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 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 Description

The modified AURORA is identical to the AURORA breast imaging system cleared by FDA through K032082 except for the addition of the RODEO fat-suppression pulse sequence.

AI/ML Overview

The provided text describes a 510(k) summary for the AURORA Magnetic Resonance Diagnostic Device. It states that "Testing was performed to validate the safety and performance of the AURORA with the new pulse sequence." However, no specific acceptance criteria or detailed study results demonstrating how the device meets those criteria are included in the provided text. The document focuses on establishing substantial equivalence to a predicate device based on similarities in intended use, design, and technological characteristics, particularly the addition of a new fat-suppression pulse sequence.

Therefore, the following information cannot be extracted from the given text:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample sized used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned.
If a standalone performance study was done: The document mentions "Testing was performed to validate the safety and performance," but doesn't detail the type of study or its results, making it impossible to confirm if standalone performance was specifically assessed and reported.
The type of ground truth used: Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

The document primarily serves as a regulatory submission (510(k)) to demonstrate substantial equivalence for a modification to an existing MRI system, focusing on the addition of a new fat-suppression pulse sequence, rather than a detailed report of clinical validation studies with specific performance metrics and acceptance criteria.

Summary

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K032678

510(k) Summary for the AURORA Magnetic Resonance Diagnostic Device (per 21CFR807.92)

1. SPONSOR

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

Contact Person: Vera Zhang Telephone: 978-975-7530, ext. 4322

Date Prepared: August 27, 2003

2. DEVICE NAME

Proprietary Name: AURORA Common/Usual Name: Magnetic resonance imaging device Classification Name: Magnetic 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 FDA through K032082 except for the addition of the RODEO fat-suppression pulse sequence.

5. INTENDED USE

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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 thebreast
• Nucleus excited:	Proton
• Diagnostic uses:	2D, 3D T1- / T2-weighted imagingTI, T2, proton density measurementsImage processing
• Imaging capabilities:	2D Spin Echo (SE)2D/3D Gradient Echo (GRE)Fat Suppression
• Imaging processing:	Image SubtractionImage 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 fat suppression.

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 a logo for the Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2003

Aurora Imaging Technology, Inc. % Mr. James R. Veale Vice President, Strategic And Technical Assistance Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760 Re: K032678

Trade/Device Name: AURORA MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II

Product Code: 90 LNH Dated: August 27, 2003 Received: August 29, 2003

Dear Mr. Veale:

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 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 the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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510(k) Number

Device Name: AURORA

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 ionizing radiation. The MR system produces transverse, coronal, sagittal, and oblique crosssectional 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 (TI), 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.

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

Image Filtering

Imaging capabilities: 2D Spin Echo (SE) . 2D/3D Gradient Echo (GRE) Fat Suppression . Imaging processing: Image Subtraction
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Bergman

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

Prescription Use _ (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.