(56 days)
The R2-MRI Analysis System is an accessory diagnostic device to International for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron in the liver.
Software tool used as an accessory to an MR scanning machine, to facilitate the import and visualization of data sets encompassing the multi-slice, spin-echo MRI independent of the MRI equipment vendor, to provide objective and reproducible determination of liver parameters to support clinicians in the assessment of liver iron status.
The provided document, a 510(k) summary for the R2-MRI Analysis System, describes the device and its intended use but does not contain specific details about acceptance criteria, a study proving device performance against those criteria, or information on training/test sets as requested.
The 510(k) focuses on demonstrating substantial equivalence to predicate devices. It lists the R2-MRI Analysis System's intended use as: "For the analysis of multi-slice, spin-echo MRI data sets of the liver for the measurement of liver R2 and liver iron concentration." and "Supporting clinical diagnoses about the status of liver iron concentration."
Without a performance study or acceptance criteria outlined in this document, the requested information cannot be directly extracted. The document primarily establishes regulatory classification and comparison to existing devices.
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K04327/
510(k) Submission: R2-MRI Analysis System
JAN 2 1 2005
Inner Vision Biometrics Pty Ltd
510(K) SUMMARY 3.
| SUBMITTED BY: | Inner Vision Biometrics Pty Ltd |
|---|---|
| 216 Stirling Highway | |
| Claremont WA 6010 | |
| Australia | |
| Contact in Australia: | Dr Janet Preuss |
| Quality Assurance and Regulatory Affairs Manager | |
| Tel: +61 8 9286 5307 | |
| Fax: +61 8 9286 5399 | |
| Contact in the US: | Mr Greg Holland |
| Regulatory Specialists Inc. | |
| 3722 Ave. Sausalito | |
| Irvine, CA 92606 | |
| Tel: 949-262-0411 | |
| Fax: 949 552 2821 | |
| DATE: | November 24 2004 |
| NAME OF DEVICE: | R2-MRI Analysis System |
| Classification Name: | System, Image Processing |
| Classification Number: | 892.1000 |
| Trade/Proprietary Name: | R-MRI Analysis System |
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Medis, MRI (Magnetic resonance Analytical PREDICATE DEVICE(S): K994283: Software System) Resonance Diagnostic KARI ARA
Magnetic Hitachi. Device Version 6 Operating System Software
Software tool used as an accessory to an MR scanning DEVICE DESCRIPTION: facilitate the import and visualization of machine, to data sets encompassing the multi-slice, spin-echo MRI independent of the MRI abdomen, with functionality equipment vendor, to provide objective and reproducible determination of liver parameters to support clinicians in the assessment of liver iron status.
- The operational principle of the R2-MRI Analysis System is Scientific Concepts: based on fitting signal decay curves to the image signal intensities (e.g. of the liver) at the different echo times for the MR data set on a voxel-by-voxel (3-D pixel) basis to determine transverse relaxation rate (R2) images, that may be further transformed by a defined calibration to provide a quantitative measure of liver iron concentrations in vivo.
- For the analysis of multi-slice, spin-echo MRI data sets of the INTENDED USE: liver for the measurement of liver R2 and liver iron concentration.
SUBSTANTIAL EQUIVALENCE INFORMATION:
The device has been shown to substantially equivalent to the Medis MRI (Magnetic resonance Analytical Software System) and the Hitachi, Magnetic Resonance Diagnostic Device Version 6 Operating System Software:
| R2-MRI AnalysisSystem | Medis, MRI (Magneticresonance AnalyticalSoftware System) | Hitachi, MagneticResonance DiagnosticDevice Version 6Operating SystemSoftware | |
|---|---|---|---|
| Regulatory Class | II | II | II |
| 510(k) number | N/A | K994283 | K961969 |
| Classification Name | System, NuclearMagnetic ResonanceImaging, System, ImageProcessing Radiological | System, ImageProcessing | System, NuclearMagnetic ResonanceImaging |
| CFR Section | 892.1000 | 892.1000 | 892.1000 |
| Product Code andClassification Panel | LNH | LNH | LNH |
| R2-MRI AnalysisSystem | Medis, MRI (Magneticresonance AnalyticalSoftware System) | Hitachi, MagneticResonance DiagnosticDevice Version 6Operating SystemSoftware | |
| Device Name | R2-MRI AnalysisSystem | MRI-MagneticResonance AnalyticalSoftware System | Magnetic ResonanceDiagnostic Device |
| Trade/Common Name | R2-MRI AnalysisSystem | MASS (Magneticresonance AnalyticalSoftware System) | Version 6 OperatingSystem Software |
| Description | Software tool tofacilitate the import andvisualization ofmulti-slice, spin-echoMRI data setsencompassing theabdomen, withfunctionalityindependent of the MRIequipment vendor, toprovide objective andreproducibledetermination of liverparameters to supportclinicians in theassessment of liver ironstatus. | Software tool tofacilitate the import andvisualization ofmulti-slice, multi-phaseMRI data setsencompassing thecardiac chambers, withfunctionalityindependent of the MRIequipment vendor, toprovide objective andreproducibledetermination of cardiacparameters to supportclinicians in theassessment of heartfunction. | Revisions of a softwareoperating system forMR scanners that"include the addition ofRF spoiling, SSP forenhanced 3D MRA, RFFat Suppression, MTCfor backgroundsuppression, 3D-FSE,3D-FIR, rephrase addedto 2D-FSE and 2D-GFE,2D-FIR Dual Contrast,RF coil uniformityimage post-processing,and adaptive imagepost-processing" where"images may beproduced in which thecontrast is primarilydependent on T1relaxation, T2 relaxation,proton density , or acombination of all three. |
