To be used in conjunction with Siemens 1.5T MAGNETOM MRI scanners to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis and spine that can be interpreted by a trained physician.

Device Description

The NeoCoil 1.5T 16-Channel Flex Coils for Siemens is a system of phased array, receiveonly coils. 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 16-Channel Flex Coils for Siemens are tuned to receive RF frequency corresponding to the proton precession in a 1.5 testa magnetic field, which is governed by the Larmor equation.

AI/ML Overview

The provided text describes the 510(k) summary for the NeoCoil 1.5T 16-Channel Flex Coils. This device is a magnetic resonance specialty coil, not an AI/ML powered device, therefore the information requested for AI/ML powered devices, e.g. sample sizes for test and training sets, number of experts used for ground truth, adjudication method, MRMC studies, and standalone performance data, are not applicable or provided in the submission.

However, the document does detail the acceptance criteria and study results for this specific medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Pass/Fail Criteria	Reported Device Performance and Result
Unplugged Surface Temperature	Acceptable level of risk	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	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	Pass: B1 field inhomogeneity meets Siemens performance requirements and demonstrates adequate active and passive transmit decoupling.
NEMA MS 6-2008	Pre-defined performance standards	Pass: SNR (Signal-to-Noise Ratio) and Image Uniformity are consistent with the requirements for indications for use.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated with a specific number of cases or patients. The document 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."
Data Provenance: Not explicitly stated (e.g., country of origin). The testing included "clinical performance testing," which implies prospective data collection, but it does not specify whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as the device is an MRI coil, not an AI/ML algorithm. Ground truth, in the context of diagnostic image interpretation, is typically established by trained physicians interpreting the images produced by the device, as mentioned in the Indications for Use ("...images...that can be interpreted by a trained physician."). The document does not specify the number or qualifications of these physicians for the performance testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable and therefore not provided for this type of medical device (MRI coil). Adjudication methods are typically relevant for studies evaluating human interpretation or AI algorithm performance against a consensus ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done, as this device is an MRI coil, not an AI-assisted diagnostic tool. Therefore, the effect size of human readers improving with or without AI assistance is not applicable and not provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

A standalone performance assessment in the context of an AI algorithm is not applicable to this MRI coil. The performance assessment focused on the coil's physical, electrical, and imaging characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the bench performance tests, the "ground truth" was based on pre-defined performance standards (e.g., maximum temperature, adequate RF decoupling, meeting Siemens performance requirements for B1 field, and NEMA MS 6-2008 standards for SNR and Image Uniformity).
For the clinical performance testing, the "ground truth" was the ability of the coil to produce diagnostic images that could be interpreted by a trained physician, as per the stated Indications for Use. No specific "expert consensus," "pathology," or "outcomes data" are explicitly mentioned as ground truth for this device's performance evaluation beyond the general statement of "performance adequate to support the Indications for Use."

8. The sample size for the training set:

This information is not applicable and not provided as the device is an MRI coil, not an AI/ML powered device that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable and not provided as the device is an MRI coil, not an AI/ML powered device.

Summary

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DEC 2 6 2013

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

K133422

Image /page/0/Picture/3 description: The image shows the logo for NeoCoil. The logo consists of a stylized circular shape with an arrow pointing to the right, followed by the word "NeoCoil" in a bold, sans-serif font. The logo is black and appears to be on a white background.

5. Abbreviated 510(k) Summary

5.1. Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA
5.2. Contact Katie Gonzalez Engineering Services Specialist 262-522-6124 (direct) 261-347-1251 (fax) Katie. Gonzalez@NeoCoil.com

5.3. Preparation Date 11/07/2013

5.4. Name of Device

Proprietary Name: .
Common Name: .
Classification: .

1.5T 16-Channel Flex Coils Magnetic Resonance Specialty Coil 21 CFR 892.1000, Product Code MOS

5.5. Model Numbers

NeoCoil Model Number	NeoCoil Model Name
NC052000	1.5T 16-Channel Flex Coil, Small
NC053000	1.5T 16-Channel Flex Coil, Large

5.6. Device Description

The NeoCoil 1.5T 16-Channel Flex Coils for Siemens is a system of phased array, receiveonly coils. 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 16-Channel Flex Coils for Siemens are tuned to receive RF frequency corresponding to the proton precession in a 1.5 testa magnetic field, which is governed by the Larmor equation.

5.7. Predicate Device

1.5T 16ch Flex SPEEDER Coil (K121362), cleared on 06/15/2012 .
5.8. Comparison to Predicate

The NeoCoil 1.5T 16-Channel Flex Coils for Siemens 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.

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

Image /page/1/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a circular shape with an arrow pointing to the right, followed by the word "NeoCoil" in bold, sans-serif font. The logo is black and white.

The differences introduced in this submission include:

Electrical interface modifications to meet the Siemens MAGNETOM Coil Interface . Description.
Cable and connector material modifications to utilize Siemens specified materials. . All materials have been evaluated for biocompatibility.
Minor dimensional changes compared to the 1.5T 16ch Flex SPEEDER, resulting . from the plastic housing modifications to accommodate electrical interface changes.

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 Siemens 1.5T MAGNETOM MRI scanners to produce diacnostic images of the upper and lower extremities, chest, abdomen, pelvis and spine that can be interpreted by a trained physician.
Intended Use 5.10.
Intended use of the NeoCoil 1.5T 16-Channel Flex Coils for Siemens is identical to that of routine MR imaging; specifically to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis 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 1.5T 16-Channel Flex Coils for Siemens are safe and effective. The devices' performance meets the requirements of pre-defined acceptance criteria 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℃.
Blocking NetworkAnalysis	Adequate transmitdecoupling	Pass: Blocking network demonstratesadequate active and passive transmitdecoupling.
B1 Field Distortion	Pre-definedperformance standards	Pass: B1 field inhomogeneity meets Siemensperformance 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.

Performance testing - Bench:

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

Image /page/2/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a stylized coil symbol with an arrow on the right side, followed by the text "NeoCoil" in a bold, sans-serif font. The coil symbol is made up of three concentric arcs, with the arrow pointing to the right. The logo is black and white.

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:

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 16-Channel Flex Coil, Large and 1.5T 16-Channel Flex Coil, Small 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 and spine and are as safe and effective as the predicate device. As such, NeoCoil 1.5T 16-Channel Flex Coils for Siemens are equivalent to their predicate, 1.5T 16ch Flex SPEEDER Coil, K121362 as cleared on 06/15/2012.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three horizontal lines above it.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

December 26, 2013

NeoCoil, LLC % Ms. Katie Gonzalez Engineering Services Specialist N27 W23910A Paul Road PEWAUKEE WI 53072

Re: K133422

Trade/Device Name: 1.5T 16-Channel Flex Coil, (Small-NC052000 and Large-NC05300) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 7, 2013 Received: November 8, 2013

Dear Ms. Gonzalez:

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. Katie Gonzalez

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

FDA
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

نيوني ويوري وي

510(k) Number (if known): K133422

Device Name: 1.5T 16-Channel Flex Coils

Indications for Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michal FDA Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K133422

Page 1 of _ 1

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.