K Number
K220727
Device Name
inHEART MODELS
Manufacturer
Date Cleared
2022-05-10

(57 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
inHEART MODELS comprises a suite of medical imaging software modules that are intended to provide qualified medical professionals with tools to aid them in reading, interpreting, and treatment planning, inHEART MODELS accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT and MR. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the users are solely responsible for making all final patient management decisions.
Device Description
inHEART MODELS is a suite of medical image processing software tools that enables 3D visualization and analysis of anatomical structures. Specifically, the software modules read DICOM compatible anonymized pre-operative CT and MR images acquired by commercially available imaging devices. These images are then processed to generate 3D models of the anatomy to allow qualified medical professionals to display, review, analyze, annotate, interpret, export, and plan therapeutic interventions. inHEART MODELS includes two non-device Medical Device Data Systems (MDDS) modules that are only intended to transfer, store and convert formats.
More Information

Not Found

No
The summary mentions "image processing" and "3D visualization and analysis" but does not explicitly mention AI, ML, deep learning, or any related terms. The description of the performance study also focuses on traditional image processing and segmentation validation methods.

No
The device aids in treatment planning but does not directly provide therapy. It is a software tool for image processing and visualization, used by medical professionals to make treatment decisions.

No
The "Intended Use" section states that the software provides "tools to aid them in reading, interpreting, and treatment planning," and that "users are solely responsible for making all final patient management decisions." It also explicitly states, "This product is not intended for use with or for the primary diagnostic interpretation of Mammography images." These phrases indicate it is not a primary diagnostic device but rather a tool to assist professionals who make diagnostic decisions.

Yes

The device description explicitly states that inHEART MODELS is a "suite of medical image processing software tools" and mentions that it accepts DICOM images from commercially available imaging devices. It also includes non-device MDDS modules, further indicating its software-only nature. There is no mention of any hardware components being part of the 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.
  • Device function: The description clearly states that inHEART MODELS is a software suite that processes medical images (CT and MR) to generate 3D models of anatomical structures (heart and coronary arteries). It aids qualified medical professionals in reading, interpreting, and treatment planning based on these images.
  • No mention of biological samples: There is no indication that this device interacts with or analyzes any biological samples from the patient. Its input is medical imaging data.

Therefore, inHEART MODELS falls under the category of medical imaging software or medical image processing software, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

inHEART MODELS comprises a suite of medical imaging software modules that are intended to provide qualified medical professionals with tools to aid them in reading, interpreting, and treatment planning, inHEART MODELS accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT and MR. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the users are solely responsible for making all final patient management decisions.

CONTRAINDICATIONS:
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Product codes

LLZ

Device Description

inHEART MODELS is a suite of medical image processing software tools that enables 3D visualization and analysis of anatomical structures. Specifically, the software modules read DICOM compatible anonymized pre-operative CT and MR images acquired by commercially available imaging devices. These images are then processed to generate 3D models of the anatomy to allow qualified medical professionals to display, review, analyze, annotate, interpret, export, and plan therapeutic interventions. inHEART MODELS includes two non-device Medical Device Data Systems (MDDS) modules that are only intended to transfer, store and convert formats.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT and MR

Anatomical Site

Heart, coronary arteries (inferred from "heart models" and "coronary arteries from CT and MR images" when discussing predicate device features)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified medical professionals (including physicians, cardiologists, radiologists, and technicians)

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

CT and MR images were selected for the performance study. In-house analysts generated 3D heart models from the imaging data. Radiologists were designated as ground-truth annotators.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Software verification and validation testing were conducted on all inHEART MODELS software modules and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

inHEART MODELS was considered as a "moderate" level of concern.

In addition, accuracy of segmentations for inHEART MODELS was compared to ground truth and to previously cleared commercially available comparable software tools. All validation criteria were met, and the performance evaluation study demonstrated that output segmentations and measurements on these segmentations for inHEART MODELS were substantially equivalent to previously cleared legally marketed software devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K200973

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

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May 10, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

inHEART, SAS % Audrey Labèque Quality and Regulatory Affairs Manager IHU LIryc - Hôpital Xavier Arnozan-Avenue du Haut Lévêque Pessac. 33600 FRANCE

Re: K220727

Trade/Device Name: inHEART MODELS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 11, 2022 Received: March 14, 2022

Dear Audrey Labèque:

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. Division Director DHT8B: Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K220727

Device Name

inHEART MODELS

Indications for Use (Describe)

inHEART MODELS comprises a suite of medical imaging software modules that are intended to provide qualified medical professionals with tools to aid them in reading, interpreting, and treatment planning, inHEART MODELS accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT and MR. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the users are solely responsible for making all final patient management decisions.

CONTRAINDICATIONS:

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

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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Image /page/3/Picture/0 description: The image shows the logo for inHEART. The logo consists of a blue circle with a swoosh design on the left side, followed by the word "inHEART" in blue, sans-serif font. The "in" is lowercase, while "HEART" is in uppercase.

