Who is the manufacturer of LiverSmart?

Resonance Health Analysis Services Pty, Ltd. filed the 510(k) submission for LiverSmart (K213776).

What is the FDA product code for LiverSmart?

PCS. It is classified under 21 CFR 892.1001 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for LiverSmart?

510(k) clearance (submission type: Special).

Does LiverSmart use AI or machine learning?

Yes. LiverSmart (K213776) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like LiverSmart?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like LiverSmart get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

LiverSmart

Q: What are the predicate devices for LiverSmart?

FerriSmart (K182218); HepaFat-AI (K201039).

K213776 · Resonance Health Analysis Services Pty, Ltd. · PCS · Dec 29, 2021 · Radiology

Device Facts

Record ID	K213776
Device Name	LiverSmart
Applicant	Resonance Health Analysis Services Pty, Ltd.
Product Code	PCS · Radiology
Decision Date	Dec 29, 2021
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1001
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Liver Iron Concentration	Convolutional neural networks	—	—	—	—	—	—
Volumetric Liver Fat Fraction	Convolutional neural networks	—	—	—	—	—	—
Proton Density Fat Fraction	Convolutional neural networks	—	—	—	—	—	—
Steatosis Grade	Convolutional neural networks	—	—	—	—	—	—

Indications for Use

For Liver: (i) For the measurement of R2 and iron concentration in the liver from MRI scans. (ii) For quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver, also known as volumetric liver fat fraction (VLFF).

Device Story

LiverSmart is a software platform that consolidates results from two existing FDA-cleared devices, HepaFat-AI and FerriSmart, into a single multiparametric report. The device takes as input a zipped folder containing DICOM MRI datasets acquired via established HepaFat-AI and FerriSmart protocols. It utilizes a Data Preparation Module to sort and route these datasets to the respective analysis engines, which employ convolutional neural networks to process the images. The system produces a summary report containing volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), steatosis grade, and liver iron concentration (LIC). Used in clinical settings by radiologists, the software requires no user input for analysis, minimizing human error. The output provides quantitative metrics that assist physicians in diagnosing and monitoring liver iron overload and fatty liver disease, supporting clinical decision-making and patient management.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing and verification of the data preparation and report generation modules. Testing confirmed that the device correctly detects anomalies in sequence acquisition and produces identical results to the predicate devices when processing the same image datasets.

Technological Characteristics

Standalone software platform; cloud-based or on-site hosting. Utilizes DICOM MRI datasets. Analysis employs convolutional neural networks for image processing, with algorithmic conversion of R2 to LIC and Alpha to VLFF. Complies with ISO 13485 and 21 CFR 820 quality system regulations.

Indications for Use

Indicated for: Liver Iron Concentration: measure liver iron concentration in individuals with confirmed or suspected systemic iron overload; monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions; aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with Deferasirox. Liver Fat Assessment: assess volumetric liver fat fraction, proton density fat fraction, and steatosis grade in individuals with confirmed or suspected fatty liver disease. When interpreted by a trained physician, results can be used to: monitor liver fat content in patients undergoing weight loss management; aid in assessment and screening of living donors for liver transplant.

Regulatory Classification

Identification

The liver iron concentration imaging companion diagnostic for deferasirox is an image processing device intended to aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox. The device calculates a numeric value for liver iron concentration based on magnetic resonance images acquired under controlled conditions. The calculated numeric value is used to assess the need for deferasirox treatment and for monitoring treatment in patients with non-transfusion-dependent thalassemia. The liver iron concentration imaging companion diagnostic for deferasirox is essential to the safe and effective use of deferasirox in patients with non-transfusion-dependent thalassemia.

Special Controls

In combination with the general controls of the FD&C Act, the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox is subject to the following special controls: (1) Labeling must specify instructions for acceptance testing of images prior to processing. (2) Labeling must specify data processing quality assurance protocols. (3) Labeling must specify the sensitivity and specificity of liver iron concentration measurements. (4) Nonclinical and clinical performance testing must be included in the premarket notification submission demonstrating the bias, precision, repeatability, and reproducibility of liver iron concentration measurements.

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include nonclinical and clinical performance testing demonstrating the bias, precision, repeatability, and reproducibility of liver iron concentration measurements. (2) Labeling must include specifying: (i) Instructions for acceptance testing of images prior to processing; (ii) Data processing quality assurance protocols; and (iii) The sensitivity and specificity of liver iron concentration measurements.

