(77 days)
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, in room display and MR-safe biopsy needles.
The software update syngo MR B17 offers additional and improved applications for MAGNETOM Systems. It includes sequences and image processing functions for oncology, neurology, orthopaedics and cardio-vascular imaging.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Siemens MAGNETOM Systems with software syngo MR B17:
Important Note: The provided document is a 510(k) summary for a software update to an MRI system. Unlike AI/CADe devices, an MRI system itself does not typically have "acceptance criteria" in the sense of a specific performance metric (like sensitivity/specificity) being met by the device's output. Instead, the "acceptance criteria" for a software update to a diagnostic imaging device like an MRI focuses on ensuring the new software maintains the safety and effectiveness of the previously cleared device, does not introduce new risks, and performs as intended without compromising image quality or diagnostic utility. This is primarily done through verification and validation testing, and demonstrating substantial equivalence to a predicate device.
Therefore, the table below reflects what would be considered "performance" and "acceptance criteria" for this type of device submission, rather than a quantifiable diagnostic accuracy metric.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (Summary of Study Findings) |
|---|---|---|
| Safety and Effectiveness | No significant concerns of safety and efficacy introduced by the software upgrade. | Siemens believes that the MAGNETOM systems with software syngo MR B17 are substantially equivalent to the predicate devices (K072237 and K062454). This implies that the safety and effectiveness are maintained at a level comparable to the cleared predicates. "The introduction of the MAGNETOM systems with software syngo MR B17 has no significant concerns of safety and efficacy." |
| Risk Management | Potential hazards identified and controlled via software development, verification, and validation testing. | Risk analysis was performed to identify potential hazards, which were controlled through software development, verification, and validation testing. |
| Compliance to Standards | Conformance to international IEC and ISO standards (where applicable) for safety and performance. | "The MAGNETOM Systems with software syngo MR B17 will conform to the measurement of safety and performance parameters to the international IEC and ISO standards, where applicable." |
| Intended Use | The device continues to fulfill its intended use as a magnetic resonance diagnostic device (MRDD) for imaging various body parts and assisting in diagnosis when interpreted by a trained physician. The new software provides "additional and improved applications for oncology, neurology, orthopaedics and cardio-vascular imaging." | The software update "offers additional and improved applications for MAGNETOM Systems," implying continued and enhanced fulfillment of the stated intended use. The FDA concurred with the stated Indications for Use. (Pages 1 & 5) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly detail specific clinical test sets, sample sizes (e.g., number of patients/scans), or data provenance (country of origin, retrospective/prospective). For a software update to an MRI system, the "test set" primarily refers to the data used in verification and validation (V&V) testing. This V&V testing typically involves technical performance evaluation, image quality assessment, and functional testing rather than a large-scale clinical study with specific patient data.
The document indicates that risks are controlled "via software development, verification and validation testing," suggesting a comprehensive engineering and quality assurance process was followed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth for any specific test set related to diagnostic performance. As noted above, the focus here is on substantial equivalence to a predicate device and technical performance, not on demonstrating improved diagnostic accuracy against a specific ground truth for a novel diagnostic claim. The "trained physician" is mentioned in the intended use as interpreting the images to assist in diagnosis, but not as part of a formal ground truth establishment for a clinical study in this submission.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method as it does not present a clinical study requiring such a method for a specific diagnostic outcome.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is more common for
AI/CADe devices that directly assist human readers in making diagnostic decisions. This submission is for a software update to an MRI system, aiming to maintain or improve image acquisition and processing capabilities.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to an MRI system software update. An MRI system itself is a diagnostic tool, not an AI algorithm performing a standalone diagnostic task. Its "performance" is inherently tied to image acquisition, processing, and display, which are then interpreted by a human. The software update improves the capabilities of this core diagnostic tool.
7. The Type of Ground Truth Used
Given the nature of the submission (software update for an MRI system), the "ground truth" used in testing would primarily revolve around:
- Technical specifications & engineering standards: Ensuring image fidelity, resolution, contrast, artifact reduction, and adherence to physical parameters.