Chapter 6. 510(k) Summary

Submitter's Name:inHEART, SAS
Address:IHU Liryc – Hôpital Xavier Arnozan
Avenue du Haut Lévêque
33600 Pessac, France
Contact:Audrey Labèque, Quality and Regulatory Affairs Manager
Telephone:+33 5 35 38 19 72
Date:March 11, 2022
Trade Name:inHEART MODELS
Common Name:Picture Archiving and Communications System (PACS)
Classification Name(s):Medical Image Management and Processing System (21 CFR
892.2050)
Classification Number(s):LLZ
Regulatory Class:Class II
Predicate Device:K200973 - Synapse 3D Cardiac Tools, FUJIFILM Healthcare
Americas Corporation

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Image /page/4/Picture/0 description: The image shows the logo for "inHEART". The logo features a stylized letter "O" with a swoosh design extending from the bottom left, transitioning into the word "inHEART" in a sans-serif font. The color scheme is a consistent light blue throughout the logo.

1. Device Description

inHEART MODELS is a suite of medical image processing software tools that enables 3D visualization and analysis of anatomical structures. Specifically, the software modules read DICOM compatible anonymized pre-operative CT and MR images acquired by commercially available imaging devices. These images are then processed to generate 3D models of the anatomy to allow qualified medical professionals to display, review, analyze, annotate, interpret, export, and plan therapeutic interventions. inHEART MODELS includes two non-device Medical Device Data Systems (MDDS) modules that are only intended to transfer, store and convert formats.

inHEART MODELS complies with the following standards:

  • · ISO, 14971 Third Edition 2019-12, Medical devices Application of Risk Management to medical devices
  • . ISO, 15223-1 Third Edition 2016-11-01, Medical devices - Symbols to be used with medical device labels, labeling and information ....
  • . IEC, 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION: Medical device software - Software life cycle processes
  • IEC, 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION: Medical devices -. Part 1 : application of usability engineering to....
  • IEC, /TR 80002-1 Edition 1.0 2009-09, Medical device software Part 1 : Guidance . of the application of ISO 14971 to medical device..
  • IEC, 82304-1 Edition 1.0 2016-10, Health software Part 1 : General requirements . for product safety

2. Indications for Use

inHEART MODELS comprises a suite of medical imaging software modules that are intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. inHEART MODELS accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT and MR. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the users are solely responsible for making all final patient management decisions.

CONTRAINDICATIONS:

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

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3. Comparison of technological characteristics with the predicate device

The inHEART MODELS software is substantially equivalent to the predicate that has already been cleared for USA distribution with 510(k) premarket notification number K200973. Briefly, the subject and predicate devices are based on the following same technological elements:

  • Software tools for the visualization of DICOM compliant CT and MR images ●
  • . Permit specialized measurement of anatomic structures
  • Support for multiple operating systems and computer hardware configurations .
  • Various image processing, meshing and image registration tools supported
  • Support for 2D and 3D visualization tools ●
  • Export of images and reports in various formats .

The following technological differences exist between the subject and predicate device:

  • The subject device is a standalone and web-based software suite whereas the predicate device is standalone and server/client configuration installed on a commercial general-purpose Windows-compatible computer
  • Vessel seqmentation is not available in the predicate device .
  • A software feature to automatically extract the heart and coronary arteries from . CT and MR images available on the predicate device is not available on the subiect device
  • . Some image processing tools used in the subject device were not available in the predicate device (Gaussian filter, frame extraction, merge volumes, meshing tools, navigation through slices, display/hide structures, colors, 3D rendering modes, export formats)

4. Performance data

The following performance data were provided in support of the substantial equivalence determination :

Software verification and validation testing were conducted on all inHEART MODELS software modules and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

inHEART MODELS was considered as a "moderate" level of concern.

In addition, accuracy of segmentations for inHEART MODELS was compared to ground truth and to previously cleared commercially available comparable software tools. CT and MR images were selected for the performance study. In-house analysts generated 3D

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Image /page/6/Picture/0 description: The image is a logo for "inHEART". The logo features a stylized blue circle on the left, with a swoosh-like tail extending from the bottom of the circle. To the right of the circle is the word "inHEART" in blue, with the "in" in lowercase and the "HEART" in uppercase. The logo has a clean and modern design.

heart models from the imaging data. Radiologists were designated as ground-truth annotators. All validation criteria were met, and the performance evaluation study demonstrated that output segmentations and measurements on these segmentations for inHEART MODELS were substantially equivalent to previously cleared legally marketed software devices.

No new safety or efficacy issues were introduced by inHEART MODELS compared to the predicate device. There are no differences in indications for use between the inHEART MODELS and the predicate Synapse 3D Cardiac Tools (K200973).

Furthermore, performance data demonstrate that the functionality, output and clinical usage of inHEART MODELS is substantially equivalent to the predicate device.