Predicate Devices

FerriSmart (K182218)
HepaFat-AI (K201039)

Submission Summary (Full Text)

{0}------------------------------------------------ December 29, 2021 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is the Department of Health & Human Services logo. The text is in blue, with "FDA" in a larger font size than the rest of the text. Resonance Health Analysis Services Pty Ltd Mitchell Wells Official Correspondent 141 Burswood Road Perth, Western Australia 6100 Australia ### Re: K213776 Trade/Device Name: LiverSmart Regulation Number: 21 CFR 892.1001 Regulation Name: Liver Iron Concentrattion Imaging Companion Diagnostic For Deferasirox Regulatory Class: Class II Product Code: PCS, LNH Dated: November 24, 2021 Received: December 2, 2021 Dear Mitchell Wells: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K213776 Device Name LiverSmart Indications for Use (Describe) LiverSmart is indicated to: For Liver Iron Concentration 1. measure liver iron concentration in individuals with confirmed or suspected systemic iron overload; 2. monitor liver iron burden in transfusion dependents and patients with sickle cell disease receiving blood transfusions: 3. aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with Deferasirox. For Liver Fat Assessment 1. assess the volumetric liver fat fraction, proton density fat fraction and steatosis grade in individuals with confirmed or suspected fatty liver disease. When interpreted by a trained physician, the results can be used to: 2. monitor liver fat content in patients undergoing weight loss management; 3. aid in the assessment and screening of living donors for liver transplant. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K213776 # 510(k)SUMMARY This Summary has been prepared in accordance with 21 CFR 807.92. ## GENERAL INFORMATION | Date Prepared | 23 December 2021 | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted by | Resonance Health Analysis Service Pty Ltd 141 Burswood Rd Burswood 6100 AUSTRALIA | | Main Contact | Mr Mitchell Wells Managing Director mitchellw@resonancehealth.com Tel: +61 8 9286 5300 Fax: +61 8 9286 5399 | | US Contact (US Agent) | Michael van der Woude Director & GM Emergo Global Representation LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 Phone: 512 3279997 Fax: 512 3279998 Email: USAgent@ul.com | # DEVICE INFORMATION | Name of Device | LiverSmart | |------------------------|-----------------------| | Trade/proprietary Name | LiverSmart™ | | Classification | Class II | | Product Code | 90-PCS and LNH | | CFR Section | 892.1001 and 892.1000 | | Panel | Radiology | {4}------------------------------------------------ #### Description of the Device LiverSmart is software that utilizes two existing FDA cleared devices, HepaFat-AI (K201039) and FerriSmart (K182218) and combines their respective results into a singular consolidated multiparametric 'LiverSmart' report. LiverSmart automatically sorts and sends magnetic resonance imaging (MRI) datasets to each of the existing HepaFat-AI and FerriSmart devices and then receives results from those devices to generate a summary report which combines the HepaFat-AI results (an estimate of the patient's volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), steatosis grade), and the FerriSmat result (an estimate of the patient's liver iron concentration (LIC)). To conduct analysis, the user simply uploads a single zipped folder containing HepaFat-AI and FerriSmart DICOM images, acquired in accordance with their respective acquisition protocols, to the LiverSmart software. No user input is required for the analysis thereby minimising the impact of human error. The LiverSmart software requires image input data that has been acquired in accordance with the existing and now well established HepaFat-AI (K201039) and FerriSmart (K182218) imaging protocols. LiverSmart has two new components that are in addition to the existing components of HepaFat-AI and FerriSmart, namely a: - (i) Data Preparation Module; and - (ii) Report Generation Module The rest of the components for LiverSmart are the existing components of the FDA cleared HepaFat-AI and FerriSmart devices, as follows: For HepaFat-AI: - (i) Magnetic Resonance Imaging Protocol - (ii) HepaFat-AI Analysis Software - (iii) Volumetric Liver Fat Fraction Measurement - (iv) Proton Density Fat Fraction Measurement - (v) Steatosis Grade Measurement For FerriSmart: - (i) Magnetic Resonance Imaging Protocol - (ii) FerriSmart Analysis Software - (iii) Liver Iron Concentration Measurement The above HepaFat-AI and FerriSmart components are the same as previously provided to the FDA as the time HepaFat-AI and FerriSmart regulatory clearances were sought (and subsequently obtained). #### Intended Use For Liver: - (i) For the measurement of R2 and iron concentration in the liver from MRI scans. - (ii) For quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver, also known as volumetric liver fat fraction (VLFF). {5}------------------------------------------------ ### Indications for Use LiverSmart is indicated to - For Liver Iron Concentration: - (i) measure liver iron concentration in individuals with confirmed or suspected systemic iron overload; - (ii) monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions; and - (iii) aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with Deferasirox. For Liver Fat Assessment: - (i) Assess the volumetric liver fat