(185 days)
The MAGNETOM Skyra 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.
The MAGNETOM Skyra 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.
TimTX TrueShape, an option for the MR system MAGNETOM Skyra, allows parallel transmission of RF pulses, shaping the RF excitation field locally and thus enabling selective excitation.
syngo ZOOMit (introduced with the software version syngo MR D13C) is the application that utilizes TimTX TrueShape. It allows "zooming into" a part of the human body by selective excitation.
The option TimTX TrueShape and syngo ZOOMit include two independent RF transmit paths fully integrated with the system, a modified whole-body RF coil, new options for B1 shimming, as well as new inline RF pulse generation. Pulse sequences allowing for different kinds of excitation, or zooming are derived from EPI and SPACE sequences. Protocol optimization for neurological, musculoskeletal, angiographic and oncological imaging is also inherent to the TimTX TrueShape option.
The provided document describes a 510(k) submission for a new Magnetic Resonance (MR) system option (TimTX TrueShape) and software version (syngo MR D13C) for the MAGNETOM Skyra. This is a submission for a device upgrade, not a new standalone AI/ML device, and thus does not contain the typical information about acceptance criteria and a study proving the device meets those criteria in the way one would expect for an AI/ML product.
Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (MAGNETOM Skyra with syngo MR D13A). This means the focus is on showing that the new features do not introduce new safety or effectiveness concerns, and that the device retains the core functionalities and performance of the predicate.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission. The "acceptance criteria" here relate more to regulatory compliance and demonstrating that the new features do not negatively impact the established safety and performance of the base device.
However, I can extract the relevant information that is provided and explain what is missing and why:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device conforms to applicable FDA recognized and international IEC, ISO, and NEMA standards. Product Risk Management in compliance with ISO 14971:2009. Minimize electrical and mechanical risks. No new issues of safety. | - Conformity to applicable FDA recognized and international IEC, ISO, and NEMA standards for performance and safety. - Product Risk Management accomplished through a process in compliance with ISO 14971:2009 to identify and mitigate potential hazards. - Risks controlled via measures in software development, SW testing, and product labeling. - Adherence to recognized industry practices and standards (e.g., IEC 60601-1 series) to minimize electrical and mechanical risk. - Conclusion: "does not introduce any new issues of safety or effectiveness." |
| Effectiveness: Same intended use as predicate device. Same basic technical characteristics as predicate (magnetic resonance features and functionalities). Enhanced capabilities without introducing new effectiveness concerns. | - Intended Use: "The MAGNETOM Skyra 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... 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." (Unchanged from predicate) - Technical Characteristics: "has the same intended use and the same basic technical characteristics as the predecessor device MAGNETOM Skyra with syngo MR D13A, with respect to the magnetic resonance features and functionalities." - Capability: "The differences... give the subject device greater capabilities than the predicate device, but have the enhanced technological characteristics as the predicate device." - Conclusion: "does not introduce any new issues of safety or effectiveness." |
Explanation: In a 510(k) for an MR system update, the "acceptance criteria" are implicitly met by demonstrating compliance with recognized standards and proving that the new features (TimTX TrueShape and syngo MR D13C) do not alter the fundamental safety or effectiveness of the device beyond what was established for the predicate. The "reported device performance" is essentially the statement that these criteria have been met through the mentioned compliance and risk management processes.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided: This document describes a traditional 510(k) for a hardware and software upgrade to an MR system, not a clinical study on an AI/ML algorithm. Therefore, there is no "test set" in the sense of a dataset for evaluating an algorithm's performance on patient data. The evaluation primarily focuses on engineering verification and validation against technical specifications and safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Provided: See explanation for point 2. Ground truth in the context of an AI/ML algorithm's clinical performance is not relevant for this type of submission. The "ground truth" for an MR system's performance is typically established through phantom studies, engineering tests, and adherence to established imaging physics principles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: See explanation for point 2 and 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No: No MRMC study was performed or described. This document is for a hardware and software upgrade to an MR scanner, not an AI/ML diagnostic aid that would assist human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided: This is not an AI/ML algorithm that operates in a "standalone" fashion for diagnosis. It's a component of an imaging system. The performance of the imaging system as a whole is subject to regulatory requirements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Provided: For an MR system upgrade, "ground truth" generally refers to physical measurements and known properties of phantoms, or established imaging capabilities. Clinical outcome data or pathology are not used to validate the core performance of the MR system itself in this context.
8. The sample size for the training set
- Not Applicable/Not Provided: This document does not describe the development or training of an AI/ML algorithm in the sense of a "training set" of data.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: See explanation for point 8.
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MAY 1 7 2013
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string begins with a capital letter 'K', followed by the numbers '123', then '5', a forward slash '/', and finally the number '0'. The handwriting is in black ink on a white background.
SIEMENS
Traditional 510(k) Submission: TimTX TrueShape and syngo MR D13C for MAGNETOM Skyra
TimTX TrueShape and syngo MR D13C for 510(k) Summary: MAGNETOM Skyra
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.
