(56 days)
No reference devices were used in this submission.
No
The description focuses on the physical components and performance characteristics of an MRI coil, with no mention of AI or ML for image processing or analysis.
No.
The device is intended for producing diagnostic images, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" states that the device is intended "to produce diagnostic images... that can be interpreted by a trained physician." This indicates its role in the diagnostic process.
No
The device description clearly outlines a physical, hardware-based medical device (a receive-only, 16-channel phased array coil) with specific materials, components, and physical testing (biocompatibility, electrical safety, bench testing). There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Atlas SPEEDER Head/Neck is an MRI coil. Its function is to receive radiofrequency signals from the body during an MRI scan to produce images. It does not analyze biological specimens.
- Intended Use: The intended use is to produce diagnostic images of the head, neck, and feet, which are then interpreted by a physician. This is a function of an imaging device, not an IVD.
The device is clearly an in vivo diagnostic imaging device, as it is used directly on the patient's body to obtain diagnostic information.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MOS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
head, neck, and feet
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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°C 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
4
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.
5
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))
6
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.