(56 days)
ECHELON Whole Spine (CTL) Coil, ALTAIRE Flex Body (Large) Coil, ALTAIRE Flex Body (Extra Large) Co, OASIS RAPID Head Coil
Not Found
No
The summary describes receive-only coils for an MRI system and mentions standard image processing techniques, but there is no mention of AI or ML.
No
The device is described as an "imaging device" intended to provide "physiological and clinical information" and for "diagnosis determination" through "diagnostic images." It does not mention any therapeutic function.
Yes
The device is described as "intended to provide the physician with physiological and clinical information... that can be useful in diagnosis determination," and its components are specifically described as "used for obtaining diagnostic images."
No
The device description explicitly states that the devices are "recieve-only multiple array devices" which are hardware components (coils) used in an MRI system. While image processing is mentioned, the core device being described is physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is an imaging device (MRI system and specialty coils). It works by detecting magnetic resonance signals from within the body to produce images of internal structures. This is a non-invasive process that does not involve analyzing samples taken from the body.
- Intended Use: The intended use clearly states that the device provides physiological and clinical information obtained non-invasively. The images are interpreted by a trained physician for diagnosis determination.
Therefore, the function and intended use of this device fall under the category of medical imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The OASIS Specialty Coils are receive-only devices that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved crosssectional images that display the internal structure of 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 indications for use for the OASIS Specialty Coils are as follows:
- The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used . for MRI imaging of the human cervical spine, and thoracic spine.
- . The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only multiple array device used for MRI imaging of the abdomen.
- The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple . array device used for MRI imaging of the abdomen.
- The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array . device used for MRI imaging of the foot.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used for obtaining diagnostic images of the human cervical spine, and thoracic spine with the OASIS MRI System.
The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only multiple array device used for obtaining diagnostic images of the abdomen with the OASIS MRI System.
The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple array device used for obtaining diagnostic images of the abdomen with the OASIS MRI System.
The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array device used for obtaining diagnostic images of the foot with the OASIS MRI System.
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
human cervical spine, thoracic spine, abdomen, foot region, muscle, born structure, cartilage
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)
Not Found
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.
ECHELON Whole Spine (CTL) Coil, ALTAIRE Flex Body (Large) Coil, ALTAIRE Flex Body (Extra Large) Co, OASIS RAPID Head Coil
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
JAN 18 2008
Submitter Information
| Submitter: | Hitachi Medical Corporation
2-1, Shintoyofuta
Kashiwa-shi, Chiba, JAPAN 277-0804 |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent: | Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, Ohio 44080-2371
ph: (330) 425-1313
fax: (330) 963-0749 |
| Contact: | Douglas J. Thistlethwaite |
| Date: | November 13, 2007 |
Device Name
| Classification Name: | Coil, magnetic resonance, specialty |
|---|---|
| Classification Number: | 90MOS |
| Trade/Proprietary Name: | OASIS CTL Coil |
| Predicate Device(s): | ECHELON Whole Spine (CTL) Coil |
| Classification Name: | Coil, magnetic resonance, specialty |
|---|---|
| Classification Number: | 90MOS |
| Trade/Proprietary Name: | OASIS QD Flexible Body Coil (L) |
| Predicate Device(s): | ALTAIRE Flex Body (Large) Coil |
| Classification Name: | Coil, magnetic resonance, specialty |
|---|---|
| Classification Number: | 90MOS |
| Trade/Proprietary Name: | OASIS QD Flexible Body Coil (XL) |
| Predicate Device(s): | ALTAIRE Flex Body (Extra Large) Co |
| Classification Name: | Coil, magnetic resonance, specialty | |
|---|---|---|
| Classification Number: | 90MOS | |
| Trade/Proprietary Name: | OASIS RAPID Foot Coil | |
| Predicate Device(s): | OASIS RAPID Head Coil |
1
Image /page/1/Picture/1 description: The image shows handwritten text that appears to be a document identifier or page number. The text includes "K07331D" on the top line, followed by "pg 2 of 4" on the second line. The letters and numbers are written in a clear, legible style, and the overall impression is that of a document label or reference.
