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 OASIS Specialty Coils are receive-only devices that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved crosssectional images that display the internal structure of 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 OASIS Specialty Coils are as follows:

The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used . for MRI imaging of the human cervical spine, and thoracic spine.
. The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only multiple array device used for MRI imaging of the abdomen.
The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple . array device used for MRI imaging of the abdomen.
The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array . device used for MRI imaging of the foot.

Device Description

The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used for obtaining diagnostic images of the human cervical spine, and thoracic spine with the OASIS MRI System.

The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only multiple array device used for obtaining diagnostic images of the abdomen with the OASIS MRI System.

The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple array device used for obtaining diagnostic images of the abdomen with the OASIS MRI System.

The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array device used for obtaining diagnostic images of the foot with the OASIS MRI System.

AI/ML Overview

This document, K073310, is a 510(k) premarket notification for several specialty magnetic resonance imaging (MRI) coils manufactured by Hitachi Medical Corporation. The purpose of a 510(k) submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective.

The provided document describes the intended use and technological characteristics of the OASIS Specialty Coils (CTL Coil, QD Flexible Body Coils (L and XL), and Rapid Foot Coil) and asserts their substantial equivalence to predicate devices (ECHELON Whole Spine (CTL) Coil, ALTAIRE Flex Body (Large) Coil, ALTAIRE Flex Body (Extra Large) Coil, and OASIS RAPID Head Coil).

*However, the document does not contain any information regarding specific acceptance criteria, study designs, sample sizes for test or training sets, expert qualifications, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies related to device performance.

The document primarily focuses on:

Device Identification: Naming the new devices and their predicate devices.
Intended Use: Specifying the anatomical regions for which each coil is designed (cervical spine, thoracic spine, abdomen, foot).
Device Description and Function: Briefly explaining that these are receive-only multiple array devices for obtaining diagnostic images with the OASIS MRI System.
Scientific Concepts: A general overview of MRI principles.
Physical and Performance Characteristics (General): Describes the number of elements in each coil and that signals are independently processed to enhance performance. It does not provide specific performance metrics or acceptance thresholds.
Technological Characteristics: States they are similar to predicate devices.
Conclusion: The submitter's opinion that the devices are substantially equivalent.
FDA Response: The FDA's letter granting 510(k) clearance based on substantial equivalence to predicate devices.

Given the content of this 510(k) submission, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on technological characteristics and intended use matching predicate devices, rather than a clinical performance study with specific acceptance criteria and detailed results.

Therefore, for each point requested, the answer will be:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the provided document.	Not specified in the provided document.

Explanation: The document describes the technological characteristics and intended use of the coils, stating they are similar to predicate devices. It does not provide specific performance metrics or quantitative acceptance criteria that would typically be seen in a clinical performance study for image quality or diagnostic accuracy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not specified in the provided document.
Data Provenance: Not specified in the provided document.

Explanation: The document does not describe a performance study with a test set of data. The submission relies on demonstrating substantial equivalence to predicate devices based on design and intended use, rather than presenting a new clinical data set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable, as no test set requiring ground truth establishment is described.
Qualifications of Experts: Not applicable.

Explanation: As no performance study with a test set is detailed, there's no mention of experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable, as no test set requiring ground truth establishment is described.

Explanation: Without a performance study or test set, adjudication methods are not relevant to the information provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC comparative effectiveness study was not described.
Effect Size: Not applicable.

Explanation: This device is a passive MRI coil, not an AI-powered diagnostic tool. The submission is for hardware (coils), and an MRMC study comparing human reader performance with and without AI assistance is not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance Study: No, a standalone performance study was not described.

Explanation: This device is a passive MRI coil and does not involve an algorithm for standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not applicable, as no performance study requiring ground truth is described.

Explanation: Since no performance study to establish the device's diagnostic performance is detailed, no ground truth types are mentioned. The submission focuses on device characteristics and equivalence.

8. The sample size for the training set

Sample Size (Training Set): Not applicable, as no training set for an algorithm is described.

Explanation: This is a hardware submission, not an AI/algorithm submission, so the concept of a training set is not relevant here.

9. How the ground truth for the training set was established

Ground Truth Establishment (Training Set): Not applicable.

Explanation: As no training set or algorithm is described, the method for establishing its ground truth is not relevant.

