(520 days)
Not Found
No
The description focuses on quantitative measurement based on physical principles (difference in resonance frequencies) and standard image processing techniques, with no mention of AI or ML terms or methodologies.
No.
The device is described as a software tool that provides information to aid in diagnosis by quantifying triglyceride fat fraction in liver MRI images; it does not directly treat or alleviate a condition.
Yes
The software device is intended for quantitative measurement of triglyceride fat fraction in liver MRI images, and the results, when interpreted by a trained physician, "provide information that can aid in diagnosis."
Yes
The device is described as a "Standalone software application" with functionality "independent of the MRI equipment," indicating it is a software-only device that processes existing MRI data.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The definition of an IVD typically involves the examination of specimens such as blood, urine, tissue, etc., outside of the body (in vitro).
- HepaFat-Scan analyzes images of the human body. The device processes magnetic resonance images (MRI) of the liver, which are generated from within the body. It's analyzing data derived from an imaging modality, not a biological sample.
- The intended use and device description clearly state it processes MRI data. The focus is on analyzing signals from hydrogen nuclei within the liver in situ using MRI technology.
Therefore, HepaFat-Scan falls under the category of a medical device that processes imaging data, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HepaFat-Scan is a software device intended for quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver. It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver.
When interpreted by a trained physician, the results provide information that can aid in diagnosis.
Product codes
90 LNH
Device Description
Standalone software application to facilitate the import visualization of multi-slice, gradient-echo MRI encompassing the abdomen, with functionality independent of the MRI equipment, to provide objective and reproducible determination of the triglyceride fat fraction in magnetic resonance images of the liver. It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance images
Anatomical Site
liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
Accuracy and reproducibility of the quantification of the triglyceride fat fraction has been demonstrated through a combination of bench testing and in-vivo human clinical studies. A phantom was utilized to demonstrate equivalence between different scanner models. Volumetric fat fractions were determined from liver biopsy samples for clinical comparison with HepaFat-Scan using a stereological method based on the Delesse principle, which directly measures volumetric fat fraction. Acceptable agreement was attained when comparing the liver biopsy volumetric fat fraction measurements to the HepaFat-Scan device output over a clinically wide range of liver fat fractions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K122035
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DEC 13 2013
and
sets
data
triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton
510(k) Summary
DATE: October 30th, 2013 SUBMITTED BY: Resonance Health Analysis Services Pty Ltd 278 Stirling Highway Claremont WA 6010 Australia Contact in Australia: Mr Andrew Bathgate Quality Assurance and Regulatory Affairs Manager Tel: +61 8 9286 5300 Fax: +61 8 9286 1179 Mr Greg Holland Contact in the US: Regulatory Specialists Inc. 3722 Ave. Sausalito Irvine, CA 92606 Tel: 949-262-0411 Fax: 949 552 2821 NAME OF DEVICE: HepaFat-Scan CLASSIFICATION NAME: Magnetic Resonance Diagnostic Device (21 CFR 892.1000) FRODUCT CODE: 90 LNH HepaFat-Scan TRADE NAME: PREDICATE DEVICE(S): KI03411: IDEAL IQ Software Option R2-MRI Analysis System K043271: DEVICE DESCRIPTION: Standalone software application to facilitate the import visualization of multi-slice, gradient-echo MRI encompassing the abdomen, with functionality independent of the MRI equipment, to provide objective and reproducible determination of the triglyceride fat fraction in magnetic resonance images of the liver. It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and
density signal in the liver.
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Image /page/1/Picture/0 description: The image shows the logo for Resonancel Health. The logo consists of the word "Resonancel" in a serif font, followed by the word "Health" in a smaller, sans-serif font. To the right of the text is a circular graphic with a pattern of small shapes inside.
INTENDED USE:
HepaFat-Scan is a software device intended for quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver. It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver.
When interpreted by a trained physician, the results provide information that can aid in diagnosis.
SUBSTANTIAL EQUIVALENCE INFORMATION:
The device has been shown to be substantially equivalent to the R2-MRI Analysis System (K043271) and the IDEAL IQ Software Option (K103411). Technological similarities between HepaFat-Scan and the two predicates include:
- . Similar Intended Uses in that the devices utilize MR images to make quantitative measurements of a physiological characteristic of the liver.
- Similar Intended Purposes in that the devices are used to support clinical diagnoses. .
- Devices are stand-alone software applications, independent from the MR scanner.
- . Devices utilize multi-echo and multi slice images.
- Devices facilitate the import, visualization and analysis of MR images. .
In addition. HepaFat-Scan has the following specific technological similarities with the Ideal IQ Software device (K103411):
- . Both devices utilize the resonance frequency differences between water and fat protons in the fat measurements.
- . Both devices incorporate techniques to take into account the effects of T2* on the fat measurement.
- Both devices provide a fat fraction measurement. .
Accuracy and reproducibility of the quantification of the triglyceride fat fraction has been demonstrated through a combination of bench testing and in-vivo human clinical studies. A phantom was utilized to demonstrate equivalence between different scanner models. Volumetric fat fractions were determined from liver biopsy samples for clinical comparison with HepaFat-Scan using a stereological method based on the Delesse principle, which directly measures volumetric fat fraction. Acceptable agreement was attained when comparing the liver biopsy volumetric fat fraction measurements to the HepaFat-Scan device output over a clinically wide range of liver fat fractions.
CONCLUSION
Resonance Health considers the HepaFat-Scan software device to be substantially equivalent to the predicate devices R2-MRI Analysis System (K043271) and the IDEAL IO Software Option (K103411), in respect to safety and effectiveness.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 13, 2013
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD % GREG HOLLAND, CONSULTANT REGULATORY SPECIALIST, INC. 3722 AVENUE SAUSALITO IRVINE CA 92606
Re: K122035
Trade/Device Name: Hepafat Scan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: October 30, 2013 Received: November 04, 2013
Dear Mr. Holland:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Mr. Holland
ﺪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﻮﺿﻮﻋﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/dclault.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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration . Pat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Indications for Use
510(k) Number (if known) K 122035
·
Device Name HepaFat-Scan
Indications for Use (Describe)
HepaFat-Scan is a software device intended for quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver. It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver.
When interpreted by a trained physician, the results provide information that can aid in diagnosis.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | |
|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Michael D. O'Hara |
FORM FDA 3881 (9/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
2017년 10월 1일 1월 1일 1월 14시 1월 14시 1 EF