Date of Summary Preparation: November 9, 2012
l. General Information
| Importer/Distributor | Siemens Medical Solutions USA, Inc. |
|---|---|
| 51 Valley Stream Pkwy | |
| Mail Code D02 | |
| Malvern, PA 19355, USA | |
| Registration Number: | 2240869 |
| Manufacturer | Siemens AG |
| Medical Solutions | |
| Henkestrasse 127 | |
| D-91052 Erlangen, Germany | |
| Registration Number: | 8010024 |
SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. Siemens MRI Center, Hi-Tech Industrial park (middle) Gaoxin C. Ave., 2nd Shenzhen 518057, P.R. CHINA 3004754211
Registration Number:
Contact Person Nadia Sookdeo
Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwy Mail Code D02 Malvern, PA 19355, USA Phone: (610) 448-4918 Fax: (610) 448-1787 Email: nadia.sookdeo@siemens.com
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Traditional 510(k) Submission:
TimTX TrueShape and syngo MR D13C for MAGNETOM Skyra
e Name and Classification
| Data | Details |
|---|---|
| Trade name /Device | MAGNETOM Skyra |
| ProprietaryName: | option TimTX TrueShape with syngo MR D13C |
| ClassificationName: | Regulation Description:- Magnetic Resonance Diagnostic Device (MRDD) |
| ClassificationPanel: | Radiology |
| DeviceClassification: | Class II devices |
| Regulationnumber: | 21 CFR § 892.1000 |
| ProductCode: | LNH |
II. Safety and Effectiveness Information Supporting Substantial Equivalence
Intended Use
The MAGNETOM Skyra 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 diaqnosis.
The MAGNETOM Skyra 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.
Device Description
TimTX TrueShape, an option for the MR system MAGNETOM Skyra, allows parallel transmission of RF pulses, shaping the RF excitation field locally and thus enabling selective excitation.
syngo ZOOMit (introduced with the software version syngo MR D13C) is the application that utilizes TimTX TrueShape. It allows "zooming into" a part of the human body by selective excitation.
The option TimTX TrueShape and syngo ZOOMit include two independent RF transmit paths fully integrated with the system, a modified whole-body RF coil, new options for
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SIEMENS
Traditional 510(k) Submission:
TimTX TrueShape and syngo MR D13C for MAGNETOM Skyra B1 shimming, as well as new inline RF pulse generation. Pulse sequences allowing for different kinds of excitation, or zooming are derived from EPI and SPACE sequences. Protocol optimization for neurological, musculoskeletal, angiographic and oncological imaging is also inherent to the TimTX TrueShape option.
General Safety and Effectiveness Concerns
Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.
Product Risk Management is accomplished through a process in compliance with ISO 14971:2009 to identify and provide mitigation to potential hazards in a risk analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in software development, SW 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 operators are healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
The MAGNETOM Skyra with option TimTX TrueShape and software syngo MR D13C conforms to the applicable FDA recognized and international IEC, ISO, and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document.
Substantial Equivalence
MAGNETOM Skyra with TimTX TrueShape and software syngo MR D13C is a magnetic resonance diagnostic device that includes all of the features of MAGNETOM Skyra with syngo MR D13A. Therefore, the MAGNETOM Skyra with the option TimTX TrueShape and software syngo MR D13C is substantially equivalent to the following current legally marketed device (please refer to Table 1):
| Predicate Device Name | FDAClearanceNumber | FDA Clearance Date |
|---|---|---|
| MAGNETOM Skyra with syngo MRD13A | K121434 | November 05, 2012. |
Table 1: Predicate device for MAGNETOM Skyra with TimTX TrueShape and software syngo MR D13C
Conclusion as to Substantial Equivalence
MAGNETOM Skyra with option TimTX TrueShape and software syngo MR D13C has the same intended use and the same basic technical characteristics as the predecessor device MAGNETOM Skyra with syngo MR D13A, with respect to the magnetic resonance features and functionalities. MAGNETOM Skyra with option TimTX TrueShape and software syngo MR D13C will be used for acquiring MR images (transverse, sagittal, coronal and obligue cross sectional images, spectroscopic
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SIEMENS
Traditional 510(k) Submission:
TimTX TrueShape and syngo MR D13C for MAGNETOM Skyra images and/or spectra). The predicate device, MAGNETOM Skyra with software syngo MR D13A, is also capable of acquiring MR images (transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra). The differences between the subject device and the predicate device, which include the aforementioned new / modified technology and software version, give the subject device greater capabilities than the predicate device, but have the enhanced technological characteristics as the predicate device. MAGNETOM Skyra with option TimTX TrueShape and software syngo MR D13C is similar to the functionalities of the predicate device, and does not introduce any new issues of safety or effectiveness.
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Image /page/4/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17. 2013
Siemens Medical Solutions, USA. INC % Ms Nadia Sookdeo Technical Specialist, Regulatory Affairs 51 Valley Stream Parkway, D 02 MALVERN PA 19355
Re: K123510
Trade/Device Name: MAGNETOM Skyra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: May 13, 2013 Received: May 15, 2013
Dear Ms. Sookdeo:
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. 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 vour 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 (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2 - Ms. Sookdeo
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Safcty/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.lda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123510
Device Name: MAGNETOM Skyra
Indications for Use:
The MAGNETOM Skyra 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.
The MAGNETOM Skyra 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
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 Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K123510 510(k)
Page 1 of 1
§ 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.