K Number

Device Name

1.5T GEM FLEX COIL

Manufacturer

NEOCOIL, LLC

Date Cleared

2012-03-16

(115 days)

Product Code

MOS

Regulation Number

892.1000

Intended Use

To be used in conjunction with a GE 1.5 HD or DV Series Magnetic Resonance Scanner to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations that can be interpreted by a trained physician.

Device Description

The NeoCoil 1.5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. This system consists of: - Three formable, flexible and detachable antennae of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes. - A multichannel low-noise coil interface matched to the MRI scanner for compatibility with 8 or 16 channel systems. - Multi-purpose accessory immobilization devices designed for patient comfort and reduced motion artifacts. The NeoCoil 1.5T GEM Flex 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K101632

Reference Devices

K101632

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical components and function of an MRI coil, with no mention of AI or ML for image processing or analysis.

Therapeutic

No
This device is described as a receive-only phased array coil system for producing diagnostic images, not for treating any condition or disease.

Diagnostic

The device is a receive-only phased array coil system used in conjunction with an MRI scanner to produce diagnostic images. It does not perform the diagnostic interpretation itself.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components such as "three formable, flexible and detachable antennae," a "multichannel low-noise coil interface," and "multi-purpose accessory immobilization devices." The performance studies also include tests related to hardware performance like "Max B1 in first fault conditions" and "Surface Temperature."

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to produce diagnostic images of various body parts using a Magnetic Resonance Scanner. This is a medical imaging device used in vivo (on a living patient), not in vitro (on samples outside the body).
Device Description: The description details a coil system that interacts with an MRI scanner to receive RF signals from the patient's body. This is consistent with an imaging device, not a device that analyzes biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.

Therefore, the NeoCoil 1.5T GEM Flex Coil is a medical imaging device, specifically an accessory for a Magnetic Resonance Scanner, and not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

MOS

Device Description

Three formable, flexible and detachable antennae of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
A multichannel low-noise coil interface matched to the MRI scanner for compatibility with 8 or 16 channel systems.
Multi-purpose accessory immobilization devices designed for patient comfort and reduced motion artifacts.
The NeoCoil 1.5T GEM Flex 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Magnetic Resonance

Anatomical Site

upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine

Indicated Patient Age Range

pediatric and adult populations

Intended User / Care Setting

trained physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing - Bench:
Max B1 in first fault conditions:
Pass/Fail Criteria: pre-defined performance standards
Result: Pass: coil does not arc or show any signs of voltage breakdown
Surface Temperature in normal and first fault conditions:
Pass/Fail Criteria: pre-defined performance standards
Result: Pass: RF heating is not greater than 39 degrees C in normal or first fault conditions
NEMA MS 6-2008:
Pass/Fail Criteria: pre-defined performance standards
Result: Pass: Expanded indications do not change acceptance criteria initially established for the 1.5T MetaFlexCoil (K101632); SNR and Uniformity are consistent with the requirements for indications for use.

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.
Clinical performance testing includes imaging from the pediatric subpopulations specified in Table 1 of the FDA guidance, Premarket Assessment of Pediatric Medical Devices.
No adverse events were reported during clinical performance testing; the 1.5T GEM Flex Coil system demonstrated performance adequate to support the expanded Indications for Use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K101632

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

K113474 PV3

5. Revised 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 11/11/2011
5.4. Name of Device
- . Proprietary Name:
- Common Name: .
- . Classification:
5.5. Model Numbers
- NC021000 .
- . NC030000
- NC023000 .
- NC024000 .
- . NC02200x
1.5T GEM Flex Coil Magnetic Resonance Specialty Coil
21 CFR 892.1000, Product Code MOS

GEM Flex Coil, 1.5T

GEM Flex Coil 16-L Array, 1.5T Receive Only

GEM Flex Coil 16-M Array, 1.5T Receive Only

GEM Flex Coil 16-S Array, 1.5T Receive Only

GEM Flex Interface 8ch Combined, 1.5T HD-Connector GEM Flex Interface 16ch Fixed, 1.5T P-Connector GEM Flex Interface 16ch Fixed, 1.5T HD-Connector

5.6. Device Description

Three formable, flexible and detachable antennae of different size that can be . wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
. A multichannel low-noise coil interface matched to the MRI scanner for compatibility with 8 or 16 channel systems.
. Multi-purpose accessory immobilization devices designed for patient comfort and reduced motion artifacts.

