(50 days)
Not Found
Not Found
No
The summary describes a receive-only MRI coil and the basic principles of MRI imaging and reconstruction. It mentions "image processing techniques" but does not refer to AI, ML, or any related concepts like deep learning, neural networks, or algorithms that learn from data. The focus is on the hardware (the coil) and the physical principles of signal acquisition and basic reconstruction.
No
The device is described as an "imaging device" intended to provide "physiological and clinical information" and for "MRI imaging," with the produced images being useful in "diagnosis determination." There is no mention of it being used for treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that "When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination," indicating the device's role in the diagnostic process.
No
The device description clearly details physical hardware components (coils with elements/channels) that are integral to the device's function of receiving MR signals. While image processing is mentioned, the core device is a hardware component.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The device description clearly states that the MR system and coils are used for non-invasive imaging of the internal structure of the body. They detect signals within the body, not from a sample taken from the body.
- The intended use is for imaging and providing physiological and clinical information. While this information is used in diagnosis, the device itself is not performing a test on a biological sample to determine the presence or absence of a condition or measure a substance.
- The device description focuses on the physics of MRI and how images are generated. This is consistent with an imaging device, not an IVD.
In summary, the device is an imaging system used to visualize the internal structure of the body, which is a different category of medical device than an In Vitro Diagnostic.
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 ECHELON Specialty Coils are receive-only devices that detect the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved cross-sectional 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 for the ECHELON Specialty Coils are as follows:
- The MR-HRF-150, ECHELON High Resolution Foot Coil is a receive-only multiple ● array device used for MRI imaging of the ankle.
- The MR-LBC-150, ECHELON Long Bone Coil is a receive-only multiple array device . used for MRI imaging of the extremities.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
Function
The MR-HRF-150, ECHELON High Resolution Foot Coil is a receive-only multiple array device used for MRI imaging of the ankle.
The MR-LBC-150. ECHELON Long Bone Coil is a receive-only multiple array device used for MRI imaging of the extremities.
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.
Physical and Performance Characteristics
The MR-HRF-150. ECHELON High Resolution Foot Coil is a receive-only device suitable for imaging the ankle. The coil consists of 8 elements. The signal output of each element is independently processed by the MRI system to enhance performance.
The MR-LBC-150. ECHELON Long Bone Coil is a receive-only device suitable for imaging extremities. The coil consists of 4 channels. The signal output of each element is independently processed by the MRI system to enhance performance.
Mentions image processing
Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
ankle, extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained 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): 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.
ECHELON RAPID Foot Coil
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
510(k) Summary
Korsor6
Submitter Information
| Submitter: | Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, Ohio 44087-2371
ph: (330) 425-1313
fax: (330) 963-0749
DEC 0 5 2008 | | |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|--|
| Contact: | Douglas J. Thistlethwaite | | |
| Date: | September 10, 2008 | | |
| Device Name | | | |
| Classification Name: | | Coil, magnetic resonance, specialty | |
| Classification Number: | | 90MOS | |
| Trade/Proprietary Name: | | MR-HRF-150, ECHELON High Resolution Foot Coil | |
| Predicate Device(s): | | ECHELON RAPID Foot Coil | |
| Classification Name: | | Coil, magnetic resonance, specialty | |
| Classification Number: | | 90MOS | |
| Trade/Proprietary Name: | | MR-LBC-150, ECHELON Long Bone Coil | |
| Predicate Device(s): | | ECHELON RAPID Foot Coil | |
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 ECHELON Specialty Coils are receive-only devices that detect the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved cross-sectional 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 for the ECHELON Specialty Coils are as follows:
- The MR-HRF-150, ECHELON High Resolution Foot Coil is a receive-only multiple ● array device used for MRI imaging of the ankle.
- The MR-LBC-150, ECHELON Long Bone Coil is a receive-only multiple array device . used for MRI imaging of the extremities.
1
Device Description
Function
The MR-HRF-150, ECHELON High Resolution Foot Coil is a receive-only multiple array device used for MRI imaging of the ankle.
The MR-LBC-150. ECHELON Long Bone Coil is a receive-only multiple array device used for MRI imaging of the extremities.
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.
Physical and Performance Characteristics
The MR-HRF-150. ECHELON High Resolution Foot Coil is a receive-only device suitable for imaging the ankle. The coil consists of 8 elements. The signal output of each element is independently processed by the MRI system to enhance performance.
The MR-LBC-150. ECHELON Long Bone Coil is a receive-only device suitable for imaging extremities. The coil consists of 4 channels. The signal output of each element is independently processed by the MRI system to enhance performance.
2
Device Technological Characteristics
The technological characteristics of the ECHELON High Resolution Foot Coil and ECHELON Long Bone Coil are similar to the predicate devices as listed in Section 10 - Substantial Equivalence Discussion.
Conclusions
It is the opinion of Hitachi Medical Systems America, Inc. that the ECHELON High Resolution Foot Coil and ECHELON Long Bone Coil are substantially equivalent to the listed predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a stylized symbol that resembles an abstract representation of a human figure or a bird in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 5 2008
Mr. Doug Thistlethwaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K083086
Trade/Device Name: Echelon High Resolution Foot Coil and Long Bone Coil Regulation Number: 21 CFR 892.1000
Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II
Product Code: MOS
Dated: October 14, 2008
Received: October 16, 2008
Dear Mr. Thistlethwaite:
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 i 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.
4
Page 2
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" (21 CFR Part. 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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,
hoque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if KOB3086 known): ECHELON High Resolution Foot Coil and Long Bone Coil Device Name:
Indications for Use:
The MR-HRF-150, ECHELON High Resolution Foot Coil is a receive-only multiple array device used for MRI imaging of the ankle.
The MR-LBC-150, ECHELON Long Bone Coil is a receive-only multiple array device used for MRI imaging of the extremities.
Prescription Use x AND/OR
Over-the-Counter Use
(21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Halus Lewis
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number