fraction, proton density fat fraction and steatosis grade in individuals with confirmed or suspected fatty liver disease. when interpreted by a trained physician the results can be used to: - (ii) Monitor liver fat content in patients undergoing weight loss management; and - (iii) Aid in the assessment and screening of living donors for liver transplant #### PREDICATE INFORMATION LiverSmart is substantially equivalent to (and is a combination of) the following Resonance Health existing 510(k) cleared devices: - FerriSmart - K182218 - HepaFat-AI - K201039 {6}------------------------------------------------ ### SUBSTANTIAL EQUIVALENCE INFORMATION The table below summarizes the main similarities and differences between LiverSmart and the predicates. | | LiverSmart (Subject Device) | FerriSmart (Predicate) | HepaFat-AI (Predicate) | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Class | II | II | II | | 510(k) number | K213776 | K182218 | K201039 | | Classification Name | Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox System, Nuclear Magnetic Resonance Imaging, System, Image Processing Radiological | Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox | System, Nuclear Magnetic Resonance Imaging, System, Image Processing Radiological | | CFR Section | 892.1001 and 892.1000 | 892.1001 | 892.1000 | | Product Code and Classification Panel | 90 PCS and 90 LNH | 90 PCS | 90 LNH | | Description | Standalone software package that automatically analyses magnetic resonance imaging (MRI) datasets to generate an estimate of the patient's volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), steatosis grade, and liver iron concentration (LIC). LiverSmart evaluates images acquired using the FerriSmart and HepaFat-AI protocols and analyses the acquired data to produce a 'multi- parametric' reporting both fat metrics and LIC. | Standalone software package that automatically analyses multi-slice, spin- echo MRI data sets encompassing the abdomen to provide objective and reproducible determination of liver parameters to support clinicians in the assessment of liver iron status. The software tool determines the signal decay rate (R2) that is used to characterize iron loading in the liver, which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentrations in vivo. | Standalone software platform designed to automatically analyse within seconds magnetic resonance imaging (MRI) datasets to generate an estimate of the patient's volumetric liver fat fraction (VLFF), converted into proton density fat fraction (PDFF) and steatosis grade. No user input is required for the analysis thus minimising the impact of human error on obtained results. | | | LiverSmart (Subject Device) | FerriSmart (Predicate) | HepaFat-AI (Predicate) | | Technology | Convolutional neural networks for the image analysis. Algorithmic for the image's quality checks, R2 conversion into LIC, and Alpha conversion into VLFF. | Convolutional neural networks for the image analysis. Algorithmic for the image's quality checks and R2 conversion into LIC. | Convolutional neural networks for the image analysis. Algorithmic for the image's quality checking and Alpha conversion into VLFF. | | Intended purpose(s) | 1. Supporting clinical diagnoses about the status of LIC and the status of liver fat content. 2. Supporting the subsequent clinical decision-making processes. 3. Supporting the use in clinical research trials, directed at studying changes in LIC and liver fat as a result of interventions. | 1. Supporting clinical diagnoses about the status of LIC. 2. Supporting the subsequent clinical decision-making processes. 3. Supporting the use in clinical research trials, directed at studying changes in LIC as a result of interventions. | 1. Supporting clinical diagnoses about the status of liver fat content. 2. Supporting the subsequent clinical decision-making processes. 3. Supporting the use in clinical research trials, directed at studying changes in liver fat as a result of interventions. | | Intended Use | 1. For the measurement of R2 and iron concentration in the liver from MRI scans. 2. For quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver, also known as volumetric liver fat fraction (VLFF). | 1. Measurement of R2 and iron concentration in the liver from MRI scans | 1. For quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver, also known as volumetric liver fat fraction (VLFF). *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. | | | LiverSmart (Subject Device) | FerriSmart (Predicate) | HepaFat-AI (Predicate) | | Indications | LiverSmart is indicated to: For Liver Iron Concentration 1. measure liver iron concentration in individuals with confirmed or suspected systemic iron overload; 2. monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions; 3. aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with Deferasirox. For Liver Fat Assessment 1. assess the volumetric liver fat fraction, proton density fat fraction and steatosis grade in individuals with confirmed or suspected fatty liver disease. When interpreted by a trained physician, the results can be used to: 2. monitor liver fat content in patients undergoing weight loss management; 3. aid in the assessment and screening of living donors for liver transplant. | FerriSmart is Indicated to: 1. measure liver iron concentration in individuals with confirmed or suspected systemic iron overload; 2. monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions; 3. aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with Deferasirox. | HepaFat-AI is indicated to: 1. assess the volumetric liver fat fraction, proton density fat fraction and steatosis grade in individuals with confirmed or suspected fatty liver disease. When interpreted by a trained physician, the results can be used to: 2. monitor liver fat content in patients undergoing weight loss management; 3. aid in the assessment and screening of living donors for liver transplant. | | User | Radiologist | Radiologist | Radiologist | | Hosting platform | Cloud-based or on-site hosting | Cloud-based or on-site hosting | Cloud-based or onsite platform | | | LiverSmart (Subject Device) | FerriSmart (Predicate) | HepaFat-AI (Predicate) | | Image-type utilized | Magnetic Resonance | Magnetic Resonance | Magnetic Resonance | | Image format | DICOM | DICOM | DICOM | | Data Acquisition method | Single Spin Echo (SSE) Gradient Recalled Echo (GRE) | Single Spin Echo (SSE) | Gradient Recalled Echo (GRE) | | Anatomical Sites | Liver | Liver | Liver | | Analysis System Components | LiverSmart: (i) Data Preparation Module; and (ii) Report Generation Module FerriSmart: (i) Magnetic Resonance Imaging Protocol; (ii) FerriSmart Analysis Software; and (iii) Liver Iron Concentration Measurement. HepaFat-AI: (i) Magnetic Resonance Imaging Protocol; (ii) HepaFat-AI Analysis Software; (iii) Volumetric Liver Fat Fraction Measurement; (iv) Proton Density Fat Fraction Measurement | (i) Magnetic Resonance Imaging Protocol (ii) FerriSmart Analysis Software (iii) Liver Iron Concentration Measurement | (i) Magnetic Resonance Imaging Protocol (ii) HepaFat-AI Analysis Software (iii) Volumetric Liver Fat Fraction Measurement (iv) Proton Density Fat Fraction Measurement (v) Steatosis Grade Measurement | | | LiverSmart (Subject Device) | FerriSmart (Predicate) | HepaFat-AI (Predicate) | | Result report content | (v) Steatosis Grade Measurement Page 1 (i) Report No., patient ID, patient name and date of birth for full identification of the patient. (ii) Scan date, and analysis date. (iii) Referrer and MRI centre. (iv) Results displayed: LIC (mg/g dry tissue), LIC (mmol/kg dry tissue), associated with confidence intervals and normal range. (v) Results displayed: VLFF (%), PDFF (%) and Steatosis grade, associated with confidence intervals and normal range. | (i) Patient ID, patient name and date of birth forfull identification of the patient. (ii) Scan date, and analysis date. (iii) Referrer and MRI centre. (iv) Results displayed: LIC (mg/g dry tissue), LIC (mmol/kg dry tissue), associated with confidence intervals and normal range. (v) Pictures of the 5 TEs of the analysed slice. (vi) LIC thresholds table | (i) Patient ID, patient name and date of birth for full identification of the patient. (ii) Scan date, and analysis date. (iii) Referrer and MRI centre. (iv) Results displayed: VLFF (%), PDFF (%) and Steatosis grade, associated with confidence intervals and normal range. (v) NASH-CRN Steatosis Grading Guide (vi) Pictures of the 3 TEs of the analysed slice. (vii) Liver colour map (for illustration purpose only, not for diagnostic) | | | Page 2 As per FerriSmart report Page 3 As per HepaFat-AI report | | | | Result report format | HTML and PDF | HTML and PDF | HTML and PDF | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ ## SUMMARY OF CHANGE(S) LiverSmart consists of two additional modules, over and above the FerriSmart and HepaFat-AI modules; - (i) the Data Preparation Module, and - (ii) the Report Generation Module. ## PERFORMANCE PARAMETERS No change from the predicates, FerriSmart (K182218) and HepaFat-AI (K201039). #### SUMMARY OF DESIGN CONTROL ACTIVITIES Hazard analysis has been performed and documented. Hazard analysis is included in this submission. The test methods used are the same as those documented in the previously cleared submissions of the predicate devices, FerriSmart (K182218) and HepaFat-AI (201039). A statement of conformity with design controls is included in this submission. ### SAFETY LiverSmart is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. LiverSmart is based upon the same technologies, operating principle, and software technology as the two predicate devices. Risk activities were conducted in concurrence with established medical device development standards and guidance. ### TESTING Risk analy sis and verification testing conducted are documented and included in this submission, which demonstrate that the performance requirements have been met. ### SUBSTANTIAL EQUIVALENCE Verification testing confirms that the data preparation module of LiverSmart detects anomalies in the sequence acquisition and reports the accurate error message. If an error is detected LiverSmart prevents further analysis. Additionally, LiverSmart yields identical results for VLFF, PDFF, steatosis grade, and LIC, when the same image datasets are analysed by HepaFat-AI and FerriSmart devices independently. ### CONCLUSION The special 510(k) premarket notification for LiverSmart contains adequate information and data to enable the FDA-CDRH to determine substantial equivalence to the predicate devices. Resonance Health believes that enough evidence has been presented in this dossier to conclude that LiverSmart is safe, effective and performs as well as two the predicates.

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