The NeoCoil 1.5T GEM Flex 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 MetaFlexCoil (K101632) ◆
5.8. Comparison to Predicate

The NeoCoil 1.5T GEM Flex Coil is identical in physical, performance, design and material characteristics to the legally marketed device, the 1.5T MetaFlexCoil, K101632, as cleared on 08/24/2010.

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

K113474

NeoCoil p²/3

The differences introduced in this submission include:

Updated Indications for Use that includes pediatric populations, as well as imaging applications in the chest, abdomen and pelvis.
Updated labeling that includes coil setup and positioning that support the . expanded Indications for Use.

The Indications for Use have been expanded to be consistent with the capabilities of the 1.5T MetaFlexCoil.

Clinical testing demonstrates that the differences in the expanded Indications for Use do not affect the safety and effectiveness of the device when used as labeled.

5.9. Indications for Use

5.10. Intended Use

Intended use of the 1.5T GEM Flex Coil is identical to that of routine MR imaging; specifically to produce diagnostic images of the upper and lower extrémities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations.

Use of the device in conjunction with a MRI scanner is unchanged; the anatomic applications have been expanded to be consistent with the capabilities of the 1.5T MetaFlexCoil.

5.11. Testing

The following data has been submitted, referenced or relied on to demonstrate that the 1.5T GEM Flex Coil is safe and effective given its expanded Indications for Use. The device's performance meets the requirements of pre-defined acceptance criteria and intended uses.

Test	Pass/Fail Criteria	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: Expanded indications do not change
acceptance criteria initially established for the
1.5T MetaFlexCoil (K101632); SNR and
Uniformity are consistent with the requirements
for indications for use.

Performance testing - Bench:

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

Image /page/2/Picture/1 description: The image contains the text "K113474" at the top, followed by "3/3" and the word "NeoCoil" in a larger, bold font. To the left of "NeoCoil" is a circular logo with an arrow pointing to the right. To the right of the text is a blurry image of what appears to be a car.

Published Standards testing:

Standard	Purpose
IEC 60601-1	Electromechanical safety
IEC 60601-2-33	Electromechanical safety
ISO 10993-1	Biocompatibility
60601-1-2	ESD

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.

Clinical performance testing includes imaging from the pediatric subpopulations specified in Table 1 of the FDA guidance, Premarket Assessment of Pediatric Medical Devices.

No adverse events were reported during clinical performance testing; the 1.5T GEM Flex Coil system demonstrated performance adequate to support the expanded Indications for Use.

5.12. Conclusion

This submission demonstrates that the expanded Indications for Use associated with pediatric, chest, abdominal and pelvic applications are as safe and effective as the predicate device.

| C 2012 N

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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 consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 W23910-A Paul Road PEWAUKEE WI 53072

Re: K113474

Trade/Device Name: 1.5T GEM Flex Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: February 28, 2012 Received: February 29, 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 101 to enaver 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 11 your device is that is is is is is not regulations affecting your device can be found in Title 21, additional controller Difficially (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 I lease of action and I Dr mination that your device complies with other requirements of the Act that I Dr Hab Intact a and regulations administered by other Federal agencies. You must or any I 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

MAR 1 6 2012

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 (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

Indications for Use

510(k) Number (if known):

Device Name: 1.5T GEM Flex Coil

Indications for Use:

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)

Samuel Morris

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113474