(141 days)
No
The summary does not mention AI, ML, or related terms, and the focus is on the hardware and basic software functionality for image acquisition and display.
No
The device is described as a "magnetic resonance diagnostic device" used for producing "cross sectional images, spectro-scopic images and/or spectra" to assist in diagnosis, and also for "imaging during interventional procedures." It does not mention any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems are "indicated for use as a magnetic resonance diagnostic device (MRDD)" and that the information derived "may assist in diagnosis."
No
The device description clearly states that the MAGNETOM Aera and MAGNETOM Skyra are "whole body scanners" utilizing a "superconducting magnet design," indicating they are physical hardware devices, not software-only.
Based on the provided information, the MAGNETOM Aera and MAGNETOM Skyra systems are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body). The description of the MAGNETOM systems clearly states they are used to produce images and spectra of the internal structure and/or function of the head, body, or extremities in vivo (within the living body).
- The intended use is for diagnostic imaging, not laboratory testing of biological samples. The systems are described as "magnetic resonance diagnostic devices (MRDD)" and are used to generate images and spectra that are interpreted by a physician to assist in diagnosis.
Therefore, the MAGNETOM Aera and MAGNETOM Skyra systems fall under the category of medical imaging devices, not IVD devices.
N/A
Intended Use / Indications for Use
The MAGNETOM Aera and the MAGNETOM Skyra systems are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectro-scopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Aera and the MAGNETOM Skyra systems 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.
Product codes
LNH, LNI
Device Description
MAGNETOM Aera (1.5 T) and MAGNETOM Skyra (3 T) are similar to the previously cleared MAGNETOM Espree and MAGNETOM Verio, utilizing a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to reduce complexity of the MR workflow.
The MAGNETOM Aera and the MAGNETOM Skyra systems will be available in fixed and mobile configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / Not Found
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)
The following measurements of performance and safety data have been performed following NEMA or equivalent IEC and ISO standards:
Safety:
- Maximum Static Field
- Rate of Change of Magnetic Field
- RF. Power Deposition
- Acoustic Noise Levels
Performance:
- Specification Volume
- Signal to Noise
- Image Uniformity
- Geometric Distortion
- Slice Profile. Thickness and Gap
- High Contrast Spatial Resolution
The MAGNETOM Aera and MAGNETOM Skyra will conform to the measurements of safety parameters to the international IEC, ISO and NEMA standards for safety issues with Magnetic Resonance Imaging Diagnostic Devices.
Furthermore performance measurements have been done on the predicate devices MAGNETOM Espree and MAGNETOM Verio to show that the performance of the MAGNETOM Aera and MAGNETOM Skyra is equivalent with respect to the predicate devices.
This will assure that the performance of these devices can be considered safe and effective with respect to the currently available MAGNETOM Espree and MAGNETOM Verio systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Section: 5 510(k) Summary
Section 5 510(k) Summary
FOCT 2 2010
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 USA. Inc. 51 Valley Stream Parkway Mail Code G01 Malvern, PA 19355, USA 2240869 Registration Number Manufacturer Siemens AG Henkestrasse 127 D-91052 Erlangen, Germany Registration Number 8010024 Contact Person Ms. Kim Rendon Manager, Regulatory Affairs/Clinical Affairs Siemens Healthcare Siemens Medical Solutions USA, Inc. Customer Solutions Group 51 Valley Stream Parkway Mail Code G01 Malvern, PA 19355, USA Phone: (610) 448-1773 Fax: (610) 448-1787 MAGNETOM Aera Trade Names: Device Name MAGNETOM Skyra Classification Name: Magnetic Resonance Diagnostic Device 21 CFR § 892.1000 CFR Code: Classification: Class II
Performance Standards
None established under Section 514 the Food, Drug and Cosmetic Act.
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Section: 5 510(k) Summary
II. Safety and Effectiveness Information Supporting Substantial Equivalence
Intended Use
The MAGNETOM Aera and the MAGNETOM Skyra systems are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectro-scopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Aera and the MAGNETOM Skyra systems 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
MAGNETOM Aera (1.5 T) and MAGNETOM Skyra (3 T) are similar to the previously cleared MAGNETOM Espree and MAGNETOM Verio, utilizing a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to reduce complexity of the MR workflow.
The MAGNETOM Aera and the MAGNETOM Skyra systems will be available in fixed and mobile configurations.
Substantial Equivalence
Siemens feels that the new systems are substantially equivalent to the following predicate devices:
| Predicate Device Name | FDA Clearance
Number | FDA Clearance
Date |
|--------------------------------|-------------------------|-----------------------|
| Siemens MAGNETOM Espree (1.5T) | K041112 | July 21, 2004 |
| Siemens MAGNETOM Verio (3T) | K072237 | October 10, 2007 |
| syngo® MR B17 Software update | K082427 | November 7, 2008 |
General Safety and Effectiveness Concerns:
Operation of the MAGNETOM Aera (1.5T) and the MAGNETOM Skyra (3T) systems is substantially equivalent to the commercially available MAGNETOM Espree (1.5T) and MAGNETOM Verio (3T) System.
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Section: 5 510(k) Summary
As specified in the FDA guidance document "Guidance for the Submission Of Premarket Notifications for Maqnetic Resonance Devices" (released Nov. 1998) the following measurements of performance and safety data have been performed following NEMA or equivalent IEC and ISO standards:
Safety:
- · Maximum Static Field
- · Rate of Change of Magnetic Field
- · RF. Power Deposition
- Acoustic Noise Levels
Performance:
- · Specification Volume
- · Signal to Noise
- · Image Uniformity
- · Geometric Distortion
- · Slice Profile. Thickness and Gap
- High Contrast Spatial Resolution
The MAGNETOM Aera and MAGNETOM Skyra will conform to the measurements of safety parameters to the international IEC, ISO and NEMA standards for safety issues with Magnetic Resonance Imaging Diagnostic Devices.
Furthermore performance measurements have been done on the predicate devices MAGNETOM Espree and MAGNETOM Verio to show that the performance of the MAGNETOM Aera and MAGNETOM Skyra is equivalent with respect to the predicate devices.
This will assure that the performance of these devices can be considered safe and effective with respect to the currently available MAGNETOM Espree and MAGNETOM Verio systems.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes extending from its body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Kim Rendon Manager, Regulatory/Clinical Affaris Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwy, Mail Code G01 MALVERN PA 19355
OCT 1 2010
Re: K101347
Trade/Device Name: Magnetom Aera and Magnetom Skyra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH and LNI Dated: August 13, 2010 Received: August 16, 2010
Dear Ms. Rendon:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895: 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Section: 4 Indications for Use Statement
Section 4 Indications for Use Statement
510(k) Number (if known)
MAGNETOM Aera and MAGNETOM Skyra Device Names:
Indications for Use:
The MAGNETOM systems described above are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM systems described above may also be used for imaging during interventional procedures when performed with MR compatible devices such as inroom 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 X | OR | Over-The-Counter Use ______ |
|---|---|---|
| -------------------- | ---- | ----------------------------- |
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510K. | K101347 |
|---|---|
| ------- | --------- |
| Siemens 510(k) Premarket Notification | May 12, 2010 | Section 4-1 |
|---|---|---|
| MAGNETOM Aera and MAGNETOM Skyra | Page 1 of 1 |