(51 days)
Not Found
No
The summary describes a passive receive-only head coil for MRI and mentions standard image processing techniques, but there is no mention of AI, ML, or related concepts.
No
The device is described as a receive-only multiple array device used for imaging of the head region, and the images are used for diagnosis determination. It does not provide therapy.
No
Explanation: The device is a head coil for an MRI system. It is used to acquire images, which can then be interpreted by a physician for diagnosis. The device itself is not performing the diagnostic function but is a component of an imaging system.
No
The device is a physical head coil used in MRI systems, not a software-only device. The description clearly details hardware components and physical testing.
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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The TRILLIUM OVAL Head Coil 32 is a component of an MRI system. It's a receive-only coil that detects magnetic resonance signals from the head to create images. It does not perform tests on biological samples.
- Intended Use: The intended use is for imaging of the head region, and the images are interpreted by a trained physician for diagnostic purposes. This is consistent with the use of imaging devices, not IVDs.
The information provided clearly describes a medical imaging device used for diagnostic imaging, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The TRILLIUM OVAL Head Coil 32 is a 32 channel recieve-only multiple array device used with the Hitachi TRILLIUM OVAL 3.0 Tesla systems for imaging of the head region that can be interpreted by a trained physician.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The TRILLIUM OVAL Head Coil 32 is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved cross-sectional images that display the internal structure of the head. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
The Head Coil 32 is used with TRILLIUM OVAL MRI System. The coil consists of 32 elements multiple array coils used for obtaining diagnostic images of the human head region in MRI System.
The MRI system produces images by using the transmitter coil. Head Coil 32 is used as receiver in the system. The use of transmitter coil ensures uniform volume excitation, while the receiver coils enhance the reception sensitivity or S/N ratio for optimal image quality.
Mentions image processing
Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance imaging (MRI)
Anatomical Site
head region
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)
Quality assurance measures were conducted on the subject device. Testing included:
- NEMA MS 1
- AAMI / ANSI ES60601-1
- IEC 60601-1-2
- NEMA MS 3
- Heat testing
- IEC 60601-2-33
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2016
Hitachi Medical Systems America, Inc. % Mr. Doug Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K162079
Trade/Device Name: TRILLIUM OVAL Head Coil 32 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 28, 2016 Received: July 29, 2016
Dear Mr. Thistlethwaite:
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.
Michael O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | |
| 510(k) Number (if known) | K162079 |
| Device Name | TRILLIUM OVAL Head Coil 32 |
| Indications for Use (Describe) | The TRILLIUM OVAL Head Coil 32 is a 32 channel recieve-only multiple array device used with the Hitachi |
| TRILLIUM OVAL 3.0 Tesla systems for imaging of the head region that can be interpreted by a trained physician. |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
3
Section 5
510(k) Summary
4
| Submitter: | Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, Ohio 44087-2371 |
|----------------------|--------------------------------------------------------------------------------------------------|
| Registration Number: | 1528028 |
| Contact: | Douglas J. Thistlethwaite |
| Telephone number: | 330-425-1313 |
| Telephone number: | 330-963-0749 |
| E-mail: | thistlethwaited@hitachimed.com |
| Date: | July 11, 2016 |
Submitter Information
Manufacturer Information
| Manufacturer: | HITACHI, LTD.
2-1, Shintoyofuta
Kashiwa-shi, Chiba-Ken, Japan 277-0804 |
|----------------------|------------------------------------------------------------------------------|
| Registration Number: | 8030405 |
Device Information
| Regulation Number: | 892.1000 |
|---|---|
| Regulation Name: | Coil, Magnetic Resonance, Specialty |
| Product Code | MOS |
| Class | 2 |
| Panel | Radiology |
| Trade/Proprietary Name: | TRILLIUM OVAL Head Coil 32 |
| Predicate Device(s): | TRILLIUM OVAL WIT Posterior Head/Neck coil and WIT Anterior Head |
| attachment (K142734) |
Device Intended Use
The TRILLIUM OVAL Head Coil 32 is a 32 channel recieve-only multiple array device used with the Hitachi TRILLIUM OVAL 3.0 Tesla systems for imaging of the head region that can be interpreted by a trained physician.
Device Description
Function
The TRILLIUM OVAL Head Coil 32 is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved cross-sectional images that display the internal structure of the head. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
Scientific Concepts
Magnetic Resonance imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static maqnetic field. these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector.
5
The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a reorientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adiacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2. A RF emission or echo that can be measured accompanies these relaxation events.
The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varying the RF excitation. applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.
Physical and Performance Characteristics
The Head Coil 32 is used with TRILLIUM OVAL MRI System. The coil consists of 32 elements multiple array coils used for obtaining diagnostic images of the human head region in MRI System.
The MRI system produces images by using the transmitter coil. Head Coil 32 is used as receiver in the system. The use of transmitter coil ensures uniform volume excitation, while the receiver coils enhance the reception sensitivity or S/N ratio for optimal image quality.
