(38 days)
Not Found
No
The document describes a hardware component (an MRI coil) and mentions standard image processing techniques, but there is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML devices.
No.
The device is used for obtaining diagnostic images and does not provide any therapeutic benefit.
Yes
The device is explicitly stated to be "used for obtaining diagnostic images of the cardiac region". Diagnostic images are a tool used in the diagnostic process.
No
The device description clearly states it is a "receive-only RF phased array coil" and a "coil designed to contour to the outline of the shoulder," indicating it is a physical hardware component used in MRI.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "magnetic resonance imaging of the musculoskeletal structures, soft tissue and vascular structures of various anatomic regions" and "obtaining diagnostic images of the cardiac region." This describes a device used for in vivo imaging (imaging within a living organism), not in vitro testing (testing outside of a living organism, typically on biological samples).
- Device Description: The description details a "receive-only RF phased array coil" used in an MRI system. This is consistent with an imaging device, not a device for analyzing biological samples.
- Input Imaging Modality: The input modality is Magnetic Resonance Imaging (MRI), which is an in vivo imaging technique.
- Anatomical Site: The anatomical sites mentioned (musculoskeletal structures, soft tissue, vascular structures, cardiac region, shoulder) are all parts of the human body, further indicating an in vivo application.
IVD devices are typically used to examine specimens such as blood, urine, or tissue samples to provide information about a person's health. This device is used to create images of the inside of the body.
N/A
Intended Use / Indications for Use
The ECHELON Rapid Cardiac Coil is a receive-only, multiple array coil used for magnetic resonance imaging of the musculoskeletal structures, soft tissue and vascular structures of various anatomic regions. It is designed to be used the Hitachi ECHELON 1.5T MRI system.
Product codes
90MOS
Device Description
The ECHELON Rapid Cardiac Coil is a receive only RF phased array coil, used for obtaining diagnostic images of the cardiac region, in an open Magnetic Resonance Imaging (MRI) system.
The ECHELON Rapid Cardiac Coil is a receive-only coil designed to contour to the outline of the shoulder. The coil consists of 12 elements. The signal output of each element is independently processed by the MRI system to enhance performance.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
cardiac region, musculoskeletal structures, soft tissue, and vascular structures of various anatomic regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MR-RCC-150 Cardiac Coil (K063513), K063513 - EchelonTM MR-RCC-150 Cardiac Coil
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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| Submitter Information | FEB 25 2011 | |
|---|---|---|
| Submitter: | Hitachi Medical Systems America, Inc. | |
| 1959 Summit Commerce Park | ||
| Twinsburg, Ohio 44087-2371 | ||
| TEL: (330) 425-1313 | ||
| FAX: (330) 963-0749 | ||
| Contact: | Douglas J. Thistlethwaite | |
| Date: | January 14, 2011 |
Device Name
| Classification Name: | Coil, magnetic resonance, specialty |
|---|---|
| Classification Number: | 90MOS |
| Trade/Proprietary Name: | ECHELON Rapid Cardiac Coil |
| Predicate Device: | MR-RCC-150 Cardiac Coil (K063513) |
Device Intended Use
The ECHELON Rapid Cardiac Coil is a receive-only, multiple array coil used for magnetic resonance imaging of the musculoskeletal structures, soft tissue and vascular structures of various anatomic regions. It is designed to be used the Hitachi ECHELON 1.5T MRI system.
Device Description
Function
The ECHELON Rapid Cardiac Coil is a receive only RF phased array coil, used for obtaining diagnostic images of the cardiac region, in an open Magnetic Resonance Imaging (MRI) system.
Scientific Concepts
Magnetic Resonance Imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2.
A RF emission or echo that can be measured accompanies these relaxation events. The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varying the RF excitation, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.
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Physical and Performance Characteristics
The ECHELON Rapid Cardiac Coil is a receive-only coil designed to contour to the outline of the shoulder. The coil consists of 12 elements. The signal output of each element is independently processed by the MRI system to enhance performance.
Device Technological Characteristics
The technological characteristics of the ECHELON Rapid Cardiac Coil are exactly the same to the predicate device as listed in Section 10 - Substantial Equivalence Discussion.
Conclusions
It is the opinion of Hitachi Medical Systems America, Inc. that the ECHELON Rapid Cardiac Coil is substantially equivalent to the listed predicate device.
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Contrast Agent Use
K110120- ECHELON Rapid Cardiac Coil
Hitachi Medical Systems America, Inc
Contact: Doug Thistlethwaite
| Feature | Predicate |
|---|---|
| The Coil Specification Document (DCA # 2-001017) | |
| contains requirements that the coil support acquisition of | |
| contrast-enhanced MRA for the heart and surrounding | |
| vasculature as well as cardiac perfusion studies. The coil | |
| does not include these protocols; a design requirement of | |
| the coil is the ability to acquire these images. | K063513 - EchelonTM MR-RCC-1 |
| 50 Cardiac Coil |
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Image /page/3/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Doug Thistlewaite Manager of Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087
FEB 2 5 2011
Re: K110120
Trade/Device Name: ECHELON Rapid Cardiac Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: January 14, 2011 Received: January 18, 2011
Dear Mr. Thistlewaite:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 vou desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary S Postel
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: ECHELON Rapid Cardiac Coil
Indications For Use:
The ECHELON Rapid Cardiac Coll is a receive-only, multiple array coil used for magnetic resonance imaging of the musculoskeletal structures, soft tissue and vascular structures of various anatomic regions. It is designed to be used the Hitachi ECHELON 1.5T MRI system.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Ove r-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OIVD Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary Shibb
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K 110120
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