(8 days)
The MJAH-137A Atlas SPEEDER Head/Cervical Coil is intended for the use of diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy.
This coil is intended to be used on the Atlas Vantage, model numbers MRT-1503/S3, /S4 and Atlas Titan, model number MRT-1504.
The Atlas SPEEDER Head/cervical is a phased Array Coil that can receive NMR signal from head, cervical region and upper chest.
The coil is configured in three sections; a head base, a removable anterior coil, and NV chest coil. There are two types of anterior coil; 1) Head anterior coil for head imaging, and 2) Neck anterior coil for cervical imaging. The Neck anterior coil includes an adjustable NV coil which is combined with Head anterior coil.
During transmission by the QD body coil this coil is deactivated by means of PIN diodes located on the internal circuit board. Upon deactivation of the transmit cycle the coil switches on to the receive mode.
This document is a 510(k) Summary of Safety and Effectiveness for a medical device, specifically an MRI coil (Atlas SPEEDER Head/Cervical Coil). It focuses on establishing substantial equivalence to existing devices rather than presenting a study to prove performance against specific acceptance criteria. Therefore, much of the requested information regarding study design, sample sizes, expert ground truth, and comparative effectiveness is not present in the provided text.
However, I can extract the relevant information that is available and indicate where the requested information is absent.
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative "acceptance criteria" for the device's imaging performance. Instead, it relies on demonstrating basic safety parameters and presenting "sample phantom images and clinical images" to show its qualitative imaging capabilities. The primary "acceptance" for this 510(k) submission is the FDA's determination of substantial equivalence to predicate devices, not performance against predefined metrics.
Below is a table summarizing the safety parameters mentioned and the implied "performance" in the context of a 510(k).
| Acceptance Criteria (or Safety Parameters) | Reported Device Performance (or Compliance) |
|---|---|
| Maximum static field strength | 1.5 T |
| Maximum dB/dt | 1st operation mode specified in IEC60601-2-33 (2005) |
| Maximum SAR | 1st operation mode specified in IEC60601-2-33 (2005) |
| Peak and A-weighted Acoustic Noise Level | Not applicable |
| Biocompatibility | All materials used in contact with the patient will have a history of use or test data that demonstrates its biocompatibility, i.e., non-toxic, non-irritating. |
| Imaging Performance | Sample phantom images and clinical images are presented in Appendix F & G (Qualitative demonstration of imaging capability). |
Study Details from the Provided Text:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "sample phantom images and clinical images are presented in Appendix F & G." However, it does not specify the sample size for these images (number of phantom scans or number of clinical cases/patients).
- Data provenance (country of origin, retrospective/prospective) is not provided.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth for any test set or clinical image review. This type of detail is typically not included in a 510(k) summary focused on substantial equivalence.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. No formal adjudication method for image interpretation or ground truth establishment is described.
-
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, an MRMC comparative effectiveness study was not done. The device is an MRI coil, not an AI-powered diagnostic tool, so this type of study is irrelevant to its 510(k) submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/No. This device is a passive hardware component (an MRI coil) and does not involve an algorithm with standalone performance.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the "sample phantom images," the ground truth would be the known properties of the phantom itself.
- For the "clinical images," the document does not specify how ground truth was established, or if formal ground truth was established at all beyond clinical reports or visual assessment. In a 510(k) for an MRI coil, the "ground truth" for showing image quality typically relies on the visual diagnostic quality as assessed by qualified personnel, often implicitly. No pathology or outcomes data is mentioned.
-
The sample size for the training set:
- Not applicable. This device is a hardware component (MRI coil); it does not involve training a machine learning model.
-
How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for a machine learning model.
{0}------------------------------------------------
KC) 3014
Appendix A
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
Classification and Device Name 1.
Classification Name
Coil, magnetic resonance, specialty; 21 CFR 892.1000 [90-MOS]
Model Number
MJAH-137A
Trade/Propriety Name
Atlas SPEEDER Head/Cervical
2. Establishment Registration
2020563
U.S. Agent Name and Address 3.
Agent Name
Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, CA 92780
Contact Person
Paul Biggins, Director Regulatory Affairs T: (714) 730-5000 F: (714) 730-1310 pbiggins@tams.com
4. Manufacturing Site
Toshiba Medical Systems Corporation 1385 Shimoishiqami Otawara-shi, Tochigi-Ken Japan 324
Date of Submission 5.
September 30, 2008
Device Intended Use 6.
The MJAH-137A Atlas SPEEDER Head/Cervical Coil is intended for the use of diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy.
This coil is intended to be used on the Atlas Vantage, model numbers MRT-1503/S3, /S4 and Atlas Titan, model number MRT-1504.
7. Device Description
The Atlas SPEEDER Head/cervical is a phased Array Coil that can receive NMR signal from head, cervical region and upper chest.
OCT 1 7 2008
{1}------------------------------------------------
Appendix A
The coil is configured in three sections; a head base, a removable anterior coil, and NV chest coil. There are two types of anterior coil; 1) Head anterior coil for head imaging, and 2) Neck anterior coil for cervical imaging. The Neck anterior coil includes an adjustable NV coil which is combined with Head anterior coil.
During transmission by the QD body coil this coil is deactivated by means of PIN diodes located on the internal circuit board. Upon deactivation of the transmit cycle the coil switches on to the receive mode.
Safety Parameter 8.
Maximum static field strength
1.5 T
Maximum dB/dt
1st operation mode specified in IEC60601-2-33 (2005)
Maximum SAR
1st operation mode specified in IEC60601-2-33 (2005)
Peak and A-weighted Acoustic Noise Level
Not applicable
Biocompatibility
All materials used in contact with the patient will have a history of use or test data that demonstrates its biocompatibility, i.e., non-toxic, non-irritating.
9. Imaging Performance Parameter
Sample phantom images and clinical images are presented in Appendix F & G.
10. Equivalency Information
Toshiba Medical Systems Corporation believes that this Atlas SPEEDER Head/Cervical is substantially equivalent to the current Atlas SPEEDER Head [K063361] and SPEEDER 1.5T Wrist coil [K072935].
11. Software
There is no additional software required for this coil.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2008
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313
Re: K083014
Trade/Device Name: Model MJAH-137A Atlas SPEEDER Head/Cervical COil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 8, 2008 Received: October 9, 2008
Dear Mr. Job:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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_
{3}------------------------------------------------
Page 2
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); 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.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
forque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K083014
Device Name: Model MJAH-137A Atlas SPEEDER Head/Cervical Coil
Indications for Use:
The MJAH-137A Atlas SPEEDER Head/Cervical Coil in intended for the use of diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography and MR Fluoroscopy.
This coil is intended to be used on the Atlas Vantage, model numbers MRT-1503/S3,S5 and the Atlas Titan, model number MRT-1504.
Prescription Use × (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 Device Evaluation (ODE)
Hulda Reimer
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Page 1 of 1
§ 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.