To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.

Device Description

The NeoCoil 3T 16ch Flex SPEEDER Coils are a receive-only phased array coil system designed to provide high resolution imaging for the upper and lower extremities, chest. abdomen, pelvis, head, neck, and spine. The system is compatible with 2D, 3D, parallel and isotropic imaging, as well as, coil signal intensity correction. The system consists of:

Two formable, flexible and detachable antennae of different size that can be . wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
. Optional accessories designed for patient comfort and reduced motion artifacts.
The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NeoCoil 3T 16ch Flex SPEEDER Coils, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Unplugged Surface Temperature	Acceptable level of risk (not greater than 41°C)	Pass: Surface temperature is not greater than 41°C when the coil is left unplugged in the MRI scanner.
Surface Temperature	Pre-defined performance standards (RF and Eddy current heating not greater than 41°C)	Pass: RF and Eddy current heating is not greater than 41°C.
Blocking Network Analysis	Adequate transmit decoupling	Pass: Blocking network demonstrates adequate active and passive transmit decoupling.
B1 Field Distortion	Pre-defined performance standards (meets Toshiba performance requirements and demonstrates adequate active and passive transmit decoupling)	Pass: B1 field inhomogeneity meets Toshiba performance requirements and demonstrates adequate active and passive transmit decoupling.
NEMA MS 6-2008 (SNR and Image Uniformity)	Pre-defined performance standards (consistent with requirements for indications for use)	Pass: SNR and Image Uniformity are consistent with the requirements for indications for use.
Clinical Performance Testing	Adequate performance to support the Indications for Use, with no adverse events.	Pass: The clinical data demonstrated performance adequate to support the Indications for Use. No adverse events were reported during clinical performance testing.

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

The document does not explicitly state the numerical sample size for the "test set" in terms of number of patients or images. It mentions "Clinical data in this section exhibits a mix of technical factors and anatomy in the axial, sagittal and coronal planes." This suggests a varied, but unspecified, sample for clinical testing.

The data provenance is not explicitly stated as 'country of origin' or 'retrospective/prospective'. However, given that it's a 510(k) submission for a device to be marketed in the USA, and the testing involves compliance with standards like NEMA MS 6-2008, it's highly likely that the testing was conducted prospectively to demonstrate performance for regulatory clearance, primarily in a research or clinical setting relevant to MRI device evaluation.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical performance testing. It simply states that the images "can be interpreted by a trained physician," which is a general statement about the intended use of the diagnostic images rather than the ground truth establishment process for the study itself.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical performance test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement:

An MRMC comparative effectiveness study was not done. This device is an MRI coil, not an AI-powered diagnostic algorithm. The testing focuses on the physical performance and imaging capabilities of the hardware. Therefore, there is no mention of AI assistance or its effect size on human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable. The device is an MRI coil, which is hardware, not a software algorithm. Therefore, "standalone (algorithm only)" performance is not relevant.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

For the clinical performance testing, the "ground truth" implicitly relies on the ability of the images generated by the coil to be "interpreted by a trained physician" for diagnostic purposes. This suggests that the ground truth would be based on clinical interpretation by physicians, likely in comparison to established diagnostic standards or findings from other imaging modalities if specific pathologies were being assessed. However, the document does not explicitly detail the method for establishing "ground truth" beyond meeting diagnostic quality for interpretation. The primary focus of the performance tests (SNR, image uniformity, B1 field distortion) is on the physical imaging capabilities of the coil.

8. The Sample Size for the Training Set:

This question is not applicable. The NeoCoil 3T 16ch Flex SPEEDER Coils are hardware (an MRI coil), not a machine learning or AI algorithm that requires a "training set."

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

This question is not applicable as there is no training set for an MRI coil.

Summary

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N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax:

Image /page/0/Picture/1 description: The image shows the logo for NeoCoil, which is a black circle with a white swirl inside and the word "NeoCoil" in bold black letters. Above the logo, there is handwritten text that reads "K141832 page 1 of 3". The text is written in black ink and appears to be a document identifier or page number.

JUL 3 1 2014

5. Traditional 510(k) Summary

5.1. Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA
5.2. Contact Michael Leigh Director, Regulatory/Quality 262-522-6127 (direct) 261-347-1251 (fax) Mike.leigh@neocoil.com

5.3. Preparation Date 07/03/2014

5.4. Name of Device
- Proprietary Name: .
- Common Name: .
- . Classification:

3T 16ch Flex SPEEDER Coils Magnetic Resonance Specialty Coil

21 CFR 892.1000, Product Code MOS
5.5. Model Numbers

NeoCoil Model Number	NeoCoil Model Name	Toshiba Model Number
NC045000	3T 16ch Flex SPEEDER Coil, Medium	MJAJ-212A
NC046000	3T 16ch Flex SPEEDER Coil, Large	MJAJ-222A

5.6. Device Description

Two formable, flexible and detachable antennae of different size that can be . wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
. Optional accessories designed for patient comfort and reduced motion artifacts.

