Atlas SPEEDER Head/Neck

K142802 · Quality Electrodynamics, LLC · MOS · Nov 24, 2014 · Radiology

Device Facts

• Record ID: K142802
• Device Name: Atlas SPEEDER Head/Neck
• Applicant: Quality Electrodynamics, LLC
• Product Code: MOS · Radiology
• Decision Date: Nov 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Atlas SPEEDER Head/Neck is intended for use with Toshiba 1.5T MR systems to produce diagnostic images of the head, neck, and feet that can be interpreted by a trained physician.

Device Story

The Atlas SPEEDER Head/Neck is a 16-channel, receive-only, phased array RF coil designed for use with Toshiba 1.5T MRI systems. It captures magnetic resonance signals from the head, neck, and feet. The device features a split-top mechanical design with a posterior section and three interchangeable anterior adaptors (neurovascular, cervical spine, and base) to accommodate different anatomical regions and patient comfort needs. It is a reusable, non-invasive device used in clinical imaging environments. The coil includes active and passive PIN diode switching circuitry for signal management. Output consists of raw MR signal data processed by the host MRI system into diagnostic images. Physicians interpret these images to support clinical decision-making. The device benefits patients by enabling high-quality diagnostic imaging of the specified regions.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including SNR and uniformity analysis per NEMA MS 6-2008, and electrical safety/EMC testing per AAMI/ANSI ES60601-1 and IEC 60601-2-33. Surface heating tests confirmed temperatures remained below 41°C. Biocompatibility was supported by the use of materials with a history of use in previously cleared MR devices.

Technological Characteristics

16-channel, receive-only, phased array RF coil. Materials: Lexan 940A polycarbonate housing, Polane S polyurethane enamel. Sensing: Active and passive PIN diode switching circuitry. Form factor: Split-top mechanical design with interchangeable anterior adaptors. Compatibility: Toshiba 1.5T MR systems. Standards: AAMI/ANSI ES60601-1, IEC 60601-2-33, NEMA MS 6-2008.

Indications for Use

Indicated for patients requiring diagnostic MRI of the head, neck, and feet using Toshiba 1.5T MR systems.

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 Atlas SPEEDER Head-Neck, Quality Electrodynamics, LLC. (K083160)

Submission Summary (Full Text)

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November 24, 2014

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

Quality Electrodynamics, LLC % Ms. Kathleen Aras Director, Regulatory and Quality Affairs 700 Beta Drive, Suite 100 MAYFIELD VILLAGE OH 44143

Re: K142802

Trade/Device Name: Atlas SPEEDER Head/Neck Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: September 26, 2014 Received: September 29, 2014

Dear Ms. Aras:

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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Robert A Ochs

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) K142802

Device Name Atlas SPEEDER Head/Neck

Indications for Use (Describe)

The Atlas SPEEDER Head/Neck is intended for use with Toshiba 1.5T MR systems to produce diagnostic images of the head, neck, and feet that can be interpreted by a trained physician.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

#### 1. Applicant

Quality Electrodynamics, LLC. (QED) 700 Beta Drive, Suite 100 Mayfield Village, OH 44143

#### 2. Contact

Kathleen Aras Director, Requlatory and Quality Affairs [phone] [e-mail]

#### Date Prepared 3.

26 September 2014

#### 4. Tradenames

Atlas SPEEDER Head/Neck

#### 5. Common name

Coil, magnetic resonance, specialty

#### 6. Model Numbers

QED Model Number: Q7000126

Toshiba Model Number: MJAH-177A

This device is manufactured and sold by QED to Toshiba. Toshiba sells the device to end users under their own model number.

#### 7. Classification

Magnetic resonance diagnostic device (21 CFR 892.1000, Product Code MOS. Class II)

#### 8. Predicate Device

1.5T Atlas SPEEDER Head-Neck, Quality Electrodynamics, LLC., K083160

No reference devices were used in this submission.

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#### 9. Device Description

The Atlas SPEEDER Head/Neck is a receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the Toshiba 1.5T MR systems. The Atlas SPEEDER Head/Neck is intended to be used for imaging the head, neck, and feet.

The Atlas SPEEDER Head/Neck is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and tensile strength, and is biocompatible.

