MODIFICATION TO AURORA MRI SYSTEM

K073425 · Aurora Imaging Technology, Inc. · LNH · Sep 16, 2008 · Radiology

Device Facts

• Record ID: K073425
• Device Name: MODIFICATION TO AURORA MRI SYSTEM
• Applicant: Aurora Imaging Technology, Inc.
• Product Code: LNH · Radiology
• Decision Date: Sep 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The AURORA MRI system is an imaging device, and is intended to provide the physician with physiological and clinical information obtained noninvasively and without the use of ionizing radiation. The MR system produces transverse, coronal, and sagittal cross-sectional images that display the internal structure of breast tissue, axilla, and chest wall local to the breast. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. The AURORA is a dedicated breast MRI system intended for breast imaging. - . Anatomical region: Breast tissue, axilla, and chest wall local to the breast - . Nucleus excited: Proton - . Diagnostic uses: 2D, 3D T1-/T2-weighted imaging T1. T2, proton density measurements Image processing - Imaging Capabilities: 2D Spin Echo (SE) . 2D/3D Gradient Echo (GRE) Fat Suppression - . Imaging Processing: Image Subtraction Image Filtering The Aurora MR Spectroscopy Package is intended for use as a noninvasive diagnostic device that provides information based on relative concentration of the Choline metabolite in breast tissues. The localized spectra reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination.

Device Story

AURORA MRI system; dedicated breast imaging device. Modified to include Spectroscopy pulse sequence protocol and user interface software. Inputs: proton NMR signals from breast tissue, axilla, and chest wall. Processing: pulse sequence application to measure proton density, T1, T2, flow, and chemical shift; spectroscopy package quantifies Choline metabolite concentration. Output: cross-sectional images and localized spectral data. Used in clinical settings by trained physicians/medical practitioners. Output interpreted by clinicians to aid in diagnosis determination. Benefits: non-invasive physiological/clinical information without ionizing radiation.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Magnetic resonance diagnostic device; proton excitation. Imaging capabilities: 2D Spin Echo (SE), 2D/3D Gradient Echo (GRE), Fat Suppression. Processing: Image subtraction, image filtering. Spectroscopy package measures Choline metabolite concentration via chemical shift. Software-based pulse sequence control.

Indications for Use

Indicated for non-invasive breast imaging, including axilla and chest wall, in patients requiring diagnostic information via proton-based MRI. Provides T1/T2-weighted imaging and Choline metabolite concentration analysis for diagnostic support by trained medical practitioners.

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

• Aurora MRI System (K032082)
• GE Probe (K930265)
• Siemens (K951650)

Submission Summary (Full Text)

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Spectroscopy Package for AURORA MRI System

SEP 1 6 2008

510 (k) Number: K073425

# 510(k) Summary for the

# AURORA Magnetic Resonance Diagnostic Device

(Revised Version of "510(k) Summary" of the Original Submission)

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### 510(k) Summary for the

## AURORA Magnetic Resonance Diagnostic Device

### (per 21 CFR 807.92)

#### 1. Sponsor

Aurora Imaging Technology Inc. 39 High Street North Andover, MA 01845

| Contact Person: | J. P. Ouellette |
|-----------------|--------------------|
| Telephone: | 978.975.7530 x4345 |

Date Prepared: September 12, 2008

#### 2. Device Name

Proprietary Name: Aurora Common/Usual Name: Magnetic Resonance Imaging Device Classification Name: Magnetic Resonance Diagnostic Device

#### 3. Predicate Device(s)

Aurora MRI System (K032082) GE Probe (K930265) Siemens (K951650)

#### 4. Device Description

The modified AURORA is identical to the AURORA breast imaging system cleared by the FDA through K032082 except for the addition of the Spectroscopy pulse sequence protocol and its corresponding user interface software.

#### 5. Intended Use

The AURORA MRI system is an imaging device, and is intended to provide the physician with physiological and clinical information obtained noninvasively and without the use of ionizing radiation. The MR system

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produces transverse, coronal, and sagittal cross-sectional images that display the internal structure of breast tissue, axilla, and chest wall local to the breast. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The AURORA is a dedicated breast MRI system intended for breast imaging.

- . Anatomical region: Breast tissue, axilla, and chest wall local to the breast
- . Nucleus excited: Proton
- . Diagnostic uses: 2D, 3D T1-/T2-weighted imaging T1. T2, proton density measurements Image processing
- Imaging Capabilities: 2D Spin Echo (SE) . 2D/3D Gradient Echo (GRE) Fat Suppression
- . Imaging Processing: Image Subtraction Image Filtering

The Aurora MR Spectroscopy Package is intended for use as a noninvasive diagnostic device that provides information based on relative concentration of the Choline metabolite in breast tissues. The localized spectra reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination.

#### Technological Characteristics and Substantial Equivalence 6.

Aurora Imaging Technology, Inc., makes a claim of substantial equivalence of the modified AURORA to the predicate AURORA (K032082) based on similarities in intended use, design, and technological and operational characteristics. Both are indicated for magnetic resonance imaging of the breast. Both systems use the same hardware and software except that the modified device includes a new Spectroscopy Package.

#### 7. Testing

Testing was performed to validate the safety and performance of the AURORA with the new pulse sequence.

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Spectroscopy Package for AURORA MRI System

510 (k) Number: K073425

## Indications for Use Statement

(Revised Version of Section "Indications for Use Statement" of the Original Submission)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 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 right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

### Public Health Service

### SEP 1 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

J.P. Ouellette, M.S. Director of Quality Assurance & Regulatory Affairs Aurora Imaging Technology, Inc. 39 High Street NORTH ANDOVER MA 01845

Re: K073425

Trade/Device Name: AURORA Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 25, 2008 Received: August 27, 2008

Dear Mr. Ouellette:

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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### Page 2

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (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 Biometrics' (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/cdrh/industry/support/index.html.

Sincerely vours.

hope Mr. Zhang

Joyce M. Whang, Ph.D. 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: K073425

## Device Name: Spectroscopy Package for AURORA MRI System

### Indications for Use: AURORA

The AURORA MRI system is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the physician without the use of ionizing radiation. The MR system produces transverse, coronal, and sagittle cross-sectional images that display the internal structure of breast tissue, axilla, and sagillal cross-sectional images production in agest. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine (hydrogen nuclei)
profon density spin Jotties relovetion (in extroperties that determine the image appearanc proton density spin-latice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained of blackers the (11), Spir-Spill relaxation that can be useful in diagnosis determination.

The AURORA is a dedicated breast MRI system intended for breast imaging.

- Anatomical region: . Breast tissue, axilla, and chest wall local to the breast
- Nucleus excited: Proton .
- Diagnostic uses: 2D, 3D T1-/T2-weighted imaging .

| Imaging Capabilities: | T1, T2, proton density measurements<br>Image processing<br>2D Spin Echo (SE)<br>2D/3D Gradient Echo (GRE)<br>Fat Suppression |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Imaging Processing: | Image Subtraction<br>Image Filtering |

The Aurora MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentration of the Choline metabolite in breast tissues. The localized spectra a the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical proctitioner, these since (12), and onemical shift. When interpreted by a trained
dotermination determination

PRESCRIPTION USE
(21 CFR 801 SUBPART D)

Over-the-counter use (21 CFR 801 Subpart C)

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

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