The Infant Array is a receive-only RF coil, used for obtaining high resolution images and spectra of the infant brain, spine, heart, torso and extremity in GE, Siemens and Philips 1.5T and 3.0T magnetic resonance imaging systems and magnetic resonance compatible incubators. Indications for use are same as that for standard MR imaging and spectroscopy.

The Infant Array when used in conjunction with GE, Siemens and Philips 1.5T and 3T MRI systems or Infant Array when used with the MRI compatible incubator and in conjunction with the abovementioned MRI systems provide imaging of the infant's brain, spine, heart, torso and extremities. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.

Device Description

The Infant Array is a 20-element receive-only radio-frequency (RF) coil array well suited for routine and parallel imaging. The Infant Array (IA) consists of an Infant Head Spine Array (IHSA) and an anterior Cardiac section (CAR). The IHSA can be used alone for spine and brain examinations or in conjunction with the anterior cardiac section necessary for cardiac and torso MRI exams. The anterior cardiac section cannot be used alone. This anterior cardiac section is supported on a sliding adjustable height gantry. Coil elements and associated circuitry are enclosed in a rigid former to prevent any exposure to patient or environment. The plastic materials used are fire rated and have a high impact and tensile strength. The coil design facilitates scanning of low birth weight pre-term babies, term newborns and small infants with different body sizes and maximizes comfort and ease of use.

20 element, receive-only RF coil array. The Infant Array consists of two sections: infant head spine array (IHSA) and anterior cardiac section (CAR), which is positioned above the IHSA and supported on a sliding adjustable height gantry. Coil elements and associated circuitry are enclosed in a rigid former to prevent any exposure to patient or environment.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Infant Array device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Testing was performed to demonstrate that the Infant Array meet the predetermined acceptance criteria." However, specific numerical acceptance criteria (e.g., signal-to-noise ratio requirements, specific image quality metrics) are not explicitly defined or reported within the provided text. The performance is primarily described through its intended use and similarity to predicate devices.

Acceptance Criteria (Not Explicitly Stated as Numerical)	Reported Device Performance (Implied by equivalence and intended use)
Ability to obtain high-resolution images and spectra.	Capable of obtaining high resolution images and spectra of the infant brain, spine, heart, torso and extremity.
Compatibility with specified MRI systems.	Compatible with GE, Siemens, and Philips 1.5T and 3.0T MRI systems and MRI compatible incubators.
Safety with regard to RF decoupling, prevention of RF burns, RF absorption.	Decoupling with RF chokes and fast-acting pin-diode switching diodes (similar to predicate). Does not transmit RF power. Coil elements and associated circuitry enclosed in non-conductive plastic housing. Active diodes and RF fuses isolate coil elements; length and routing of output cable does not permit looping (similar to predicate).
Ability to provide information useful for diagnosis when interpreted by a trained physician.	Images provide information that can be useful in the determination of the diagnosis (when interpreted by a trained physician).

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally mentions "testing" and "usage," but no details on the patients or data used, or how they were collected.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not provide any information on the number of experts used to establish ground truth or their qualifications. It only states that images should be "interpreted by a trained physician."

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The focus is on demonstrating substantial equivalence to predicate devices, not on comparing reader performance with and without AI assistance.

6. Standalone Performance Study:

The document does not explicitly state that a standalone (algorithm only without human-in-the-loop performance) study was performed. The device is a hardware component (RF coil), not an algorithm. The testing would have focused on the physical and functional performance of the coil itself.

7. Type of Ground Truth Used:

The document does not specify the type of ground truth used, as it doesn't detail specific performance metrics beyond the general ability to obtain images useful for diagnosis. Given that the device is an RF coil, the "ground truth" would likely relate to objective image quality metrics (e.g., SNR, image uniformity, spatial resolution) rather than disease detection or classification which would involve a separate diagnostic algorithm or human interpretation.

8. Sample Size for the Training Set:

The document does not mention a training set sample size. As the Infant Array is a hardware device (RF coil) and not a machine learning algorithm, the concept of a "training set" in the context of AI/ML models is not directly applicable.

9. How the Ground Truth for the Training Set Was Established:

The concept of "ground truth for the training set" is not applicable to this device, as it is a hardware component rather than an AI/ML diagnostic tool.

Summary

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K113365

MAR 2 9 2012

Attachment B

510(k) Summary

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1.	Manufacturer:	Advanced Imaging Research, Inc.4700 Lakeside Avenue, Suite 400Cleveland, OHIO 44114	(Physical Location)
		PO Box 603220Cleveland, OHIO 44103	(Use for Correspondence)
		1262 E 49th Street, Suite 400Cleveland, OHIO 44114	(Courier Address)
		Phone: 216-426-1461
		Fax: 216-426-1180
2.	Registration Number:	3004036149
3.	Contact:	Ravi Srinivasan, President
		Phone: 216-426-1461email: ravi@sreemedical.com	Fax: 216-426-1180
4.	Device Name:	Magnetic Resonance Diagnostic Device
	Proprietary Name:	Infant Array
5.	Type of Submission:	Traditional
6.	Classification of Device:	21CFR 892.1000
	Class of Device:	Class II
	Product Code:	90 MOS (Magnetic Resonance Specialty Coil)
7.	Intended Use:	The Infant Array is a receive-only RF coil, used forobtaining high resolution images and spectra of the infantbrain, spine, heart, torso and extremity in GE, Siemens andPhilips 1.5T and 3.0T magnetic resonance imaging systemsand magnetic resonance compatible incubators. Indicationsfor use are same as that for standard MR imaging andspectroscopy.
8.	Device Description:	The Infant Array is a 20-element receive-onlyradio-frequency (RF) coil array well suited for routine andparallel imaging. The Infant Array (IA) consists of anInfant Head Spine Array (IHSA) and an anterior Cardiacsection (CAR). The IHSA can be used alone for spine and
		brain examinations or in conjunction with the anteriorcardiac section necessary for cardiac and torso MRI exams.The anterior cardiac section cannot be used alone. Thisanterior cardiac section is supported on a sliding adjustableheight gantry. Coil elements and associated circuitry areenclosed in a rigid former to prevent any exposure topatient or environment. The plastic materials used are firerated and have a high impact and tensile strength. The coildesign facilitates scanning of low birth weight pre-termbabies, term newborns and small infants with differentbody sizes and maximizes comfort and ease of use.
9.	Marketed Device:	Infant Head Spine Array, Infant Array for GE, Siemens,Philips 1.5T and 3.0T MRI Scanners
10.	Comparison to Predicate:	1.5T 16 Channel GE Brain Spine Array (K052621)3.0T 16 Channel GE Head Neck Spine Array (K093348)

