The Pediatric 16 is intended for use with the Siemens 1.5T/3T MRI systems to produce diagnostic images of the head and neck of neonates and infants that can be interpreted by a trained physician.

Device Description

This filing describes local RF coils intended to be used with the MAGNETOM Aera and Skyra MR systems. The Pediatric 16 is a sixteen-channel receive-only array coil designed for magnetic resonance imaging (MRI) using the Siemens MAGNETOM Aera (1,5T) and Skyra (3T) MR systems. The Pediatric 16 is intended to be used for imaging of the head and neck of neonates and infants.

AI/ML Overview

The provided document describes a medical device, the Pediatric 16, which is a magnetic resonance imaging (MRI) coil. It details the device's technical characteristics, its intended use, and non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Electrical Safety	AAMI/ANSI ES60601-1 conformance	Conforms to AAMI/ANSI ES60601-1
Medical Electrical Equipment	IEC 60601-2-33 conformance	Conforms to IEC 60601-2-33
Surface Heating	Maximum temperature ≤ 41°C (plugged and unplugged)	Never exceeded 41°C in either configuration
Image Quality (SNR & Uniformity)	NEMA MS 9-2008 conformance	Conforms to NEMA MS 9-2008

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

The provided document does not mention a "test set" in the context of patient data. The testing described is for the device's physical and electrical performance, not its diagnostic accuracy using a dataset of patient images. Therefore, information on sample size or data provenance for a test set of patient data is not applicable/available in this document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable/available as the testing described is not related to establishing diagnostic ground truth from patient images.

4. Adjudication Method for the Test Set

This information is not applicable/available as the testing described is not related to establishing diagnostic ground truth from patient images.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was NOT done based on the provided document. The submission focuses on non-clinical performance testing of the coil itself, not the diagnostic performance of human readers with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of an algorithm was NOT done. This device is an MRI coil, a hardware component, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance criteria in this document refers to:

Standard safety limits (e.g., maximum temperature).
Standard performance specifications (e.g., NEMA standards for SNR and uniformity).
Compliance with recognized industry standards (AAMI/ANSI ES60601-1, IEC 60601-2-33).

There is no mention of ground truth related to clinical diagnoses, pathology, or outcomes data in this document.

8. Sample Size for the Training Set

This information is not applicable/available. The device is an MRI coil, and its non-clinical performance testing does not involve a "training set" of data for an algorithm.

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

This information is not applicable/available as there is no training set for an algorithm.

Summary

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K140998
Page 1 of 3

JUL 1 1 2014

Section 5: 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

Applicant 1.
Quality Electrodynamics, LLC. (QED) 700 Beta Drive, Suite 100 Mayfield Village, OH 44143

2. Contact

Kathleen Aras Director, Regulatory and Quality Affairs (440) 484-2964 kathleen.aras@qualedyn.com

3. Date Prepared

16 April 2014

4. Tradenames

Pediatric 16

Pediatric 16, A 1.5T Tim Coil

Pediatric 16, A 3T Tim Coil

5. Common name

Coil, magnetic resonance, specialty

Classification 6.

21 CFR 892.1000

7. Equivalent Device

Infant Array, Advanced Imaging Research, Inc., K113365

8. Device Description

This filing describes local RF coils intended to be used with the MAGNETOM Aera and Skyra MR systems.

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The Pediatric 16 is a sixteen-channel receive-only array coil designed for magnetic resonance imaging (MRI) using the Siemens MAGNETOM Aera (1,5T) and Skyra (3T) MR systems. The Pediatric 16 is intended to be used for imaging of the head and neck of neonates and infants.

9. Indications for Use

The Pediatric 16 is intended for use with the Siemens 1.5T/3T MRI systems to produce diagnostic images of the head and neck of neonates and infants that can be interpreted by a trained physician.

Summary of Technological Characteristics Compared to the 10. Predicate Device

Quality Electrodynamics believes that the Pediatric 16 is substantially equivalent to the Infant Array manufactured by Advanced Imaging Research and cleared through 510(k) #K113365 on March 29 2012.

The Pediatric 16 and the Infant Array are both receive-only, array RF coils intended to provide images of the head and neck in neonates and infants. Both the Pediatric 16 and the Infant Array are intended to be used with the Siemens 1.5T and 3T MR systems. The intended uses of the devices are essentially identical.

Summary of Non-Clinical Performance Testing as Basis for 11. Substantial Equivalence

The Pediatric 16 was tested to and found to conform to AAMI/ANSI ES60601-1 and IEC 60601-2-33.

Surface heating was tested in both plugged in and unplugged configurations according to AAMI/ANSI ES60601-1. The measured temperature of the surface of the coil never exceeded the maximum limit of 41℃ in either configuration.

The SNR and uniformity of the Pediatric 16 was analyzed per and found to conform to NEMA MS 9-2008.

12. Conclusion

It is the opinion of Quality Electrodynamics that the Pediatric 16 is substantially equivalent to the above-listed, legally-marketed predicate device. Non-clinical performance testing verified that the use of the

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K140998
Page 3 of 3

Quality Electrodynamics coils does not result in any new potential hazards.

ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ

Quality Electrodynamics, LLC. Traditional 510(k) Pediatric 16

CONFIDENTIAL P a g e | 5-3

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Image /page/3/Picture/0 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird in flight or a series of flowing lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 11, 2014

Quality Electrodynamics, LLC % Ms. Kathleen Aras Director, Regulatory and Quality Affairs 700 Beta Drive, Suite 100 MAYFIELD VILLAGE OH 44143

Re: K140998

Trade/Device Name: Pediatric 16, A 1.5T Tim Coil/Pediatric 16, A 3T Tim Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: April 16, 2014 Received: April 18, 2014

Dear Ms. Aras:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Aras

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara
for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140998

Device Name Pediatric 16

Indications for Use (Describe) The Pediatric 16 is intended for use with the Siemens 1.57/3T MRI systems to produce diagnostic images of the head and neck of neonates and infants that can be interpreted by a trained physician

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Michael D. O'Hara

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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.