O-SCAN MR SYSTEM

K092469 · Esaote, S.p.A. · LNH · Dec 23, 2009 · Radiology

Device Facts

• Record ID: K092469
• Device Name: O-SCAN MR SYSTEM
• Applicant: Esaote, S.p.A.
• Product Code: LNH · Radiology
• Decision Date: Dec 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

O-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, calf and knee, but excluding the thigh. O-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

O-scan is a dedicated extremity Magnetic Resonance (MR) system; utilizes permanent magnet technology to generate cross-sectional images of limbs and joints. System components include magnetic unit, electronic unit, console (PC, monitor, input devices), patient seat, and receiving coils. Operates by detecting spatial distribution of protons based on T1, T2, nuclei density, flow velocity, and chemical shift. Used in clinical settings by trained medical experts to interpret images for diagnostic purposes. Provides non-invasive visualization of internal limb structures to assist in clinical decision-making.

Clinical Evidence

No clinical data. Non-clinical bench testing demonstrated performance requirements met and safety/effectiveness equivalent to predicate devices.

Technological Characteristics

Permanent magnet MR system; includes magnetic unit, electronic unit, console, patient seat, and receiving coils. Produces transversal, sagittal, coronal, and oblique cross-section images. Operates based on proton density and MR parameters (T1, T2, flow velocity, chemical shift).

Indications for Use

Indicated for patients requiring MR imaging of limbs and joints, specifically hand, wrist, forearm, elbow, foot, ankle, calf, and knee. Excludes upper arm and thigh. For use by medical experts trained in MR equipment.

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

• C-scan (K040877)
• S-scan (K080968)
• AIRIS II (K001334)

Submission Summary (Full Text)

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

# 510(k) Summary

K092469

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

### Submitter Information

DEC 2 3 2009

Allison Scott, Official Correspondent 11460 N. Meridian St., Suite 150 Carmel, IN 46032 [phone] x106 Phone: Facsimile: [phone]

Contact Person: Allison Scott, RAC

Date: August 7, 2009

Trade Name: O-Scan

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 |
|-----------|--------------------------------------------|-------|--------------|-------------------------|----------|
| C-scan | System, nuclear magnetic resonance imaging | II | LNH | ESAOTE S.P.A. | K040877 |
| S-scan | System, nuclear magnetic resonance imaging | II | LNH | ESAOTE S.P.A. | K080968 |
| AIRIS II | System, nuclear magnetic resonance imaging | II | LNH | HITACHI MEDICAL SYSTEMS | K001334 |

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O-Scan 510(k)

8/7/2009

Page 10 of 905

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

#### Device Description

O-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.

The system comprises three main parts:

1. Magnetic unit, containing a permanent magnet

2. Electronic unit

3. Console, comprising a PC, Keyboard, mouse, monitor and operating table.

4. Patient seat

5. Receiving coils

## Intended Use(s)

O-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, calf and knee, but excluding the thigh.

O-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.

### Technological Characteristics

The technological characteristics of the O-Scan are substantially equivalent to those of the predicate devices.

## Performance Data

Non-clinical testing of the O-Scan system demonstrated that it met performance requirements and is as safe and effective as the predicate devices.

page 2 of 2

O-Scan 510(k)

8/7/2009

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 Consultant The Anson Group, LLC 11460 N. Meridian St., Suite 150 CARMEL IN 46032

DEC 2 3 2009

Re: K092469

Trade/Device Name: O-Scan MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 17, 2009 Received: November 18, 2009

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known): K092469

Device Name: O-Scan MR System

Indications for Use:

O-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, calf and knee, but excluding the thigh.

O-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.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lozano Mtz

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev

510(k) Number K072462

O-Scan 510(k)

8/7/2009