Caas Qardia

K212376 · Pie Medical Imaging BV · LLZ · May 16, 2022 · Radiology

Device Facts

• Record ID: K212376
• Device Name: Caas Qardia
• Applicant: Pie Medical Imaging BV
• Product Code: LLZ · Radiology
• Decision Date: May 16, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Standalone diagnostic bioimaging software is intended to measure and visualize cardiovascular structures.

Device Story

Caas Qardia is a web-based, standalone or network-integrated software for diagnostic echocardiography. It ingests multi-dimensional echocardiographic images from PACS or local storage. The software enables clinicians to perform segmentation of cardiovascular structures, calculate quantitative indices (e.g., left ventricular ejection fraction, strain, geometric/velocity measurements), and generate reports. The physician reviews the processed images and quantitative overlays to assist in diagnosing cardiovascular conditions. The output is intended to support, not replace, clinical judgment. The device benefits patients by providing standardized, reproducible measurements of cardiac function and structure to aid in clinical decision-making.

Clinical Evidence

Bench testing only. Performance evaluated via comparison of ED/ES volumes, EF, and global longitudinal strain (GLS) against manual annotations and predicate device results. Acceptance criteria included Pearson correlation ≥ 0.7 and ICC ≥ 0.6. Inter- and intra-observer variability for ED/ES volume, EF, and GLS showed Pearson correlation > 0.9. Compliance with ISO 14971, IEC 62304, IEC 62366-1, NEMA PS 3.1-3.20, and IEC 82304-1 verified.

Technological Characteristics

Web-based software for image post-processing. Connectivity via DICOM (NEMA PS 3.1-3.20). Operates in network or standalone environments. Compliant with ISO 13485:2016. Software lifecycle processes per IEC 62304. Usability engineering per IEC 62366-1.

Indications for Use

Indicated for adult populations to support physicians with diagnostics via segmentation, quantification, review, and reporting of cardiac structures based on multi-dimensional echocardiographic images. Not to be used as the sole, irrefutable basis for clinical decision-making.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• TomTec Arena (K201632)

Submission Summary (Full Text)

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Pie Medical Imaging B.V. % Annemiek Bouts Regulatory Affairs Coordinator Philipsweg 1 Maastricht, Limburg 6227 AJ NETHERLANDS

Re: K212376

May 16, 2022

Trade/Device Name: Caas Qardia Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 14, 2022 Received: April 18, 2022

Dear Annemiek Bouts:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K212376

Device Name Caas Qardia

Indications for Use (Describe)

Standalone software for medical intended for advanced visualization and quantitative analysis in adult populations to support physicians with diagnostics by means of enabling segmentation, quantification, review, and reporting of cardiac structures based on multi-dimensional echocardiographic images. Caas Qardia facilitates the following use:

· Segmentation of cardiovascular structures

· Calculation of quantitative indices describing cardiovascular function and structure

When the results provided by Caas Qardia are used in a clinical decision making, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.

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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## 510(k) Summary

#### Caas Qardia – K212376

Pie Medical Imaging BV

| I - General Information | | |
|-------------------------|-----------------------------------------------------------------------|-------------------------|
| Submitter/Owner Name | Pie Medical Imaging BV | |
| Address | Philipsweg 1, 6227 AJ Maastricht, The Netherlands | |
| Phone Number | [phone] | |
| Contact Person | Annemiek Bouts, Regulatory Affairs Coordinator | |
| Email Address | [e-mail] | |
| Preparation Date | 14-Apr-22 | |
| Trade Name | Caas Qardia | |
| Common Name | Caas Qardia | |
| Classification | Regulation Name: | Image Processing System |
| | Regulation Class: | Class II |
| | Regulation Number: | 21 CFR 892.2050 |
| | Classification Product Code: | LLZ |
| Predicate Device | TomTec Arena (K201632, Image Processing System, 21 CFR 892.2050, LLZ) | |

## II - Device Description

Caas Qardia is an image post-processing software package for diagraphy, which offers functionality to view echocardiographic images, to segment cardiovascular structures in these images, to analyze and quantify these cardiovascular structures and to present the analysis results in different formats.

Caas Qardia is a web-based solution for diagnostic echocardiography, intended for usage in a network environment or standalone usage. Caas Qardia is composed of the following key analysis features:

- -Study selection (from PACS server or local data)
- -Image viewing
- -Left ventricular ejection fraction analysis
- -Left ventricular strain analysis
- -Cardiac geometric measurements and velocity measurements
- -Reporting
- -Export of results

Results can be displayed on the screen, printed, or saved in a variety of formats to hard disk, network, PACS system or CD. Results and clinical images with overlay can also be printed as a hardcopy and exported in various electronic formats.

