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.

Device Description

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. 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.

AI/ML Overview

The provided text does not contain information about acceptance criteria, a study that proves the device meets specific criteria, or performance data in the format requested. The document is a 510(k) summary for a medical device (AIRIS Elite Rapid Body Coil) that outlines its intended use, function, scientific concepts, and concludes that it is substantially equivalent to a predicate device.

Specifically, the following information is not available in the provided text:

A table of acceptance criteria and the reported device performance: The document does not define any specific acceptance criteria (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio thresholds) or provide performance metrics from a study that evaluates the device against such criteria.
Sample size used for the test set and the data provenance: There is no mention of a test set, its size, or the origin of any data (country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and their qualifications: No test set means no ground truth establishment for it is discussed.
Adjudication method for the test set: Not applicable as no test set is mentioned.
Multi-reader multi-case (MRMC) comparative effectiveness study information: There is no mention of an MRMC study or any impact of AI assistance on human readers.
Standalone (algorithm only) performance: This device is a hardware component (a coil for an MRI system), not an algorithm, so standalone algorithm performance is not applicable.
Type of ground truth used: No ground truth is discussed in relation to performance evaluation.
Sample size for the training set: Not applicable, as this is a hardware device, not an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable.

The document primarily focuses on establishing "substantial equivalence" to a predicate device based on similar technological characteristics and intended use. It describes the physical and performance characteristics of the body coil in a general sense, noting it's a "receive only RF phased array coil" and how it functions within the MRI system, but it does not present a formal study with acceptance criteria and measured performance outcomes. The "performance characteristics" mentioned are descriptive of the device's design (e.g., four channel vs. two in predicate) rather than quantitative results from a performance study.

Summary

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K050307

Section 2 510(k) Summary of Safety and Effectiveness

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Submitter Information

Submitter:	Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44080-2371ph: (330) 425-1313fax: (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:

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Device Description

Function

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.

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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.

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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.

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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

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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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Regulation Number and Section

§ 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.