(28 days)
Not Found
No
The device description explicitly states that the underlying technology and materials are identical to standard MRI coil technology that has existed for several years, and there is no mention of AI or ML in the document.
No.
The device is described as an accessory to a magnetic resonance scanner for general human anatomy imaging to assist in medical diagnosis, and it does not transmit energy into the patient. Its flexible design is for optimal image acquisition, not for treatment.
No
The device is an accessory to a magnetic resonance scanner used for imaging. The images produced may assist in medical diagnosis, but the device itself does not perform the diagnosis.
No
The device description clearly describes a physical MRI coil, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The description clearly states that this device is an MRI coil used as an accessory to an MRI scanner. Its purpose is to acquire images of general human anatomy.
- No Specimen Analysis: The device does not interact with or analyze any specimens taken from the patient's body. It works externally to capture magnetic resonance signals.
- Imaging Modality: The input imaging modality is Magnetic Resonance, which is an in-vivo imaging technique, not an in-vitro diagnostic method.
The device is a medical device used for imaging, which is a different category than in-vitro diagnostics.
N/A
Intended Use / Indications for Use
The coil is indicated for use by the order of a physician to be used as an accessory to a Siemens 3.07 magnetic resonance scanner for general human anatomy imaging as supported by the scanner. These images, when interpreted by a trained physician, may assist in medical diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The Siemens 3.0T Blanket Array Coil embeds an MRI antenna set within a quilt-like enclosure providing high-quality images of general human anatomy. It is flexible enough to wrap snuggly around small bodies as well as large adult extremities so it can be used to image those challenging regions such as bilateral brachial plexus, bilateral lower extremities, and even heads. This lightweight SemiFlex™ design facilitates effortless and accurate positioning and ensures the multiple antenna elements as close as possible to the target anatomies regardless of patient size. The Blanket Array Coil is an MRI coil contained within a water-resistant case, featuring a soft and cleanable cover. What the patient feels is a lightweight, warm and soothing blanket. What the radiologist sees is a flawless image without compromising comfort. The underlying technology and materials used for manufacture are identical to standard MRI coil technology that has existed for several years. The coil uses similar blocking networks and impedance matching circuits, and it does not transmit energy into the patient, neither predicate nor current submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
General human anatomy, bilateral brachial plexus, bilateral lower extremities, heads.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Non-Clinical Tests:
- Blocking network analysis
- SNR and uniformity analysis
- Risk management (including hazard analysis and FMEA)
- Heat testing
- Compliance testing to IEC60601-1 3rd Edition. IEC60601-1 was chosen for compliance in other world markets. A gap analysis of ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, a2:2010/(r)2012 with IEC60601-1 was performed and for our devices, the US deviations described by ES60601-1 do not modify the requirements of IEC60601-1. Consequently, we are compliant with ES60601-1.
Clinical Tests:
- Analyses in all 3 planes (sagittal, coronal, and axial) were run on the Siemens 3.0T Blanket Array Coil to show that the anatomies of the submitted and predicate coils have substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 2, 2014
Resonance Innovations LLC % Mr. Brian Carter Quality Assurance Manager 9840 S. 140th Street, Suite 8 OMAHA NE 68138
Re: K142755
Trade/Device Name: Siemens 3.0T Blanket Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: September 24, 2014 Received: September 25, 2014
Dear Mr. Carter:
This letter corrects our substantially equivalent letter of October 23, 2014. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Siemens 3.0T Blanket Array Coil
Indications for Use (Describe)
The coil is indicated for use by the order of a physician to be used as an accessory to a Siemens 3.07 magnetic resonance scanner for general human anatomy imaging as supported by the scanner. These images, when interpreted by a trained physician, may assist in medical diagnosis.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
EF
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Image /page/3/Picture/0 description: The image is a logo for ScanMed. The word "ScanMed" is written in a large, bold, sans-serif font, with the letters in a dark blue color. Below the word "ScanMed" is the tagline "The Image is Everything" in a smaller, gray font. The logo is simple and modern, and the tagline suggests that ScanMed is a company that is focused on providing high-quality images.