The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation.

5.7. Predicate Device

. 1.5T 16ch Flex SPEEDER Coil, K121362 as cleared on 06/15/2012.

			------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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NeoCoil, LLC

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N27 W23910A Paul Rd Pewaukee. WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax:

Image /page/1/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a circular graphic on the left and the word "NeoCoil" on the right. The graphic is a black circle with a white crescent shape inside and a small arrow pointing to the right. The word "NeoCoil" is written in a bold, sans-serif font.

5.8. Comparison to Predicate

The NeoCoil 3T 16ch Flex SPEEDER Coils are similar in physical, performance, design and material characteristics to the legally marketed device, the 1.5T 16ch Flex SPEEDER, K121362, as cleared on 06/15/2012.

The differences introduced in this submission include:

DC and RF chains have been modified to meet the Toshiba Vantage Titan 3T Coil . Interface Description.
Additional decoupling circuit in the 3T 16ch Flex SPEEDER Large compared to the . 1.5T 16ch Flex SPEEDER Large for the purpose of improved uniformity.
. Compared to the 1.5T 16ch Flex SPEEDER, the preamplifier circuitry was moved from the antenna housing, to the cable, within a pre-amp cover located further away from the imaging volume to improve stability.

The Indications for Use are consistent with the capabilities of the predicate device, the NeoCoil 1.5T 16ch Flex SPEEDER Coil, K121362 as cleared on 06/15/2012.

Clinical testing demonstrates that the differences in the devices do not affect the safety and/or the effectiveness of the device when used as labeled.

5.9. Indications for Use
To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.

5.10. Intended Use

Intended use of the 3T 16ch Flex SPEEDER Coils is identical to that of routine MR imaging: specifically to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine.

Use of the device in conjunction with an MRI scanner is unchanged.

5.11. Testing
The following data has been submitted, referenced or relied on to demonstrate that the NeoCoil 3T 16ch Flex SPEEDER Coils are safe and effective. The devices' performance meets the requirements of pre-defined acceptance cnteria and intended uses.

Test	Pass/Fail Criteria	Result
Unplugged SurfaceTemperature	Acceptable level of risk	Pass: Surface temperature is not greater than41°C when the coil is left unplugged in the MRIscanner.
Surface Temperature	Pre-definedperformance standards	Pass: RF and Eddy current heating is notgreater than 41°C.
Blocking NetworkAnalysis	Adequate transmitdecoupling	Pass: Blocking network demonstratesadequate active and passive transmitdecoupling.

Performance testing - Bench:

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Page 3 of 3

N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax:

Image /page/2/Picture/2 description: The image shows the logo for NeoCoil. The logo consists of a stylized, circular graphic to the left of the word "NeoCoil". The graphic appears to be a coil shape with an arrow incorporated into the design. The text "NeoCoil" is in a bold, sans-serif font.

Test	Pass/Fail Criteria	Result
B1 Field Distortion	Pre-definedperformance standards	Pass: B1 field inhomogeneity meets Toshibaperformance requirements and demonstratesadequate active and passive transmitdecoupling.
NEMA MS 6-2008	Pre-definedperformance standards	Pass: SNR and Image Uniformity areconsistent with the requirements for indicationsfor use.

Published Standards testing:

Standard	Purpose
IEC 60601-1	Electromechanical safety
IEC 60601-1-2	ESD
IEC 60601-2-33	Electromechanical safety
ISO 10993-1	Biocompatibility
NEMA MS-6	SNR and Image Uniformity

Performance testing - Clinical:

The clinical data in this section exhibits a mix of technical factors and anatomy in the axial, sagittal and coronal planes as recommended in the FDA guidance, Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 14, 1998.5

No adverse events were reported during clinical performance testing; the 3T 16ch Flex SPEEDER Coil, Large and 3T 16ch Flex SPEEDER Coil, Medium demonstrated performance adequate to support the Indications for Use.

5.12. Conclusion

This submission demonstrates that the Indications for Use are in line with the predicate device to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine and are as safe and effective as the predicate device. As such, the 3T 16ch Flex SPEEDER Coils are equivalent to their predicate, 1.5T 16ch Flex SPEEDER Coil, K121362 as cleared on 06/15/2012.

@ 2014 NeoCoil, LLC

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

July 31, 2014

NEOCOIL. LLC MICHAEL LEIGH N27 W23910A PAUL RD. PEWAUKEE WI 53072

Re: K141832

Trade/Device Name: 3t 16ch Flex Speeder, Medium , 3t 16ch Flex Speeder, Large Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 3, 2014 Received: July 7, 2014

Dear Mr. Leigh:

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.

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

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Page 2-Mr. Leigh

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

Janine 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.

510(k) Number (if known)	K141832
Device Name	3T 16ch Flex SPEEDER Coils
Indications for Use (Describe)	To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine 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)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

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information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)	Page 1 of 1
NeoColl, LLC	3T 16ch Flex SPEEDER Colls - 510k Submission	Page 37 of 1021

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.