(49 days)
Not Found
No
The device description focuses on the hardware components of an MRI coil and does not mention any software or algorithms that would incorporate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as an "imaging" device intended for "imaging of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest," and it is also identified as a "receive-only phased Array Coil that can receive NMR signal." There is no mention of it being used for treatment or therapy.
Yes
This device is an imaging coil for an MRI system, and imaging devices are used to capture data that aids in the diagnosis of medical conditions. The stated "intended use" is "for imaging of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest," which directly supports its role in acquiring diagnostic information.
No
The device description explicitly states it is a "receive-only phased Array Coil" consisting of physical components like "coil elements" and a "PC board," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "imaging of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest." This describes a device used for medical imaging, which is a diagnostic tool, but not an in vitro diagnostic.
- Device Description: The description details a "receive-only phased Array Coil" for an MR system. This is a component of an imaging system, not a device that analyzes samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be characteristic of an in vitro diagnostic device.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is used to acquire images directly from the patient's body.
N/A
Intended Use / Indications for Use
The Octave SPEEDER Head is intended for imaging of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest.
The MJAH-167A is intended to be used on a Toshiba 1.5T MR System
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The Octave SPEEDER Head is a receive-only phased Array Coil that can receive NMR signal from head, cervical region and upper chest. The coil consists two parts of a head base, a removable anterior coil. The head base includes 7 coil elements, which are divided into 3 sections. The removable anterior coil includes 4 coil elements, which are divided into 2 sections: 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
Magnetic Resonance
Anatomical Site
Head, cervical region and upper chest.
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): 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.
Not Found
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.
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Appendix A
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
1. Classification and Device Name
Classification Name
Magnetic Resonance Diagnostic Device
Model Number
MJAH-167A
Trade/Propriety Name
Octave SPEEDER Head
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/Official Correspondent
Paul Biggins, Director, Regulatory Affairs T: (714) 730-5000 F: (714) 730-1310e-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 7/24/2012)
6. Device Intended Use
Field Strength
1.5 T
AUG 1 7 2012
1
Resonant Nucleus
Hydrogen
Anatomical Region of Interest
Head, cervical region and upper chest.
Diagnostic Use
Diagnostic imaging of the the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest.
7. Device Description
The Octave SPEEDER Head is a receive-only phased Array Coil that can receive NMR signal from head, cervical region and upper chest. The coil consists two parts of a head base, a removable anterior coil. The head base includes 7 coil elements, which are divided into 3 sections. The removable anterior coil includes 4 coil elements, which are divided into 2 sections: 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 Head is intended for imaging of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest.
The MJAH-167A is intended to be used on a Toshiba 1.5T MR System
Design Change 9.
The SPEEDER technology has been previously cleared under K083014 as an Atlas SPEEDER Head/Cervical coil. The primary difference is the creation of an 8ch SPEEDER Head. The new Octave (8ch) SPEEDER Head will use the same SPEEDER technology as other cleared SPEEDER devices.
10. 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
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Biocompatibility
All patient contacting materials have a history of use or test data that demonstrates its its its its its its its its its its its its its its its its its its its its its its biocompatibility, i.e., non-toxic, non-irritating.
Summary of Testing
Testing was conducted utilizing phantoms and accepted imaging quality metrics.
.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Imaging Performance Parameter 12.
Sample phantom images and clinical images are presented in Appendix F & G .
13. Software
The Octave SPEEDER Head coil does not contain software.
. . . . .
.
14. Equivalency Information
Toshiba Medical Systems Corporation believes that this Octave SPEEDER. Head is substantially equivalent to the current Atlas SPEEDER Head/Cervical [K083014]. 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)
Conclusion
The new Octave SPEEDER Head (MJAH-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 Head.
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Image /page/3/Picture/0 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle with its wings spread.
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: K121910
Trade/Device Name: Octave SPEEDER Head; MJAH-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 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
4
medical device-related adverse events) (21 CFR 803); and good manufacturing pactice mourements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as be form in art quality device as described in your Section 510(k) premarket will anow you to oogin marketing your and equivalence of your device to a legally marketed nonlication. THE I D71 imating of Saction 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 11 you desire specific advise of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5456. Thise, process not 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 I ou inter 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,
Janine M. Morris
Acting 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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| Indications for Use |
|---|
| --------------------- |
| 510(k) Number (if known): | K121910 |
|---|---|
| Device Name: | Octave SPEEDER Head, MJAH-167A |
| Indications for Use: |
|---|
| ---------------------- |
The Octave SPEEDER Head is intended for imaging of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest.
The MJAH-167A is intended to be used on a Toshiba 1.5T MR System
| Prescription Use | 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 | K121910 |
|---|---|
| --------------- | --------- |
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