(23 days)
Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankle, wrist and elbow), and body (chest, abdomen and pelvis)
The 4ch Flex SPEEDER is a phased array coil that can receive NMR signal from the extremities, joints, and trunk of the body. The 4ch Flex SPEEDER is mechanically flexible, and can wrap around various regions as mentioned above. The 4ch Flex SPEEDER consists of four coil elements and PC board. The coil elements shape single loop and the four single loop coil elements are arranged to the row. The coil is decoupled during transmission from QD whole body by means of activating the PIN diodes.
Acceptance Criteria and Study Details for the 4ch Flex SPEEDER
The provided document describes the 4ch Flex SPEEDER, a phased array coil for Magnetic Resonance Diagnostic Devices. The document is a 510(k) Summary of Safety and Effectiveness, aiming to demonstrate substantial equivalence to previously cleared devices.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the 4ch Flex SPEEDER, as is common for medical device accessories demonstrating substantial equivalence, does not explicitly state quantitative acceptance criteria or provide a table of performance metrics in the same way a de novo device might. Instead, its primary method of demonstrating equivalency is through comparing its intended use, design, and performance characteristics to legally marketed predicate devices.
The document states: "Sample phantom images and clinical images are presented in Appendix F & G of this submission." This indicates that visual assessment of image quality from both phantom and clinical studies was submitted to demonstrate performance equivalent to the predicate devices. The implicit acceptance criterion is that the image quality (resolution, signal-to-noise ratio, artifact levels, etc.) produced by the 4ch Flex SPEEDER, as evidenced by these sample images, is comparable to, and not worse than, the image quality of the predicate devices.
Since specific quantitative metrics are not provided in this summary, a table for acceptance criteria vs. reported performance cannot be generated with numerical values. However, based on the submission's structure, we can infer the qualitative performance assessment:
| Performance Aspect | Implicit Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Image Quality (Phantom) | Comparable to predicate devices (Atlas SPEEDER Body [K063361] and φ200 flex coil [K060003]) in terms of signal-to-noise, uniformity, and artifact levels. | Sample phantom images provided in Appendix F show image quality consistent with predicate devices. |
| Image Quality (Clinical) | Diagnostic quality images for the specified anatomical regions (extremities, joints, trunk) comparable to predicate devices. | Sample clinical images provided in Appendix G demonstrate diagnostic quality imaging across various anatomical regions. |
| Safety Parameters | Compliance with specified maximum static field strength, dB/dt, and SAR as per IEC60601-2-33 (2002). Biocompatibility of patient-contacting materials. | Device meets stated safety parameters: Maximum static field 1.5 T, 1st operation mode for dB/dt and SAR per IEC60601-2-33 (2002), and biocompatibility confirmed by material history or test data. |
| Mechanical Flexibility/Fit | Ability to wrap around various regions (extremities, joints, trunk) effectively. | Device is "mechanically flexible, and can wrap around various regions as mentioned above." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample size for a formal test set in terms of number of patients or images. It mentions "Sample phantom images and clinical images are presented in Appendix F & G." This suggests a qualitative, rather than large-scale quantitative, comparison for equivalence.
The data provenance (country of origin, retrospective/prospective) is also not specified in the provided summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The 510(k) summary does not mention the use of experts to establish ground truth for a test set. This type of review by experts is more common for software algorithms or AI devices where diagnostic accuracy is explicitly being measured against a gold standard. For a coil accessory demonstrating substantial equivalence, the focus is typically on the physical and electrical performance leading to acceptable image quality.
4. Adjudication Method
Given that no formal test set with ground truth establishment by experts is described, there is no adjudication method mentioned or implied.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned in the 510(k) summary. The device is a hardware accessory (an MRI coil), not an AI algorithm or a diagnostic software tool that directly interprets images. Therefore, the concept of improving human reader performance "with AI vs without AI assistance" is not applicable to this device submission.
