(49 days)
No
The device description focuses on the hardware components and functionality of a receive-only phased array coil for MRI, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a receive-only phased array coil intended for imaging the thoracolumbar spine using an MR system. Its function is to receive NMR signals for image acquisition, not to directly treat a condition or provide therapy.
No
The device is described as a "receive-only phased Array Coil" intended for "imaging the thoracolumbar spine" and receives an "NMR signal from spine." It is a component that enables image acquisition (data collection) but does not analyze or interpret that data to provide a diagnosis.
No
The device description clearly states it is a "receive-only phased Array Coil" which is a hardware component used in MRI systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "imaging the thoracolumbar spine." This describes a device used for medical imaging, not for examining specimens (like blood, urine, or tissue) outside the body to diagnose diseases or conditions.
- Device Description: The description details a "receive-only phased Array Coil" for an MR system. This is a component of a medical imaging system, not a device for performing in vitro tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
Therefore, the Octave SPEEDER Spine is a medical imaging device, specifically an accessory for an MRI system, and does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Octave SPEEDER Spine is intended for imaging the thoracolumbar spine.
The MJAS-167A is intended to be used on a Toshiba 1.5T MR System
Product codes
MOS
Device Description
The Octave SPEEDER Spine is a receive-only phased Array Coil that can receive NMR signal from spine. The coil consists of a 12 rectangular loop surface coil. 3 loops (1 section) are aligned perpendicular to a body axis and 4 sections are aligned to a body axis. Users select the sections according to region of interest via a system user interface. The PC board switches transmit mode and receive mode with PIN diode. This coil is detuned during transmission by our QD whole body coil by means of activating the PIN diodes (transmit mode) and tuned during no transmission by means of not activating the PIN diodes (receive mode).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
1.5 T MR System
Anatomical Site
Spine, thoracolumbar spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Testing was conducted utilizing phantoms and accepted imaging quality metrics.
Sample phantom images and clinical images are presented in Appendix F & G.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Appendix A
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
1. Classification and Device Name
Classification Name
Magnetic Resonance Diagnostic Device
Model Number
MJAS-167A
Trade/Propriety Name
Octave SPEEDER Spine
2. Establishment Registration
2020563
3. Contact Person, U.S. Agent Name and Address
Contact Person
Charlemagne Chua, Manager, Regulatory Affairs T: (714) 730-5000 F: (714) 730-1310 e-mail: cchua@tams.com
U.S. Agent Name
Paul Biggins, Director, Regulatory Affairs T: (714) 730-5000 F: (714) 730-1310 e-mail: pbiggins@tams.com
Address:
Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, CA 92780
4. Manufacturing Site
Toshiba Medical Systems Corporation (TMSC) 1385, Shimoishigami, Otawara-Shi, Tochigi 324-8550, Japan
5. · Date of Submission
June 28, 2012 (revised August 3, 2012)
Device Intended Use 6.
Field Strength
1.5 T
AUG 1 7 2012
1
Resonant Nucleus
Hydrogen
Anatomical Region of Interest
Spine
Diagnostic Use
Diagnostic imaging of the thoracolumbar spine.
7. Device Description
The Octave SPEEDER Spine is a receive-only phased Array Coil that can receive NMR signal from spine. The coil consists of a 12 rectangular loop surface coil. 3 loops (1 section) are aligned perpendicular to a body axis and 4 sections are aligned to a body axis. Users select the sections according to region of interest via a system user interface. The PC board switches transmit mode and receive mode with PIN diode. This coil is detuned during transmission by our QD whole body coil by means of activating the PIN diodes (transmit mode) and tuned during no transmission by means of not activating the PIN diodes (receive mode).
8. Indication for use
The Octave SPEEDER Spine is intended for imaging the thoracolumbar spine.
The MJAS-167A is intended to be used on a Toshiba 1.5T MR System
9. Design Change
The SPEEDER technology has been previously cleared under K063361 as an Atlas SPEEDER Spine coil. The primary difference is the creation of an 8ch SPEEDER Spine. The new Octave (8ch) SPEEDER Spine will use the same SPEEDER technology as other cleared SPEEDER devices.
10. Safety Parameter
Maximum static field strength
1.5 T
Maximum dB/dt
1 st 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
2
Biocompatibility
All patient contacting materials have a history of use or test data that demonstrates its biocompatibility, i.e., non-toxic, non-irritating.
11. Summary of Testing
Testing was conducted utilizing phantoms and accepted imaging quality metrics.
12. Imaging Performance Parameter
Sample phantom images and clinical images are presented in Appendix F & G.
13. Software ·
The Octave SPEEDER Spine coil does not contain software.
14. Equivalency Information
Toshiba Medical Systems Corporation believes that this Octave SPEEDER Spine is substantially equivalent to the current Atlas SPEEDER Spine [K063361]. Testing was done in accordance with applicable recognized consensus standards as listed below.
IEC60601-1 (1998), Amd1 (1991), Amd2 (1995) IEC 60601-2 (2001), Amd1 (2004) IEC60601-1-6 (2006) IEC62366 (2007) IEC60601-2-33 (2002), Amd1 (2005), Amd2 (2007)
15. Conclusion
The new Octave SPEEDER Spine (MJAS-167A) does not change the indication for use or the intended use of the predicate device. The safety and effectiveness has been verified via risk management and application of design controls to the new Octave SPEEDER Spine.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
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
AUG 1 7 2012
Toshiba Medical System Corporation, Japan % Mr. Paul Biggins Director Regulatory Affairs/US Agent Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K121911
Trade/Device Name: Octave SPEEDER Spine, MJAS-167A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 24, 2012 Received: July 26, 2012
Dear Mr. Biggins:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Security of the device is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivalent in i referenced above and nave determined the arredicate devices marketed in interstate for use stated in the enclosue) to tegally management date of the Medical Device Amendments, or to commerce prior to May 28, 1970, the enactified in accordance with Federal Food. Drug, devices that have been reclassified in accordance will as proval application (PMA).
and Cosmetic Act (Act) that do not require approval on treasissers provisions of the Act. and Cosmetic Act (Act) that do not require approvate approvisions of the Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, sucject success for amual registration, listing of
general controls provisions of the Act include requirements for among miskranding an general controls provisions of the receiners and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (see alove) alles ones affecting your device can be found in Title 21, additional controls. Existing major Tegulations areoning John in The may publish further
Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish Code of Pederal Regaring your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualite of a substitute with other requirements of the Act
that FDA has made a determination that your device with other requires. You must that FDA has made a determination und your diver Federal agencies. You must
or any Federal statutes and regulations administered by other Federal and listin or any Federal statures and regulations and including, but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not ice reporti comply with all the Act s requirements, incruaing, our are cal device reporting (reporting of
4
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 800). This letter requirents as set forum in the quality by stires (X | AND/OR | Over-The-Counter Use |
|-----------------------------|----------|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | | (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)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) Number | K121911 |
|---|---|
| --------------- | --------- |
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