SUITEHEART by NEOSOFT, LLC | FDA 510(k) Summary

suiteHEART is an analytical software tool. which provides reproducible tools for the review and reporting of medical images. suiteHEART can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization.

A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point, distance, area, and volume measurement tools such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements.

Semi-automatic tools are available for left ventricular contour detection, valve plane detection, vessel contour detection for flow analysis, signal intensity analysis for myocardium and infarct sizing measurement, and T2 star analysis.

The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.

When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.

Device Description

suiteHEART is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. suiteHEART can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in cine mode to facilitate visualization.

Measurement tools on the report interface include: point, distance, area, and volume measurements (including ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements). Semi-automatic tools are available for left ventricular contour detection, valve plane detection, vessel contour detection for flow analysis, signal intensity analysis for myocardium and infarct sizing measurement, T2 Star analysis, and patent foramen ovale (PFO) analysis.

AI/ML Overview

The provided text states that suiteHEART is an analytical software tool that offers reproducible tools for reviewing and reporting medical images. It can import medical images from an MR system and display them. According to the document, semi-automatic tools are available for several medical measurements.

Here's an analysis of the provided information:

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly state specific acceptance criteria with numerical targets or reported performance metrics for the suiteHEART device regarding its semi-automatic tools (e.g., accuracy, sensitivity, specificity, or inter-reader variability improvement). The document focuses on regulatory compliance and substantial equivalence to a predicate device, rather than detailed performance benchmarks.

The summary of non-clinical tests mentions "Performance testing (Verification)" as a quality assurance measure, but the specifics of this performance testing or its results against defined criteria are not detailed.

2. Sample size used for the test set and the data provenance

Sample Size: The document states that "The MR acquired clinical images that were used for the completion of verification and validation testing for suiteHEART was obtained from East Side Medical Radiology, LLC and other third-party facilities under the provisions of a nonsignificant risk investigation for internal volunteer scanning. In addition, multi-vendor anonymized MR contrast-enhanced images were obtained from a third-party clinical research study."
- However, a specific numerical sample size for the test set is not provided.
Data Provenance:
- Images from "East Side Medical Radiology, LLC and other third-party facilities."
- Images were obtained "under the provisions of a nonsignificant risk investigation for internal volunteer scanning." This suggests a prospective collection of data, likely of healthy volunteers or patients undergoing scans for other reasons, with their consent.
- "multi-vendor anonymized MR contrast-enhanced images were obtained from a third-party clinical research study." This implies a retrospective collection from existing studies, anonymized, and from multiple vendors, indicating diversity in the data.
- The country of origin is not explicitly stated, although the submitter is based in Pewaukee, WI, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The text does not detail the process of establishing ground truth for the test set images, nor does it mention the number or qualifications of experts involved in this process.

4. Adjudication method for the test set

This information is not provided in the document. There is no mention of an adjudication method (e.g., 2+1, 3+1, none) used to establish ground truth or resolve discrepancies in the test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: The document does not explicitly state that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The device description primarily focuses on the tool's features and its use by a physician for interpretation, rather than its impact on human reader performance in a controlled study.
Effect Size: Consequently, no effect size or data on human reader improvement with vs. without AI assistance is provided. The statement "When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis" suggests assistive capability but not quantified improvement in a comparative study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes suiteHEART as an "analytical software tool" that provides "reproducible tools for the review and reporting of medical images" and specifically states that "The results of the measurement tools are interpreted by the physician." This indicates that the device is intended for human-in-the-loop performance. While the semi-automatic tools perform tasks like contour detection, the final interpretation and diagnosis are explicitly placed with the physician. Therefore, a standalone (algorithm only) performance assessment, independent of human interpretation, is not described or implied as a primary evaluation method for regulatory submission.

7. The type of ground truth used

The document does not explicitly state the type of ground truth used for the semi-automatic features. For example, it does not specify whether ground truth for ventricular contours or infarct sizing was established by expert consensus, comparison to another imaging modality (e.g., gold standard MRI sequences), or pathology.

8. The sample size for the training set

The document does not provide a specific sample size for the training set. It only mentions the source of images for "verification and validation testing." Typically, training set information is distinct from test set information, and it's not detailed here.