6. Standalone Performance Study
The focus of this submission is on the standalone performance of the 4ch Flex SPEEDER as an MRI coil, rather than its performance in conjunction with an AI. The "sample phantom images and clinical images" would reflect the standalone performance of the coil when integrated into a standard MRI system. However, the summary does not detail the methodology or metrics of such a study beyond mentioning the provision of images.
7. Type of Ground Truth Used
For a hardware component like an MRI coil, the "ground truth" for image quality is typically established by physical phantom measurements (e.g., signal-to-noise ratio, uniformity, resolution targets) and the assessment of clinical diagnostic utility by qualified radiologists (though not explicitly detailed in this summary). There is no mention of pathology or outcomes data being used for ground truth in this submission.
8. Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or AI models. Since the 4ch Flex SPEEDER is a hardware coil, there is no training set in the context of an algorithm. Its design and development would have involved engineering specifications, simulations, and iterative prototyping and testing, not data training.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this hardware device, this question is not applicable.
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K11125|
Appendix A
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
1. Classification and Device Name
Classification Name
Magnetic Resonance Diagnostic Device
Model Number
MJAJ-197A
Trade/Propriety Name
4ch Flex SPEEDER
2. Establishment Registration
2020563
3. U.S. Agent Name and Address
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 (TMSC) 1385, Shimoishigami, Otawara-Shi, Tochigi 324-8550, Japan
Date of Submission 5.
May 3, 2011
-
- Device Intended Use
Field Strength
1.5 T
Resonant Nucleus
Hydrogen
Anatomical Region of Interest
The extremities, joints, and trunk of the body.
Company Confidential MAY 2011
MAY 2 7 2011
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Diagnostic Use
Diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography, MR fluoroscopy and MRS
7. Device Description
The 4ch Flex SPEEDER is a phased array coil that can receive NMR signal from the extremities, joints, and trunk of the body. The 4ch Flex SPEEDER is mechanically flexible, and can wrap around various regions as mentioned above.
The 4ch Flex SPEEDER consists of four coil elements and PC board. The coil elements shape single loop and the four single loop coil elements are arranged to the row. The coil is decoupled during transmission from QD whole body by means of activating the PIN diodes.
8. Safety Parameter
Maximum static field strength
1.5 T
Maximum dB/dt
1st operation mode specified in IEC60601-2-33 (2002)
Maximum SAR
1st operation mode specified in IEC60601-2-33 (2002)
Peak and A-weighted Acoustic Noise Level
Not applicable
Biocompatibility
All materials used in contact with the patient 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 of this submission.
10. Equivalency Information
Toshiba Medical Systems Corporation believes that this 4ch Flex SPEEDER is substantially equivalent to the current Atlas SPEEDER Body [K063361] and ¢ 200 flex coil [K060003].
11. Software
There is no software required for this coil.
A-2
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Toshiba Medical Systems Corporation, Japan % Mr. Paul Biggins Director Regulatory Affairs/US Agent Toshiba America Medical Systems, Inc. 2441 Michelle Dr TUSTIN CA 92780
MAY 2 7 2011
Re: K111251
Trade/Device Name: 4ch Flex SPEEDER, MJAJ-197A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: April 29, 2011 Received: May 4, 2011
Dear Mr. Biggins:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) 4ch Flex SPEEDER, MJAJ-197A
PHONE MARK CONSULTION COLLECTION CONSULTERS CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONTRACTOR COLLECTION CONTRACTORS CONTACTORS CONTACTORS CONSTITUTION CONSTI
Indications for Use
510(k) Number (if known): K11251
Device Name:
4 ch Flex SPEEDER, MJAJ-197A
Indications for Use:
-
- Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankle, wrist and elbow), and body (chest, abdomen and pelvis)
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
- Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankle, wrist and elbow), and body (chest, abdomen and pelvis)
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 Diagnostic Devices (OIVD)
Mary S Postel
(Division Sign Off)
vision Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
| Labels | Values |
|---|---|
| 510(k) Number | K111251 |
Page 1 of
Indication for Use Page 1 of 1
510(k): 4ch Flex SPEEDER Page 10 of 175
§ 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.