(23 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the AURORA Magnetic Resonance Diagnostic Device:
Critical Observation: The provided document is a 510(k) summary for a modification to an existing medical device (AURORA MRI system, K012154). The modification is specifically an upgrade from a 0.5 T magnet to a 1.5 T magnet and associated RF system and spectrometer changes. This significantly impacts the type of "study" described, as it's not a full de novo clearance for a new device, but rather a demonstration of substantial equivalence.
Based on the provided text, the "study" conducted for this 510(k) clearance is primarily focused on technical performance validation rather than clinical efficacy or diagnostic accuracy with human interpretation.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this specific 510(k) are implicitly tied to demonstrating that the 1.5 T AURORA system performs as expected for an MRI device and is substantially equivalent to the predicate device, despite the magnet strength increase. The testing focused on technical specifications rather than diagnostic performance.
| Acceptance Criterion (Implicit) | Reported Device Performance and Methodology |
|---|---|
| Maintain acceptable imaging functionality post magnet upgrade | "Testing was performed to validate the performance of the AURORA operating at 1.5 T." The document explicitly states: - Acoustic Noise Measurement: Measured to ensure it meets safety and performance standards. - Specific Absorption Rate (SAR) Measurement: Measured to ensure patient safety regarding RF energy absorption. - Slice Thickness Measurement: Measured to confirm imaging precision. - Signal-to-Noise Ratio (SNR) Measurement: Measured to assess image quality and clarity. - Image Uniformity Measurement: Measured to ensure consistent image quality across the scanned area. Methodology: According to NEMA (National Electrical Manufacturers Association) standards, indicating recognized industry testing protocols for MR systems. |
| Substantial Equivalence to Predicate Device (K012154) | The entire submission is based on the claim of substantial equivalence. The argument is that the intended use, design, and technological/operational characteristics are similar, with the key difference being the magnet strength and corresponding RF/spectrometer changes. |
Study Details
Given the nature of the 510(k) (upgrade to an existing system, not a new clinical diagnostic device), many of the requested details about clinical studies, expert-read data, and ground truth are not present or applicable in this specific document. The "study" described is a technical validation of system performance.
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. The testing described focuses on device parameters (acoustic noise, SAR, etc.) using standards and phantoms, not a sample of patient data for diagnostic evaluation.
- Data Provenance: Not applicable in the context of clinical data. The testing was conducted according to NEMA standards, which implies controlled laboratory or testing environments using phantoms or specialized measurement equipment. No country of origin for clinical data is mentioned as no clinical data study of diagnostic accuracy is discussed. The testing is likely internal engineering validation.
- Retrospective/Prospective: Not applicable to the described technical testing.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. Ground truth for diagnostic performance is not established because the "test set" is not a set of clinical cases requiring diagnosis. The "ground truth" for the technical measurements would be the NEMA standard specifications themselves.
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Adjudication Method for the Test Set:
- Not applicable. No expert adjudication of diagnostic findings is mentioned.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. No MRMC study is mentioned. The focus is on the technical performance of the MRI hardware, not on reader performance or diagnostic accuracy.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no AI component or clinical reader study is discussed.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, in spirit, but not as an "algorithm." The "standalone" performance here refers to the device's technical specifications (SNR, uniformity, etc.) measured independently, without human diagnostic interpretation as part of the evaluation for this 510(k). There is no "algorithm" in the sense of AI being evaluated.
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The Type of Ground Truth Used:
- For the technical performance evaluations (acoustic noise, SAR, slice thickness, SNR, image uniformity), the ground truth is against pre-defined technical specifications and NEMA standards. There is no clinical "ground truth" (e.g., pathology, outcomes data) mentioned in this submission as it's not a clinical performance study.
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Sample Size for the Training Set:
- Not applicable. This device is an MRI scanner, not an AI-powered diagnostic tool. There is no "training set" in the context of machine learning or algorithms. The "training" for the device would involve calibration and quality control procedures, not data for an algorithm.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" for an algorithm.
In summary, this 510(k) is for a technical upgrade of an existing MRI device. The "study" described is a technical validation of the physical and imaging performance characteristics of the 1.5 T system against established engineering and NEMA standards, not a clinical study to assess diagnostic accuracy or the performance of an AI algorithm.
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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
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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.
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- 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
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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.
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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 (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 imagingT1, T2, proton density measurementsImage processing |
| • | Imaging capabilities: | 2D Spin Echo (SE)2D/3D Gradient Echo (GRE)Fat Suppression |
| • | Imaging processing: | Image SubtractionImage 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)
§ 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.