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 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.

AI/ML Overview

The provided text is a 510(k) Summary for the "Atlas SPEEDER Head/Neck" magnetic resonance coil. It describes the device, its intended use, and the performance data submitted to support its substantial equivalence to a predicate device. While it mentions performance data, it does not include acceptance criteria or a detailed study proving the device meets those criteria in the format requested.

Specifically, the document states: "The Atlas SPEEDER Head/Neck was tested to and found to be compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33." and "The SNR and uniformity of the Atlas SPEEDER Head/Neck was analyzed per and found to conform to NEMA MS 6-2008." It also mentions surface heating measurements. However, it does not provide the specific "acceptance criteria" (e.g., a minimum SNR value, specific uniformity metrics with thresholds) or the results of a detailed study designed to meet those specific criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in quantitative terms in the document. The document refers to compliance with standards (AAMI/ANSI ES60601-1, IEC 60601-2-33, NEMA MS 6-2008) which would contain the criteria, but the specific values are not extracted or presented here.
Reported Device Performance:
- Biocompatibility: Lexan 940A polycarbonate and Polane S polyurethane enamel have a history of use in MR applications and other medical devices (K122638 and K140998).
- Electrical Safety & EMC: Compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33.
- Surface Heating: Never exceeded 41°C (maximum limit).
- Bench Testing (SNR & Uniformity): Analyzed per and found to conform to NEMA MS 6-2008.

Acceptance Criteria (Not explicitly stated with values, only referenced standards)	Reported Device Performance
Biocompatibility standards/requirements	Lexan 940A polycarbonate and Polane S polyurethane enamel have a history of use in MR applications and other medical devices (cleared through 510(k) numbers K122638 and K140998).
Electrical Safety (AAMI/ANSI ES60601-1)	Compliant
Electromagnetic Compatibility (IEC 60601-2-33)	Compliant
Surface Heating (Max temperature limit of 41°C)	Measured temperature never exceeded 41°C in either plugged in or unplugged configurations.
SNR and Uniformity (NEMA MS 6-2008)	Analyzed per and found to conform to NEMA MS 6-2008. (Specific SNR and uniformity metrics/values are not provided, only compliance to the standard). The document implies it "performs as well as or better than the predicate device" based on this testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. This document only details bench testing and compliance with standards, not a clinical trial with a "test set" of patients.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document describes a medical device, not an AI or diagnostic algorithm that requires expert ground truth establishment for a test set. The images produced "can be interpreted by a trained physician," implying human interpretation, but no specific study involving experts establishing ground truth for the device's diagnostic output is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No diagnostic test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is an MR coil, not an AI system. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is an MR coil, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The testing described focuses on physical performance parameters (electrical safety, heat, SNR, uniformity) of the MR coil itself, not diagnostic accuracy requiring a "ground truth" in the clinical sense.

8. The sample size for the training set

Not applicable. This is an MR coil; there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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 (440) 484-2964 kathleen.aras@qualedyn.com

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 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.

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.