(19 days)
Not Found
No
The summary describes a set of receive-only coils for an existing MRI system. There is no mention of AI/ML in the intended use, device description, or performance studies. The focus is on the physical characteristics and performance metrics (SNR, uniformity) of the coils themselves.
No.
The device is described as a diagnostic imaging device used to produce images for determining a diagnosis, not for treatment.
Yes
The text explicitly states, "The Flex and Loop Coils are indicated for use as a diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body" and "When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis."
No
The device description explicitly states it consists of physical components (coils and an interface containing preamplifiers, cable traps, and a combiner network), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "MR examination of the human body" and to "produce transversal, sagittal, coronal and oblique images of the internal structures of the body." This describes an in vivo imaging process, where the device interacts with the living body to produce images.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro). This device does not perform such tests.
- Device Description: The description details coils and an interface for use with an MR scanner, consistent with an imaging device, not a device for analyzing biological samples.
The device is a component of a Magnetic Resonance Imaging (MRI) system, which is a medical imaging modality used for diagnosis based on images of the body's internal structures. This is distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the Flex and Loop Coil Set 1.5 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body.
Used in the MAGNETOM Avanto, Espree and Symphony a Tim System, the Flex and Loop Coils are indicated for use 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 MAGNETOM Avanto, Espree and Symphony a Tim System with the Flex and Loop Coils 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, Espree and Symphony a Tim System is not affected in any way by the use of the new Flex and Loop Coil Set 1.5 T.
Product codes
MOS
Device Description
The Flex and Loop Coil Set 1.5 T consists of five receive-only coils and one interface, which contains the preamplifiers, cable traps and a combiner network. The coils are two 4-channel flexible coils (Flex Coil Large and Flex Coil Small) and three linear polarized (LP) flexible coils (Loop Coil 4 cm, 7 cm and 11 cm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
human body / internal structures of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The following parameters were considered for the new Flex and Loop Coil Set 1.5 T
[Safety] - Biocompatibility
[Performance] - Signal to Noise Ratio - Image Uniformity
No new materials were used for the new Flex and Loop Coil Set 1.5 T compared to their predicate device. Therefore no biocompatibility tests were performed. Signal to Noise Ratio (SNR) and image uniformity tests acc. to NEMA MS-6 standard were performed for the new Flex and Loop Coil Set 1.5 T and the results presented in this submission show that they are equivalent with the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
Section 8 510(k) Summary
8 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
I. General Information MAR 2 6 2007 Date of summary preparation: February 13, 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. Helmut Neumann Regulatory Affairs Manager Henkestrasse 127 D-91052 Erlangen, Germany
Siemens 510(k) Premarket Notification February 13, 2007
e-mail: helmut.neumann@siemens.com
Phone: +49 (9131) 84-7445 Fax: +49 (9131) 84-2200
1
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: | Special Purpose Coil |
| Trade Name: | Flex and Loop Coil Set 1.5 T |
Safety and Effectiveness Information Supporting Substantial II. Equivalence
Intended Use
The intended use of the Flex and Loop Coil Set 1.5 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Used in the MAGNETOM Avanto, Espree and Symphony a Tim System, the Flex and Loop Coils are intended to produce transversal, sagittal, coronal and oblique images of the internal structures of the body.
Device Description
The Flex and Loop Coil Set 1.5 T consists of five receive-only coils and one interface, which contains the preamplifiers, cable traps and a combiner network. The coils are two 4-channel flexible coils (Flex Coil Large and Flex Coil Small) and three linear polarized (LP) flexible coils (Loop Coil 4 cm, 7 cm and 11 cm).
Image /page/1/Figure/8 description: The image shows two lines labeled (1) and (2). According to the text, (1) is the coil socket and (2) is the plug for the coil socket on the patient table. The lines point to the respective parts in the image.
Figure 8.II.1: Flex loop interface
2
Image /page/2/Figure/1 description: The image shows three diagrams of a coil loop and coil plug. Each diagram has two labeled parts: (1) Coil loop and (2) Coil plug. The diagrams are simple line drawings, and the labels are placed near the corresponding parts of the coil.
Figure 8.II.2: Loop coils 4 cm, 7 cm, and 11 cm
Image /page/2/Figure/3 description: The image shows two diagrams of an electronic component, possibly a circuit board or a similar device. Each diagram has labels indicating different parts: (1) Center markings, (2) Electronic boxes, and (3) Coil plug. The diagrams appear to be technical illustrations, providing a visual representation of the component's structure and key features.
Figure 8.II.3: Flex Coil large and small
77
3
Equivalency Information
Siemens believes that the Flex and Loop Coil Set 1.5 T for MAGNETOM Avanto, Espree and Symphony a Tim System is substantially equivalent to the Flex Loop Coil Set for MAGNETOM 3 T systems described in the following submission:
| Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| Flex Loop Coil Set | ||
| 3 T | K063373 | Nov 17, 2006 |
4
Summary of Technological Characteristics of the Principal Device as Compared with the Predicate Device
Although the new Flex and Loop Coils are designed for a field strength of 1.5 T, Siemens believes that they are substantially equivalent to the predicate Flex Loop Coils for the 3 T MAGNETOM Trio a Tim System.
General Safety and Effectiveness Concerns
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 Flex and Loop Coil Set 1.5 T
[Safety] - Biocompatibility
[Performance] - Signal to Noise Ratio - Image Uniformity
No new materials were used for the new Flex and Loop Coil Set 1.5 T compared to their predicate device. Therefore no biocompatibility tests were performed. Signal to Noise Ratio (SNR) and image uniformity tests acc. to NEMA MS-6 standard were performed for the new Flex and Loop Coil Set 1.5 T 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.
5
Image /page/5/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The logo is presented in black and white, with the text and emblem appearing in black against a white background.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Siemens Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891
MAR 2 6 2007
Re: K070629
Trade/Device Name: Flex and Loop Coil Set 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 7, 2007 Received: March 7, 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 (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.
Image /page/5/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1886-1986" at the top, followed by the letters "PA" in a large, bold font. Below the letters, the word "Centennial" is written in a cursive font. There are four stars at the bottom of the logo. The logo appears to be a commemorative emblem for the centennial anniversary of an organization or event.
Protesting and Promoting Public Health
6
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). 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/cdrl/industry/support/index.html.
Sincerely vours.
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
7
2 Indications for Use Statement
510(k) Number (if known) _ K 070629
Device Name: Flex and Loop Coil Set 1.5 T
Indications for Use:
The intended use of the Flex and Loop Coil Set 1.5 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body.
Used in the MAGNETOM Avanto, Espree and Symphony a Tim System, the Flex and Loop Coils are indicated for use 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 MAGNETOM Avanto, Espree and Symphony a Tim System with the Flex and Loop Coils 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, Espree and Symphony a Tim System is not affected in any way by the use of the new Flex and Loop Coil Set 1.5 T.
Prescription Use __ X (Part 21 CFR 801 Subpart D) Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel h. Sepermm
sion of Reproductive, adiological Devices
Siemens 510(k) Premarket Notification
February 13, 2007
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