(65 days)
The Medtronic CardioInsight® Cardiac Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
The Medtronic CardioInsight® Cardiac Mapping System is a non-invasive mapping system for beat-by-beat, multichamber, 3D mapping of the heart. The CardioInsight Cardiac Mapping System displays cardiac maps and virtual electrograms from real-time chest ECG signals (measured by a Sensor Array placed on the torso) and CT scan data. The ECG signals in concert with the CT scan information (geometrical information) are used in mathematical algorithms to transform the measured body surface signals into epicardial signals via solving the cardiac inverse problem. The CardioInsight Cardiac Mapping System software uses this data to provide various cardiac signal analyses and displays interactive 3D color maps including potential, activation, voltage, propagation, and phase maps. The CardioInsight Cardiac Mapping System system is mobile and can be used for mapping at the patient's bedside or in the EP lab.
This looks like a 510(k) summary for the Medtronic CardioInsight® Cardiac Mapping System.
Based on the provided document, the device described is a cardiac mapping system, not an AI/ML algorithm that predicts or diagnoses. Therefore, much of the requested information (like acceptance criteria for AI performance, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable to this device submission.
The document focuses on demonstrating substantial equivalence to a predicate device (ECVUE MAPPING SYSTEM) based on shared intended use, technology, and performance, rather than providing specific performance metrics against clinical acceptance criteria in the context of an AI model's output.
Here's what can be extracted and what is explicitly stated as not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes various performance tests conducted to verify the device's compliance with safety and specifications, and that it "performs as designed." However, it does not present a table of specific clinical acceptance criteria with corresponding performance metrics in the way one would for a diagnostic or predictive AI device. The performance data highlighted are primarily related to electrical safety, mechanical safety, software/firmware verification, algorithm testing (to ensure it met requirements and functioned as intended), packaging validation, and usability testing.
| Performance Area | Acceptance Criteria (Implied/General) | Reported Device Performance |
|---|---|---|
| Overall Performance | Suitable for its intended use, complies with safety and specifications, performs as designed. (General statement, specific quantitative criteria for mapping accuracy are not provided in this summary.) | "Performance testing was completed on the CardioInsight Cardiac Mapping System which verified that the System complies with the safety and specifications and performs as designed; it is suitable for its intended use." "Testing demonstrated that the CardioInsight Cardiac Mapping System met the requirements and functioned as intended." |
| Hardware Verification | Compliance with dimensions, cart functionality, mechanical safety, amplifier mechanical and electrical functionality, and electrical safety. | Verified. |
| Labeling Verification | Compliance with applicable requirements. | Verified. |
| Electrical Safety | Compliance per ANSI/AAMI ES 60601-1:2005/A1:2012, IEC 60601-1:2005/A1:2012, EN 60601 1:2006/A1:2013 (excluding biocompatibility, usability, EMC). | Compliant. |
| EMC/EMI | Compliance per AAMI / ANSI / IEC 60601-1-2:2007/(R)2012. | Compliant. |
| Mechanical Safety | Compliance per ANSI/AAMI ES 60601-1:2005/A1:2012, IEC 60601-1:2005/A1:2012, EN 60601 1:2006/A1:2013 (excluding biocompatibility, usability, EMC). | Compliant. |
| Software/Firmware/Algorithm | Software: Met requirements per "FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and AAMI / ANSI / IEC 62304:2006 (moderate level of concern). Firmware: Met requirements. Algorithms: Met requirements and functioned as intended, and performed as expected when integrated. | Verified. Demonstrated firmware met requirements. Algorithms met requirements and functioned as intended and performed as expected when integrated. |
| Packaging Validation | Met environmental conditioning and simulated shipping per applicable sections of ASTM D4332-14 and ASTM D4169. | Demonstrated. |
| Usability Testing | Performed. | Performed. |
| System V&V (Functionality & Performance) | Performed in a simulated environment. | Performed. |
2. Sample size used for the test set and the data provenance:
- Not Applicable in the traditional AI sense. The document states: "Preclinical and clinical testing were not required for the CardioInsight Cardiac Mapping System." This implies there wasn't a specific "test set" of clinical cases used to evaluate an algorithm's performance against ground truth in the way an AI model would be tested. The validation was primarily system functionality and safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical "test set" was described for an AI algorithm's output, there's no mention of experts establishing ground truth in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-assisted diagnostic device where human reader improvement would be measured. The device provides data and maps for analysis by a physician.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The device is a system for "acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician." It's an instrument providing information to a human. There is no mention of a standalone diagnostic algorithm being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the context of AI performance. The system's "truth" is its ability to accurately acquire and transform ECG and CT data into epicardial signals and maps, which is verified through engineering and functional testing rather than clinical expert ground truth for interpretation.
