(19 days)
The intended uses of the 1.5T 32-channel Head Coil and the 3T 32-channel Head Coil are, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human head.
Used in the 1.5 T MAGNETOM Avanto, MAGNETOM Espree or MAGNETOM Symphony, a Tim System, the 1.5 T 32-channel Head Coil and in the 3 T MAGNETOM Trio, a Tim System, the 3T 32-channel Head Coil are indicated for uses as a diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. The images produced by the 1.5 T MAGNETOM Avanto, MAGNETOM Espree or MAGNETOM Symphony, a Tim System with the 1.5 T 32-channel Head Coil and the images produced by the 3 T MAGNETOM trio a Tim System with the 3T 32-channel Head Coil reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The intended use of the MAGNETOM Avanto, MAGNETOM Espree or MAGNETOM Symphony a Tim System is not affected in any way by the use of the new 1.5T 32-channel Head Coil.
The intended use of the MAGNETOM Trio a Tim System is not affected in any way by the use of the new 3T 32-channel Head Coil.
The 1.5T 32-channel Head Coil and the 3T 32-channel Head Coil are receive only MR coils for imaging the human head. The coils comprises a split design for easy patient positioning. An addition mirror is provided for patient comfort. A high number of 32 receive elements has been chosen to make use of high acceleration factors in the so-called parallet imaging technique (iPAT). The inner dimensions of the coil have been chosen to be smaller than the Head Matrix Coil to optimize the signal-to-noise ratio.
The Siemens 1.5T 32-channel Head Coil and 3T 32-channel Head Coil are subject to safety and performance parameters, as outlined in the FDA Guidance document for MR Diagnostic Devices. These parameters, including Maximum Static Field, Rate of Change of Magnetic Field, RF Power Deposition, Acoustic Noise Level, Geometric Distortion, Slice Profile, Thickness and Gap, and High Contrast Spatial Resolution, were considered unaffected by the modifications described in the notification.
For the new coils, additional parameters like Biocompatibility, Signal to Noise Ratio (SNR), and Image Uniformity were also evaluated. Biocompatibility tests were not performed as no new materials were used compared to the predicate devices.
The study performed to demonstrate substantial equivalence involved laboratory testing of the new 1.5T 32-channel Head Coil and the 3T 32-channel Head Coil. The specific details of the study, such as sample sizes, data provenance, ground truth establishment methods, and expert qualifications, are not provided in the document.
The document states that Signal to Noise Ratio (SNR) and image uniformity tests according to IEC 62464-1 standard were performed. The results, as presented in the submission, demonstrated that the new coils are equivalent to the predicate devices in these performance aspects. This finding supported the claim of substantial equivalence and indicated that the technological differences did not raise new questions regarding effectiveness.
Here’s a table summarizing the available information regarding acceptance criteria and performance:
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety Parameters | ||
| Maximum Static Field | (Implicitly) Unaffected by modifications, consistent with FDA Guidance doc. for MR Diagnostic Devices. | Unaffected by the modifications described within this notification. |
| Rate of Change of Magnetic Field | (Implicitly) Unaffected by modifications, consistent with FDA Guidance doc. for MR Diagnostic Devices. | Unaffected by the modifications described within this notification. |
| RF Power Deposition | (Implicitly) Unaffected by modifications, consistent with FDA Guidance doc. for MR Diagnostic Devices. | Unaffected by the modifications described within this notification. |
| Acoustic Noise Level | (Implicitly) Unaffected by modifications, consistent with FDA Guidance doc. for MR Diagnostic Devices. | Unaffected by the modifications described within this notification. |
| Biocompatibility | New materials would require testing. | No new materials were used, therefore no new biocompatibility tests were performed. |
| Performance Parameters | ||
| Geometric Distortion | (Implicitly) Unaffected by modifications, consistent with FDA Guidance doc. for MR Diagnostic Devices. | Unaffected by the modifications described within this notification. |
| Slice Profile, Thickness and Gap | (Implicitly) Unaffected by modifications, consistent with FDA Guidance doc. for MR Diagnostic Devices. | Unaffected by the modifications described within this notification. |
| High Contrast Spatial Resolution | (Implicitly) Unaffected by modifications, consistent with FDA Guidance doc. for MR Diagnostic Devices. | Unaffected by the modifications described within this notification. |
| Signal to Noise Ratio (SNR) | Equivalence to predicate devices as per IEC 62464-1 standard. | Tests performed acc. to IEC 62464-1 standard, and results presented in the submission show they are equivalent with the predicate devices. |
| Image Uniformity | Equivalence to predicate devices as per IEC 62464-1 standard. | Tests performed acc. to IEC 62464-1 standard, and results presented in the submission show they are equivalent with the predicate devices. |
Additional Information Not Available in the Document:
- Sample size used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified, as the performance evaluation relies on objective measurements against a standard (IEC 62464-1) rather than expert interpretation of images for ground truth.
- Adjudication method for the test set: Not applicable, as the evaluation is based on objective measurements.
- 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: Not applicable, as this is a device clearance for an MRI head coil, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For SNR and Image Uniformity, the ground truth is established by the specified standards in IEC 62464-1. Other parameters are implicitly considered consistent with FDA guidance.
- The sample size for the training set: Not applicable, as this device does not involve a "training set" in the context of machine learning.
- How the ground truth for the training set was established: Not applicable.
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K072909
Page 1 of 3
Section 5: 510(k) Summary
5 510(k) Summary
OCT 3 : 2007
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.
General Information I.
