To be used in conjunction with Toshiba Magnetic Resonance Scanners with DL96 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 1.5T 16ch Flex SPEEDER is 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 1.5T 16ch Flex SPEEDER coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the NeoCoil 1.5T 16ch Flex SPEEDER Coil:

Acceptance Criteria and Device Performance Study

The NeoCoil 1.5T 16ch Flex SPEEDER Coil is a receive-only phased array coil system designed for high resolution imaging. The submission focuses on demonstrating its substantial equivalence to a predicate device (1.5T GEM Flex Coil, K113474) and its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance/Result
Max B1 in first fault conditions	Pre-defined performance standards	Pass: Coil does not arc or show any signs of voltage breakdown.
Surface Temperature in normal and first fault conditions	Pre-defined performance standards	Pass: RF heating is not greater than 39° C in normal or first fault conditions.
NEMA MS 6-2008	Pre-defined performance standards	Pass: SNR (Signal-to-Noise Ratio) and Uniformity are consistent with the requirements for indications for use.
Unplugged Surface Temperature	Acceptable level of risk	Pass: Surface temperature rise results in acceptable residual risk after mitigation.

Note: The document explicitly states, "The device's performance meets the requirements of pre-defined acceptance criteria and intended uses."

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

The document does not explicitly state a specific numerical sample size for the "clinical performance testing" or the test set used for evaluating the acceptance criteria. It mentions:

"Clinical data submitted exhibits a mix of scanner configurations, pulse sequences, imaging options, field of view 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."
This suggests retrospective data across various clinical scenarios, but the specific origins (e.g., country) are not detailed. It implies a diverse set of imaging scenarios rather than a single, controlled prospective study with a defined sample size.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for any test set. The "Indications for Use" state that images "can be interpreted by a trained physician," implying clinical interpretation, but no details on expert review for the study itself are provided. The study primarily focuses on demonstrating technical performance and equivalence, rather than diagnostic accuracy that would typically require expert ground truth.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the nature of the tests (bench testing for electrical, thermal, and imaging parameters), expert adjudication of images for diagnostic purposes (which would require a ground truth panel) was likely not the primary method for evaluating these specific acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported in these documents. This device is an MRI coil, not an AI-powered diagnostic algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device itself is a standalone hardware component that produces images, there is no mention of an "algorithm only" performance study in the context of an AI device. The coil's performance was assessed as a standalone component of the MRI system.

7. The Type of Ground Truth Used

For the bench tests evaluating electrical, thermal, and NEMA MS 6-2008 standards:

The ground truth was based on pre-defined performance standards and objective measurements (e.g., temperature readings, arc detection, SNR and uniformity metrics).
For the "Unplugged Surface Temperature" test, the ground truth was defined by an "acceptable level of risk."

For the "clinical performance testing":

The ground truth appears to be a qualitative assessment that the coils "demonstrated performance adequate to support the Indications for Use," implying that the images produced were clinically usable and comparable to what would be expected for diagnostic imaging. There is no mention of a reference standard like pathology, biopsy, or long-term outcomes.

8. The Sample Size for the Training Set

The document does not mention a "training set" as this device is a hardware component and not a machine learning algorithm requiring a separate training phase.

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

Not applicable, as there is no training set for this device.

Summary

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JUN 1 5 2012

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

5. Abbreviated 510(k) Summary

5.1. Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072

5.2. Contact Steven Nichols Chief Operating Officer 262-347-1250 (office) 261-347-1251 (fax) steve.nichols@neocoil.com

5.3. Preparation Date 04/13/2012

5.4. Name of Device

Proprietary Name: .
Common Name:
Classification:

5.5. Model Numbers

NeoCoil Model Number	NeoCoil Model Name	Toshiba Model
NC043000	1.5T 16ch Flex SPEEDER Coil Large	MJAJ-227A/S1 (Japan)
		MJAJ-227A/J1 (USA)
		MJAJ-227A/E1 (Europe)
NC042000	1.5T 16ch Flex SPEEDER Coil Medium	MJAJ-217A/S1 (Japan)
		MJAJ-217A/J1 (USA)
		MJAJ-217A/E1 (Europe)

1.5T 16ch Flex SPEEDER Coil

Magnetic Resonance Specialty Coil

21 CFR 892.1000, Product Code MOS

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 1.5T 16ch Flex SPEEDER coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.

5.7. Predicate Device

1.5T GEM Flex Coil (K113474) .
5.8. Comparison to Predicate

The NeoCoil 1.5T 16ch Flex SPEEDER coils are identical in physical, performance, design and material characteristics to the legally marketed device, the 1.5T GEM Flex Coil, K113474, as cleared on 03/16/2012.

NeoCoil, LLC

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

The differences introduced in this submission include: '

. Electrical interface with the MRI scanner, in order to ensure compatibility.
. Coil cable, cable covering and connector, in order to satisfy Toshiba requirements and achieve MRI scanner compatibility.
Minor dimensional changes compared to the GEM Flex arrays, resulting from the . elimination of the GEM Flex interface module.

The Indications for Use are consistent with the capabilities of the 1.5T GEM Flex Coil.

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

5.10. Intended Use

Intended use of the 1.5T 16ch Flex SPEEDER Coil 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 1.5T 16ch Flex SPEEDER Coil is safe and effective. The device's performance meets the requirements of pre-defined acceptance criteria and intended uses.

Test	Pass/Fail Criteria	Result
Max B1 in first faultconditions	Pre-definedperformance standards	Pass: Coil does not arc or show any signs ofvoltage breakdown.
Surface Temperaturein normal and firstfault conditions	Pre-definedperformance standards	Pass: RF heating is not greater than 39° C innormal or first fault conditions.
NEMA MS 6-2008	Pre-definedperformance standards	Pass: SNR and Uniformity are consistent withthe requirements for indications for use.
Unplugged SurfaceTemperature	Acceptable level of risk	Pass: Surface temperature rise results inacceptable residual risk after mitigation.

Performance testing - Bench:

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

Image /page/2/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a circular graphic with an arrow pointing to the right, followed by the text "NeoCoil" in a bold, sans-serif font. Above the logo, the text "p. 3 of 3" is written in handwriting.

1121362

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

Performance testing - Clinical:

Clinical data submitted exhibits a mix of scanner configurations, pulse sequences, imaging options, field of view 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.

No adverse events were reported during clinical performance testing; the 1.5T 16ch Flex SPEEDER Large and 1.5T 16ch Flex SPEEDER Medium coils 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, 1.5T 16ch Flex SPEEDER coils are equivalent to their predicate, 1.5T GEM Flex Coil, K113474.

© 2012 NeoCoil, LLC
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Mr. Steven Nichols Chief Operating Officer NeoCoil, LLC N27 W23910A Paul Road PEWAUKEE WI 53072

JUN 1 5 2012

Re: K121362

Trade/Device Name: 1.5T 16ch Flex SPEEDER Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: April 13, 2012 Received: May 7. 2012

Dear Mr. Nichols:

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 Mav 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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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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K12136.2

Indications for Use

510(k) Number (if known):

Device Name: 1.5T 16ch Flex SPEEDER

Indications for Use:

To be used in conjunction with Toshiba Magnetic Resonance Scanners with DL96 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.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)K121362

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.