MSK EXTREME MR SCANNER, MODEL AA5000

K080048 · Oni Medical Systems, Inc. · LNH · Feb 6, 2008 · Radiology

Device Facts

• Record ID: K080048
• Device Name: MSK EXTREME MR SCANNER, MODEL AA5000
• Applicant: Oni Medical Systems, Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 6, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MSK Extreme™ MR Scanner is intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.

Device Story

The MSK Extreme™ MRI Scanner is a stationary superconducting magnetic resonance imaging system. It acquires 2D single-slice, multi-slice, and 3D volume images of extremities. The system utilizes various pulse sequences, including spin echo, fast spin echo, and 2D/3D gradient echo acquisitions. Imaging options such as inversion recovery, flow compensation, and fat/water suppression are employed to mitigate physiological motion artifacts and enhance image quality. The device is operated by trained personnel in a clinical setting. The resulting cross-sectional images (axial, sagittal, coronal, oblique) are displayed for review by a medical expert to provide diagnostically useful information regarding internal limb and joint structures, aiding in clinical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and demonstration of technological equivalence to legally marketed predicate devices.

Technological Characteristics

Superconducting magnet MRI system; 2D/3D imaging capabilities; pulse sequences include spin echo, fast spin echo, and gradient echo; features include inversion recovery, flow compensation, and fat/water suppression. Stationary form factor. Manufactured using processes and materials equivalent to the ONI OrthOne Extremity MRI Scanner.

Indications for Use

Indicated for diagnostic MRI imaging of the leg (excluding thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. Produces cross-sectional images for interpretation by medical experts.

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

• OrthOne Extremity MRI Scanner (K001773)
• Philips Medical Systems Achieva 1.5T (K052013)
• MAGNETOM Systems with Software syngo MR 2006A (1.5T Symphony version) (K052164)

Submission Summary (Full Text)

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## 510(k) Summary

| Submitter: | ONI Medical Systems, Inc.<br>301 Ballardvale Street, Suite 4<br>Wilmington, MA 01887<br>USA | FEB - 6 2008 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Mark Puopolo<br>Quality Assurance/Regulatory Affairs Manager<br>781.262.5539<br>978.658.0898<br>[e-mail] | |
| Date Prepared: | January 4, 2008 | |
| Trade Name: | MSK Extreme™ MRI Scanner | |
| Common Name: | Magnetic Resonance Diagnostic Device | |
| Classification<br>Name: | Magnetic Resonance Diagnostic Device | |
| Predicate Device: | OrthOne Extremity MRI Scanner (K001773)<br>Philips Medical Systems Achieva 1.5T(K052013)<br>MAGNETOM Systems with Software syngo MR 2006A<br>(1.5T Symphony version) (K052164) | |
| Device<br>Description: | The MSK Extreme™ MR Scanner utilizes a<br>superconducting magnet to acquire 2D single-slice<br>and multi-slice and 3D volume images. A wide<br>variety of pulse sequences are provided to the<br>operator, including spin echo, fast spin echo, 2D and<br>3D gradient echo acquisitions. Imaging options such<br>as inversion recovery, flow compensation and<br>fat/water suppression are provided to suppress<br>artifacts due to physiological motion and improve<br>image quality. The system is used as a stationary<br>system. | |
| Statement of<br>Intended Use: | The MSK Extreme™ MR Scanner is intended for<br>use as a diagnostic imaging device to produce axial,<br>sagittal, coronal and oblique images of the internal<br>structures of the leg (excluding the thigh), knee,<br>ankle, foot, forearm, elbow, wrist and hand. | |

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| Summary of<br>Technological<br>Characteristics: | In addition to being technologically equivalent to the<br>predicate devices, the MSK Extreme™ MR Scanner has been<br>subjected to performance testing and it has been determined<br>that the MSK Extreme™ MR Scanner is suitable for its<br>intended use. |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Non-<br>clinical Data: | The MSK Extreme™ MR Scanner is manufactured under the<br>same conditions, using the similar processes and equivalent<br>materials, as the ONI OrthOne Extremity MRI Scanner, the<br>legally marketed ONI predicate device. In addition to being<br>technologically equivalent, the indications for use have not<br>changed. |

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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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 2008

Mr. Mark Puopolo Quality Assurance/Regulatory Affairs Manager ONI Medical Systems, Inc. 301 Ballardvale Street, Suite 4 WILMINGTON MA 01887-4405

Re: K080048

Trade/Device Name: MSK Extreme™ MRI Scanner Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: January 4, 2008 Received: January 8, 2008

Dear Mr. Puopolo:

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 either class II (Special Controls) or class III (PMA). it may be subject to such 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.

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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); 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.

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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for ONI Medical Systems, Inc. The logo consists of the letters "ONI" in a stylized font, with the letters overlapping each other and surrounded by a dark circle. To the right of the circle, the words "ONI Medical Systems, Inc." are written in a simple, sans-serif font. The text is aligned to the left and the words "Medical Systems, Inc." are stacked below the word "ONI".

## Indications for Use

510(k) Number (if known):

Device Name: MSK Extreme™ MRI Scanner

Indications: The ONI MSK Extreme™ MR Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.

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

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

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| Page 1 of | 1 |
|---------------|--------------------------------------------------------|
| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
| | (Division Sign-Off) |
| | Division of Reproductive, Abdominal and |
| | Radiological Devices |
| 510(k) Number | K080048 |