INFANT ARRAY

K113365 · Advanced Imaging Research Dba Sree Medical Systems · MOS · Mar 29, 2012 · Radiology

Device Facts

• Record ID: K113365
• Device Name: INFANT ARRAY
• Applicant: Advanced Imaging Research Dba Sree Medical Systems
• Product Code: MOS · Radiology
• Decision Date: Mar 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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.

Device Story

Infant Array is a 20-element receive-only RF coil array for infant MRI. Comprises an Infant Head Spine Array (IHSA) and an anterior Cardiac section (CAR). IHSA functions independently for brain/spine exams; CAR attaches via sliding adjustable height gantry for cardiac/torso exams. Enclosed in rigid, fire-rated, high-impact plastic housing to prevent patient exposure. Operates in clinical MRI environments; used by radiologists/technicians. Receives RF signals from infant anatomy; transforms signals into high-resolution images/spectra for GE, Siemens, and Philips 1.5T/3T systems. Facilitates scanning of low birth weight pre-term babies and newborns. Enhances diagnostic capability by providing high-resolution imaging of infant anatomy.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was validated against predetermined acceptance criteria for imaging performance and safety, demonstrating substantial equivalence to predicate adult-sized arrays.

Technological Characteristics

20-element receive-only RF coil array. Materials: Polycarbonate and polyurethane plastic (fire-rated, high impact/tensile strength). Decoupling: RF chokes and fast-acting PIN-diode switching. Safety: Non-conductive housing, RF fuses to isolate elements from transmit fields. Form factor: Rigid former with sliding adjustable height gantry for cardiac section. Connectivity: Compatible with GE, Siemens, and Philips 1.5T/3T MRI systems.

Indications for Use

Indicated for imaging of the brain, spine, heart, torso, and extremities in pre-term and term newborn infants. Used in conjunction with GE, Siemens, and Philips 1.5T and 3T MRI systems, including use with MRI-compatible incubators. Images are interpreted by a trained physician for diagnostic purposes.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• 1.5T 16 Channel GE Brain Spine Array (K052621)
• 3.0T 16 Channel GE Head Neck Spine Array (K093348)

Reference Devices

• Advanced Imaging Research's Neonate Coils (K023929)
• Advanced Imaging Research's Neonate Coils (K083541)
• Advanced Imaging Research's infant cardiac array (K083539)

Submission Summary (Full Text)

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# K113365

MAR 2 9 2012

# Attachment B

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# 510(k) Summary

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| 1. | Manufacturer: | Advanced Imaging Research, Inc.<br>4700 Lakeside Avenue, Suite 400<br>Cleveland, OHIO 44114 | (Physical Location) |
|-----|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| | | PO Box 603220<br>Cleveland, OHIO 44103 | (Use for Correspondence) |
| | | 1262 E 49th Street, Suite 400<br>Cleveland, OHIO 44114 | (Courier Address) |
| | | Phone: [phone] | |
| | | Fax: [phone] | |
| 2. | Registration Number: | 3004036149 | |
| 3. | Contact: | Ravi Srinivasan, President | |
| | | Phone: [phone]<br>email: [e-mail] | Fax: [phone] |
| 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 for<br>obtaining high resolution images and spectra of the infant<br>brain, spine, heart, torso and extremity in GE, Siemens and<br>Philips 1.5T and 3.0T magnetic resonance imaging systems<br>and magnetic resonance compatible incubators. Indications<br>for use are same as that for standard MR imaging and<br>spectroscopy. | |
| 8. | Device Description: | The Infant Array is a 20-element receive-only<br>radio-frequency (RF) coil array well suited for routine and<br>parallel imaging. The Infant Array (IA) consists of an<br>Infant Head Spine Array (IHSA) and an anterior Cardiac<br>section (CAR). The IHSA can be used alone for spine and | |
| | | brain examinations or in conjunction with the anterior<br>cardiac section necessary for cardiac and torso MRI exams.<br>The anterior cardiac section cannot be used alone. This<br>anterior cardiac section is supported on a sliding adjustable<br>height gantry. Coil elements and associated circuitry are<br>enclosed in a rigid former to prevent any exposure to<br>patient or environment. The plastic materials used are fire<br>rated and have a high impact and tensile strength. The coil<br>design facilitates scanning of low birth weight pre-term<br>babies, term newborns and small infants with different<br>body sizes and maximizes comfort and ease of use. | |
| 9. | Marketed Device: | Infant Head Spine Array, Infant Array for GE, Siemens,<br>Philips 1.5T and 3.0T MRI Scanners | |
| 10. | Comparison to Predicate: | 1.5T 16 Channel GE Brain Spine Array (K052621)<br>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,<br>chemical shift, diffusion weighted imaging, angiography,<br>functional MRI, chemical shift imaging, spectroscopy |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Infant Array when used in conjunction with GE,<br>Siemens and Philips 1.5T and 3T MRI systems or Infant<br>Array when used with the MRI compatible incubator and in<br>conjunction with the abovementioned MRI systems provide<br>imaging of the infant's brain, spine, heart, torso and<br>extremities. When interpreted by a trained physician, these<br>images provide information that can be useful in the<br>determination of the diagnosis. |
| Coil Enclosure Material | Polycarbonate, polyurethane plastic. The plastic materials<br>used are fire rated and have a high impact and tensile<br>strength similar to Advanced Imaging Research's Neonate<br>Coils (K023929, K083541) and infant cardiac array<br>(K083539) |
| Coil Design | 20 element, receive-only RF coil array. The Infant Array<br>consists of two sections: infant head spine array (IHSA)<br>and anterior cardiac section (CAR), which is positioned<br>above the IHSA and supported on a sliding adjustable<br>height 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).

- 11. 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
- 2. Statement of Indications
- Device Characteristics: Drawings/Illustrations 3.
- 4. Device Characteristics: Imaging Performance
- న. Safety
- 6. Labeling - Product Brochures, Operator's Manuals
- 7. Comparison to Predicate Device
- 8. Images
- 9. Publications
- 10. 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: [phone] Fax: [phone] email: [e-mail]

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 [phone]. 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 [phone] or [phone] 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)