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In general, the Infant Array is similar in use to the above-mentioned adult sized head neck spine arrays and is considered a scaled-down version that is receive-only and well suited for parallel imaging as follows:

Intended use	Proton 1H 1D, 2D, 3D T1, T2 weighting, proton density,chemical shift, diffusion weighted imaging, angiography,functional MRI, chemical shift imaging, spectroscopy
Indications for Use	The Infant Array when used in conjunction with GE,Siemens and Philips 1.5T and 3T MRI systems or InfantArray when used with the MRI compatible incubator and inconjunction with the abovementioned MRI systems provideimaging of the infant's brain, spine, heart, torso andextremities. When interpreted by a trained physician, theseimages provide information that can be useful in thedetermination of the diagnosis.
Coil Enclosure Material	Polycarbonate, polyurethane plastic. The plastic materialsused are fire rated and have a high impact and tensilestrength similar to Advanced Imaging Research's NeonateCoils (K023929, K083541) and infant cardiac array(K083539)
Coil Design	20 element, receive-only RF coil array. The Infant Arrayconsists of two sections: infant head spine array (IHSA)and anterior cardiac section (CAR), which is positionedabove the IHSA and supported on a sliding adjustableheight gantry. Coil elements and associated circuitry are

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enclosed in a rigid former to prevent any exposure to patient or environment.

Decoupling With RF chokes and fast acting pin-diode switching diodes similar to GE's 1.5T and 3.0T 16 channel head neck spine arrays (K052621, K093348).
Does not transmit RF power, decoupling isolates the coil Prevention of RF Burns elements from RF fields during RF transmission similar to GE's 1.5T and 3.0T 16 channel head neck spine arrays (K052621, K093348). Coil elements and associated circuitry are enclosed in a non-conductive plastic housing.
Radio-Frequency Absorption Coil is receive-only and does not transmit RF power, similar to GE's 1.5T and 3.0T 16 channel head neck spine arrays (K052621, K093348).
Formation of Resonance Loops Active diodes and RF fuses isolate the coil elements from whole body RF coil transmit; length and routing of output cable does not permit looping similar to similar to GE's 1.5T and 3.0T 16 channel head neck spine arrays (K052621, K093348).
1. Testing was performed to demonstrate that the Infant Summary of Studies: Array meet the predetermined acceptance criteria
  Conclusion:

It is the opinion of Advanced Imaging Research that the Infant Array herein is substantially equivalent to GE's adult head and neck spine arrays. Testing and usage of the Infant Array does not result in any new potential hazards.

l 2. List of Attachments

1. 510(k) Summary
1. Statement of Indications
Device Characteristics: Drawings/Illustrations 3.
1. Device Characteristics: Imaging Performance
న. Safety
1. Labeling - Product Brochures, Operator's Manuals
1. Comparison to Predicate Device
1. Images
1. Publications
1. Form 3654, Form 3674

We believe this narrative, the foregoing information, and the referenced attachments demonstrate the substantial equivalence of the Infant Array to the predicate devices, and will be sufficient for the Food and Drug Administration to reach a favorable decision on this submission.

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I certify that, in my capacity as the Official Correspondent for Advanced Imaging Research Inc., I believe that, to the best of my knowledge, all data and information submitted in this pre-market notification are truthful and accurate and that no material fact has been omitted. I can be reached at the following, if necessary. Thank you for your consideration of this submission.

Contact Information: Phone: 216-426-1461 Fax: 216-426-1180 email: ravi@sreemedical.com

Respectfully Submitted,

Ravi Srinivasan, President

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles facing to the right, with flowing lines beneath them.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

MAR 2 9 2012

Mr. Ravi Srinivasan President Advanced Imaging Research, Inc. P.O. Box 603220 CLEVELAND OH 44103

Re: K113365

Trade/Device Name: Infant Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: February 22, 2012 Received: February 28, 2012 ·

Dear Mr. Srinivasan:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); medical device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if Known):

K113365

Device Name:

Infant Array

Indications for Use:

The Infant Array when used in conjunction with GE, Siemens and Philips 1.5T and 3T MRU systems or Infant Array when used with the MRI compatible incubator and in conjunction with the abovementioned MRI systems provide imaging of the infant's brain, spine, heart, torso and extremities. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.

. Anatomical Region:

. Nucleus Excited:

. Diagnostic Uses:

Pre-, term newborn infant heart and torso Proton 1H 1D, 2D, 3D T1, T2 Weighting Proton Density Chemical Shift Diffusion Weighted Imaging Functional MRI MR Blood Flow (angiography) MR Spectroscopy

(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (Per 21 CFR 801-109 810k

Over-the-Counter Use_

(Optional Format 1-2-96)

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.