(70 days)
IEN/EC 60601-2-3.1
No
The document explicitly states "No changes in software or pulse sequences were necessary" for the upgrade, and there is no mention of AI, ML, or related terms in the description of the device or its enhancements. The image processing mentioned refers to standard techniques like subtraction and filtering, not AI/ML-based methods.
No
The device is described as an "imaging device" and "diagnostic device" intended to provide "physiological and clinical information" useful in "diagnosis determination," and to "produce transverse, coronal, sagittal, and oblique cross-sectional images," not to treat conditions.
Yes
The "Intended Use / Indications for Use" section states: "When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination." Additionally, the "Device Description" explicitly refers to the device as "The AURORA Magnetic Resonance Diagnostic Device."
No
The device description explicitly states that the enhancement is a "forklift upgrade" involving a new main MRI magnet, improved RF-chain, and gradient-chain subsystems, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the AURORA MR system is an imaging device used to provide physiological and clinical information through non-invasive imaging. IVD devices, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body).
- Device Description: The description focuses on the hardware components of an MRI system (magnet, RF-chain, gradient-chain subsystems). This is consistent with an imaging device, not an IVD.
- Input Imaging Modality: The input is Magnetic Resonance (MR), which is an imaging modality, not a method for analyzing biological specimens.
- Anatomical Site: The device is used to image specific anatomical sites within the body (breast tissue, axilla, chest wall). IVDs analyze samples taken from the body.
The fact that it mentions "image processing" and "diagnostic uses: image processing" further reinforces that it's an imaging device that processes the acquired images for diagnostic purposes, rather than an IVD that analyzes biological samples.
N/A
Intended Use / Indications for Use
The AURORA MR 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 (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.
Product codes
90LNH
Device Description
The AURORA Magnetic Resonance Diagnostic Device is being enhanced by a "forklift upgrade" to increase the clinical utility of the AURORA in the stationary configuration. With the "forklift upgrade," the AURORA is available in a stand-alone configuration, and as an upgrade path to existing AURORA installations.
The "forklift upgrade" enhancement is an alternate main MRI magnet, operating at a nominal field strength of 0.5T, and improved RF-chain and gradient-chain subsystems. No changes in software or pulse sequences were necessary to support full functionality of these "forkliff upgrade" enhancements.
Mentions image processing
Images depicting the spatial distribution of NMR characteristics of the nuclei under consideration can be constructed by using image processing techniques similar to those used in CT.
image processing
Image Subtraction
Image Filtering
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
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)
Laboratory and clinical testing to internationally-accepted standards were performed to support this claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
IEN/EC 60601-2-3.1
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
SEP 1 9 2001
Image /page/0/Picture/1 description: The image shows a logo for Aurora Advancing Implant Imaging. The logo features the word "AURORA" in large, bold letters at the top, followed by the words "Advancing Implant Imaging" in smaller letters at the bottom. In the center of the logo is a stylized image of a person with a heart-shaped head and a ribbon-like body. The logo is simple and modern, and it conveys a sense of hope and progress.
K012154
Page 1 of 4
Aurora Imaging Technology, Inc. 39 High Street · North Andover, MA 01845 TFP: 877.975.7530 • P: 978.975.7530 F: 975.978.9930
1.0 SUBMITTER INFORMATION:
- 1.1 Submitter: Aurora Imaging Technology, Inc. 39 Hiah Street North Andover, MA 01845 Medical Establishment Registration No.: 1225267 TFP: 877.975.7530x4313
- 978.975.7530x4313 P:
- 978.975.9930 F:
- 412.596.2578 ்:
- jrogers@auroramri.com ட்:
- 1.2 James Jochen Rogers Contact:
- 1.3 Date: September 5, 2001
DEVICE NAME: 2.0
- 2.1 Classification Panel: Radiology
- 2.2 Classification Number: 892.1000 Magnetic Resonance Diagnostic Device
- 2.3 Product Nomenclature: System, Nuclear Magnetic Resonance Imaging
- 2.4 Product Code(s): 90гин
- 2.5 Trade/Proprietary Name: AURORA
- 2.6 PREDICATE DEVICE(s):
AURORA K003561
3.0 DEVICE DESCRIPTION:
- 3.1 FUNCTION:
The AURORA Magnetic Resonance Diagnostic Device is being enhanced by a "forklift upgrade" to increase the clinical utility of the AURORA in the stationary configuration. With the "forklift upgrade," the AURORA is available in a stand-alone configuration, and as an upgrade path to existing AURORA installations.
The "forklift upgrade" enhancement is an alternate main MRI magnet, operating at a nominal field strength of 0.5T, and improved RF-chain and gradient-chain subsystems. No changes in software or pulse sequences were necessary to support full functionality of these "forkliff upgrade" enhancements.
