MRI Dynamic Analysis Plus

K153039 · Esaote, S.p.A. · LNH · Jan 8, 2016 · Radiology

Device Facts

• Record ID: K153039
• Device Name: MRI Dynamic Analysis Plus
• Applicant: Esaote, S.p.A.
• Product Code: LNH · Radiology
• Decision Date: Jan 8, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

S-scan 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. S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spinlattice 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

S-scan is an MR imaging system for limbs, joints, and spine. The 'MRI Dynamic Analysis Plus' software option enhances existing dynamic imaging capabilities; it processes sequences of dynamic MR images acquired after contrast agent administration. The software automatically calculates signal intensity over time, interpolates curves, and determines maximum slope and asymptotic values. Unlike the predicate, it performs pixel-wise evaluation across the entire image rather than relying on averaged regions of interest (ROI); it eliminates the need for external intensity reference vials; it utilizes raw image data prior to intensity normalization to mitigate RF perturbation effects. Operated by trained medical experts in clinical settings, the output provides quantitative uptake curves to assist in diagnostic interpretation. The device benefits patients by improving the reliability, robustness, and productivity of dynamic contrast-enhanced MR examinations.

Clinical Evidence

No clinical tests were performed.

Technological Characteristics

Magnetic resonance diagnostic device (21 CFR 892.1000). System includes MRI hardware and 'MRI Dynamic Analysis Plus' software. Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-33, IEC 62304, IEC 62366, ISO 10993-1, NEMA MS-1, and NEMA MS-3. Software performs automated pixel-wise signal intensity analysis and curve interpolation.

Indications for Use

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

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

• S-scan (K151668)
• S-scan (K080968)

Submission Summary (Full Text)

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

January 8, 2016

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

Re: K153039

Trade/Device Name: S-scan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 15, 2015 Received: December 16, 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

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Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. 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

# 510(k) Number (if known)

UNKNOWN

Device Name

S-scan

Indications for Use (Describe)

S-scan 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.

S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spinlattice 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.

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) Submission S-scan Esaote, S.p.A.

# Special 510(k) Summary

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

### Submitter Information

Esaote S.p.A. Via Siffredi 58 16153 Genova - Italy

Contact Person:

Allison Scott, RAC Managing Regulatory Consultant Tel. [phone] Fax [phone] [e-mail]

| Date: | October 15, 2015 |
|------------------------|--------------------------------------------|
| Tradename: | S-scan |
| Common name: | System, Nuclear Magnetic Resonance Imaging |
| Classification Name: | Radiology |
| Classification Number: | 90LNH |

#### Predicate Devices

| Trade name | Common name | Class | Product code | Manufacturer | K number |
|------------|--------------------------------------------|-------|--------------|--------------|----------|
| S-scan | System, nuclear magnetic resonance imaging | II | LNH | ESAOTE S.P.A | K151668 |
| S-scan | System, nuclear magnetic resonance imaging | II | LNH | ESAOTE S.P.A | K080968 |

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# Device Description

MRI Dynamic Analysis Plus is the Esaote commercial name of a software option intended for use on S-scan Esaote MRI systems; this option allows the extension of the functionalities of the option MRI Dynamic Analysis (cleared for S-scan K080968). MRI Dynamic Analysis enables the acquisition of a set of dynamic images and subsequent display of the time varying signals that is due to absorption of the contrast agent over time in the image series acquired. The software described above provides values of signal intensity over time and calculates the interpolation curve of these values, the maximum slope and the asymptotic value. The MRI Dynamic Analysis Plus software option has been implemented to enhance the performance of the MRJ Dynamic Analysis in terms of ease of use, reliability (operator independence) of the uptake-curves calculation, productivity and robustness. The MRI Dynamic Analysis Plus software option enhances performance of the existing MRI Dynamic Analysis (K080968) software in the following regard:

- Evolution of the available and consolidated Uptake Curve ●
- . Enabled by the options «MRI Dynamic Analysis» + «MRI Dynamic Analysis Plus»
- . Reliability (Operator independence) - Curve is automatically evaluated pixel on the whole image, instead of on an averaged ROI
- . Productivity - An intensity reference on images (vial placed alongside the wrist) is no more required
- . Robustness - Image data in extended scale is used, that is before "intensity normalization", in order to eliminate RF perturbations effects and to ensure that the pixel intensities along different series of dynamic examination are homogenous

## Intended Use

S-scan 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.

S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spinlattice 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 S-scan systems with the addition of the MRI Dynamic Analysis Plus software option, reflected in this Special 510(k), do not alter the scientific technology of the S-scan system and are substantially equivalent to those of the predicate devices.

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## Summary of Non-Clinical Tests

The devices have been evaluated for biocompatibility, electrical, electromagnetic, and mechanical safety, and have 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 ●
- IEC62304
- IEC62366 ●
- ISO10993-1
- NEMA MS-1 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic ● Resonance Imaging
- NEMA MS-3 Determination of Image Uniformity in Diagnostic Resonance ● Images

## Summary of Clinical Tests

No clinical tests were performed.

## Conclusion

The changes proposed to the S-scan System are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.