Date of summary preparation: August 24", 2007
Manufacturer
Siemens AG, Medical Solutions Henkestrasse 127 D-91052 Erlangen, Germany
Headquarters: Siemens AG Wittelsbacherplatz 2 D-80333 Munich, Germany
Registration Number 8010024
Importer/Distributor
Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Registration Number 2240869
Contact Person
Mr. Lutz Mahn Regulatory Affairs Manager Henkestrasse 127 D-91052 Erlangen, Germany Phone: +49 (9131) 84-2274 Fax: +49 (9131) 84-2200 e-mail: lutz.mahn@siemens.com
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KC729C9
Page 2 of 3
Section 5: 510(k) Summary
| Classification and Device Name | |
|---|---|
| Classification Panel: | Radiology |
| Classification Name: | Magnetic Resonance Diagnostic Device Accessory |
| Device Class: | Class II [21 CFR § 892.1000] |
| Product Code: | MOS |
| Common Name: | Volume Coil |
| Trade Name: | 1.5 T 32-channel Head Coil3 T 32-channel Head Coil |
II. Safety and Effectiveness Information Supporting Substantial Equivalence.
Intended Use
The 1.5T 32-channel Head Coil and the 3T 32-channel Head Coil are indicated for use as magnetic resonance diagnostic devices (MRDD) that produces 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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Device Description
The 1.5T 32-channel Head Coil and the 3T 32-channel Head Coil are receive only MR coils
Image /page/1/Picture/8 description: The image shows a white object against a black background. The object appears to be a piece of equipment or machinery, possibly a component of a larger system. The object has a rounded shape with some linear features and protrusions on the sides. Due to the high contrast and lack of detail, it is difficult to determine the exact nature or function of the object.
for imaging the human head. The coils comprises a split design for easy patient positioning. An addition mirror is provided for patient comfort. A high number of 32 receive elements has been chosen to make use of high acceleration factors in the so-called parallet imaging technique (iPAT). The inner dimensions of the coil have been chosen to be smaller than the Head Matrix Coil to optimize the signal-tonoise ratio.
Substantial Equivalence
Siemens believes that the 1.5T 32-channel Head Coil and the 3T 32-channel Head Coil are substantially equivalent to the following cleared medical devices:
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| Siemens MAGNETOM Avanto1.5T(Head MATRIX coil) | K032428 | Oct 16, 2003 |
| Siemens MAGNETOM Trio a Tim System3T(Head MATRIX coil) | K050200 | Feb 28, 2005 |
General Safety and Effectiveness Concerns:
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K072909
Page 3 of 3
Section 5: 510(k) Summary
The following safety and performance parameters:
[Safety]
- Maximum Static Field
- Rate of Change of Magnetic Field
- RF Power Deposition
- Acoustic Noise Level
[Performance]
- Geometric Distortion
- Slice Profile, Thickness and Gap
- High Contrast Spatial Resolution
specified by the FDA Guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification.
The following parameters were considered for the new 1.5T 32-channel Head Coil and the 3T 32-channel Head Coil
- [Safety] - Biocompatibility
[Performance] - Signal to Noise Ratio - Image Uniformity
No new materials were used for the new 1.5T 32-channel Head Coil and the 3T 32-channel Head Coil compared to their predicate device. Therefore no new biocompatibility tests were performed. Signal to Noise Ratio (SNR) and image uniformity tests acc. to IEC 62464-1 standard were performed for the new 1.5T 32-channel Head Coil and the 3T 32-channel Head Coil and the results presented in this submission show that they are equivalent with the predicate devices.
Conclusion as to Substantial Equivalence
Laboratory testing was performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to effectiveness.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with wavy lines below them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2007
Siemens AG Medical Solutions c/o Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America, Inc. 1775 Old Highway 8, Suite 104 NEW BRIGHTON MN 55112-1891
Re: K072909
Trade/Device Name: 1.5T 32-channel Head Coil and 3T 32-channel Head Coil Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 8, 2007 Received: October 12, 2007
Dear Mr. Preiss:
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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR | Description | Number |
|---|---|---|
| 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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,
Nancy 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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4 Indications for Use Statement
510(k) Number (if known)
1.5T 32-channel Head Coil and 3T 32-channel Head Coil
Device Name: 1.5T 32-channel Head Coil and 3T 32-channel Head Coil
Indications for Use:
The intended uses of the 1.5T 32-channel Head Coil and the 3T 32-channel Head Coil are, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human head.
Used in the 1.5 T MAGNETOM Avanto, MAGNETOM Espree or MAGNETOM Symphony, a Tim System, the 1.5 T 32-channel Head Coil and in the 3 T MAGNETOM Trio, a Tim System, the 3T 32-channel Head Coil are indicated for uses as a diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. The images produced by the 1.5 T MAGNETOM Avanto, MAGNETOM Espree or MAGNETOM Symphony, a Tim System with the 1.5 T 32-channel Head Coil and the images produced by the 3 T MAGNETOM trio a Tim System with the 3T 32-channel Head Coil reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The intended use of the MAGNETOM Avanto, MAGNETOM Espree or MAGNETOM Symphony a Tim System is not affected in any way by the use of the new 1.5T 32-channel Head Coil.
The intended use of the MAGNETOM Trio a Tim System is not affected in any way by the use of the new 3T 32-channel Head Coil.
(Please do not write below this line- continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use | X |
|---|---|
| OR | Over-The-Counter Use ______ |
| (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices | |
|---|---|
| -- | -------------------------------------------------------------------------------------------------------- |
| Siemens 510(k) Premarket Notification | August 24, 2007 |
|---|---|
| 510(k) Number | K072909 |
§ 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.