(221 days)
Not Found
No
The summary describes image analysis software that calculates a specific value (SQuEEZ) based on CT data to assess cardiac function. It mentions image processing and quantitative evaluation but does not use terms like AI, ML, deep learning, neural networks, or describe any training or testing of models, which are typical indicators of AI/ML use in medical devices. The performance studies focus on comparisons to existing methods and software testing, not on validating an AI/ML model.
No
The device is an image analysis software used to assist in assessing function, not to treat a condition.
Yes
The software assists cardiologists and radiologists in assessing heart function by calculating a SQuEEZ value and displaying regional motion properties, which are used to evaluate and understand the state of the heart.
Yes
The device is described as a "post processing image analysis software application" that operates on existing cardiac CT studies. It does not mention 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 SQuEEZ Software analyzes medical images (cardiac CT scans) to assess heart function. It does not analyze biological samples.
- Intended Use: The intended use is to assist cardiologists and radiologists in assessing function based on image analysis, not on the results of a test performed on a biological sample.
Therefore, the SQuEEZ Software falls under the category of medical image analysis software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SQuEEZ Software is an image analysis for cardiac Computer Tomgraphy (CT) studies to assist cardiologists in assessing function when producing a cardiates a Stretch Quantifier for Endocardial Engraved Zones (SQUEZ) value to highlight and color code the wall motions of the heart. Tools are provided to display regional motion properties of the heart.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Cardiowise SQuEEZ Software is a post processing image analysis software application for cardiac Computer Tomography (CT) studies to assist cardiologists and radiologists in assessing left ventricle function when producing a cardiac evaluation. SQuEEZ Software enables a quantitative evaluation of the regional myocardial strain using the data from an ultra-high-resolution cardiac CT scan that requires an acquisition time of as short as a single heartbeat. This is done by calculating a Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ) value to highlight and color code the wall motions of the heart. The resulting analysis is graphically presented in threedimensional color contour maps or regional graphical representations that indicate the level of strain the left ventricle experiences during the cardiac cycle.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cardiac Computer Tomography (CT)
Anatomical Site
cardiac / heart / left ventricle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiologists and radiologists
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)
The following tests were performed to demonstrate safety based on current industry standards:
- Software testing per IEC 62304
- Non-clinical performance testing including:
- Digital phantom study
- Comparison to tagged MRI (magnetic resonance imaging) in acutely infarcted dogs for noninvasive regional myocardial function analysis
The results of these tests indicate that SQuEEZ Software is substantially equivalent to the predicate device. Additionally, a peer-reviewed publication describing a study of SQuEEZ values in human subjects with normal left ventricle function was provided to support a determination of substantial equivalence for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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December 18, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cardiowise, Inc. % Pierre Bounaud, Ph.D. Principal Consultant AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 SAN DIEGO CA 92110
Re: K201250
Trade/Device Name: SQuEEZ Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: November 23, 2020 Received: November 25, 2020
Dear Dr. Bounaud:
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 (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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K201250
Device Name
SQuEEZ Software
Indications for Use (Describe)
The SQuEEZ Software is an image analysis for cardiac Computer Tomgraphy (CT) studies to assist cardiologists in assessing function when producing a cardiates a Stretch Quantifier for Endocardial Engraved Zones (SQUEZ) value to highlight and color code the wall motions of the heart. Tools are provided to display regional motion properties of the heart.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D) [ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
1. Applicant/Submitter
| Company Name: | Cardiowise, Inc. |
|---|---|
| Phone Number: | (479) 571-2592 |
| Company Street Address | 535 W. Research Center Blvd., Suite 135 |
| Fax Number: | (479) 571-8814 |
| City: | Fayetteville |
| State: | AR |
| Country: | USA |
| Zip Code: | 72701 |
2. Contact Person
| Full Name: | John Coats |
|---|---|
| Job Title: | CEO |
| Phone: | (240) 405-8312 |
| Email: | jcoats@cardiowiseinc.com |
3. Correspondent Information
| Full Name: | Pierre Bounaud, Ph.D. |
|---|---|
| Job Title: | Principal Consultant |
| Phone: | (619) 458-9547 |
| Email: | pbounaud@acknowledge-rs.com |
4. Date of Preparation
Date of Preparation:
December 15, 2020
5. Device Information
| Trade Name | SQUEEZ Software |
|---|---|
| Common or Usual Name | Picture archiving and communications system. |
| Classfication Name | 21 CFR 892.2050 |
| Regulatory Class | 2 |
| Product Code | LLZ |
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6. Predicate Device
| Predicate Type | 510(k) Number | Device Name | Manufacturer |
|---|---|---|---|
| Primary Device | K112531 | VITREA CT | VITAL IMAGES, |
| MYOCARDIAL | INC. | ||
| ANALYSIS |
7. Device Description
Cardiowise SQuEEZ Software is a post processing image analysis software application for cardiac Computer Tomography (CT) studies to assist cardiologists and radiologists in assessing left ventricle function when producing a cardiac evaluation. SQuEEZ Software enables a quantitative evaluation of the regional myocardial strain using the data from an ultra-high-resolution cardiac CT scan that requires an acquisition time of as short as a single heartbeat. This is done by calculating a Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ) value to highlight and color code the wall motions of the heart. The resulting analysis is graphically presented in threedimensional color contour maps or regional graphical representations that indicate the level of strain the left ventricle experiences during the cardiac cycle.
8. Intended Use/Indications for Use
The SQuEEZ Software is an image analysis software application for cardiac Computer Tomography (CT) studies to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The software calculates a Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ) value to highlight and color code the wall motions of the heart. Tools are provided to display regional motion properties of the heart.
9. Comparison of Technological Characteristics with Predicate ·
SQuEEZ Software is substantially equivalent to the predicate device based on the information summarized here:
The subject device has the same intended use as the predicate device cleared in K112531, i.e. software application for post-processing analysis of radiological images to assist in the assessment of the regional function of the heart muscle (myocardium).
The subject device and the device cleared in K112531 both use cardiac CT studies as inout for post-processing. The device cleared in K112531 achieves its intended use by evaluating heart tissue density as an indicator of wall thickening. Transmural wall thickening happens during the ventricular relaxation-contraction process, thus indirectly representing heart wall motions. The predicate device includes tools (segmentation, color-coding, polar maps) to visualize hypo/hyperdense areas of the myocardium. The subject device creates an endocardial mesh to directly track the left ventricle movements through the same ventricular relaxation-contraction process. Form the endocardial mesh, the subject device derives a calculated value, SQuEEZ, representing local motion of the endocardial surface. The subject device includes similar visualization tools for its SQuEEZ values as the predicate device (i.e. segmentation, color-coding, polar maps).
Based on the testing performed, including software verification and validation, digital
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phantom study, and animal performance testing, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed SQuEEZ Software are assessed to be substantially equivalent to the predicate device.
10. Performance Data
The following tests were performed to demonstrate safety based on current industry standards:
- . Software testing per IEC 62304
- Non-clinical performance testing including: .
- o Digital phantom study
- o Comparison to tagged MRI (magnetic resonance imaging) in acutely infarcted dogs for noninvasive regional myocardial function analysis
The results of these tests indicate that SQuEEZ Software is substantially equivalent to the predicate device.
Additionally, a peer-reviewed publication describing a study of SQuEEZ values in human subjects with normal left ventricle function was provided to support a determination of substantial equivalence for the subject device.
11. Conclusion
Based on the testing performed, including software testing, digital phantom study, and non-clinical performance testing in animals, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed SQuEEZ Software are assessed to be substantially equivalent to the predicate device.