| Section 8. | 510(k) Summary | |
|---|---|---|
| Submitter's Name: | Resonance Innovations LLC | |
| Submitter's Address: | 9840 South 140th St., Suite 8 | |
| Omaha, NE 68138 | ||
| Submitter's Telephone: | 402-934-2650 | |
| Submitter's Contact: | Randall Jones, President | |
| Date 510(k) Summary prepared: | September 24, 2014 | |
| Proprietary Name: | Siemens 3.0T Blanket Array Coil Model | |
| 516SI3001 | ||
| Common or Usual Name: | MRI coil(s) | |
| Classification Name: | Coil, Magnetic Resonance, Specialty | |
| Classification Code: | MOS | |
| Predicate Device: | 1.5T and 3.0T GE PROCURETM Array Coil | |
| K140606 |
Description of the Device
The Siemens 3.0T Blanket Array Coil embeds an MRI antenna set within a quilt-like enclosure providing high-quality images of general human anatomy. It is flexible enough to wrap snuggly around small bodies as well as large adult extremities so it can be used to image those challenging regions such as bilateral brachial plexus, bilateral lower extremities, and even heads. This lightweight SemiFlex™ design facilitates effortless and accurate positioning and ensures the multiple antenna elements as close as possible to the target anatomies regardless of patient size. The Blanket Array Coil is an MRI coil contained within a water-resistant case, featuring a soft and cleanable cover. What the patient feels is a lightweight, warm and soothing blanket. What the radiologist sees is a flawless image without compromising comfort. The underlying technology and materials used for manufacture are identical to standard MRI coil technology that has existed for several years. The coil uses similar blocking networks and impedance matching circuits, and it does not transmit energy into the patient, neither predicate nor current submission.
4
Image /page/4/Picture/0 description: The image is a logo for ScanMed. The word "ScanMed" is written in a sans-serif font, with the "Sca" in a darker blue and the "nMed" in a lighter blue. Below the word "ScanMed" is the tagline "The Image is Everything" in a smaller, gray font. There is a registered trademark symbol in the upper right corner of the logo.
| Device Model Number | Device Description |
|---|---|
| 516SI3001 | Siemens 3.0T Blanket Array Coil |
Indications for Use
The coil is indicated for use by the order of a physician to be used as an accessory to a Siemens 3.0T magnetic resonance scanner for general human anatomy imaging as supported by the scanner. These images, when interpreted by a trained physician, may assist in medical diagnosis.
Technological Characteristics
The comparison between the predicate and the current submission is described, below.
-
- Design. This submission is for a dedicated coil that mav give diagnostic quality images of general human anatomy. It is a multi-channel coil with all channels designed to work at once, receive-only, in conjunction with the system body coil. The predicate multi-channel GE PROCURE™ Array Coil covers similar anatomy, also working as receive-only to the body coil. Both predicate and modified coils have resonant coil elements enclosed in semi-flexible assemblies. The modified device has been slightly modified to integrate with the Siemens MRI scanner. All design principles employed are mature and well-known throughout the industry.
-
- Principles of operation: The scientific principles of operation (magnetic resonance) are identical between the predicate and modified devices. Theory of operation is very well understood throughout the industry.
-
- Materials. The same materials are used in the construction of the predicate and modified device. All internal circuitry is encapsulated in flame retardant EVA foam, then completely covered with a nylon fabric or compressed EVA. This nylon fabric has been successfully used for over 10 years in the predicate device with no reported biocompatibility issues. Both modified and predicate devices have been tested for mechanical and electrical safety using IEC60601-1 3rd Edition, which for our application is identical to ES60601-1.
-
- Chemical Composition. Both predicate and modified devices have a successful biocompatibility track record, as demonstrated by cytotoxicity testing and by their history of use in previously cleared devices.
-
- Energy Source. This device is a receive-only coil that does not generate its own power, but rather is controlled by the MRI system as the energy source.
Non-Clinical Tests
The predicate and current submission have been subject to similar risk management studies, as listed below, and determined to be substantially equivalent.
5
Image /page/5/Picture/0 description: The image shows the logo for ScanMed. The word "Scan" is in a bold, dark blue font, while the word "Med" is in a lighter blue, thinner font. Below the company name is the tagline "The Image is Everything" in a smaller, gray font.
-
- Blocking network analysis
-
- SNR and uniformity analysis
-
- Risk management (including hazard analysis and FMEA)
-
- Heat testing
-
- Compliance testing to IEC60601-1 3rd Edition. IEC60601-1 was chosen for compliance in other world markets. A gap analysis of ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, a2:2010/(r)2012 with IEC60601-1 was performed and for our devices, the US deviations described by ES60601-1 do not modify the requirements of IEC60601-1. Consequently, we are compliant with ES60601-1.
Clinical Tests
Analyses in all 3 planes (sagittal, coronal, and axial) were run on the Siemens 3.0T Blanket Array Coil to show that the anatomies of the submitted and predicate coils have substantial equivalence.
Substantial Equivalence Decision
As described in this summary, the modified device is substantially equivalent to the predicate device based on the analysis herein. The modified device raises no new concerns of safety or efficacy.