Summary

{0}------------------------------------------------

K073310

JAN 18 2008

Submitter Information

Submitter:	Hitachi Medical Corporation2-1, ShintoyofutaKashiwa-shi, Chiba, JAPAN 277-0804
Correspondent:	Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44080-2371ph: (330) 425-1313fax: (330) 963-0749
Contact:	Douglas J. Thistlethwaite
Date:	November 13, 2007

Device Name

Classification Name:	Coil, magnetic resonance, specialty
Classification Number:	90MOS
Trade/Proprietary Name:	OASIS CTL Coil
Predicate Device(s):	ECHELON Whole Spine (CTL) Coil

Classification Name:	Coil, magnetic resonance, specialty
Classification Number:	90MOS
Trade/Proprietary Name:	OASIS QD Flexible Body Coil (L)
Predicate Device(s):	ALTAIRE Flex Body (Large) Coil

Classification Name:	Coil, magnetic resonance, specialty
Classification Number:	90MOS
Trade/Proprietary Name:	OASIS QD Flexible Body Coil (XL)
Predicate Device(s):	ALTAIRE Flex Body (Extra Large) Co

Classification Name:	Coil, magnetic resonance, specialty
Classification Number:	90MOS
Trade/Proprietary Name:	OASIS RAPID Foot Coil
Predicate Device(s):	OASIS RAPID Head Coil

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows handwritten text that appears to be a document identifier or page number. The text includes "K07331D" on the top line, followed by "pg 2 of 4" on the second line. The letters and numbers are written in a clear, legible style, and the overall impression is that of a document label or reference.

Device Intended Use

The indications for use for the OASIS Specialty Coils are as follows:

The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used . for MRI imaging of the human cervical spine, and thoracic spine.
. The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only multiple array device used for MRI imaging of the abdomen.
The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple . array device used for MRI imaging of the abdomen.
The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array . device used for MRI imaging of the foot.

Device Description

Function

The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used for obtaining diagnostic images of the human cervical spine, and thoracic spine with the OASIS MRI System.

The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only multiple array device used for obtaining diagnostic images of the abdomen with the OASIS MRI System.

The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple array device used for obtaining diagnostic images of the abdomen with the OASIS MRI System.

The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array device used for obtaining diagnostic images of the foot with the OASIS MRI System.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows handwritten text that appears to be a document identifier or page number. The text reads 'K073310 pg. 3 of 4'. The 'K' is capitalized, followed by a series of numbers. Below this, 'pg.' is written, followed by '3 of 4', indicating page 3 of a 4-page document.

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-CTL-120, OASIS CTL Coil is a recieve-only device suitable for imaging human cervical spine, thoracic spine, lumber spine and etc. The coil consists of 8 elements. The signal output of each element is independently processed by the MRI system to enhance performance.

The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only suitable for imaging the abdomen. The coil consists of 2 elements. The signal output of each element is independently processed by the MRI system to enhance performance.

The MR-QFC-120, OASIS QD Flexible Body Coil (XL) recieve-only suitable for imaging the abdomen. The coil consists of 2 elements. The signal output of each element is independently processed by the MRI system to enhance performance.

The MR-RFC-120, OASIS Rapid Foot Coil recieve-only suitable for imaging human foot region, muscle, born structure, cartilage, etc. The coil consists of 8 elements. The signal output of each element is independently processed by the MRI system to enhance performance.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows a handwritten note with the text "K073310 pg. 4 of 4". The text is written in black ink on a white background. The handwriting is somewhat stylized, with the numbers and letters having a distinct appearance. A black line is present below the text.

Device Technological Characteristics

The technological characteristics of the OASIS Specialty Coils are similar to the predicate devices as listed in Section 7 - Predicate Device Comparison.

Conclusions

It is the opinion of Hitachi Medical Systems America, Inc. that OASIS Specialty Coils substantially equivalent to the listed predicate devices.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human figures, representing the department's focus on health and human well-being. The text is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2008

Hitachi Medical Corporation % Mr. Doug Thistlethwaite Manager, Regulatory Affairs Hitachi Medical System America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087

Re: K073310

Trade/Device Name: OASIS CTL Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 19, 2007 Received: November 23, 2007

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 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.

{5}------------------------------------------------

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 (OS) 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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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,

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{6}------------------------------------------------

510(k) Number (if known):	K073310
Device Name:	OASIS CTL Coil

Indications for Use:

The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used for MRI imaging of the human cervical spine, and thoracic spine.

Prescription Use × 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)

Tonui Thihhang

(Division Sign-Off) 0 Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

{7}------------------------------------------------

510(k) Number (if known):	K073310
Device Name:	OASIS QD Flexible Body Coil (L)

Indications for Use:

The MR-QFC-120, OASIS QD Flexible Body Coil (L.) is a recieve-only multiple array device used for MRI imaging of the abdomen.

Prescription Use Х 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)

Tomi M. Why
(Division Sign-Off)

h Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

{8}------------------------------------------------

510(k) Number (if known): Device Name: OASIS QD Flexible Body Coil (XL)

Indications for Use:

The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple array device used for MRI imaging of the abdomen.

Prescription Use × 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)

Tony K. Whang

on Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

{9}------------------------------------------------

510(k) Number (if known):	K073310
Device Name:	OASIS Rapid Foot Coil

Indications for Use:

The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array device used for MRI imaging of the foot.

Prescription Use × 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)

Louie M. White
(Division Sign Off)

(Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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.