(79 days)
The MAGNETOM Avanto is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Avanto may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
The MAGNETOM Avanto System is a 1.5 T closed superconducting magnet designed scanner. It consists of the same types of hardware (with a modified gradient coil. RF body resonator and magnet) that are currently available with the MAGNETOM Sonata and Symphony systems.
Here's a breakdown of the acceptance criteria and the study information for the MAGNETOM Avanto System, based on the provided text.
Based on the provided 510(k) summary, the MAGNETOM Avanto System is a 1.5 T closed superconducting magnet designed scanner which is substantially equivalent to previously cleared magnetic resonance diagnostic devices (MRDDs). The evaluation primarily focuses on safety and performance parameters compared to these predicate devices, rather than a clinical study demonstrating diagnostic accuracy in a specific patient population.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MAGNETOM Avanto System are based on its substantial equivalence to the predicate devices (Siemens MAGNETOM 1.5 T Sonata and Siemens MAGNETOM 1.5 T Symphony) and adherence to recognized standards. The "reported device performance" in this context refers to the device's conformance to these established safety and performance levels, ensuring it is at least as safe and effective as the predicates.
| Category | Acceptance Criteria (Reference Standard/Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Safety Parameters | Substantially equivalent to commercially available MAGNETOM 1.5 T Sonata System and 1.5 T Symphony System, adhering to FDA guidance document for MR Diagnostic Devices. This includes specific action levels for: - Maximum Static Field - Rate of Change of Magnetic Field - RF Power Deposition - Acoustic Noise Levels | The MAGNETOM Avanto will conform to the FDA recognized NEMA Standards for the measurement of safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. (Implies satisfactory performance meeting these standards, leading to substantial equivalence). |
| Performance Parameters | Substantially equivalent to commercially available MAGNETOM 1.5 T Sonata System and 1.5 T Symphony System, adhering to FDA guidance document for MR Diagnostic Devices. This includes specific performance levels for: - Specification Volume - Signal to Noise - Image Uniformity - Geometric Distortion - Slice Profile, Thickness and Gap - High Contrast Spatial Resolution | The MAGNETOM Avanto will conform to the FDA recognized NEMA Standards for the measurement of performance parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. (Implies satisfactory performance meeting these standards, leading to substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not describe a clinical test set in the traditional sense of a study involving patient data for diagnostic accuracy. The evaluation revolves around engineering and physical measurements to demonstrate conformance to standards and equivalence to predicate devices. There is no mention of a specific "test set" of patient images or data used for a clinical performance evaluation. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As noted above, there was no clinical test set requiring ground truth established by experts for diagnostic performance.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided text. The document focuses on technical and safety equivalence to predicate devices, not on a direct comparison of human reader performance with and without AI assistance for this specific device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a Magnetic Resonance Diagnostic Device (MRDD), an imaging system. It's not an AI algorithm that exists independently of human interpretation. Its performance is inherent in the quality of the images and spectra it produces, which are then interpreted by a trained physician. Therefore, the concept of a "standalone" AI algorithm performance is not applicable to this type of device submission.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the established technical and safety standards, as well as the performance characteristics of the predicate devices. The study implicitly uses these established standards and predicate device performance as the "ground truth" against which the new device's conformance is measured. There is no mention of pathology, outcomes data, or expert consensus on clinical diagnoses as ground truth for a diagnostic performance study.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware imaging system, not an AI algorithm that undergoes "training."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for one.
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12 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.
I. General Information
| Establishment | Siemens Medical Solutions. Inc.51 Valley Stream ParkwayMalvern. PA 19355 |
|---|---|
| Registration Number | 2240869 |
| Manufacturer | Siemens AG. Bereich MedHenkestrasse 127D-91052 Erlangen. Germany |
| Registration Number | 8010024 |
| Contact Person | Ms. Nealie HartmanTechnical Specialist. Regulatory Submissions51 Valley Stream ParkwayMalvern. PA 19355Phone: (610)448-1769Fax: (610) 448-1787 |
| Device Name | Trade Name: MAGNETOM Avanto System |
| Classification Name: Magnetic Resonance Diagnostic Device | |
| CFR Code: 21 CFR § 892.1000 | |
| Classification: Class II |
Performance Standards
None established under Section 514 the Food. Drug. and Cosmetic Act.
CONFIDENTIAL
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II. Safety and Effectiveness Information Supporting Substantial Equivalence.
Intended Use
The MAGNETOM Avanto is indicated for use as magnetic resonance diagnostic devices (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Avanto may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
Device Description
The MAGNETOM Avanto System is a 1.5 T closed superconducting magnet designed scanner. It consists of the same types of hardware (with a modified gradient coil. RF body resonator and magnet) that are currently available with the MAGNETOM Sonata and Symphony systems.
Substantial Equivalence
The system is substantially equivalent to the following cleared medical devices:
| Predicate Device Name | FDA ClearanceNumber | FDA Clearance Date |
|---|---|---|
| Siemens MAGNETOM 1.5 T Sonata | K993731 | 12/23/99 |
| Siemens MAGNETOM 1.5 T Symphony | K971684 | 08/05/97 |
General Safety and Effectiveness Concerns:
Operation of the MAGNETOM Avanto System is substantially equivalent to the commercially available MAGNETOM 1.5 T Sonata System and 1.5 T Symphony System. Specified by the FDA guidance document for MR Diagnostic Devices that will be evaluated. below are the safety parameter with the following levels:
Action Levels
- · Maximum Static Field
- · Rate of Change of Magnetic Field
- · RF Power Deposition
- Acoustic Noise Levels
Performance Levels
- · Specification Volume
- · Signal to Noise
- · Image Uniformity
- · Geometric Distortion
- · Slice Profile. Thickness and Gap
- High Contrast Spatial Resolution
The MAGNETOM Avanto will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Sonata and Symphony systems.
CONFIDENTIAL
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three parallel lines extending from its head, resembling feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2003
Ms. Nealie Hartman Technical Specialist, Regulatory Submissions Siemens Medical Solutions, Inc. 51 Valley Stream Parkway MALVERN PA 19355
Re: K032428
Trade/Device Name: MAGNETOM Avanto MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH and LNI Dated: August 4, 2003 Received: August 6, 2003
Dear Ms. Hartman:
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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3 Indications for Use Statement
510(k) Number (if known)
Device Name: MAGNETOM Avanto
Indications for Use:
The MAGNETOM Avanto is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Avanto may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
(please do not write below this line- continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use 7
OR
Over-The-Counter Use
Nancy C. Brogdon
Division Sign Off
Division of Reproductive, and Radiological Device 510(k) Number
Siemens 510(k) Premarket Notification MAGNETOM Avanto
August 1, 2003
Page 13
CONFIDENTIAL
§ 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.