(73 days)
The MAGNETOM Systems -- I-class and T-class releases 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.
They may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and safe biopsy needles.
The MAGNETOM Systems - I-class and T-class releases are based on the syngo MR B15 software upgrade will be available for the following MAGNETOM Family systems: MAGNETOM Avanto, MAGNETOM Espree, MAGNETOM Symphony a Tim System, MAGNETOM Trio a Tim System. Siemens Medical Solutions, Inc., intends to offer a software and hardware upgrade syngo MR B15.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria or report device performance in terms of metrics like sensitivity, specificity, accuracy, or any quantitative measures. Instead, it focuses on demonstrating substantial equivalence to previously cleared devices. The "performance" mentioned relates to the system's general function as a Magnetic Resonance Diagnostic Device.
Given the information, the acceptance criteria are implicitly met by demonstrating that the new software/hardware upgrade (syngo MR B15) for MAGNETOM systems has no significant effect on MR safety and performance parameters compared to the predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Implicit Acceptance Criterion: No significant effect on MR safety and performance parameters compared to predicate devices. | The document states: "The introduction of the MAGNETOM systems - I-class and T-class releases with syngo MR B15 has no significant effect on the MR safety and performance parameters." |
| Conformance to FDA recognized NEMA Standards for measurement of performance and safety parameters. | The document states: "The MAGNETOM Systems will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters..." |
| Conformance to international IEC standard for safety issues with Magnetic Resonance Imaging Devices. | The document states: "...and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices." |
| Continued safe and effective use. | The document states: "This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM systems." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. The document describes a software and hardware upgrade for existing MR systems and focuses on substantial equivalence rather than a new device requiring a clinical efficacy study with a specific test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given text. As no explicit test set or clinical study for establishing ground truth is mentioned, this detail is absent.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No MRMC comparative effectiveness study is described in the provided text. The submission is for a software/hardware upgrade and focuses on maintaining substantial equivalence, not on improving human reader performance with AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
The provided device, "MAGNETOM Systems - I-class and T-class releases," refers to Magnetic Resonance Diagnostic Devices (MRDD). These are imaging systems that produce images for interpretation by a trained physician. The text does not describe an AI algorithm or a standalone algorithm-only performance study. The focus is on the safety and performance of the MR system itself.
7. The Type of Ground Truth Used
This information is not explicitly stated or detailed in the provided text. Since the submission is for an upgrade to an existing MR system, the ground truth would inherently be related to the established medical understanding and diagnostic capabilities that the MR system generates images for. However, there's no mention of specific ground truth for a new diagnostic claim or algorithm.
8. The Sample Size for the Training Set
This information is not provided in the given text. As no AI algorithm is detailed, a training set is not applicable to the information given.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the given text, as no AI algorithm or training set is discussed.
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Section 1: 510(k) Summary
510(k) Summary Section 1:
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 -- I-class and T-class releases |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| CFR Section: | 21 CFR § 892.1000 |
| Classification: | Class 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 - I-class and T-class releases 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.
They may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and safe biopsy needles.
The MAGNETOM systems -- I-class and T-class releases are based on the syngo MR B15 software upgrade will be available for the following MAGNETOM Family systems:
| System | FDA ClearanceNumber | FDA Clearance Date |
|---|---|---|
| MAGNETOM Avanto | K032428 | October 16, 2003 |
| MAGNETOM Espree | K041112 | July 21, 2004 |
| MAGNETOM Symphony a TimSystem | K050199 | February 18, 2005 |
| MAGNETOM Trio a Tim System | K050200 | February 28, 2005 |
Siemens Medical Solutions, Inc., intends to offer a software and hardware upgrade syngo MR B15. The indications for use will stay exactly the same, with respect to the previous software versions mentioned in the comparison matrix.
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Substantial Equivalence
The systems 1.5 T MAGNETOM Avanto, Espree, Symphony a Tim System and the 3 T MAGNETOM Trio a Tim System, I-class and T-class releases with syngo MR B15 are substantially equivalent to the following cleared medical devices:
| System | FDA ClearanceNumber | FDA Clearance Date |
|---|---|---|
| MAGNETOM Avanto | K032428 | October 16, 2003 |
| MAGNETOM Espree | K041112 | July 21, 2004 |
| MAGNETOM Symphony a TimSystem | K050199 | February 18, 2005 |
| MAGNETOM Trio a Tim System | K050200 | February 28, 2005 |
with software platform syngo MR 2006A that was described in premarket nonification K052164 that received FDA clearance on October 4, 2005.
General Safety and Effectiveness Concerns:
The introduction of the MAGNETOM systems - I-class and T-class releases with syngo MR B15 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 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. To minimize electrical and mechanical hazards, Siemens adheres to recognized and established industry practices and standards.
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 consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
NOV -3 2006
Ms. Judith Campbell Technical Specialist, Regulatory Submissions Siemens Medical Solutions, Inc. 51 Valley Stream Parkway MALVERN PA 19355
Re: K062454
Trade/Device Name: MAGNETOM Systems - I-class and T-class releases Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 17, 2006 Received: August 22, 2006
Dear Ms. Campbell:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Bocation of the device is substantially equivalent (for the indications for releved above and nave acternment and one icate devices marketed in interstate commerce ass stated in the encreases to the Medical Device Amendments, or to devices that prov to may 20, 1970, and charge with the provisions of the Federal Food, Drug, and Cosmetic nat (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 oontrols provisions ince, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is onastired (600 more) additional controls. Existing major regulations affecting your Apploral), it may of subject of additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/10 description: The image is a circular logo with the text "FDA Centennial" and the years "1906 - 2006". The logo is black and white and has a simple design. The letters "FDA" are prominently displayed in the center of the logo. The word "Centennial" is written below the letters "FDA". The years "1906" and "2006" are written above the letters "FDA".
Protecting and Promoting Public Health
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Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dr. 3 issuates of a basicines with other requirements of the Act that I DA has made a decemination and Joinistered by other Federal agencies. You must of any Federal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements) and 801); good manufacturing practice requirements as set CFR Part 807), laboling (21 CFR Part 820); and if applicable, the electronic form in the quanty systems (QD) regalation (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) I his letter will anow you to oegin manceang your a
premarket notification. The FDA finding of substantial equivalence of your device to a legally premarket hotheadon. The PDA mailing sification 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 If you desire specific arree for your do 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" ATSO, prease note the regulation other general information on your responsibilities under (21CFK Tall 607.77). Tod may obtain offer government
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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices ()ffice 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
510(K) Number (if known): K062454
Device Name: MAGNETOM Systems – I-Class and T-Class Releases
Indications for Use:
The MAGNETOM Systems -- I-class and T-class releases are indicated for use as magnetic The MAGNE I OM Systems - I-class and 1 chass retuss rensverse, sagittal, coronal and oblique resonance diagnostic devices (MRDD) that s and/or spectra, and that display the internal cross sectional mages, spectronoople hadges, or extremities. These images and/or spectra, structure and/or lunchon of the nead, 6007, or extention that may assist in diagnosis.
They may also be used for imaging during interventional procedures performed with MR They may anso oo ased for thing and safe biopsy and safe biopsy needles.
(Please do not write below this line- continue on another page if needed)
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Concurrepee of CDRH, Office of Device Evaluation
Prescription Use V
Over-The-Counter Use
Siemens 510(k) Premarket Notification Page 12 Shellens From Systems - 1-class and T-class releases with syngo MR B15 noallyn (Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
§ 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.