Performance Evaluation
Quality assurance measures were conducted on the subject device. Testing included:
-
NEMA MS 1
. -
AAMI / ANSI ES60601-1 ●
-
IEC 60601-1-2
-
NEMA MS 3 . Heat testing
-
. IEC 60601-2-33
6
Device Technological Characteristics
The technological characteristics (intended use, hardware, and performance) of the subject device are very similar to the predicate device as indicated in Table 1.
| Table 1 Head Coil 32 Predicate Comparison Table |
|---|
| Parameter | | Predicate Device: WIT Posterior
Head/Neck coil and WIT Anterior Head
attachment | Subject Device: Head Coil 32 | |
|----------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--|
| Intended Use | Indications for
Use Statement | The WIT Posterior Head/Neck coil with
WIT Anterior Head attachment is recieve-
only multiple array device used for MRI
imaging of the head region. | The TRILLIUM OVAL Head Coil 32 is a
recieve-only multiple array device used for
MRI imaging of the head region. | |
| | Coil length | 575 mm | 520 mm | |
| | Coil height | 359 mm | 380 mm | |
| | Coil width | 550 mm | 550 mm | |
| Dimensions | Figure | 359 | 520 | |
| | Coil type | Receive only, 15 channel | Receive only, 32 channel | |
| Coil
Architecture | Housing type | Rigid | Rigid | |
| | Coil Elements | 19 Element | 32 Element | |
| | Primary
Decoupling | Active and passive | Active and passive | |
| Performance | NEMA MS 1
Method 4 | 145 +/- 20% | 245 +/- 20% | |
| Electrical
Safety | Electrical safety
standards applied | UL-60601-1 | UL-60601-1 | |
| | Safety Class (IEC
60601-1) | Class II | Class II | |
| | Waterproof | No | No | |
| | Explosion proof | No | No | |
| Operator's
Labeling
Manual | | WIT Posterior Head/Neck coil Instruction
Manual | Head Coil 32 Instruction Manual | |
7
The technological differences from the TRILLIUM OVAL Head Coil 32 to the predicate device are analyzed in Table 2.
| FDA
Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not
constitute a new intended use; and any differences in technological characteristics are accompanied by information that
demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and effectiveness
than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see section
513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)).
21 CFR 807.87(f)). | | | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------|----------------------------------|
| Device
Modification
Summary | Coil was designed with 32 channels. | | | |
| Significant
Changes | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance |
| | □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) |
| HITACHI
Rationale
Statement | The performance and technological characteristics of coil are similar to the predicate device. | | | |
Table 2 Differences Analysis
There are no functionality differences from the TRILLIUM OVAL Head Coil 32 to the predicate device as analyzed in Table 3.
| Table 3 Functionality Comparison Analysis | ||||
|---|---|---|---|---|
| FDA Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not constitute a new intended use; and any differences in technological characteristics are accompanied by information that demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). | |||
| Device Modification Summary | None | |||
| Significant Changes | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance |
| □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) | |
| HITACHI Rationale Statement | There is no new intended use. |
8
Substantial Equivalence
A summary decision was based on analysis of Table 8.
| Table 8 Rationale Analysis: TRILLIUM OVAL V5.1 MRI vs. Predicate | |||
|---|---|---|---|
| ------------------------------------------------------------------ | -- | -- | -- |
| ITEM | Overall Rationale Analysis |
|---|---|
| Hardware | Different specifications do not constitute a new intended use. There are no significant changes in technological |
| characteristics, safety and effectiveness. | |
| Functionality | Enhanced features do not constitute a new intended use. There are no significant changes in technological characteristics, |
| safety and effectiveness. |
Therefore, based on a thorough analysis and comparison of the functions, scientific concepts, physical and performance characteristics, performance comparison and technological characteristics, the proposed TRILLIUM OVAL Head Coil 32 is considered substantially equivalent to the currently marketed predicate device.
Summary of Non-Clinical Testing
The TRILLIUM OVAL Head Coil 32 is in conformance with the applicable parts of the following standards:
- . NEMA MS 1-2008, Determination of Signal-to-noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- . NEMA MS 3-2008, Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- AAMI / ANSI ES60601-1:2005/(R) 2012 and A1:2012, c1:2009/(r) 2012 and a2:2010/(r ) . 2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
- . IEC 60601-1-2 Edition 3:2007-03. medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
- IEC 60601-2-33 Edition 3.1 2013-04, medical electrical equipment part 2-33: particular . requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic.
In addition, heat testing was conducted on the new TRILLIUM OVAL Head Coil 32.
Summary of Clinical Testing
No clinical tests were conducted to support the TRILLIUM OVAL Head Coil 32 and the substantial equivalence conclusion. However, clinical images of the head were provided to support the effectiveness of the subject device.
Conclusions
It is the opinion of Hitachi Medical Systems America. Inc. the TRILLIUM OVAL Head Coil 32 has the same intended use and the same basic technological characteristics as the predicate device. While there are some technical features that vary with respect to the predicate device, the conclusions from the non-clinical data suggest that the subject device bears an equivalent safety and performance profile as that of the predicate device.
Therefore, the TRILLIUM OVAL Head Coil 32 is substantially equivalent to the predicate device.