(67 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the software modification focuses on "Compressed Sensing (CS) Cardiac Cine," which is a known image reconstruction technique, not inherently AI/ML.
No.
The device is a magnetic resonance diagnostic device used to produce images and/or spectra that assist in diagnosis, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a magnetic resonance diagnostic device (MRDD)". It also mentions that the images and/or spectra and derived physical parameters, when interpreted by a trained physician, "yield information that may assist in diagnosis."
No
The device description explicitly states "Your MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD)..." and "The subject device, MAGNETOM Avanto® with software syngo MR E11E. is a modification of the previously cleared predicate device, MAGNETOM Avanto". This indicates the device is a physical MR system with associated software, not a standalone software-only device.
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 device is a "magnetic resonance diagnostic device (MRDD)" that produces images and spectra of the internal structure and/or function of the head, body, or extremities. This is a description of an in-vivo imaging device, not a device used to examine specimens taken from the body (which is the definition of in vitro).
- Device Description: The description focuses on the hardware (MAGNETOM Avanto) and software for image acquisition and processing. This aligns with an in-vivo imaging system.
- Input Imaging Modality: The input modality is Magnetic Resonance (MR), which is an in-vivo imaging technique.
- Anatomical Site: The device is used to image the head, body, or extremities, which are parts of a living organism.
IVD devices are used to examine specimens such as blood, urine, tissue, etc., outside of the body to provide information for diagnosis. This device operates by imaging the inside of a living patient.
N/A
Intended Use / Indications for Use
Your MAGNETOM MR system is 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.
Your MAGNETOM MR system may also be used for imaging during interventional procedures with MR compatible devices such as in-room displays and MR Safe biopsy needles.
Product codes (comma separated list FDA assigned to the subject device)
LNH, LNI, MOS
Device Description
The subject device, MAGNETOM Avanto® with software syngo MR E11E. is a modification of the previously cleared predicate device, MAGNETOM Avanto" with software syngo MR E11C-AP04 (K173592). The software version syngo E11E for MAGNETOM Avanto™ has been modified to include the software application "Compressed Sensing (CS) Cardiac Cine." This software application was migrated unchanged from the previously cleared MAGNETOM Skyra and Aera systems with syngo MR E11C-AP02 (K163312).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician, healthcare professionals familiar with and responsible for the acquisition and-post processing of magnetic resonance images.
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)
Software verification and validation testing was completed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", dated May 11, 2005.
Performance testing was completed in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices", dated November 18, 2016.
The results from each set of tests demonstrate that the device performs as intended and is therefore substantially equivalent to the predicate device to which it has been compared.
No clinical tests were conducted to support the claim of substantial equivalence between the subject and predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
Siemens Medical Solution USA, Inc. % Cordell L Fields, Esq. Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code 65-1A MALVERN PA 19355
Re: K190757
Trade/Device Name: MAGNETOM Avantofft Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: March 22, 2019 Received: March 25, 2019
Dear Mr. Fields:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good
May 31, 2019
1
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a bright teal. The letters are evenly spaced and the word is horizontally oriented.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| Indications for Use | See PRA Statement below. |
510(k) Number (if known)
K190757 Device Name MAGNETOM Avantofit
Indications for Use (Describe)
Your MAGNETOM MR system is 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.
Your MAGNETOM MR system may also be used for imaging during interventional procedures with MR compatible devices such as in-room displays and MR Safe biopsy needles.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740
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510(k) Summary MAGNETOM Avantofit with software syngo MR E11E
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Establishment Registration Number: 2240869
March 22, 2019 Date Prepared
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR ട്ട 807.92.
1. General Information
Importer/Distributor:
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Establishment Registration Number: 2240869
Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Establishment Registration Number: 3002808157
2. Contact Information
Cordell L. Fields, Esq. Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA Phone: (610) 448-6545 Fax: (610) 448-6469 E-mail: cordell.fields@siemens-healthineers.com
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3. Device Name and Classification
| Trade Name | MAGNETOM Avantofit |
|---|---|
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | Class II |
| Product Code: | Primary: LNH |
| Secondary: LNI, MOS |
4. Legally Marketed Predicate Device
| Trade Name | MAGNETOM Avantofit |
|---|---|
| ------------ | -------------------- |
| 510(k) Number | K173592, Cleared February 13, 2018 |
|---|---|
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | Class II |
| Product Code: | Primary: LNH |
| Secondary: LNI, MOS |
5. Device Description
The subject device, MAGNETOM Avanto® with software syngo MR E11E. is a modification of the previously cleared predicate device, MAGNETOM Avanto" with software syngo MR E11C-AP04 (K173592). The software version syngo E11E for MAGNETOM Avanto™ has been modified to include the software application "Compressed Sensing (CS) Cardiac Cine." This software application was migrated unchanged from the previously cleared MAGNETOM Skyra and Aera systems with syngo MR E11C-AP02 (K163312).
6. Indication for Use
The indications for use for the subject device is the same as the predicate device and is as follows:
Your MAGNETOM MR system is 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.
