(33 days)
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-IBC-120, OASIS RAPID Breast Coil is a recieve-only multiple array . device used for MRI imaging of the breast.
- The MR-NVC-120, OASIS NV Coil is a recieve-only multiple array device used . for MRI imaging of the head and neck.
The MR-IBC-120, OASIS RAPID Breast Coil is a recieve-only multiple array device used for obtaining diagnostic images of the breast with the OASIS MRI System. The MR-NVC-120, OASIS NV Coil is a recieve-only multiple array device used for obtaining diagnostic images of the head and neck with the OASIS MRI System.
The provided 510(k) summary (K080062) for the Hitachi Medical Systems America, Inc. OASIS RAPID Breast Coil and OASIS RAPID NV Coil does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This document is a premarket notification for a Class II medical device, essentially asserting its substantial equivalence to previously cleared predicate devices. The focus of this type of submission is on demonstrating that the new device has "technological characteristics similar to the predicate devices" and is "substantially equivalent" in terms of its intended use, function, and scientific concepts. It is not a clinical performance study demonstrating the device meets specific acceptance criteria for diagnostic accuracy or other performance metrics.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample size, data provenance, number or qualifications of experts, or adjudication methods for any test set.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or human reader improvement with AI assistance. (This device is a receive-only coil, not an AI-powered diagnostic tool, so this would not be applicable).
- Details regarding standalone algorithm performance studies.
- Information on the type of ground truth used.
- Sample size for training sets or how ground truth for training sets was established. (Again, this is a hardware component, not a trainable algorithm).
The document is purely a regulatory submission focused on demonstrating substantial equivalence for an MRI coil, which is a hardware component of an MRI system, not a software algorithm that would typically undergo the types of performance validation studies you're asking about.
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510(k) Summary
K080062
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Submitter Information
| Submitter: | Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44080-2371ph: (330) 425-1313fax: (330) 963-0749 |
|---|---|
| Contact: | Douglas J. Thistlethwaite |
| Date: | January 3, 2008 |
Device Name
| Classification Name: | Coil, magnetic resonance, specialty |
|---|---|
| Classification Number: | 90MOS |
| Trade/Proprietary Name: | OASIS Breast Coil |
| Predicate Device(s): | Biopsy Breast Coil, Model BBC |
| Classification Name: | Coil, magnetic resonance, specialty |
| Classification Number: | 90MOS |
| Trade/Proprietary Name: | OASIS NV Coil |
| Predicate Device(s): | NVA-63-8 Neurovascular Array Coil |
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-IBC-120, OASIS RAPID Breast Coil is a recieve-only multiple array . device used for MRI imaging of the breast.
- The MR-NVC-120, OASIS NV Coil is a recieve-only multiple array device used . for MRI imaging of the head and neck.
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Image /page/1/Picture/1 description: The image shows a handwritten text that appears to be a combination of numbers and letters. The text includes the sequence "K08002" on the top line, followed by "DCI-A01 3" on the second line. The writing style suggests it could be a code, label, or identifier, possibly related to document management or tracking.
Device Description
Function
The MR-IBC-120, OASIS RAPID Breast Coil is a recieve-only multiple array device used for obtaining diagnostic images of the breast with the OASIS MRI System. The MR-NVC-120, OASIS NV Coil is a recieve-only multiple array device used for obtaining diagnostic images of the head and neck with the OASIS MRI System.
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 maqnetic 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-IBC-120. OASIS RAPID Breast Coil is a recieve-only device suitable for imaging the breast. The coil consists of 8 elements. The signal output of each element is independently processed by the MRI system to enhance performance.
The MR-NVC-120, OASIS NV 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.
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Image /page/2/Picture/1 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text includes characters such as 'K', 'O', 'S', '0', '0', '6', '2', 'P', 'g', and '3'. The writing is somewhat stylized and has a slightly rough or imperfect quality, as if written quickly or with a thick marker.
Device Technological Characteristics
The technological characteristics of the OASIS RAPID Breast Coil and OASIS RAPID NV Coil are similar to the predicate devices as listed in Section 10 - Substantial Equivalence Discussion.
Conclusions
It is the opinion of Hitachi Medical Systems America, Inc. that the OASIS RAPID Breast Coil and OASIS RAPID NV Coil are substantially equivalent to the listed predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three horizontal lines forming its body and head. Below the figure are three wavy lines, possibly representing water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 11 2008
Mr. Doug Thistlethwaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K080062
Trade/Device Name: OASIS RAPID NV Coil and OASIS RAPID Breast Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: January 3, 2008 Received: January 9, 2008
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.
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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 not 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 (QS) regulation (21 CFR Part 820); and if applicable, the electionic 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, verrorts volup 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 Cranbliance a 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/cdrb/industry/support/index.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if K080062 known): Device Name: OASIS RAPID Breast Coil
Indications for Use:
The MR-IBC-120, OASIS RAPID Breast Coil is a recieve-only multiple array device used for MRI imaging of the breast.
Prescription Use X
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)
Arnt Arnt Whing
(Division Stan-010
lalon of Reproductive, Abdominal and Hadiological Devices 510(k) Number
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| 510(k) Number (if known): | K080062 |
|---|---|
| Device Name: | OASIS RAPID NV Coil |
Indications for Use:
The MR-NVC-120, OASIS RAPID NV Coil is a recieve-only multiple array device used for MRI imaging of the head and neck.
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)
Vornet Arvohn
(Division Sign Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 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.