1.5T GEM FLEX COIL

K113474 · Neocoil, LLC · MOS · Mar 16, 2012 · Radiology

Device Facts

• Record ID: K113474
• Device Name: 1.5T GEM FLEX COIL
• Applicant: Neocoil, LLC
• Product Code: MOS · Radiology
• Decision Date: Mar 16, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Pediatric

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 extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations.

Device Story

The 1.5T GEM Flex Coil is a receive-only phased array MRI coil system. It consists of three flexible, detachable antennae of varying sizes that can be wrapped or laid flat to accommodate diverse anatomical shapes, plus a multichannel low-noise interface matched to 8 or 16-channel GE 1.5T MRI scanners. Accessory immobilization devices are included to improve patient comfort and reduce motion artifacts. The system receives RF signals corresponding to proton precession in a 1.5T magnetic field. Operated by MRI technicians or clinicians in a clinical imaging environment, the coil facilitates high-quality diagnostic imaging. The output is raw RF data processed by the host MRI scanner into diagnostic images for physician interpretation. By providing flexible, form-fitting signal reception, the device enables imaging of complex anatomies across pediatric and adult populations, aiding in clinical diagnosis and treatment planning.

Clinical Evidence

Clinical performance testing included imaging across various scanner configurations, pulse sequences, and anatomies, including pediatric subpopulations as per FDA guidance. No adverse events were reported. Bench testing confirmed SNR and uniformity met requirements for the expanded indications. Standards testing included IEC 60601-1, IEC 60601-2-33, ISO 10993-1, and 60601-1-2.

Technological Characteristics

Receive-only phased array coil system; 1.5T RF tuning; 8 or 16-channel interface; flexible/formable antennae; biocompatible materials (ISO 10993-1); electromechanical safety (IEC 60601-1, IEC 60601-2-33); ESD compliant (60601-1-2).

Indications for Use

Indicated for use with GE 1.5 HD or DV Series MRI scanners to produce diagnostic images of upper/lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. For interpretation by trained physicians.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• 1.5T MetaFlexCoil (K101632)

Submission Summary (Full Text)

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N27 W23910A Paul Rd Pewaukee. WI 53072 Direct: [phone] [phone] 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) [e-mail]

- 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

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.

## 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.

© 2012 NeoCoil, LLC

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N27 W23910A Paul Rd Pewaukee, WI 53072 Direct: [phone] [phone] 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

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.

### 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<br>conditions | pre-defined<br>performance standards | Pass: coil does not arc or show any signs of<br>voltage breakdown |
| Surface Temperature<br>in normal and first<br>fault conditions | pre-defined<br>performance standards | Pass: RF heating is not greater than 39° C in<br>normal or first fault conditions |
| NEMA MS 6-2008 | pre-defined<br>performance standards | Pass: Expanded indications do not change<br>acceptance criteria initially established for the<br>1.5T MetaFlexCoil (K101632); SNR and<br>Uniformity are consistent with the requirements<br>for indications for use. |

Performance testing - Bench:

© 2012 NeoCoil, LLC

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N27 W23910A Paul Rd Pewaukee, WI 53072 Direct: [phone] [phone] Fax:

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### 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.

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# 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

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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 [phone]. 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 [phone] or [phone] 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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# Indications for Use

510(k) Number (if known):

Device Name: 1.5T GEM Flex Coil

Indications for 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.

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