(56 days)
The MAGNETOM Systems with the syngo MR2006A 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. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.
The "MAGNETOM Espree", the "MAGNETOM Avanto", the "MAGNETOM Symphony a Tim System", the "MAGNETOM Trio a Tim System" may also be used for imaging during interventional procedures performed with MR compatible instruments in room display and MR safe biopsy needles.
The MAGNETOM Systems with the syngo MR2006A 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.
This document describes a 510(k) premarket notification for a software and hardware upgrade (syngo MR2006A) to existing Siemens MAGNETOM MRI systems. The primary claim is substantial equivalence to previously cleared devices.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, there are no specific quantitative acceptance criteria or reported device performance metrics listed in a table format. The submission focuses on demonstrating substantial equivalence by stating that the upgrade has "no significant effect on the MR safety and performance parameters" and that "the values are not significantly changed and, in the case of safety parameters remain below the level of concern."
The key "performance" claim is that the device will "conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices." However, no specific performance values against these standards are provided in the excerpt.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not mention any specific test set sample size or data provenance (e.g., country of origin, retrospective or prospective) for proving the device meets acceptance criteria. The focus is on the upgrade's impact on existing, cleared MRI systems.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
No information is provided regarding the number or qualifications of experts used to establish ground truth for a test set. This type of information would typically be present in studies evaluating diagnostic accuracy or clinical performance, which are not detailed in this submission.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned. Since there's no described test set involving human interpretation for ground truth establishment, adjudication methods are not applicable here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No MRMC comparative effectiveness study is mentioned. The submission does not discuss human readers or improvements with AI assistance. The device is an MRI system software/hardware upgrade, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
No standalone study demonstrating "algorithm only" performance is explicitly mentioned. The document states that the new software has "no significant effect on the MR safety and performance parameters" of the existing MRI systems. This implies that the upgrade itself was tested for its impact on the system's performance, but not as a standalone algorithm with a specific diagnostic output.
7. The Type of Ground Truth Used:
Given the nature of the submission (upgrade to an existing MRI system for substantial equivalence), the "ground truth" used for evaluation would primarily be derived from technical performance specifications and safety parameters as defined by NEMA and IEC standards for MRI devices. It's not a clinical ground truth like pathology or outcome data in the context of diagnostic accuracy. The key point is that the upgraded system continues to meet the established performance and safety characteristics of the predicate devices.
8. The Sample Size for the Training Set:
No training set sample size is mentioned. This type of information is typically relevant for machine learning or AI models, which are not the focus of this submission.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned, there is no information on how its ground truth was established.
Summary of Key Findings from the provided text:
- Acceptance Criteria/Performance: The primary acceptance criterion appears to be maintaining the safety and performance parameters of the predicate devices, conforming to NEMA and IEC standards, with "no significant effect" from the upgrade. Specific quantitative criteria and reported values are not provided in this excerpt.
- Study Design: The document describes an assessment for "substantial equivalence" of a software/hardware upgrade to existing MRI systems. It implies internal testing against established industry standards for performance and safety, rather than a clinical trial with a distinct test set or human readers.
- Lack of Detail: The provided text is a 510(k) summary focused on establishing substantial equivalence based on the minor nature of the changes. It does not contain the detailed study protocols, acceptance criteria tables, or performance metrics typically found in submissions for novel diagnostic devices or AI algorithms.
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52164
OCT 4 - 2005 Section 1: 510(k) Summary
Section 1: 510(k) Summary
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. Bereich MedHenkestrasse 127D-91052 Erlangen. Germany |
| Registration Number | 8010024 |
| Contact Person | Ms. Judy CampbellTechnical Specialist, Regulatory Submissions51 Valley Stream ParkwayMalvern. PA 19355Phone: (610)448-4918Fax: (610) 448-1787 |
| Device Name | Trade Name:MAGNETOM Systems with Software syngo MR2006A |
| Classification Name:CFR Section:Classification: | Magnetic Resonance Diagnostic Device21 CFR § 892.1000Class II |
Performance Standards None established under Section 514 the Food, Drug, and Cosmetic Act.
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II. Safety and Effectiveness Information Supporting Substantial Equivalence.
Intended Use
The MAGNETOM Systems with the syngo MR2006A 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. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.
