SPEEDUP SOFTWARE OPTION

K120748 · Esaote, S.p.A. · LNH · May 1, 2012 · Radiology

Device Facts

• Record ID: K120748
• Device Name: SPEEDUP SOFTWARE OPTION
• Applicant: Esaote, S.p.A.
• Product Code: LNH · Radiology
• Decision Date: May 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

SpeedUp is an imaging technique to increase scan speed reducing the acquisition time. The sparsity which is implicit in MR images is exploited to significantly undersample the kspace, resulting in incoherent artifacts (noise like). Time is decreased reducing the number of acquired k-space lines (i.e. undersampling) and the final image can be reconstructed accurately with an appropriate non-linear reconstruction method.

Device Story

SpeedUp is a software option for Esaote G-scan and O-scan MRI systems; designed to reduce scan acquisition time. Device exploits implicit sparsity in MR images to perform significant k-space undersampling; resulting in incoherent, noise-like artifacts. System utilizes non-linear reconstruction methods to accurately reconstruct final images from undersampled data. Operated by MRI technicians or clinicians in clinical settings; output is viewed by radiologists/physicians to assist in diagnostic imaging. Benefit is reduced patient scan time.

Clinical Evidence

Clinical images obtained using G-scan and O-scan systems with the SpeedUp software option were evaluated. Testing demonstrated that the systems met performance requirements and are as safe and effective as the predicate devices.

Technological Characteristics

Software-based imaging technique for MRI systems. Utilizes non-linear reconstruction algorithms to process undersampled k-space data. Operates as an add-on option for existing G-scan and O-scan MRI hardware platforms.

Indications for Use

Indicated for use as an imaging technique to increase scan speed and reduce acquisition time on G-scan and O-scan MRI systems. No specific patient population, age, or contraindications are defined.

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 (K111803)
• S-scan (K080968)
• O-scan (K092469)
• Achieva (K043147)

Submission Summary (Full Text)

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Esaote, S.p.A. 510(k) Summary SpeedUp

# MAY - 1 2012

P / 2

K120 748

## 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.928(a).

#### Submitter Information

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

Contact Person:

Allison Scott, RAC Phone: [phone] x 106 Facsimile:[phone] [e-mail]

Date:

March 9, 2012

Trade Name: SpeedUp

Common Name:

System, Nuclear Magnetic Resonance Imaging

Classification Name(s): Magnetic resonance diagnostic device

Classification Number: 90LNH

### Predicate Device(s)

| Tradename | Common name | Class | Product code | Manufacturer | K number |
|-----------|-----------------------------------------------|-------|--------------|---------------|----------|
| G-scan | System, nuclear magnetic<br>resonance imaging | II | LNH | ESAOTE S.P.A. | K111803 |
| S-scan | System, nuclear magnetic<br>resonance imaging | II | LNH | ESAOTE S.P.A. | K080968 |
| O-scan | System, nuclear magnetic<br>resonance imaging | II | LNH | ESAOTE S.P.A. | K092469 |
| Achieva | System, nuclear magnetic<br>resonance imaging | II | LNH | PHILIPS | K043147 |

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Esaote, S.p.A. 510(k) Summary SpeedUp

#### Device Description

SpeedUp is a software option intended for use on G-scan and O-scan Esaote MRI svstems.

SpeedUp is an imaging technique to increase scan speed reducing the acquisition time. The sparsity which is implicit in MR images is exploited to significantly undersample the kspace, resulting in incoherent artifacts (noise like). Time is decreased reducing the number of acquired k-space lines (i.e. undersampling) and the final image can be reconstructed accurately with an appropriate non-linear reconstruction method.

#### Intended Use(s)

SpeedUp is an imaging technique to increase scan speed reducing the acquisition time. The sparsity which is implicit in MR images is exploited to significantly undersample the kspace, resulting in incoherent artifacts (noise like). Time is decreased reducing the number of acquired k-space lines (i.e. undersampling) and the final image can be reconstructed accurately with an appropriate non-linear reconstruction method.

#### Technological Characteristics

The technological characteristics of the G-scan, S-scan systems with the addition of the SpeedUp software option, reflected in this Traditional 510(k), are substantially equivalent to those of the predicate devices.

#### Non-Clinical Summary

Non-clinical verification and validation testing of the G-scan and O-scan systems. with the addition of the SpeedUp software option, was conducted according to design controls per CFR820.30. Testing demonstrated that the systems met performance requirements and are as safe and effective as the predicate devices.

#### Clinical Summary

Clinical images of the G-scan and O-scan systems with the addition of the SpeedUp software option demonstrated that the systems met performance requirements and are as safe and effective as the predicate devices.

#### Conclusion

The G-scan. S-scan and O-scan systems with the addition of the Speed Up software are safe and effective, and perform substantially equivalent to the legally marketed devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion 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. % Ms. Allison Scott, RAC Regulatory Consultant Anson Group, LLC 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268

Re: K120748

Trade/Device Name: SpeedUp Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 8, 2012 Received: March 12, 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

MAY - 1 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 [phone]. 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 [phone] or [phone] 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 Form

510(k) Number (if known):

Device Name: SpeedUp

SpeedUp is an imaging technique to increase scan speed reducing the acquisition time. The sparsity which is implicit in MR images is exploited to significantly undersample the k-space, resulting in incoherent artifacts (noise like). Time is decreased reducing the number of acquired k-space lines (i.e. undersampling) and the final image can be reconstructed accurately with an appropriate non-linear reconstruction method.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Andrew D. Ohm

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120748