(21 days)
Not Found
No
The document describes a standard MRI coil and system, with no mention of AI or ML in the intended use, device description, or any other section. The image processing mentioned is a standard technique for reconstructing MRI images, not indicative of AI/ML.
No.
The device is described as an "imaging device" used to obtain "diagnostic images" for diagnosis determination, not for treatment.
Yes
The document states that the images, when interpreted by a trained physician, "provide information that can be useful in diagnosis determination," and that the cardiac coil is "used for obtaining diagnostic images of the cardiac region." This explicitly indicates the device's role in diagnosis.
No
The device description clearly states it is a "receive only RF phased array coil" and a "receive-only multiple array coil," which are hardware components used in MRI systems.
No, 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 (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is an MRI system and a cardiac coil. It works by using magnetic fields and radio waves to create images of the internal structure of the body, specifically the heart and surrounding areas. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to provide physiological and clinical information through non-invasive imaging, which is then interpreted by a physician for diagnosis. This is distinct from analyzing biological samples.
The device is an imaging device used for diagnostic purposes, but it falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The cardiac coil is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the body. The images produced by the MR system 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 diagnosis determination.
The indications for use are as follows:
The MR-RCC-150 Cardiac Coil is a receive-only multiple array coil used for MRI imaging of the heart, its surrounding structures.
The MR-RCC-150 Cardiac Coil is a receive-only multiple array coil used for MRI imaging of the heart and its surrounding anatomy.
Product codes
MOS
Device Description
Function
The Echelon 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 reorientation 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 receive coil detects these emissions which 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.
Physical and Performance Characteristics
The 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
heart, its surrounding structures, cardiac region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
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.
0
DEC 1 2 2006
Section 2
510(k) Summary of Safety and Effectiveness
:
1
Submitter Information
| Submitter: | Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, Ohio 44080-2371
ph: (330) 425-1313
fax: (330) 963-0749 |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Douglas J. Thistlethwaite |
| Date: | October 23, 2006 |
| Device Name | |
vice Name
| Classification Name: | Coil, magnetic resonance, specialty |
|---|---|
| Classification Number: | 90MOS |
| Trade/Proprietary Name: | Echelon™ MR-RCC-150 Cardiac Coil |
| Predicate Device(s): | Rapid Torso Coil (Cf. K041185) |
Device Intended Use
The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The cardiac coil is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the body. The images produced by the MR system 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 diagnosis determination.
The indications for use are as follows:
The MR-RCC-150 Cardiac Coil is a receive-only multiple array coil used for MRI imaging of the heart, its surrounding structures.
2
Device Description
Function
The Echelon 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 reorientation 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 receive coil detects these emissions which 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.
Physical and Performance Characteristics
The 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 this device are similar to the predicate device.
Conclusions
lt is the opinion of Hitachi Medical Systems America that the Echelon™ Cardiac Coil is substantially equivalent to the Rapid Torso coil (Cf. K041185). The technological characteristics and intended use are identical to the Predicate Device.
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Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads "MINISTRY OF HEALTH & HUMAN". The graphic in the center consists of three curved lines that are parallel to each other.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
DEC 1 2 2006
Mr. Douglas Thistlethwaite Official Correspondent Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44080
Re: K063513
Trade/Device Name: MR-RCC-150 Cardiac Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 15, 2006 Received: November 21, 2006
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 cither 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/3/Picture/9 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle in a bold, stylized font. The word "Centennial" is below the letters. Three stars are below the word "Centennial".
Protecting and Promoting Public Health
4
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 fordination 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 yours,
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
5
510(k) Number 1063513 (if known): Device Name: MR-RCC-150 Cardiac Coil
Indications for Use:
The MR-RCC-150 Cardiac Coil is a receive-only multiple array coil used for MRI imaging of the heart and its surrounding anatomy.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lippman
(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number