(23 days)
Not Found
No
The summary describes a standard MRI system with modifications to the magnet and RF system for higher field strength. There is no mention of AI or ML in the intended use, device description, or performance studies. The image processing mentioned (subtraction, filtering) are standard techniques and do not necessarily imply AI/ML.
No
The device is described as an "imaging device" intended to "provide the physician with physiological and clinical information" and "useful in diagnosis determination," indicating a diagnostic rather than therapeutic purpose.
Yes
The intended use states that the images, when interpreted by a trained physician, provide information useful in "diagnosis determination."
No
The device description explicitly states it is a modified version of an existing MRI system, which is a hardware device. The modifications mentioned are related to the magnet, RF system, and spectrometer, all of which are hardware components. While it mentions image processing, this is a function of the overall hardware system, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AURORA MRI system is an imaging device. It produces images of the internal structure of the body (specifically the breast and surrounding areas) using magnetic resonance. This is a non-invasive method that does not involve analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's an "imaging device" and provides "physiological and clinical information obtained non-invasively". It's used as an "adjunct to conventional breast screening methods" by providing images for interpretation by a trained physician.
The key distinction is that IVDs analyze biological samples outside the body (in vitro), while this device creates images of the body inside the body (in vivo).
N/A
Intended Use / 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 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 nucle) 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
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The modified AURORA is identical to the AURORA breast imaging system cleared by FDA through K012154 except that the magnet is ramped to 1.5 T and the RF system and spectrometer have been changed to operate at the higher frequencies required for 1.5 T operation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic resonance imaging
Anatomical Site
Breast tissue, axilla, and chest wall local to the breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed to validate the performance of the AURORA operating at 1.5 T. Testing included measurement of acoustic noise, Specific Absorption Rate, slice thickness, SNR and image uniformity according to NEMA standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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K032082
page 1 of 2
JUL 3 0 2003
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 978-975-7530 x 4322 Telephone:
Date Prepared: July 3, 2003
2. DEVICE NAME
Proprietary Name: AURORA Common/Usual Name: Magnetic resonance imaging device Magnetic resonance diagnostic device Classification Name:
3. PREDICATE DEVICES
AURORA MRI system (K012154)
4. DEVICE DESCRIPTION
The modified AURORA is identical to the AURORA breast imaging system cleared by FDA through K012154 except that the magnet is ramped to 1.5 T and the RF system and spectrometer have been changed to operate at the higher frequencies required for 1.5 T operation.
INTENDED USE 5.
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
1
K032082
Page 2 of 2
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.
- Breast tissue, axilla, and chest wall local to the . Anatomical region: breast
- . Nucleus excited: Proton
- 2D, 3D T1- / T2-weighted imaging . Diagnostic uses: TI, 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
- TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
Aurora Imaging Technology, Inc. makes a claim of substantial equivalence of the modified AURORA to the predicate AURORA (K012154) 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 magnet is ramped to 1.5 T for the upgraded AURORA instead of 0.5 T for the predicate AURORA, and the RF system and spectrometer have been modified to increase their frequency of operation.
-
- TESTING
Testing was performed to validate the performance of the AURORA operating at 1.5 T. Testing included measurement of acoustic noise, Specific Absorption Rate, slice thickness, SNR and image uniformity according to NEMA standards.
- TESTING
2
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. Inside the circle is a stylized image of an eagle with three stripes representing its wings. The seal is black and white and appears to be a logo or emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2003
Aurora Imaging Technology, Inc. c/o Mr. James R. Veale Vice President. Strategic and Technical Assistance Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760 Re: K032082
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: July 3, 2003 Received: July 7, 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.
3
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
4
510(k) Number (if known):
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 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 nucle) 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 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel D. Seymore
(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, Divisionogical Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)