(204 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on hardware and software updates for existing MR systems.
No.
Explanation: The device is explicitly described as a "magnetic resonance diagnostic device (MRDD)" that produces images and spectra to assist in diagnosis, rather than for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the systems are "indicated for use as magnetic resonance diagnostic devices (MRDD)" and that the information derived from them "may assist in diagnosis."
No
The device description explicitly states that both software and hardware of the previously cleared systems have been modified and updated, indicating it is not a software-only 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. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that the MAGNETOM Aera and MAGNETOM Skyra systems are magnetic resonance diagnostic devices (MRDD). They produce images and spectra of the internal structure and function of the body. This is an in vivo diagnostic method, meaning it is performed within the living body.
- Intended Use: The intended use describes imaging the head, body, or extremities and assisting in diagnosis based on these images and derived parameters. This is consistent with the function of an MRI machine, not an IVD.
Therefore, the information provided indicates that this device is an MRI system, which is a type of medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MAGNETOM Aera and the MAGNETOM Skyra systems are 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.
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
Device Description
The software and some of the hardware of the previously cleared MAGNETOM Aera and MAGNETOM Skyra have been modified and updated. The updates enable new options, including sequences, applications, coils and coil adapters, for MAGNETOM Aera and MAGNETOM Skyra.
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K101347, K082427, K072237, K041112, K103275, K100113
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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NOV 2 3 2011
KII1242
Section 5 Statement of Conformity | | | | | |
Section 5 - 510(k) Summary
This 510(k) summary is being submitted in accordance with 21 CFR § 807.92.
1.1 General Information
| Establishment | Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA
Registration Number 2240869 |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Siemens AG
Henkestrasse 127
D-91052 Erlangen, Germany
Registration Number 8010024
SIEMENS MINDIT MAGNETIC RESONANCE LTD.
Siemens MRI Center, Hi-Tech
Industrial park (middle)
Gaoxin C. Ave., 2nd
Shenzhen 518057, P.R. CHINA
Registration Number 3004754211 |
| Contact Person | Ms. Michelle L. Byrne
Regulatory Affairs Technical Specialist
Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA
Phone: (610) 448-4293
Fax: (610) 448-1787
E-mail: michelle.l.byrne@siemens.com |
| Device Name | MAGNETOM Aera and MAGNETOM Skyra with
syngo MR D11
Please note: syngo MR D11 is the broad name for the
software version; it includes all iterations of the software
(i.e. the previously cleared software version |
Page 1 of 3
1
Classification Name: CFR Code: Classification: Product Code:
Magnetic Resonance Diagnostic Device 21 CFR § 892.1000 Class II LNH
1.2 Safety and Effectiveness Information Supporting Substantial Equivalence
Device Description
The software and some of the hardware of the previously cleared MAGNETOM Aera and MAGNETOM Skyra have been modified and updated. The updates enable new options, including sequences, applications, coils and coil adapters, for MAGNETOM Aera and MAGNETOM Skyra.
Substantial Equivalence
The modified MAGNETOM Aera and MAGNETOM Skyra are substantially equivalent to the following predicate devices:
| Predicate Device Name | 510(k) Number | FDA Clearance
Date |
|---------------------------------------------------------------------------|---------------|-----------------------|
| Siemens MAGNETOM Aera (1.5T)
and MAGNETOM Skyra with
syngo® MR D11A | K101347 | October 1, 2010 |
| Siemens MAGNETOM Skyra (3T)
with syngo® MR D11A | K101347 | October 1, 2010 |
| syngo® MR B17 Software update | K082427 | November 7, 2008 |
| Siemens MAGNETOM Verio (3T) | K072237 | October 10, 2007 |
| Siemens MAGNETOM Espree
(1.5T) | K041112 | July 21, 2004 |
| Specialty coils for MAGNETOM
Aera and MAGNETOM Skyra | K103275 | January 11, 2011 |
| Sentinelle Vanguard Breast Coils | K100113 | April 22, 2010 |
Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
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Risk Management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions USA, Inc. and Siemens AG adhere to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards.
The modified MAGNETOM Aera and MAGNETOM Skyra conform to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as required by the respective MR FDA Guidance Document.
Intended Use
The MAGNETOM Aera and the MAGNETOM Skyra systems are 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.
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.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
NOV 2 3 2011
Ms Mitchelle L. Byrne Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, Mail Code D02 MALVERN PA 19355
Re: K111242
Trade/Device Name: MEGNETOM Aera and MAGNETOM Skyra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 17, 2011 Received: November 18, 2011
Dear Ms. Byrne:
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/ReportalProblem/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.
Mary Pastel
Mary S. Pastel, Sc.D. 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
510(k) Number (if known) K111242
MAGNETOM Aera and MAGNETOM Skyra Device Names:
Indications for Use
The MAGNETOM systems described above are 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.
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 in-room display and MR-safe biopsy needles.
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Arachnol D'O'Hara
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k