The syngo MR2006A (VB13A) software upgrade will be available for the following MAGNETOM Family systems:
- The MAGNETOM 1.5 Telsa Avanto system with syngo MR2004V was described in . premarket notification K032428 which received FDA clearance October 16, 2003.
- The MAGNETOM 1.5 Telsa Espree system with syngo MR2005E was described in . premarket notification K041112 which received FDA clearance July 21, 2004.
- The MAGNETOM 1.5 Telsa Symphony a Tim System with syngo MR2006T was . described in premarket notification K050199 which received FDA clearance February 18, 2005.
- The MAGNETOM 3 Telsa Trio a Tim System with syngo 2006T was described in . premarket notification K050200 which received FDA clearance February 28, 2005.
Siemens Medical Solutions, Inc., intends to offer a software and hardware upgrade syngo MR2006A. The indications for use will stay exactly the same, with respect to the previous software versions mentioned in the comparison matrix.
Substantial Equivalence
The systems 1.5 T MAGNETOM Espree, Avanto, Symphony a Tim System and the 3 T MAGNETOM Trio a Tim System with syngo MR2006A are substantially equivalent to the following cleared medical devices:
| Predicate Device Name | FDA ClearanceNumber | FDA ClearanceDate |
|---|---|---|
| Siemens MAGNETOM 1.5 T Avanto | K032428 | 10/16/03 |
| Siemens MAGNETOM 1.5 T Espree | K041112 | July 21, 2004 |
| Siemens MAGNETOM 1.5 TSymphony a Tim System | K050199 | February 18, 2005 |
| Siemens MAGNETOM 3 T Trio a TimSystem | K050200 | February 28, 2005 |
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General Safety and Effectiveness Concerns:
The introduction of the new syngo MR2006A has no significant effect on the MR safety and performance parameters.
Siemens Medical Solutions is adding an upgrade in software and hardware to the currently available MAGNETOM Systems. The MRI systems are exactly the same as those described and cleared in the predicate device premarket notifications. Various safety and performance testing was completed; however the values are not significantly changed and, in the case of safety parameters remain below the level of concern.
The MAGNETOM Systems will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM systems.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Judith Campbell Technical Specialist Siemens Medical Solutions, USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355
Re: K052164 Trade/Device Name: MAGNETOM Systems with Software syngo MR 2006A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 8, 2005 Received: August 9, 2005
Dear Ms. Campbell:
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 (Premarket Approval), 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.
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.
OCT 4 - 2005
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter with and in Jours of substantial equivalence of your device to a legally prematics notification: "The PDF minenig site and thus, permits 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 If you desire specific acvice for your de received to the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation entired, formation on your responsibilities under the Act from the 807.77). Tournay oount outer general missanal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 3: Indications for Use
Section 3: Indications for Use Statement
652164
Device Name:
| MAGNETOM Symphony a Tim System | 510(k) Number (if known) K050199 |
|---|---|
| MAGNETOM Trio a Tim System | 510(k) Number (if known) K050200 |
| MAGNETOM Espree | 510(k) Number (if known) K041112 |
| MAGNETOM Avanto | 510(k) Number (if known) K032428 |
Indications for Use:
- The "MAGNETOM Espree" .
- the "MAGNETOM Avanto" .
- the "MAGNETOM Symphony a Tim System" .
- the "MAGNETOM Trio a Tim System" .
is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces Is indicated for use as a magnete resolise cross sectional images, spectroscopic images and/or transverse, sagntail, coronal and come structure and/or function of the head, body, or specula, and that shoplays and interpreted by a trained physician, yield information that may assist in diagnosis.
- The "MAGNETOM Espree" .
- the "MAGNETOM Avanto" ●
- the "MAGNETOM Symphony a Tim System" .
- the "MAGNETOM Trio a Tim System" .
may also be used for imaging during interventional procedures performed with MR may also be accords in room display and MR safe biopsy needles.
(please do not write below this line- continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use | ✓ |
|---|---|
| ------------------ | ---------------------------------------------------- |
OR
| Over-The-Counter Use | ____________________ |
|---|---|
| ---------------------- | ---------------------- |
David A. Syverson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K052164 |
|---|---|
| --------------- | ---------------------------------------------------------- |
Siemens 510(k) Premarket Notification
syngo MR 2006A
Page 12
CONFIDENTIAL
§ 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.