## III - Intended Use and Indications for Use

### Intended Use

Standalone diagnostic bioimaging software is intended to measure and visualize cardiovascular structures.

### Indications for Use

Standalone software for medical image analysis intended visualization and quantitative analysis in adult populations to support physicians with diagnostics by means of enabling segmentation, review, and reporting of cardiac structures based on multi-dimensional images. Caas Qardia facilitates the following use:

- . Segmentation of cardiovascular structures
- Quantification and reporting of cardiovascular function and structure

When the results provided by Caas Qardia are used in a clinical setting to support clinical decision-making, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision- making.

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# IV - Substantial equivalence comparison

The Tomtec Arena clinical software package (K201632) was selected as a predicate device specifically for its ability for review, quantification and reporting of cardiovascular structures and function based on echocardiographic images. Unlike Tomtec Arena, which can be used for cardiovascular, fetal and abdominal on medical data acquired with different modalities, Caas Qardia can only be used for the analysis of cardiovascular structures in adult populations acquired with echocardiographic images. The Tomtec Arena device, amongst others, consists of analysis workflows for left ventricular ejection fraction analysis, left ventricular strain analysis, cardiac performance analysis (geometric and velocity measurements) and features like image viewing and reporting similar to the Caas Qardia device.

The selected device has technological features and characteristics comparable to Caas Qardia and is intended to be used or under supervision of a medical specialist to support clinical decision making of cardiovascular conditions.

The basic features and technology of the new Caas Qardia product are the same in terms of intended use and indications for use and have the same technological characteristics as the predicate device Tomtec Arena (K201632).

Both Caas Qardia and Tomtec Arena (K201632) software applications use the same types of data (echocardiographic images) and operating principles for the user and technology regarding data import, contour definition, image display and storage of results.

# V - Performance Data

Caas Qardia was developed and tested according to PMI's design and has been extensively tested for safety and performance. Non-clinical verification of the Caas Qardia showed that the system requirements – derived from indications for use – as well as risk control measures were implemented correctly, and that the device meets its specifications including conformance to the following recognized consensus standards:

| Consensus standard | Recognition<br>number |
|----------------------------------------------------------------------------------------------|-----------------------|
| ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices | 5-125 |
| IEC 62304:2015 – Medical Device Software – Software Life Cycle Processes | 13-79 |
| IEC 62366-1:2015 – Medical Devices – Application of Usability Engineering to Medical Devices | 5-114 |
| NEMA PS 3.1-3.20 (2016) - Digital Imaging and Communication in Medicine (DICOM) | 12-300 |
| IEC 82304-1:2016 – Health Software – Part 1: General Requirements for Product Safety | 13-97 |

In addition, Caas Qardia is compliant with the international standard ISO13485:2016.

Usability testing is performed in accordance with IEC62366 which demonstrated that the use Cars Qardia for the purpose it was developed for.

Performance testing to demonstrate substantial equivalence to the predicate device was conducted. ED and ES volume calculation and EF determination, directly resulting from segmented contours on clinical images are compared to ED and ES volumes and EF resulting from manually annotated ED and ES contours. The acceptance criteria for ED and ES volume, and EF calculations were as follows: A Pearson correlation of 0.7 or higher, an ICC of at least 0.6 and a bias not more than one pooled standard deviation from zero from the comparison with literature. For all values these acceptance criteria were met.

The global longitudinal strain was evaluated on clinical datasets by performing a comparative test of the results against the predicate device. The acceptance criteria for global longitudinal strain were as follows: A Pearson correlation of 0.7 or higher and an ICC of at least 0.6. For all values these acceptance criteria were met.

Inter- and intra-observer variability was evaluated for the ED and ES volume calculation, EF determination and global longitudinal strain (GLS) calculation. Both inter-observer variability demonstrated acceptable performance with a Pearson correlation higher than 0.9.

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Image /page/5/Picture/0 description: The image shows the logo for PIE Medical Imaging. The logo is set against a blue background. The text "PIE MEDICAL IMAGING" is stacked vertically, with each word on a separate line. The word "IMAGING" is slightly larger than the other words.

The verification and validation results demonstrate the safety and effectiveness of Caas Qardia in relation to its intended use and indications for use and therefore Caas Qardia can be considered as safe and effective as its predicate devices.

# VI - Conclusion

Based on the application of risk management and performance testing inherent to PMI's QA system (compliant with recognized standards as stated above) the conclusion is that Caas Qardia is as safe and effective as its predicate devices in terms of indications for use, technological characteristics, measurements, and operating environment and does not raise any new issues related to safety and effectiveness compared to the predicate devices.