(167 days)
The Hitachi Oasis MRI with Spectroscopy is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination.
This package is indicated for use as follows:
Anatomical Region: Head, whole body Nuclei Excited: "H
MR Spectroscopy is an imaging and analysis feature that can provide unique information about tissue within a human body. Spectroscopy can be used to complement or augment information and images obtained through other MR imaging and analysis techniques.
The acquisition of spectroscopic information is fundamentally the same as for other MR imaging techniques. For example, a modified spin echo sequence is used to collect data for one or more voxels of tissue. This data collection utilizes existing MR hardware and software, for example, the main magnetic field, gradient coils, RF transmitter, RF receiver coils, and memory or "K-Space".
The analysis of the collected data is what differentiates MR Spectroscopy from other more conventional MR imaging and analysis techniques. The data that is collected from the MR pulse sequence as described above is processed through MR spectroscopy algorithms. After computation and analysis on this data, information is displayed for the operator/reviewer. Spectroscopy data may be displayed in multiple ways, for example as data, graphs or images.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Hitachi Oasis MRI with Spectroscopy:
Device: Oasis MRI with Spectroscopy
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness is identical to the predicate device. | The submitter states: "The safety and effectiveness of this MR Spectroscopy Package is identical to the predicate device. The addition of this package does not impact the safety and effectiveness of the Oasis MRI system (K072279)." |
| Intended Use is identical to the listed predicate device. | The submitter states: "The intended use is identical to the listed predicate device." |
| Provides information based on relative concentrations of metabolites in body tissues. | The device is described as providing "information based on relative concentrations of metabolites in body tissues." |
| NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. | The device is described as providing "NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift." |
| Spectral data, when interpreted by a trained medical practitioner, provides information useful in diagnosis determination. | It is stated that "When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination." |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not specify a separate test set, its sample size, or the provenance of any data used for a performance study. The submission relies on substantial equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as the submission relies on substantial equivalence and does not detail a separate performance study with a test set requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided as the submission relies on substantial equivalence and does not detail a separate performance study with a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this submission. The basis for approval is substantial equivalence to a predicate device, not a head-to-head comparison demonstrating improved human reader performance with AI assistance.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study of the algorithm without human-in-the-loop performance was not performed or reported in this submission. The document describes the system as a diagnostic device where the spectral data is "interpreted by a trained medical practitioner."
7. Type of Ground Truth Used
The concept of a "ground truth" for a performance study is not directly applicable or mentioned in this submission, as the basis for approval is substantial equivalence to a predicate device rather than a de novo clinical performance study against a defined ground truth. The device's utility is described as providing information useful in diagnosis when interpreted by a medical practitioner.
8. Sample Size for the Training Set
This information is not provided. The submission does not describe the development or training of new algorithms for which a training set would be required. It focuses on the capabilities of the spectroscopy package using existing MR hardware and software.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, as a training set and its ground truth establishment are not discussed in the context of this substantial equivalence submission.
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| Submitter: | Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44080-2371ph: (330) 425-1313fax: (330) 425-1410 |
|---|---|
| Contact: | Douglas J. Thistlethwaite |
| Date: | 9/23/09 |
Device Name
| Classification Name: | System, Nuclear Magnetic Resonance Imaging |
|---|---|
| Classification Number: | 90LNI |
| Trade/Proprietary Name: | Oasis MRI with Spectroscopy |
| Predicate Device(s): | Echelon MR Spectroscopy Package (K071506) |
Device Intended Use
The Hitachi Oasis MRI with Spectroscopy is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination.
This package is indicated for use as follows:
Anatomical Region: Head, whole body Nuclei Excited: "H
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Device Description
MR Spectroscopy is an imaging and analysis feature that can provide unique information about tissue within a human body. Spectroscopy can be used to complement or augment information and images obtained through other MR imaging and analysis techniques.
The acquisition of spectroscopic information is fundamentally the same as for other MR imaging techniques. For example, a modified spin echo sequence is used to collect data for one or more voxels of tissue. This data collection utilizes existing MR hardware and software, for example, the main magnetic field, gradient coils, RF transmitter, RF receiver coils, and memory or "K-Space".
The analysis of the collected data is what differentiates MR Spectroscopy from other more conventional MR imaging and analysis techniques. The data that is collected from the MR pulse sequence as described above is processed through MR spectroscopy algorithms. After computation and analysis on this data, information is displayed for the operator/reviewer. Spectroscopy data may be displayed in multiple ways, for example as data, graphs or images.
Safety and Effectiveness
The safety and effectiveness of this MR Spectroscopy Package is identical to the predicate device. The addition of this package does not impact the safety and effectiveness of the Oasis MRI system (K072279).
Conclusions
It is the opinion of Hitachi Medical Systems America, Inc. that the Oasis MRI system with Spectroscopy is substantially equivalent to the listed predicate device. The intended use is identical to the listed predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an abstract caduceus, which is a symbol often associated with healthcare. The caduceus is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
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
MAR 1 5 2010
Mr. Doug Thistlethwaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K093044
Trade/Device Name: Oasis MRI System with Spectroscopy Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNI Dated: March 5, 2010 Received: March 8, 2010
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 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
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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 2000). This letter will allow you to begin marketing your device as described in your Section 5 04/1) memarket 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 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of advertancevents 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 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.
Donald J. Trump
Donald J. St.Pierre 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): K093044
Device Name: Oasis MRI System with Spectroscopy
Indications for Use:
The Hitachi Oasis MRI with spectroscopy is intended for use as a non-invasive diagnostic device that provides information based on relative concentration of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination.
Anatomical Region: Head, body, spine, extremities Nucleus excited: proton Diagnostic uses: T1, T2, proton density weighted imaging, diffusion weighted imaging, MR angiography, Image processing, spectroscopy, whole body
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
DA
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K043044
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§ 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.