The Atlas SPEEDER Head/Neck includes one posterior section and three anterior pieces, a neurovascular (NV) adaptor used for head, brain, and neurovascular imaging, a cervical spine (C-spine) adaptor used for neck and cervical spine imaging, and a base adaptor used when claustrophobia or space contraints are an imaging issue.

The Atlas SPEEDER Head/Neck also includes the accessories listed in Table 0-1. The accessories consist of pads, straps, a mirror and a phantom holder.

| QED Part Number | Description | Qty |
|-----------------|-----------------------|-----|
| 3003150 | SHOULDER PAD | 1 |
| 3003152 | NECK PAD | 1 |
| 3003153 | 10 DEGREE TILT PAD | 1 |
| 3003154 | 20 DEGREE TILT PAD | 1 |
| 3003486 | ACR PHANTOM HOLDER | 1 |
| 3003685 | HEAD PAD THICK | 1 |
| 3003686 | HEAD PAD THIN | 1 |
| 3003813 | 25MM TAPERED PAD | 2 |
| 3003814 | 40MM TAPERED PAD | 2 |
| 3003579 | COMBO PAD | 1 |
| 3003649 | COMBO PAD STRAP LEFT | 2 |
| 3003683 | COMBO PAD STRAP RIGHT | 2 |
| 2001171 | MIRROR ASSEMBLY | 1 |

Table 0-1: Atlas SPEEDER Head/Neck Accessories

#### 10. Indications for Use

The Atlas SPEEDER Head/Neck is intended for use with Toshiba 1.5T MR systems to produce diagnostic images of the head, neck, and feet that can be interpreted by a trained physician.

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The Indications for Use statement for the Atlas SPEEDER Head/Neck is not identical to the predicate device; however, the differences do not alter the intended diagnostic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both Indications for Use statements indicate that the device is intended to be used in conjuction with an MR system to produce images of the head and neck and that the images can be interpreted by a trained physician. The Indications for Use statements differ in that the proposed Atlas SPEEDER Head/Neck is also intended for use in imaging of the foot.

### 11. Summary of Technological Characteristics Compared to the Predicate Device

The proposed Atlas SPEEDER Head/Neck and the predicate 1.5T Atlas SPEEDER Head/Neck are both 16-channel, receive-only, phased array RF coils intended to be used with a 1.5T MR system to provide images of the head and neck.

At a high level, the subject and predicate devices are based on the following same technological elements:

- 16-channel, receive-only, phased array RF coils
- Intended for imaging of the head and neck ●
- Compatible with 1.5T MR systems
- Active PIN diode switching blocking circuitry. Passive blocking circuitry.
- Split-top mechanical design with an inner cross section shaped to fit . the head
- Three anterior adaptors included
- . Housing materials are rigid, fire-rated, and biocompatible

The following technological differences exist between the subject and predicate devices:

- . Housing material (Lexan 940A polycarbonate (subject) versus polycarbonate-ISO (predicate))
- Indications for use (head, neck, and foot (subject) versus head and . neck (predicate))

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#### 12. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

## Biocompatibility Testing

The only patient contact material on the Atlas SPEEDER Head/Neck is Lexan 940A polycarbonate painted with Polane S polyurethane enamel. Both the polycarbonate and the polyurethane enamel have a history of use in MR applications and other medical devices. For example, these materials were patient contact materials in the devices cleared through 510(k) numbers K122638 and K140998.

## Electrical Safety and Electromagnetic Compatibility

The Atlas SPEEDER Head/Neck was tested to and found to be compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33.

Surface heating was tested in both plugged in and unplugged configurations according to AAMI/ANSI ES60601-1. The measured temperature of the surface of the coil never exceeded the maximum limit of 41℃ in either configuration.

## Bench Testing

The SNR and uniformity of the Atlas SPEEDER Head/Neck was analyzed per and found to conform to NEMA MS 6-2008.

#### Conclusion 13.

The electrical safety and electromagnetic compatibility and biocompatibility data support the safety of the Atlas SPEEDER Head/Neck and the bench testing per the NEMA standards demonstrates the performance and effectiveness of the device under the specified use conditions. This testing demonstrates that the Atlas SPEEDER Head/Neck performs as well as or better than the predicate device.