(27 days)
Yes
The summary explicitly states that the device utilizes "Convolutional neural networks for the image analysis," which is a type of artificial intelligence/machine learning. Furthermore, the predicate devices, HepaFat-AI and FerriSmart, are mentioned, and the name "HepaFat-AI" strongly suggests the use of AI in one of the underlying components.
No.
The device is described as software that measures and monitors liver conditions (iron concentration and fat assessment) and aids in diagnosis and monitoring, which are diagnostic and monitoring functions, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states that LiverSmart is indicated to "measure liver iron concentration" and "assess the volumetric liver fat fraction, proton density fat fraction and steatosis grade." It also states that "When interpreted by a trained physician, the results can be used to... monitor liver iron burden," "aid in the identification and monitoring of non-transfusion-dependent thalassemia patients," "monitor liver fat content," and "aid in the assessment and screening of living donors for liver transplant." These are all diagnostic activities.
Yes
The device is described as "software that utilizes two existing FDA cleared devices" and its components are listed as software modules and existing software components from the predicate devices. There is no mention of new hardware being part of the LiverSmart device itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- LiverSmart's Function: LiverSmart analyzes Magnetic Resonance Imaging (MRI) data. MRI is an imaging technique that uses magnetic fields and radio waves to create detailed images of organs and tissues inside the body.
- Input Data: The input data for LiverSmart is DICOM images acquired from MRI scans, not biological samples.
- Analysis Method: LiverSmart processes and analyzes these images to provide measurements of liver iron concentration and liver fat. This is image analysis, not laboratory testing of biological specimens.
Therefore, LiverSmart falls under the category of medical imaging software rather than an in vitro diagnostic device.
No
The input explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found", meaning the letter does not contain the required language to answer "Yes" based on the Key Decision Rules.
Intended Use / Indications for Use
For Liver Iron Concentration:
- measure liver iron concentration in individuals with confirmed or suspected systemic iron overload;
- monitor liver iron burden in transfusion dependents 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.
For Liver Fat Assessment:
- 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.
Product codes
PCS, LNH
Device Description
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Convolutional neural networks for the image analysis.
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologist
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)
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.
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
N/A
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
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Indications for Use
510(k) Number (if known) K213776
Device Name LiverSmart
Indications for Use (Describe) LiverSmart is indicated to:
For Liver Iron Concentration
-
measure liver iron concentration in individuals with confirmed or suspected systemic iron overload;
-
monitor liver iron burden in transfusion dependents 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.
For Liver Fat Assessment
- 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:
-
monitor liver fat content in patients undergoing weight loss management;
-
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)
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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 |
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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).
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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:
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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. |
- Supporting the subsequent clinical
decision-making processes. - 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. - Supporting the subsequent clinical
decision-making processes. - 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. - Supporting the subsequent clinical
decision-making processes. - 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. - 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
- 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.
For Liver Fat Assessment
-
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: -
monitor liver fat content in patients
undergoing weight loss management; -
aid in the assessment and screening of
living donors for liver transplant. | FerriSmart is Indicated to: -
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. | HepaFat-AI is indicated to: -
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: -
monitor liver fat content in patients
undergoing weight loss management; -
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 |
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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.