(39 days)
No
The description focuses on the hardware (RF coil) and standard image processing techniques, with no mention of AI, ML, or related concepts.
No.
The device is used for obtaining diagnostic images and does not provide any therapy or treatment.
Yes
The device is described as "for obtaining diagnostic images," which directly indicates its role in diagnosis.
No
The device description clearly details a physical RF coil with a flexible structure and independent parts, indicating it is a hardware component for an MRI system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a receive-only RF coil for obtaining diagnostic images using Magnetic Resonance Imaging (MRI). MRI is an imaging modality that creates images of the inside of the body without taking samples.
- Intended Use: The intended use is for "Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures." This is a description of an imaging procedure, not a test performed on a biological sample.
Therefore, this device falls under the category of a medical imaging device, not an in vitro diagnostic device.
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 general-purpose coil is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and 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 are as follows:
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures in various anatomic regions.
Product codes
90MOS
Device Description
The HHF Echelon Multi-purpose Coil (hereby referred to as GP coil) is a receive only RF THT Dencion Mana Frontaining diagnostic images of the abdominal region, in an open Magnetic Resonance Imaging (MRI) system.
The General-purpose coil consists of two independent parts A and B. The two parts can be r no Gellerar parpose overher. The main body of each coil is housed in a flexible structure to used individually of the body. The coil consists of a single element. The signal output of each part is independently processed by the system to enhance performance.
Mentions image processing
Images y, and 2 directions, and vistibution 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
musculoskeletal structures, soft tissue and vascular structures in various anatomic regions.
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)
T/R Body coil cleared in HHF1 Echelon MRI System (Cf. K052172)
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
Ko6 1950
AUG 1 8 2006
Section 2
510(k) Summary of Safety and Effectiveness
:
: 11:
11 24522 1 82
1
K06 150
Submitter Information
Submitter:
Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, Ohio 44080-2371 ph: (330) 425-1313 fax: (330) 425-1410
Contact:
July 5, 2006
Douglas J. Thistlethwaite
Date:
Device Name
| Classification Name: | Coil, magnetic resonance, specialty |
|---|---|
| Classification Number: | 90MOS |
| Trade/Proprietary Name: | HHF1™ Echelon™ Multi-purpose Coil |
| Predicate Device(s): | T/R Body coil cleared in HHF1 Echelon MRI |
| System (Cf. K052172) |
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 general-purpose coil is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and 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 are as follows:
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures in various anatomic regions.
2
Device Description
Function
The HHF Echelon Multi-purpose Coil (hereby referred to as GP coil) is a receive only RF The THT Dencion Mana Frontaining diagnostic images of the abdominal 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 Magnetic resolutios maging (incre) them to act as small spinning bar magnets. The most electionagietic properties that caseen, which makes it the primary nuclei currently used in ubiquitous of these nations in a static magnetic field, these nuclei assume a magnetic robenance mith the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength vector. The magnetic field strength and to the atomic nuclei under consideration can specific to the magnetization vector. When the RF excitation is removed, Cause a to origination or their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This revaries with the onaracter vacterized 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 rechoes 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 y, and 2 directions, and vistibution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.
Physical and Performance Characteristics
The General-purpose coil consists of two independent parts A and B. The two parts can be r no Gellerar parpose overher. The main body of each coil is housed in a flexible structure to used individually of the body. The coil consists of a single element. The signal output of each part is independently processed by the system to enhance performance.
3
Device Technological Characteristics
The technological characteristics of this device are similar to the predicate device.
Conclusions
It is the opinion of Hitachi Medical Systems America that the HHF1™ Echelon™ Multipurpose Coil is substantially equivalent to the T/R Body coil cleared in HHF1 Echelon MRI System (Cf. K052172). The technological characteristics and intended use are identical to the Predicate Device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 1 8 2006
Mr. Douglas Thistlewaite Manager of Regulatory Affairs Hitachi Medical Systems America 1959 Summit Commerce Park TWINSBURG OH 44087-2371
Re: K061950
Trade/Device Name: HHF1 Echelon Multi-purpose Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 5, 2006 Received: July 10, 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 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/4/Picture/10 description: The image is a black and white circular logo or seal. The text "1906 - 2006" is at the top of the circle. The letters "PA" are in the center of the circle in a stylized font. The word "Centennial" is below the letters "PA". Three stars are at the bottom of the circle.
Protecting and Promoting Public Health
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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" (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/cdrh/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
6
1166 1950 510(k) Number (if known): Device Name: HHF1 Echelon Multi-purpose Coil
Indications for Use:
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures in various anatomic regions.
| Prescription Use | X | AND/OR | Over-the-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
| (Division Sign-Off) | Nancy Brogdon |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K061950 |
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©2006 Hitachi Medical Systems America, Inc. Echelon Multi-purpose Coil Section 3
Section 3
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©2006 Hitachi Medical Systems America, Inc.