1.5T 16CH FLEX SPEEDER LARGE

K121362 · Neocoil, LLC · MOS · Jun 15, 2012 · Radiology

Device Facts

• Record ID: K121362
• Device Name: 1.5T 16CH FLEX SPEEDER LARGE
• Applicant: Neocoil, LLC
• Product Code: MOS · Radiology
• Decision Date: Jun 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

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.

Device Story

The 1.5T 16ch Flex SPEEDER is a receive-only phased array MRI coil system. It consists of two formable, flexible, detachable antennae of varying sizes that wrap around or lie flat against the patient to accommodate different anatomical shapes. The device receives RF signals corresponding to proton precession in a 1.5T magnetic field. It is used in clinical settings with Toshiba MRI scanners (DL96 connectors) to acquire 2D, 3D, parallel, and isotropic images. The system includes optional accessories for patient comfort and motion artifact reduction. Output images are viewed by physicians to support diagnostic decision-making. The device benefits patients by providing high-resolution diagnostic imaging across multiple body regions, including extremities, chest, abdomen, pelvis, head, neck, and spine.

Clinical Evidence

Clinical performance testing was conducted using a mix of scanner configurations, pulse sequences, imaging options, and anatomies (axial, sagittal, coronal planes). No adverse events were reported. Performance was deemed adequate to support the indications for use. Bench testing included RF heating (max 39°C), B1 field safety, and NEMA MS 6-2008 standards for SNR and uniformity.

Technological Characteristics

Receive-only phased array MRI coil. Materials comply with ISO 10993-1 biocompatibility. Sensing principle: RF signal reception tuned to proton precession in 1.5T field. Form factor: flexible, formable antennae. Connectivity: hardwired via DL96 connector to Toshiba MRI scanners. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33.

Indications for Use

Indicated for use 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 for interpretation by a trained physician.

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 GEM Flex Coil (K113474)

Submission Summary (Full Text)

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JUN 1 5 2012

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

## 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) [e-mail]

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

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.

## 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.

© 2012 NeoCoil, LLC

NeoCoil, LLC

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

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.

#### 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:

© 2012 NeoCoil, LLC

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

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 [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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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