1
KOI 2154
Page 2 of 4
3.2 SCIENTIFIC CONCEPTS:
Magnetic Resonance (MR) is based on the fact that certain atomic nuclei have electromagnetic properties which cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nucleus used in current imaging experiments in magnetic resonance. When placed in a magnetic field, there is a slight net orientation or alignment of these atomic nuclei with the magnetic field. The introduction of a short burst of radiofrequency (RF) excitation of wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a reorientation of the proton's magnetization vector. When the RF excitation is removed, the proton relaxes and returns to its original orientation. The rate of relaxation is exponential, and varies with the character of the proton and its adjacent molecular environment. This reorientation process is characterized by two exponential relaxation times called 11 and T2 which can be measured.
These relaxation events are accompanied by an RF emission or echo which can be measured and used to develop a representation of these emissions on a three dimensional matrix. Spatial localization is encoded into the echo by varying the RF excitation and by appropriately applying magnetic field gradients in x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of NMR characteristics of the nuclei under consideration can be constructed by using image processing techniques similar to those used in CT.
For maanetic fields up to 1.5T, the RF frequencies commonly used range up to 65MHz. The RF fields have pulse powers from several watts to greater than 10 kilowatts, and repeat at rates from once every few seconds to greater than fifty per second. The time-varying magnetic gradient fields have a typical duration of sub-millisecond to several milliseconds.
3.3 PHYSICAL AND PERFORMANCE CHARACTERISTICS:
MR is currently of areat interest because it is capable of producing high quality anatomical images without the associated risks of ionizing radiation. In addition, the biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In x-ray imaging, differences in x-ray attenuation, largely based on differences in electro density are responsible for the contrast observed in x-ray images. In MR imaging, differences in proton density, blood flow, and relaxation times T1 and T2 all may contribute to image contrast. In addition, by varying the duration and spacing of the RF pulses, images may be produced in which the contrast is primarily dependent on T1 relaxation, T2 relaxation, proton density, or a combination of all three.
DEVICE TECHNOLOGICAL CHARACTERISTICS: 3.4
Identical to the Predicate Device.
2
K012154
Page 3 of 4
4.0 DEVICE INTENDED USE:
The AURORA MR 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 (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.
| • 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 |
GENERAL SAFETY AND EFFECTIVENESS CONCERNS: 5.0
Operation of the AURORA MRI System is substantially equivalent to standard operation of the predicate device. Operation of all MRI Systems is contraindicated for the following classes of patients:
- Patients with pacemakers or other electrically- or magnetically activated ● implants.
- Patients with intracranial aneurysm clips, unless the physician is certain that the ● clip is not magnetically active.
Operation of all MRI Systems for the following classes of patients requires particular caution, however, these classes of patients are not contraindicated:
- Patients with implanted surgical clips or other ferromagnetic material ●
- Patients engaged in occupations or activities which may cause accidental lodaina of ferrornaanetic materials (especially in the eves), or who may have embedded metal fragments from military activities
- Neonates and infants (for whom data establishing safety are lacking) ●
- Patients with permanent tattoo eye-liner, or with facial make-up (severe eye . irritation has been reported)
- Patients with compromised thermoregulatory systems .
- Patients with metallic implants, because they may cause artifacts in the diagnostic images due to magnetic field distortion
- Patients who are, or are suspected to be, pregnant. The safety of magnetic resonance imaging has not been completely established for embryos and fetuses.
3
K012154
Page 4 of 4
The reader is referred to internationally-accepted safety standard, IEN/EC 60601-2-3.1 (first edition), Medical Electrical Equipment, Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis for more detailed MRI safety information.
SUBSTANTIAL EQUIVALENCE CONCLUSIONS: 6.0
Laboratory and clinical testing to internationally-accepted standards were performed to support this claim of substantial equivalence. It is the manufacturer's contention that the AURORA MR System does not include any new indications for use, and that use of the device does not pose any new potential hazards.
4
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 caduceus symbol, which is often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three lines forming a stylized human figure, and the text is in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James Jochen Rogers Director, Regulatory Affairs & Quality Assurance Aurora Imaging Technology, Inc. 39 High Street NORTH ANDOVER MA 01845
Re: K012154
SEP 1 9 2001
Trade/Device Name: Aurora (MRI) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Imaging System Regulatory Class: II Product Code: 90 LNH Dated: June 29, 2001 Received: July 11, 2001
Dear Mr. Rogers:
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.
5
This letter will allow you to begin marketing your device as described in your 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:
| 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" (21 CFR Part 807.97). 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
Enclosures
6
K012154 510(k) Number (if known):
Device Name: AURORA
Indications for Use:
The AURORA MR 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 (TI), spin-spin relaxation time (12), 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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-the-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801-109 | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K012154 |
|---|---|
| --------------- | --------- |