Your MAGNETOM MR system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
5
7. Substantial Equivalence
The MAGNETOM Avanto® with software syngo MR E11E is substantially equivalent to the following device:
| Predicate Device | FDA
Clearance
Number | FDA
Clearance
Date | Product
Code |
|-----------------------------------------------------------|----------------------------|--------------------------|------------------|
| MAGNETOM Avantofit
with Software syngo MR
E11C-AP04 | K173592 | February 13,
2018 | LNH, LNI,
MOS |
As described above, the MAGNETOM Avanto" with software syngo MR E11E includes one new feature that is already cleared with the following reference device:
| Reference Device | FDA
Clearance
Number | FDA
Clearance
Date | Product
Code |
|------------------------------------------------------|----------------------------|--------------------------|------------------|
| MAGNETOM Aera with
Software syngo MR
E11C-AP02 | K163312 | January 27, 2017 | LNH, LNI,
MOS |
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device
The subject device MAGNETOM Avanto®" with software syngo MR E11E is substantially equivalent to the predicate device, MAGNETOM Avanto™ with software syngo MR E11C-AP04, with regard to the operational environment, programming language, operating system, and performance.
The subject device, MAGNETOM Avanto" with software syngo MR E11E, conforms to the IEC 62304, Edition 1.1, 2015-06, standard for software medical devices and other relevant IEC and NEMA standards.
While there is a difference in technological characteristics between the subject device and predicate device (the difference being the software application migrated from the previously cleared MAGNETOM Aera system with syngo MR E11C-AP02 (K163312)), this difference has been tested and the conclusions from the nonclinical data suqgests that the feature bear an equivalent safety and performance profile as that of the predicate device.
9. Nonclinical Performance Testing
The following performance testing was conducted on the subject device:
- Software verification and validation testing was completed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", dated May 11, 2005.
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SIEMENS
- Performance testing was completed in accordance with the FDA guidance । document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices", dated November 18, 2016
The results from each set of tests demonstrate that the device performs as intended and is therefore substantially equivalent to the predicate device to which it has been compared.
MAGNETOM Avanto™ with software syngo MR E11E conforms to the following FDA recognized and international IEC and ISO standards:
| Recogniton
Number | Product
Area | Title of Standard | Reference
Number and
date | Standards
Development
Organization |
|----------------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------|
| 19-4 | General II
(ES/EMC) | C1:2009/(R)2012 and A2:2010/(R)2012
(Consolidated Text) Medical electrical
equipment - Part 1: General
requirements for basic safety and
essential performance (IEC 60601-
1:2005, MOD) | ES60601-
1:2005/(R)2012
and A1:2012, | AAMI ANSI |
| 19-8 | General | Medical electrical equipment - Part 1-2:
General requirements for basic safety
and essential performance - Collateral
Standard: Electromagnetic
disturbances - Requirements and tests | 60601-1-2 Edition
4.0 2014-02 | IEC |
| 12-295 | Radiology | Medical electrical equipment - Part 2-
33: Particular requirements for the
basic safety and essential performance
of magnetic resonance equipment for
medical diagnostic | 60601-2-33 Ed.
3.2 B:2015 | IEC |
| 5-40 | General I
(QS/RM) | Medical devices - Application of risk
management to medical devices | 14971 Second
Edition 2007-03-
01 | ISO |
| 5-114 | General | Medical devices - Application of
usability engineering to medical devices | 62366-1:2015 | AAMI ANSI
IEC |
| 13-32 | Software/Info
rmatics | Medical device software - Software life
cycle processes | IEC 62304 Edition
1.1 2015-06 | AAMI ANSI
IEC |
| 12-300 | Radiology | Digital Imaging and Communications in
Medicine (DICOM) Set 03/16/2012
Radiology | PS 3.1 - 3.20
(2016) | NEMA |
No clinical tests were conducted to support the claim of substantial equivalence between the subject and predicate device.
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10. General Safety and Effectiveness Concerns
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Risk management is ensured via compliance with ISO 14971:2007 to identify and provide mitigation of potential hazards in a risk analysis early in the design phase and continuously throughout the development of the product. These risks are controlled via measures realized in hardware and software development, testing, and product labeling. To minimize risks. Siemens adheres to recognized and established industry practices and standards, such as the IEC 60601-1 series, to minimize electrical and mechanical risk. Furthermore, the device is intended for healthcare professionals familiar with and responsible for the acquisition and-post processing of magnetic resonance images.
11.Conclusion as to Substantial Equivalence
There are no changes to the indications for use for the subject device as compared to that of the legally marketed predicate device, MAGNETOM Avanto™ with software syngo MR E11C-AP04 (K173592).
While the new software feature provides an additional capability compared to the predicate device, the additional capability is currently cleared features of the reference device MAGNETOM Aera with software syngo MR E11C-AP02 (K163312) and do not raise new questions of safety and effectiveness. All features have been verified and validated to support the claim of substantial equivalence to the predicate device.
For the aforementioned mentions Siemens believes that the subject device, MAGNETOM Avanto™ with software syngo MR E11E, is substantially equivalent to the predicate device, MAGNETOM Avanto10 with software syngo MR E11C-AP04.