- Clinical utility assessments: Ensuring the "additional and improved applications" (for oncology, neurology, etc.) align with current clinical practice and provide diagnostically relevant information.
- Comparison to predicate device: The fundamental "ground truth" for substantial equivalence is that the modified device performs as safely and effectively as the previously cleared predicate, producing images of comparable diagnostic quality.
The document does not mention specific pathology, outcomes data, or expert consensus in the context of a clinical study for establishing ground truth for this software update.
8. The Sample Size for the Training Set
The document does not mention a training set as this is not an AI/machine learning device that requires a training set in that context. The "training" for the software development would be based on engineering principles and clinical requirements.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a "training set" in the context of AI/ML, this question is not applicable to the provided document.
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5 510(k) Summary NOV - 7 2008
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. Inc.51 Valley Stream ParkwayMalvern. PA 19355 |
|---|---|
| Registration Number | 2240869 |
| Manufacturer | Siemens AG.Henkestrasse 127D-91052 Erlangen. Germany |
| Registration Number | 8010024 |
| Contact Person | Elizabeth LazaroRegulatory Technical Specialist.51 Valley Stream ParkwayMalvern, PA 19355Phone: (610) 448-3393Fax: (610) 448-1787 |
| Device Name | |
| Trade name | MAGNETOM Systems with software syngo MR B1 |
| Classification Name | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| Regulation number: | 21 CFR § 892.1000 |
| Device Class: | II |
| Product Code: | LNH |
Summary Device Description
The software update syngo MR B17 offers additional and improved applications for MAGNETOM Systems. It includes sequences and image processing functions for oncology, neurology, orthopaedics and cardio-vascular imaging.
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II. Safety and Effectiveness Information Supporting Substantial Equivalence.
MAGNETOM Systems:
MAGNETOM Avanto MAGNETOM Espree MAGNETOM Symphony a Tim System MAGNETOM Trio a Tim System MAGNETOM Verio
with software syngo MR B17
Intended 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 in-room display and MR-safe biopsy needles
Performance Standards
None established under Section 514 the Food. Drug. and Cosmetic Act.
{2}------------------------------------------------
Substantial Equivalence
Siemens believes that the MAGNETOM systems with software syngo MR B17 are substantially equivalent to the following cleared medical devices:
| PredicateDevice Name | PredicateSoftware Name | FDA ClearanceNumber | FDA ClearanceDate |
|---|---|---|---|
| MAGNETOMVerio | software syngo MRB15V | K072237 | Oct 10, 2007 |
| MAGNETOMSystems - I andT-class releases | software syngo MRB15 | K062454 | Nov 3, 2006 |
General Safety and Effectiveness Concerns:
The introduction of the MAGNETOM systems with software syngo MR B17 has no significant concerns of safety and efficacy.
Siemens is adding a software upgrade to the currently available MAGNETOM Systems. 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 Risk Analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing.
The MAGNETOM Systems with software syngo MR B17 will conform to the measurement of safety and performance parameters to the international IEC and ISO standards, where applicable.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight, representing the department's mission to protect and promote the health and well-being of Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Lazaro Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MALVERN PA 19533
Re: K082427
Trade/Device Name: Magnetom Systems: Magnetom Avanto, Magnetom Espree, Magnetom Symphony a Tim System, Magnetom Trio a Tim System and Magnetom Verio with software Syngo MR B17
Regulation Number: 21 CFR 892,1000
Regulation Name: Magnetic resonance diagnostic device
· Regulatory Class: II
Product Code: LNH
Dated: August 22, 2008
Received: August 22, 2008
Dear Ms. Lazaro:
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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.
NOV - 7 200
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Page 2
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); 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.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
hope M. Zhang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K082427
Magnetom Systems:
MAGNETOM Avanto MAGNETOM Espree MAGNETOM Symphony a Tim System MAGNETOM Trio a Tim System MAGNETOM Verio with software syngo MR B17
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, in room 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helu Remu
(Division Sign-Off)
Division of Reproductive, Abdominal Radiological Devices 510(k) Number
Page / of /
§ 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.