R2-MRI ANALYSIS SYSTEM

K043271 · Inner Vision Biometrics Pty, Ltd. · LNH · Jan 21, 2005 · Radiology

Device Facts

• Record ID: K043271
• Device Name: R2-MRI ANALYSIS SYSTEM
• Applicant: Inner Vision Biometrics Pty, Ltd.
• Product Code: LNH · Radiology
• Decision Date: Jan 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

For the objective and reproducible analysis of multi-slice, spin-echo MR data sets of the liver for the measurement of liver R2 and liver iron concentration.

Device Story

Software tool for import/visualization of multi-slice, spin-echo MRI data sets of abdomen; vendor-independent. Principle of operation: fits signal decay curves to image signal intensities at different echo times on voxel-by-voxel basis to determine transverse relaxation rate (R2) images; transforms R2 images via calibration to provide quantitative measure of liver iron concentration in vivo. Used in clinical settings to support clinicians in assessment of liver iron status and clinical research trials. Output provides objective, reproducible liver parameters; assists clinical decision-making regarding iron status and intervention monitoring.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Software-based image processing tool. Operates on multi-slice, spin-echo MRI data sets. Principle: voxel-by-voxel signal decay curve fitting to determine transverse relaxation rate (R2). Vendor-independent. Connectivity: imports MRI data sets.

Indications for Use

Indicated for use as an accessory diagnostic device to present images reflecting magnetic resonance spectra for the determination of iron in the liver. Intended for prescription use.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Medis, MRI (Magnetic resonance Analytical Software System) (K994283)
• Hitachi, Magnetic Resonance Diagnostic Device Version 6 Operating System Software (K961969)

Submission Summary (Full Text)

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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: [phone] |
| | Fax: [phone] |
| Contact in the US: | Mr Greg Holland |
| | Regulatory Specialists Inc. |
| | 3722 Ave. Sausalito |
| | Irvine, CA 92606 |
| | Tel: [phone] |
| | Fax: [phone] |
| 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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Image /page/1/Picture/1 description: The image shows a handwritten note with the word "KOBZZZI" on the top line. The second line contains the text "June 2024". The handwriting is somewhat cursive and slightly difficult to read.

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 Analysis<br>System | Medis, MRI (Magnetic<br>resonance Analytical<br>Software System) | Hitachi, Magnetic<br>Resonance Diagnostic<br>Device Version 6<br>Operating System<br>Software |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Class | II | II | II |
| 510(k) number | N/A | K994283 | K961969 |
| Classification Name | System, Nuclear<br>Magnetic Resonance<br>Imaging, System, Image<br>Processing Radiological | System, Image<br>Processing | System, Nuclear<br>Magnetic Resonance<br>Imaging |
| CFR Section | 892.1000 | 892.1000 | 892.1000 |
| Product Code and<br>Classification Panel | LNH | LNH | LNH |
| | R2-MRI Analysis<br>System | Medis, MRI (Magnetic<br>resonance Analytical<br>Software System) | Hitachi, Magnetic<br>Resonance Diagnostic<br>Device Version 6<br>Operating System<br>Software |
| Device Name | R2-MRI Analysis<br>System | MRI-Magnetic<br>Resonance Analytical<br>Software System | Magnetic Resonance<br>Diagnostic Device |
| Trade/Common Name | R2-MRI Analysis<br>System | MASS (Magnetic<br>resonance Analytical<br>Software System) | Version 6 Operating<br>System Software |
| Description | Software tool to<br>facilitate the import and<br>visualization of<br>multi-slice, spin-echo<br>MRI data sets<br>encompassing the<br>abdomen, with<br>functionality<br>independent of the MRI<br>equipment vendor, to<br>provide objective and<br>reproducible<br>determination of liver<br>parameters to support<br>clinicians in the<br>assessment of liver iron<br>status. | Software tool to<br>facilitate the import and<br>visualization of<br>multi-slice, multi-phase<br>MRI data sets<br>encompassing the<br>cardiac chambers, with<br>functionality<br>independent of the MRI<br>equipment vendor, to<br>provide objective and<br>reproducible<br>determination of cardiac<br>parameters to support<br>clinicians in the<br>assessment of heart<br>function. | Revisions of a software<br>operating system for<br>MR scanners that<br>"include the addition of<br>RF spoiling, SSP for<br>enhanced 3D MRA, RF<br>Fat Suppression, MTC<br>for background<br>suppression, 3D-FSE,<br>3D-FIR, rephrase added<br>to 2D-FSE and 2D-GFE,<br>2D-FIR Dual Contrast,<br>RF coil uniformity<br>image post-processing,<br>and adaptive image<br>post-processing" where<br>"images may be<br>produced in which the<br>contrast is primarily<br>dependent on T1<br>relaxation, T2 relaxation,<br>proton density , or a<br>combination of all three. |
| Intended use | For the objective and<br>reproducible analysis of<br>multi-slice, spin-echo<br>MR data sets of the liver<br>for the measurement of<br>liver R2 and liver iron<br>concentration. | For the objective and<br>reproducible analysis of<br>multi-slice, multi-phase<br>left and right ventricular<br>function from cardiac<br>MR data sets. | "... intended to provide<br>the physician with<br>physiological and<br>clinical information,<br>obtained non-invasively<br>and without the use of<br>ionizing radiation" of<br>"... cross-sectional<br>images that display the<br>internal structure of the<br>head, body, or<br>extremities". |
| Intended purpose(s) | 1. Supporting clinical<br>diagnoses about the<br>status of liver iron<br>concentration.<br>2. Supporting the | "1. Supporting clinical<br>diagnoses about the<br>status of the global and<br>regional function and<br>anatomy of the cardiac<br>chambers. | "Intended to provide the<br>physician with<br>physiological and<br>clinical information,<br>obtained non-<br>invasively." "When |
| | R2-MRI Analysis<br>System | Medis, MRI (Magnetic<br>resonance Analytical<br>Software System) | Hitachi, Magnetic<br>Resonance Diagnostic<br>Device Version 6<br>Operating System<br>Software |
| | decision-making<br>processes.<br>3. Supporting the use<br>in clinical research<br>trials, directed at<br>studying changes in<br>liver iron concentration<br>as a result of<br>interventions. | 2. Supporting the<br>subsequent clinical<br>decision-making<br>processes.<br>3. Supporting the use<br>in clinical research<br>trials, directed at<br>studying changes in<br>function and anatomy of<br>the heart chambers as a<br>result of interventions." | interpreted by a trained<br>physician, these images<br>provide information that<br>can be useful in<br>diagnosis<br>determination."<br>"Diagnostic uses"<br>include "T1, T2, proton<br>density measurements". |
| Image-type utilized | Magnetic Resonance | Magnetic Resonance | Magnetic Resonance |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

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