(91 days)
The MAGNETOM Spectra 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 Spectra may also be used for imaging during interventional procedures when performed with MR compatible devices such as inroom display and MR-safe biopsy needles.
MAGNETOM Spectra (3T) is similar to the previously cleared MAGNETOM Skyra 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 simplify the MR workflow.
The MAGNETOM Spectra systems will be available in a fixed configuration.
The provided text is a 510(k) summary for the Siemens MAGNETOM Spectra 3T System. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, this document does not contain acceptance criteria for specific device performance metrics or the details of a study involving such criteria.
Instead, it lists general performance and safety parameters that were measured to demonstrate equivalence to predicate devices, and that the device conforms to NEMA, IEC, and ISO standards. It does not provide the specific numerical acceptance criteria or the results of those measurements for the MAGNETOM Spectra, nor does it describe a study specifically designed to prove the device meets predefined acceptance criteria in the way you've outlined.
Therefore, I cannot populate the table or answer many of your questions as the requested information is not present in the provided text.
Here is what can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document lists "Performance: Specification Volume, Signal to Noise, Image Uniformity, Geometric Distortion, Slice Profile. Thickness and Gap, High Contrast Spatial Resolution" as parameters that were measured, but it does not give specific acceptance criteria (e.g., "SNR > X") or the reported performance values for the MAGNETOM Spectra against those criteria. It only states that performance measurements were done and that the MAGNETOM Spectra is equivalent to predicate devices.
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. No specific "test set" of patient data or phantoms is described with sample sizes or provenance for demonstrating performance. The evaluation seems to be based on engineering measurements against standards and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. There is no mention of a "test set" requiring expert ground truth establishment. The intended use indicates that images are "interpreted by a trained physician," but this pertains to clinical use, not a study evaluating the device's performance against expert consensus.
4. Adjudication method for the test set:
This information is not provided in the document. As no test set requiring expert ground truth is described, no adjudication method is mentioned.
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:
This information is not provided in the document. This is a submission for a Magnetic Resonance Diagnostic Device (an MRI machine), not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided in the document. This is an MRI system, not a standalone algorithm.
7. The type of ground truth used:
This information is not provided in the document. The document focuses on technical performance metrics as evaluated against industry standards and predicate devices, rather than clinical ground truth (like pathology or outcomes data) from a patient study.
8. The sample size for the training set:
This information is not provided in the document. There is no mention of a "training set" as this is not an AI/machine learning device submission.
9. How the ground truth for the training set was established:
This information is not provided in the document. As there is no training set mentioned, no establishment of ground truth for it is discussed.
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510K Summary
SIEMENS
Traditional 510(k) Submission: MAGNETOM Spectra 3T System
I. General Information
Establishment
Siemens Medical Solutions USA. Inc. 51 Valley Stream Parkway Mail Code G01 Malvern, PA 19355, USA
JUL 16 2012
Date Prepared
April 13, 2012
2240869
Registration Number
Manufacturer
Siemens Shenzhen Magnetic Resonance Ltd. Siemens MRI Center Gaoxin C. Ave., 2nd Hi-Tech Industrial Park, Shenzhen 518057, P.R. China
Registration Number
Contact Person
3004754211
Ms. Nadia Sookdeo Regulatory Affairs Technical Specialist Siemens Healthcare
Siemens Medical Solutions USA, Inc. Customer Solutions Group 51 Valley Stream Parkway Mail Code G01 Malvern, PA 19355, USA Phone: (610) 448-4918 Fax: (610) 448-1787
Device Name
Trade Names: MAGNETOM Spectra 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.
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SIEMENS
Traditional 510(k) Submission: MAGNETOM Spectra 3T System
II. Safety and Effectiveness Information Supporting Substantial Equivalence
Intended Use
The MAGNETOM Spectra 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 Spectra may also be used for imaging during interventional procedures when performed with MR compatible devices such as inroom display and MR-safe biopsy needles.
Device Description
MAGNETOM Spectra (3T) is similar to the previously cleared MAGNETOM Skyra 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 simplify the MR workflow.
The MAGNETOM Spectra systems will be available in a fixed configuration.