| Intended use | For the objective andreproducible analysis ofmulti-slice, spin-echoMR data sets of the liverfor the measurement ofliver R2 and liver ironconcentration. | For the objective andreproducible analysis ofmulti-slice, multi-phaseleft and right ventricularfunction from cardiacMR data sets. | "... intended to providethe physician withphysiological andclinical information,obtained non-invasivelyand without the use ofionizing radiation" of"... cross-sectionalimages that display theinternal structure of thehead, body, orextremities". |
| Intended purpose(s) | 1. Supporting clinicaldiagnoses about thestatus of liver ironconcentration.2. Supporting the | "1. Supporting clinicaldiagnoses about thestatus of the global andregional function andanatomy of the cardiacchambers. | "Intended to provide thephysician withphysiological andclinical information,obtained non-invasively." "When |
| R2-MRI AnalysisSystem | Medis, MRI (Magneticresonance AnalyticalSoftware System) | Hitachi, MagneticResonance DiagnosticDevice Version 6Operating SystemSoftware | |
| decision-makingprocesses.3. Supporting the usein clinical researchtrials, directed atstudying changes inliver iron concentrationas a result ofinterventions. | 2. Supporting thesubsequent clinicaldecision-makingprocesses.3. Supporting the usein clinical researchtrials, directed atstudying changes infunction and anatomy ofthe heart chambers as aresult of interventions." | interpreted by a trainedphysician, these imagesprovide information thatcan be useful indiagnosisdetermination.""Diagnostic uses"include "T1, T2, protondensity measurements". | |
| Image-type utilized | Magnetic Resonance | Magnetic Resonance | Magnetic Resonance |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2005
Inner Vision Biometrics Pty Ltd. % Mr. Greg Holland Regulatory Consultant 3722 Ave. Sausalito IRVINE CA 92606
Re: K043271
Trade/Device Name: R2-MRI Analysis System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: November 24, 2004 Received: November 26, 2004
Dear Mr. Holland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leveleved your becared by equivalent (for the indications for use stated in above and have deteninmed the at predicate devices marketed in interstate commerce prior to the cliciosure) to regally markets president Device Amendments, or to devices that have been May 26, 1770, the clacinent dato of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordation with the proval application (PMA). You may, therefore, market the do not require approval on a premanes approvisions of the Act. The general controls provisions of the Act device, subject to the general volual 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 (Premarket 11 your device is classinod (300 as 10) and controls. Existing major regulations affecting your Apploval), it may be sabject to addreaderal Regulations, Title 21, Parts 800 to 898. In addition, FDA device can oc round in moncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that F Case of advised that + Dr. I on that your device complies with other requirements of the Act or any For has made a decemination and mistered by other Federal agencies. You must comply with all the I car statues and regulations as and limited to registration and listing (21 CFR Part 807); labeling ACC STEQuirements, mediating practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This fetter will anow you to begin manuting of substantial equivalence of your device to a legally premarket nothication. The I DA midnig of bassification 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 Part 801), please If you desire specific advice tor your correct 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" (21 CFR Also, please note the regulation entires) formation on your responsibilities under the Act from the 807.97). Tou may obtain other general and Consumer Assistance at its toll-free number (800) DVISION of 311an Manufacturers, Internet address http://www.fda.gov/cdrb/dsmadsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. È rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT 2.
510(k) Number (if known): Ko 4 327/
R2-MRI Analysis System Device Name:
The R2-MRI Analysis System is an accessory diagnostic device to Indications For Use: The R. Nr. International for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron in the liver.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
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 Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Nancy C. Brogdon
Olvision Sign-Off) ivision of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Inner Vision Biometrics Pty Ltd
Confidential
Page 10
§ 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.