G-scan Brio

K142421 · Esaote, S.p.A. · LNH · Apr 9, 2015 · Radiology

Device Facts

• Record ID: K142421
• Device Name: G-scan Brio
• Applicant: Esaote, S.p.A.
• Product Code: LNH · Radiology
• Decision Date: Apr 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal, 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, 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.

Device Story

G-scan Brio is a magnetic resonance imaging (MRI) system; produces cross-sectional images of limbs, joints, and spine. Input: spatial distribution of protons (hydrogen nuclei) based on T1, T2, nuclei density, flow velocity, and chemical shift. Output: transversal, sagittal, coronal, and oblique MR images. Used in clinical settings by trained medical experts to provide diagnostically useful information. Modifications from predicate (K133490) include new Bilateral TMJ coil, DPA Lumbar spine coil with extra-large flexible section, thoracic spine examination capability, and software updates (customizable image enhancement, PACS overlay, isotropic 3D acquisition).

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by non-clinical bench testing, including image quality evaluation and software verification.

Technological Characteristics

Magnetic resonance diagnostic device. Modifications include new hardware (Bilateral TMJ coil, DPA Lumbar spine coil) and software updates. Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-33, ISO 14971, ISO 62304, IEC 62366, NEMA MS-1, and NEMA MS-3.

Indications for Use

Indicated for MR imaging of upper limbs (hand, wrist, forearm, elbow, arm, shoulder), lower limbs (foot, ankle, calf, knee, thigh, hip), temporomandibular joint, and spinal column (cervical, thoracic, lumbosacral sections).

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• G-scan Brio (K133490)
• G-scan (K111803)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

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

April 9, 2015

Esaote, S.p.A. % Ms. Allison Scott Senior Regulatory Consultant Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268

Re: K142421

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: March 30, 2015 Received: March 31, 2015

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 (QS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

for

Robert Ochs, Ph.D. Acting 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) K142421

Device Name G-scan Brio

#### Indications for Use (Describe)

G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal, 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, 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 magnetics and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chenical 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)

### 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)

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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

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

Contact Person: Allison Scott, RAC P: 317.228.8719 F: 317.228.8701 [e-mail]

| Date: | March 24, 2015 |
|-------------------------|--------------------------------------------|
| 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 Brio | System, nuclear magnetic<br>resonance imaging | II | LNH | ESAOTE S.P.A. | K133490 |
| G-scan | System, nuclear magnetic<br>resonance imaging | II | LNH | ESAOTE S.P.A. | K111803 |

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# Device Description

The changes performed to G-scan Brio, with respect to the cleared version – G-scan Brio K133490 – 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:

- A new Bilateral TMJ Coil
- Introduction of the DPA Lumbar spine coil n° 10 with a new extra-large flexible section
- Introduction of the thoracic spine section examination
- A new software version including the following features:
- o Customization of Image Enhancement
- o Overlay sending to PACS
- o Isotropic 3D acquisition

# Intended Use(s)

G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal, 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, 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 modifications reflected in this Traditional 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 K133490.

#### 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
- IEC 60601-1-2
- IEC 60601-1-6
- IEC 60601-2-33
- ISO 14971
- ISO 62304
- IEC 62366

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

- . NEMA MS-1
- NEMA MS-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 to applicable medical device safety and performance standards.