Substantial Equivalence
Siemens feels that the new system is substantially equivalent to the following predicate devices:
| Predicate Device Name | FDAClearanceNumber | FDA ClearanceDate |
|---|---|---|
| Siemens MAGNETOM Skyra (3T) | K101347 | October 1, 2010 |
| Siemens MAGNETOM Verio (3T) | K072237 | October 10, 2007 |
| syngo® MR B17 Software update | K082427 | November 7, 2008 |
| Hardware and Software Updates toMAGNETOM Aera (1.5T) and Skyra (3T) | K111242 | November 23, 2011 |
General Safety and Effectiveness Concerns:
Operation of the MAGNETOM Spectra system is substantially equivalent to the commercially available MAGNETOM Skyra and MAGNETOM Verio System.
Siemens 510(k) for MAGNETOM Spectra
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Traditional 510(k) Submission: MAGNETOM Spectra 3T System
As specified in the FDA guidance document "Guidance for the Submission Of Premarket Notifications for Magnetic 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
SIEMENS
- · 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 Spectra also conforms 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 Skyra and MAGNETOM Verio to show that the performance of the MAGNETOM Spectra is equivalent with respect to the predicate devices, assuring that the performance of these devices can be considered safe and effective with respect to the currently available MAGNETOM Skyra and MAGNETOM Verio systems.
Siemens 510(k) for MAGNETOM Spectra
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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 stylized eagle or bird-like figure with three wing-like shapes extending upwards and to the right. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference of the circle.
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
Ms. Nadia Sookdeo Technical Specialist, Regulatory Submissions Siemens Medical Solutions, USA, Inc. 51 Valley Stream Parkway, D 02 MALVERN PA 19355
Re: K121160
Trade/Device Name: MAGNETOM Spectra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, KNI, and MOS Dated: April 13, 2012 Received: April 16, 2012
JUL 16 2012
Dear Ms. Sookdeo:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section >10(x) promative is substantialy enuivalent (for the indications
referenced above and have determined the device is substantialy marketed in int referenced above and have ustemmed the actives marketed in interstate for use stated in the encrosure) to regary manation to the Medical Device Ameralments, or to commerce prof to May 28, 1970, the cidemic and of the provisions of the Federal Food, Drug, devices that have been reciassified in accordance with the provisions of the Act. The and Cosmetic Act (Act) that do not require apper of the general controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject equirements for annual registration, listing of
general controls provisions of the Act include requirements for annual registra general controls provisions of the necessor squals would the sugainst misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (see above) and class affecting your device , an be found in Title 21 ,
additional controls. Existing major regulations , 2005 , also supplish fu additional controls. Existing major regulations and to 195. In addition, FDA may publish further
Code of Federal Regulations (CFR), Parts 800 to 195. In and 195 Couc of I ederal regaration your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substitive with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has made a determination and your corred by other Federal agencies: You must or any Federal statutes and regulances and including, but not limited to: registing (21)
comply with all the Act's requirements, and act and section (reporting (reporting of comply with an the Act s requirements, theracing, our november of the reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related adverse cromby (21 cegulation (21 CFR Part 820). This letter requirents as set form in the quality of evice as described in your Section 510(k) premaket will anow you to begin marketing your as not equivalence of your device to a legally marketed notification. The FDA imanig of subbantial organ 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 II you uesne specific advice for your covice earonstic Device Evaluation and Safety at (301) 796-007), promote 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
under the MDA regulation (21 Of Ferrare 60) personal of 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 Tou may 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,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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SIEMENS
Traditional 510(k) Submission: MAGNETOM Spectra 3T System
Section 4 Indications for Use Statement
510(k) Number (if known)
MAGNETOM Spectra Device Names:
Indications for Use:
The MAGNETOM Spectra 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 cross socional images, are function of the head, body, or extremities.
Other physical parameters derived from the images and/or spectra may also be other priysiour paramotions on the region of interest, contrast agents may be used. produce. Boponaing 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 Spectra may also be used for imaging during interventional The MAGNETOm opeona with MR compatible devices such as inroom display and MR-safe biopsy needles.
× Prescription Use (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 Diagnostic Devices (OVID)
.A.D.N.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K12160
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.