S-SCAN

K131996 · Esaote, S.p.A. · LNH · Dec 13, 2013 · Radiology

Device Facts

• Record ID: K131996
• Device Name: S-SCAN
• Applicant: Esaote, S.p.A.
• Product Code: LNH · Radiology
• Decision Date: Dec 13, 2013
• 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 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 of the temporomandibular joint and imaging the cervical spine and the lumbar spine 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 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 Story

S-scan is a magnetic resonance imaging (MRI) system; produces cross-sectional images of limbs, joints, and spinal column; utilizes proton spatial distribution based on T1, T2, nuclei density, flow velocity, and chemical shift. Operated by trained medical experts in clinical settings; output interpreted by physicians for diagnostic decision-making. Modifications from predicate (K121650) include upgraded electronics, patient bed unlocking function, and new software version. System provides diagnostic information to assist in clinical assessment of musculoskeletal and spinal conditions.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing and design verification of system modifications.

Technological Characteristics

Magnetic resonance diagnostic device; produces cross-sectional images via proton density and relaxation time mapping. System includes upgraded electronics and patient bed unlocking mechanism. Software-controlled imaging system.

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 cervical/lumbar spine sections in patients requiring diagnostic imaging.

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 (K121650)

Submission Summary (Full Text)

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510(k) Summary S-Scan Esaote S.p.A.

# 510(k) Summary

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

807.92(a)(1)

# Submitter Information

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

Allison Scott, RAC Contact Person: P: 317.569.9500 x106 F: 317.569.9520 [e-mail]

June 26, 2013 Date:

807.92(a)(2)

#### Devices

Trade Name: S-scan Common Name: System, Nuclear Magnetic Resonance Imaging Classification Name(s): Magnetic Resonance Diagnostic Device Classification Number: аогин

807.92(a)(3)

#### Predicate Device(s)

| Trade Name | Common name | Class | Product code | Manufacturer | K number |
|------------|-----------------------------------------------|-------|--------------|---------------|----------|
| S-scan | System, nuclear magnetic<br>resonance imaging | II | LNH | ESAOTE S.P.A. | K121650 |

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510(k) Summary S-Scan Esaote S.p.A.

807.92(a)(4)

#### Device Description

The changes performed on the modified S-scan device, with respect to the cleared version - Sscan K121650 - 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. Upgrading of the electronics
- 2. Patient bed unlocking function
- 3. A new software version

807.92(a)(5)

### Intended Use(s)

S-scan 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 of the temporomandibular joint and imaging the cervical spine and the lumbar spine 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 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.

807.92(a)(6)

# Technological Characteristics

The changes to the S-scan system, reflected in this Special 510(k), do not alter the fundamental scientific technology of the S-scan system, the predicate device, cleared via K121650.

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Image /page/2/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 a stylized symbol featuring three abstract shapes that resemble a human figure.

Public Health Service

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

December 13, 2013

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

Re: K131996

Trade/Device Name: S-scan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 14, 2013 Received: November 15, 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 (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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Page 2-Ms. Scott

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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 [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" (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/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michal D. O. O. D.

Janine M. Morris 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) KI31996

#### Device Name S-scan MR System

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#### Indications for Use (Describe)

S-scan 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 of the temporomandibular joint and imaging the cervical spine and the lumbar spine 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 spin-lattice relaxation time (TI), 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.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

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