(133 days)
The following MAGNETOM systems:
MAGNETOM 1.5 T Avanto MAGNETOM 1.5 T Espree MAGNETOM 1.5 T Symphony a Tim System MAGNETOM 3.0 T Trio a Tim System MAGNETOM 1.0 T Harmony MAGNETOM 1.5 T Symphony MAGNETOM 1.5 T Sonata MAGNETOM 0.2 T Concerto MAGNETOM 3.0 T Trio
with syngo Expert—i option described in this premarket notification 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 MR safe biopsy needles.
Siemens Medical Solutions, Inc., intends to offer a software option called syngo Expert—i. The indications for use will stay exactly the same, with respect to the previous > oftware versions mentioned in the comparison matrix.
The syngo Expert-i feature allows the local user of the MRI (e.g. tech) to get help and assistance from other personnel of the radiology department (e.g. other tech or physician) to perform scans faster and with better quality. For this purpose, a remote user within the local network of the MRI (i.e. the network of the radiology) can log onto the MR main or satellite console.
Not Found
The provided text is related to a 510(k) premarket notification for the "MAGNETOM Systems with syngo Expert-i option." This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices and outlining the intended use of the device. It does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria.
The document details the device's general intended use as a magnetic resonance diagnostic device (MRDD) for producing various types of images and spectra to assist in diagnosis, and for imaging during interventional procedures. The "syngo Expert-i option" is described as a software feature that allows remote assistance for MRI users to perform scans faster and with better quality.
Therefore, I cannot provide the requested information from the given text. This document is a regulatory submission for substantial equivalence, not a performance study report.
To answer your request, a document detailing performance testing, clinical studies, or engineering verification and validation reports would be necessary.
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JAN I 3 2006 (052423 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 Medical SolutionsHenkestrasse 127D91052 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 syngo Expert—i option |
| 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.
H. Safety and Effectiveness Information Supporting Substantial Equivalence.
Intended Use The following MAGNETOM systems:
MAGNETOM 1.5 T Avanto MAGNETOM 1.5 T Espree MAGNETOM 1.5 T Symphony a Tim System MAGNETOM 3.0 T Trio a Tim System
Siemens 510(k) Premarket Notiification 1 Syngo Expert-I Option for MAGNETOM Systerns CONFIDENTIAL
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K05 2423
MAGNETOM 1.0 T Harmony MAGNETOM 1.5 T Symphony MAGNETOM 1.5 T Sonata MAGNETOM 0.2 T Concerto MAGNETOM 3.0 T Trio
with syngo Expert—i option described in this premarket notification 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 MR safe biopsy needles.
Siemens Medical Solutions, Inc., intends to offer a software option called syngo Expert—i. The indications for use will stay exactly the same, with respect to the previous > oftware versions mentioned in the comparison matrix.
Substantial Equivalence
Within the definition of the Safe Medical Devices Act of 1990, the
MAGNETOM 1.5 T Avanto MAGNETOM 1.5 T Esprec MAGNETOM 1.5 T Symphony a Tim System MAGNETOM 3.0 T Trio a Tim System MAGNETOM 1.0 T Harmony MAGNETOM 1.5 T Symphony MAGNETOM 1.5 T Sonata MAGNETOM 0.2 T Concerto MAGNETOM 3.0 T Trio
with syngo Expert-i Option are substantially equivalent to the following cleared medical devices:
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Section 2: Required Forms and Documents
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| MAGNETOM 1.5 T Avanto | K032428 | October 16, 2003 |
| MAGNETOM 1.5 T Espree | K041112 | July 21, 2004 |
| MAGNETOM 1.5 T Symphony a Tim System | K050199 | February 18, 2005 |
| MAGNETOM 3.0 T Trio a Tim System | K050200 | February 28, 2005 |
| MAGNETOM 1.0 T Harmony | K970852 | June 5, 1997 |
| MAGNETOM 1.5 T Symphony | K971684 | August 5, 1997 |
| MAGNETOM 1.5 T Sonata | K993731 | December 23, 1999 |
| MAGNETOM 0.2 T Concerto | K003192 | December 21, 2000 |
| MAGNETOM 3.0 T Trio | K013586 | December 28, 2001 |
KOSZ
General Safety and Effectiveness Concerns:
The introduction of the syngo Expert—i Option has effect on the MR safety. Therefore a risk analysis has been performed including new safety measures to reduce the residual risks to an acceptable level.
The MRI systems are exactly the same as what was described and cleared in the predicate premarket notifications. Safety testing will be completed before commercial introduction to the market.
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Image /page/3/Picture/1 description: The image shows a logo with a stylized eagle and text around it. The eagle is depicted with three curved lines forming its body and wings. The text is arranged in a circular pattern around the eagle, following the curve of the circle. The text is not fully legible, but it appears to be part of a government agency or organization's name.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2006
Ms. Judith Campbell Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355
Re: K052423
Trade/Device Name: MAGNETOM Systems with syngo Expert-i option Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 22, 2005 Received: December 30, 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.
{4}------------------------------------------------
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 (o 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.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 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
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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Kos 2423 Section 3 - Indications for Use
| Device Name | FDA Clearance Number |
|---|---|
| MAGNETOM 1.5 T Avanto | K032428 |
| MAGNETOM 1.5 T Espree | K0411-12 |
| MAGNETOM 1.5 T Symphony a Tim System | K050199 |
| MAGNETOM 3.0 T Trio a Tim System | K050200 |
| MAGNETOM 1.0 T Harmony | K970852 |
| MAGNETOM 1.5 T Symphony | K971684 |
| MAGNETOM 1.5 T Sonata | K993731 |
| MAGNETOM 0.2 T Concerto | K003192 |
| MAGNETOM 3.0 T Trio | K013586 |
The above listed MAGNETOM systems 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. 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 MR safe biopsy needles.
The syngo Expert-i feature allows the local user of the MRI (e.g. tech) to get help and assistance from other personnel of the radiology department (e.g. other tech or physician) to perform scans faster and with better quality. For this purpose, a remote user within the local network of the MRI (i.e. the network of the radiology) can log onto the MR main or satellite console.
(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 |
| (Division Sign-Off) | |
|---|---|
| -- | ----------------------------------------------- |
| Siemens 510(k) Premarket Notification | Division of Reproductive, Abdominal, and Radiological Devices |
|---|---|
| Syngo Expert-I Option for MAGNETOM Systems | (k) Number K052473 CONFIDENTIAL |
Syngo Expert-I Option for MAGNETOM Systems(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.