN 46268

Re: K133490

Trade/Device Name: G-scan Brio Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 12, 2013 Received: November 13, 2013

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. 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 801); medical device reporting (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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Medical/Devices/Safety/ReportalProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

for

Janine M. Могтіs Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 .... See PRA Statement on last page.

510(k) Number (if known) K133490

Device Name G-Scan Brio

Indications for Use (Describe)

G-scan Brio is a Magnetic Resorance (MR) system that produces und coronal and obligue cross-scrion inages of the limbs, joints and spinal column. It is intended for imaging portions including the hand, wrist, forcarm, elbov, ann and shoulder, imaging portions of the lower limb, including the food, ankle, call, knee, thigh and hip, inaging the temporomandibular joint and imaging the cervices spine sections as portions of the spinal column.

G-scan Brio images corespond to the spaial distribution of protons (hydrogen nuclei) that delection of properties and are dependent on the MR parameters, including spin-latice relaxation time (TI), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert mined in 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Mechal D. O'Hara

FORM FEA8888pf919-Scan Special 510(k)
Page 1 of 1
0016111

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.