9. How the ground truth for the training set was established

Since the document does not specify the training set or its sample size, it also does not explain how the ground truth for any potential training set was established.

Summary

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Image /page/0/Picture/1 description: The image shows the NEOSOFT logo on the left side of the image. On the right side of the image, it says 510(k) Premarket Notification Submission. Underneath that, it says K130228 Page 1 of 3. In the center of the image, it says 510(k) Summary.

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	December 14, 2012
Submitter:	NeoSoft, LLCN27W23910A Paul RoadPewaukee, WI 53072
	FDA Registration Number: NA
Primary Contact Person:	Jackie SchwabeDirector of InnovationNeoSoft, LLCPhone (262) 522-6120Fax (262) 347-1251
Secondary Contact Person:	Tim RoloffQuality EngineerNeoSoft, LLCPhone (262) 522-6120Fax (262) 347-1251
Device:Trade Name:	suiteHEART
Common/Usual Name:	System, image processing, radiological- Picturearchiving and communications system.
Classification Names:	21CFR 892.2050
Product Code:	LLZ
Predicate Device:
Predicate Device Name:Predicate 510k Number:Predicate Manufacturer:	CardiacVXK121762GE Medical Systems

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Image /page/1/Picture/0 description: The image shows the word "NEOSOFT" in a simple, sans-serif font. To the left of the word is a stylized graphic, possibly representing a globe or abstract shape. The text and graphic are presented in a dark color, contrasting with the lighter background.

Image /page/1/Picture/1 description: The image shows a document with the text "510(k) Premarket Notification Submission" at the top. Below this text is the identifier "K130228" and the page number "Page 2 of 3". The document appears to be part of a submission for premarket notification, likely related to medical devices or equipment.

Device Description:

slice, multi-phase images. Multi-phase sequences of images can be displayed in cine mode to facilitate visualization.

Indications for Use:

The NeoSoft, LLC suiteHEART for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. suiteHEART can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to studies and series of multi-slice, multiphase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization.

The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians. When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.

Technology:

The proposed medical device, suiteHEART, employs the same fundamental scientific technology as its predicate device CardiacVX. The proposed device (suiteHEART) is substantially equivalent to the predicate device because it is a post-processing software option for use on cardiac MR image datasets.

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Image /page/2/Picture/0 description: The image shows the logo for NEOSOFT on the left side of the image. On the right side of the image, the text "510(k) Premarket Notification Submission" is written above the text "K130228 Page 3 of 3". The text on the right side of the image appears to be handwritten.

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

suiteHEART complies with the following voluntary standards: ISO 14971 -Medical devices-Application of Risk management to medical devices, IEC 62304 - Medical device software - Software life cycle processes, and NEMA PS 3.1 -3.20 (2011), Digital Imaging and Communications in Medicine (DICOM). The following quality assurance measures were applied to the development of the system:

· Risk Analysis
· Requirements Reviews
· Design Reviews
· Integration testing (Verification)
· Performance testing (Verification)
· Safety testing (Verification)
· Simulated use testing (Validation)

Summary of Clinical Tests:

The MR acquired clinical images that were used for the completion of verification and validation testing for suiteHEART was obtained from East Side Medical Radiology, LLC and other third-party facilities under the provisions of a nonsignificant risk investigation for internal volunteer scanning. In addition, multi-vendor anonymized MR contrast-enhanced images were obtained from a third- party clinical research study.

Conclusion:

NeoSoft, LLC considers the suiteHEART application to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of two main elements: the HHS symbol and the department's name. The HHS symbol is a stylized representation of a human figure embracing another, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20, 2013

Ms. Jackie Schwabe Director of Innovation NeoSoft, LLC N27 W23910A Paul Road PEWAUKEE WI 53072

Re: K130228

Trade/Device Name: suiteHEART Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 21, 2013 Received: February 4, 2013

Dear Ms. Schwabe:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh.p)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130228

Device Name: suiteHEART

Indications for Use:

The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.

When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Smh. 7)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130228 510(k)

Page 1 of 1

Regulation Number and Section

§ 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).