Device Intended Use
The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The OASIS Specialty Coils are receive-only devices that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved crosssectional images that display the internal structure of 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 indications for use for the OASIS Specialty Coils are as follows:
- The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used . for MRI imaging of the human cervical spine, and thoracic spine.
- . The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only multiple array device used for MRI imaging of the abdomen.
- The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple . array device used for MRI imaging of the abdomen.
- The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array . device used for MRI imaging of the foot.
Device Description
Function
The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used for obtaining diagnostic images of the human cervical spine, and thoracic spine with the OASIS MRI System.
The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only multiple array device used for obtaining diagnostic images of the abdomen with the OASIS MRI System.
The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple array device used for obtaining diagnostic images of the abdomen with the OASIS MRI System.
The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array device used for obtaining diagnostic images of the foot with the OASIS MRI System.
2
Image /page/2/Picture/1 description: The image shows handwritten text that appears to be a document identifier or page number. The text reads 'K073310 pg. 3 of 4'. The 'K' is capitalized, followed by a series of numbers. Below this, 'pg.' is written, followed by '3 of 4', indicating page 3 of a 4-page document.
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 magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. 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 re-orientation 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 adjacent 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 MR-CTL-120, OASIS CTL Coil is a recieve-only device suitable for imaging human cervical spine, thoracic spine, lumber spine and etc. The coil consists of 8 elements. The signal output of each element is independently processed by the MRI system to enhance performance.
The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only suitable for imaging the abdomen. The coil consists of 2 elements. The signal output of each element is independently processed by the MRI system to enhance performance.
The MR-QFC-120, OASIS QD Flexible Body Coil (XL) recieve-only suitable for imaging the abdomen. The coil consists of 2 elements. The signal output of each element is independently processed by the MRI system to enhance performance.
The MR-RFC-120, OASIS Rapid Foot Coil recieve-only suitable for imaging human foot region, muscle, born structure, cartilage, etc. The coil consists of 8 elements. The signal output of each element is independently processed by the MRI system to enhance performance.
3
Image /page/3/Picture/1 description: The image shows a handwritten note with the text "K073310 pg. 4 of 4". The text is written in black ink on a white background. The handwriting is somewhat stylized, with the numbers and letters having a distinct appearance. A black line is present below the text.
Device Technological Characteristics
The technological characteristics of the OASIS Specialty Coils are similar to the predicate devices as listed in Section 7 - Predicate Device Comparison.
Conclusions
It is the opinion of Hitachi Medical Systems America, Inc. that OASIS Specialty Coils substantially equivalent to the listed predicate devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human figures, representing the department's focus on health and human well-being. The text is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2008
Hitachi Medical Corporation % Mr. Doug Thistlethwaite Manager, Regulatory Affairs Hitachi Medical System America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K073310
Trade/Device Name: OASIS CTL Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 19, 2007 Received: November 23, 2007
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.
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.
5
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 (OS) 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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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 yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
6
| 510(k) Number (if known): | K073310 |
|---|---|
| Device Name: | OASIS CTL Coil |
Indications for Use:
The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used for MRI imaging of the human cervical spine, and thoracic spine.
Prescription Use × AND/OR
Over-the-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Tonui Thihhang
(Division Sign-Off) 0 Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
7
| 510(k) Number (if known): | K073310 |
|---|---|
| Device Name: | OASIS QD Flexible Body Coil (L) |
Indications for Use:
The MR-QFC-120, OASIS QD Flexible Body Coil (L.) is a recieve-only multiple array device used for MRI imaging of the abdomen.
Prescription Use Х AND/OR
Over-the-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Tomi M. Why
(Division Sign-Off)
h Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
8
510(k) Number (if known): Device Name: OASIS QD Flexible Body Coil (XL)
Indications for Use:
The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple array device used for MRI imaging of the abdomen.
Prescription Use × AND/OR
Over-the-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Tony K. Whang
on Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
9
| 510(k) Number (if known): | K073310 |
|---|---|
| Device Name: | OASIS Rapid Foot Coil |
Indications for Use:
The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array device used for MRI imaging of the foot.
Prescription Use × AND/OR
Over-the-Counter Use
(21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Louie M. White
(Division Sign Off)
(Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number