(20 days)
Not Found
No
The description focuses on the hardware components and basic image processing techniques, with no mention of AI, ML, or related concepts.
No
The device is described as an RF phased array coil used for obtaining diagnostic images, which means it aids in diagnosis rather than providing therapy.
Yes
The device is described as being "used for obtaining diagnostic images" and is intended for use in MRI and MRA, which are diagnostic imaging modalities.
No
The device description clearly states it is a "receive only RF phased array coil" with mechanical sections, electrical pins, and coil elements enclosed in a rigid plastic housing. This indicates a physical hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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 within the anatomic regions from the chest to the pelvic region." This describes an in vivo imaging procedure performed on a living patient, not a test performed on a sample taken from the body (which is the definition of in vitro).
- Device Description: The device is a "receive only RF phased array coil" used in an MRI system. This is a component of an imaging system, not a device that analyzes biological samples.
- Input Imaging Modality: The input is "Magnetic Resonance Imaging (MRI)," which is an in vivo imaging technique.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used to create images of the inside of a living body.
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 body 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 within the anatomic regions from the chest to the pelvic region.
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.
Product codes (comma separated list FDA assigned to the subject device)
90MOS
Device Description
Function
The AIRIS Elite Body Coil (hereby referred to as body coil) is a receive only RF phased array coil, used for obtaining 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 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 maquetic 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 specific to the magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and the prototte rear. Caracter of the proton and its adjacent molecular environment. This revarres with arocess 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 echnes 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 body coil consists two mechanical sections: a rigid removable upper section and a base, which is positioned above and below the patient abdomen respectively. The upper section can be connected to the base by the electrical pins. There is a latch on the upper section. The coil consists of four coil elements: a two-turn solenoid, an anterior saddle, a posterior saddle and an anti-turn loop. All the elements are enclosed in a rigid plastic housing. The signal output of each element is independently processed by the system to enhance performance.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.
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.
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
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) 425-1410 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Douglas J. Thistlethwaite |
| Date: | February 4, 2005 |
Device Name
| Classification Name: | Coil, magnetic resonance, specialty |
|---|---|
| Classification Number: | 90MOS |
| Trade/Proprietary Name: | AIRIS Elite Rapid Body Coil |
| Predicate Device(s): | AIRIS Elite (K032232) |
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 body 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 within the anatomic regions from the chest to the pelvic region.
2
Device Description
Function
The AIRIS Elite Body Coil (hereby referred to as body coil) is a receive only RF phased array coil, used for obtaining 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 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 maquetic 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 specific to the magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and the prototte rear. Caracter of the proton and its adjacent molecular environment. This revarres with arocess 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 echnes 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 body coil consists two mechanical sections: a rigid removable upper section and a base, which is positioned above and below the patient abdomen respectively. The upper section can be connected to the base by the electrical pins. There is a latch on the upper section. The coil consists of four coil elements: a two-turn solenoid, an anterior saddle, a posterior saddle and an anti-turn loop. All the elements are enclosed in a rigid plastic housing. The signal output of each element 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. The device has four channels vs. two in the predicate device. Each channel output is independently processed.
Conclusions
It is the opinion of Hitachi Medical Systems Amcrica that the AIRIS Elite RAPID Body Coil is substantially equivalent to the body coil cleared with the AIRIS Elite MRI System. The technological characteristics and intended use are identical to the Predicate Device.
4
Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
FEB 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Douglas Thistlewaite Manager of Regulatory Affairs Hitachi Medical Systems America 1959 Summit Commerce Park TWINSBURG OH 44087-2371
Re: K050307
Trade/Device Name: AIRIS Elite Rapid Body Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: February 4, 2005 Received: February 8, 2005
Dear Mr. Thistlewaite:
We have reviewed your Section 510(k) premarket notification of intent to maket the device referenced in We have reviewed your Section 510(K) premants interests (for the indications for use stated in
above and have determined the device is substantially equivalse commerce prior above and have determined the devices marketed in interstate commerce prior to the enclosure) to legally marketed predical Device Amendments, or to devices that have been
May 28, 1976, the enactment date of the Medical Execut Development Casemane Ast (A May 28, 1976, the enactment date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the provinsions of the A.). You may, therefore, market the do not require approval of a prematics approval approval controls provisions of the Act
device, subject to the general controls provisions of the Act. The Act device, subject to the general controls of the real "The game"
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 (Prematket If your device is classified (see above) incols. Existing major regulations affecting your Approval), it may be subject to such additional controls. "Little 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Pa device can be found in the Code of I concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised mat I DA S Issualice of a substance of the Act or any of the Act or any
FDA has made a determination that your device complies with semply with all FDA has made a determination mar your device comples. You must complex You must comply with all the Federal statutes and regulations administered by their reson and listing (21 CFR Part 807); labeling Act 's requirements, including, out not minited to registration as a to the internations of the visions (2) CFR Part 801); good filandiaciumig practice realertedic product radiation control provisions
regulation (21 CFR Part 820); and if applicable, the electronic product radia (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
This letter will allow you to begin marketing your device as described in your Section 510(k)
10 legal This letter will allow you to begin harketing your avression of your device to a legally premarket notification. The FDA Inding of substantial equice 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 If you desire specific advice for your device on our labering regardants ( the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "visorianting of tresponsibilities under the Act from the 807.97). You may obtain other gelleral information on your respections
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) Division of Binan Mas-6597 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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _AIRIS Elite Rapid Body Coil
Indications for Use:
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the Magnetic resonance imaging (MRT) and magnetic resolulies within the anatomic regions from the chest to the pelvic region.
Over-the-Counter Use X AND/OR Prescription 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)
David G. Legare
KD50307
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