MODIFICATION TO: AURORA

K052698 · Aurora Imaging Technology, Inc. · LNH · Nov 8, 2005 · Radiology

Device Facts

• Record ID: K052698
• Device Name: MODIFICATION TO: AURORA
• Applicant: Aurora Imaging Technology, Inc.
• Product Code: LNH · Radiology
• Decision Date: Nov 8, 2005
• Decision: SESE
• Submission Type: Special
• 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, sagittal, and oblique cross-sectional images that display the internal structure of the extremities (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 to be used as an adjunct to conventional breast screening methods.

Device Story

AURORA MRI system provides non-invasive cross-sectional imaging of breast tissue, axilla, and chest wall; utilizes magnetic resonance of protons to generate images based on T1, T2, proton density, and flow. System operates via 2D/3D pulse sequences, including RODEO Spiral 3D; performs image subtraction and filtering. Used in clinical settings by trained physicians to assist in diagnosis. Output consists of cross-sectional images interpreted by clinicians to inform diagnostic decisions; benefits patient through non-ionizing radiation imaging.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Dedicated breast MRI system; utilizes proton magnetic resonance; supports 2D Spin Echo (SE) and 2D/3D Gradient Echo (GRE) imaging; includes fat suppression, image subtraction, and image filtering capabilities. Features RODEO Spiral 3D pulse sequence.

Indications for Use

Indicated for non-invasive MRI imaging of breast tissue, axilla, and chest wall local to the breast for diagnostic purposes as an adjunct to conventional breast screening methods.

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)

Submission Summary (Full Text)

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# NOV - 8 2005

K052698

## 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: | Michael A. Douglas |
|-----------------|--------------------|
| Telephone: | 978.975.7530 x4345 |

Date Prepared: September 12, 2005

#### 2. DEVICE NAME

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

#### 3. PREDICATE DEVICES

Aurora MRI System (K032082)

#### 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 RODEO Spiral 3D pulse sequence.

#### 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, sagittal, and oblique cross-sectional images that display the internal structure of the extremities (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 to be used as an adjunct to conventional breast screening methods.

- . 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

#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

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 pulse sequence for RODEO Spiral 3D.

#### 7. Testing

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

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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 is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2005

Mr. Michael A. Douglas Director of QA and Regulatory Affairs Aurora Imaging Technology, Inc. 39 High Street NORTH ANDOVER MA 01845

Re: K052698

Trade/Device Name: AURORA MRI System Regulation Number: 21 CDR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: September 23, 2005 Received: October 12, 2005

Dear Mr. Douglas:

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 (Premarket Approval), it mav 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.

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.

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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.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" (21 CFR 807.97). 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,

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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follow the procedures outlined in the "A Suggested Approach to Resolving Least Burdensome Issues" document. It is available on our Center web page at: http://www.fda.gov/cdrh/modact/leastburdensome.html

510(k) Number:

K052698
Aurora

Device Name:

Indications for Use:

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 use of lonizing radiation. The MR system produces transverse, coronal, sagittel, and oblique cross-sectional images that display the internal structure of the extremities (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 relaxstion 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.

- Anatomical region: Breast tissue, axilla, and chest wall local to the breast .
- Nucleus excited: Proton ●
- Diagnostic uses: 2D. 3D T1-772-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 |

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)

Nancy Brogdon
Division Sign Off

Division Sign-Off Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Aurora Imaging Special 510(k) September 23, 2005 AURORA SPIRAL Pulse Sequence

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