1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM

K123272 · Neocoil, LLC · MOS · Mar 28, 2013 · Radiology

Device Facts

• Record ID: K123272
• Device Name: 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM
• Applicant: Neocoil, LLC
• Product Code: MOS · Radiology
• Decision Date: Mar 28, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

To be used in conjunction with Toshiba 1.5T Magnetic Resonance Scanners with DL96 connectors 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 Story

Receive-only phased array MRI coil system; consists of two flexible, detachable antennae of varying sizes; wraps or lays flat to accommodate diverse anatomical shapes. Used with Toshiba 1.5T MRI scanners (DL96 connectors) to receive RF signals corresponding to proton precession. Includes optional accessories for patient comfort and motion artifact reduction. Operated by trained clinicians in clinical settings. Produces high-resolution diagnostic images for physician interpretation; supports 2D, 3D, parallel, and isotropic imaging. Benefits patients by enabling diagnostic imaging across a wide range of body parts and sizes, including pediatric populations.

Clinical Evidence

Clinical performance testing conducted using a mix of scanner configurations, pulse sequences, and anatomies across pediatric subpopulations per FDA guidance. No adverse events reported. Performance demonstrated to be adequate for intended use.

Technological Characteristics

Receive-only phased array coil; 1.5T RF tuning; flexible/formable antennae; compatible with Toshiba 1.5T scanners (DL96 connectors). Biocompatible materials (ISO 10993-1). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, NEMA MS 6-2008.

Indications for Use

Indicated for pediatric and adult populations requiring diagnostic MRI imaging of upper/lower extremities, chest, abdomen, pelvis, head, neck, and spine using Toshiba 1.5T scanners.

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 16ch Flex SPEEDER Coil (K121362)

Submission Summary (Full Text)

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

AR 2 8 2013

# 5. Abbreviated 510(k) Summary

- 5.1. Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072
- 5.2. Contact Katie Gonzalez Engineering Services Specialist 262-347-1250 (office) 261-347-1251 (fax) [e-mail]

5.3. Preparation Date 9/17/2012

## 5.4. Name of Device

- Proprietary Name: .
- Common Name: .
- Classification: .

1.5T 16ch Flex SPEEDER Coil Magnetic Resonance Specialty Coil 21 CFR 892.1000, Product Code MOS

-
## 5.5. Model Numbers

| NeoCoil Model Number | NeoCoil Model Name | Toshiba Model |
|----------------------|------------------------------------|---------------|
| NC043000 | 1.5T 16ch Flex SPEEDER Coil Large | MJAJ-227A/S1 |
| NC042000 | 1.5T 16ch Flex SPEEDER Coil Medium | MJAJ-217A/S1 |

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 in pediatric and adult populations that can be interpreted by a trained physician. 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 16ch Flex SPEEDER Coil (K121362), cleared on 06/15/2012 ●
- 5.8. Comparison to Predicate

The NeoCoil 1.5T 16ch Flex SPEEDER coils are unchanged 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.

The differences introduced in this submission include:

- Expanded Indications for Use with specific claims relating to pediatric populations. .

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K123272 Page 2 of 3

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

Image /page/1/Picture/2 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 text "NeoCoil" in a bold, sans-serif font. The circular shape is made up of two concentric circles, with the arrow extending from the inner circle to the outer circle.

- . Updated labeling that includes coil setup and positioning that support the expanded Indications for Use.
Use of the device in conjunction with an MRI scanner is unchanged; the specific claims in the expanded Indications for Use relating to pediatric populations have been added and are consistent with the capabilities of the 1.5T 16ch Flex SPEEDER 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 1.5T Magnetic Resonance Scanners with DL96 connectors 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 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.

#### 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 fault<br>conditions | Pre-defined<br>performance standards | Pass: Coil does not arc or show any signs of<br>voltage breakdown.<br>*No change from the legally marketed device,<br>the 1.5T 16ch Flex SPEEDER, K121362, as<br>cleared on 06/15/2012. |
| 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: SNR and Uniformity are consistent with<br>the requirements for the expanded Indications<br>for Use.<br>*No change from the legally marketed device,<br>the 1.5T 16ch Flex SPEEDER, K121362, as<br>cleared on 06/15/2012. Additional SNR and<br>Uniformity measurements demonstrate<br>acceptable performance when used with the<br>Pediatric Stabilizer for head, neck and spine<br>imaging. |
| Unplugged Surface<br>Temperature | Acceptable level of risk | Pass: Surface temperature rise results in<br>acceptable residual risk after mitigation. |

### Performance testing - Bench:

© 2012 NeoCoil, LLC

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K123272 page 3 of 3

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

# Published Standards testing:

The expanded Indications for Use introduced for the 1.5T 16ch Flex SPEEDER Coil in this submission have no impact to the results of standards testing of the predicate device, 1.5T 16ch Flex SPEEDER Coil, K121362, as cleared on 06/15/2012.

Additional standards testing were performed incorporating the added accessory, Pediatric SPEEDER accessory. Standards Data Report Forms (FDA 3654) are included in this submission, as applicable.

NOTE: Where indicated in the table below, new Standards testing was performed, as necessary, to support the expanded Indications for Use for pediatric populations. Standards testing that was not impacted by the introduction of the Pediatric SPEEDER accessory is listed as 'No change'.

| Standard | Purpose | Comment |
|----------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1 | Electromechanical safety | No change since K121362 |
| IEC 60601-1-2 | ESD | No change since K121362 |
| IEC 60601-2-33 | Electromechanical safety for<br>magnetic resonance equipment | No change since K121362 |
| ISO 10993-1 | Biocompatibility | Additional risk assessment of Pediatric<br>SPEEDER accessory performed. |
| NEMA MS6 | Characterization of Special<br>Purpose Coils for Diagnostic<br>Magnetic Resonance Images | Characterization of 1.5T 16ch Flex<br>SPEEDER Large and 1.5T 16ch Flex<br>SPEEDER Medium in conjunction with the<br>Pediatric SPEEDER accessory performed. |

### 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, issued November 14, 1998.

Clinical performance testing includes imaging from the pediatric subpopulations specified in Table 1 of the FDA guidance, Premarket Assessment of Pediatric Medical Device issued May 14, 2004.

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 expanded Indications for Use associated with pediatric use are as safe and effective as the predicate device, 1.5T 16ch Flex SPEEDER coil, K121362, as cleared on 06/15/2012.

| | © 2012 NeoCoil, LLC | |
|--|---------------------|--|
| | | |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and tail feathers. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 28. 2013

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

Re: K123272

Trade/Device Name: 1.5T 16ch Flex SPEEDER Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 8, 2013 Received: March 13, 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. Ilisting 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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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/ReportalProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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# Indications for Use

510(k) Number (if known): K123272

Device Name: 1.5T 16ch Flex SPEEDER

Indications for Use:

To be used in conjunction with Toshiba 1.5T Magnetic Resonance Scanners with DL96 connectors 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 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)

Michael D. O'Hara

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

510(k) K123272

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