8. The sample size for the training set:
- Not Applicable. The device is not an AI/ML model that undergoes a "training phase" with a specific dataset. Its algorithms are based on mathematical principles (solving the cardiac inverse problem) and are validated through standard software and system verification.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2016
Medtronic Inc. Laurie Lewandowski Regulatory Associate 8200 Coral Sea St NE Mounds View, MN 55112
Re: K162440
Trade/Device Name: Medtronic CardioInsight® Cardiac Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: October 6, 2016 Received: October 7, 2016
Dear Laurie Lewandowski:
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, 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 (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162440
Device Name
Medtronic CardioInsight® Cardiac Mapping System
Indications for Use (Describe)
The Medtronic CardioInsight Cardiac Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
| 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 Medtronic logo. The logo consists of a gray circular graphic above the company name. The graphic shows a human figure in motion, rotating within the circle. The company name, "Medtronic," is written in a bold, blue font.
510(k) Summary per 21 CFR §807.92
| Date SummaryPrepared: | October 4, 2016 |
|---|---|
| Applicant: | Medtronic (Owner/Operator)CardioInsight Technologies11000 Cedar Avenue Suite 210Cleveland, OH 44106Establishment Registration No.: 3006526833 |
| Primary Contact: | Laurie LewandowskiRegulatory Affairs Specialist (consultant)Telephone: 612-770-4038Email: laurie.a.lewandowski@medtronic.com |
| Alternate Contact: | Kristyn BensonDirector, Regulatory AffairsTelephone 763-526-2523Email: Kristyn.m.benson@medtronic.com |
| Medtronic Inc./AF Solutions8200 Coral Sea Street NEMounds View, MN 55112Fax: 763.367.9903 | |
| Trade Name: | Medtronic CardioInsight® Cardiac Mapping System |
| Common Name: | Electrophysiological cardiac mapping system |
| Classification Name: | Programmable diagnostic computer, |
| Classification &Panel: | Class IICardiovascular |
| Product Code: | DQK |
| Regulation: | 21 CFR 870.1425 |
| Predicate Device(s): | ECVUE MAPPING SYSTEM. (K150990) |
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Image /page/4/Picture/0 description: The image contains the Medtronic logo. The logo features a circular graphic with three stylized human figures in different positions, suggesting movement or transformation. Below the graphic is the word "Medtronic" in a bold, blue sans-serif font. The overall design is clean and corporate, conveying a sense of innovation and healthcare focus.
Device Description:
The Medtronic CardioInsight® Cardiac Mapping System is a non-invasive mapping system for beat-by-beat, multichamber, 3D mapping of the heart. The CardioInsight Cardiac Mapping System displays cardiac maps and virtual electrograms from real-time chest ECG signals (measured by a Sensor Array placed on the torso) and CT scan data. The ECG signals in concert with the CT scan information (geometrical information) are used in mathematical algorithms to transform the measured body surface signals into epicardial signals via solving the cardiac inverse problem. The CardioInsight Cardiac Mapping System software uses this data to provide various cardiac signal analyses and displays interactive 3D color maps including potential, activation, voltage, propagation, and phase maps. The CardioInsight Cardiac Mapping System system is mobile and can be used for mapping at the patient's bedside or in the EP lab.
| SystemComponent | orModel Number |
|---|---|
| CardioInsight CardiacMapping System | CIT 200 |
| Work StationComputer | CIT 200-PC-0001 (w/SW) |
| Sensor Array (Vest) | CIT200-SA-0001 (S) |
| CIT 200-SA-0002 (M) | |
| CIT 200-SA-0003 (L) | |
| CIT 200-SA-0004 (XL) | |
| Cart | 200-WC-0001 |
| Amplifier | CIT 200-AMP-0001 |
| Connector Cables | CIT 200-AMP-0002 Signal Cable (Right) |
| CIT 200-AMP-0003 Signal Cable (Left) | |
| CIT 200-AMP-0004 Signal Cable (Back Left) | |
| CIT 200-AMP-0005 Signal Cable (Back Right) | |
| Patient/GroundReference Cable | CIT 200-AMP-0021 |
Model numbers of the system components are as follows:
Indications for Use: The Medtronic CardioInsight Cardiac Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
The Indications for Use statement is identical to the predicate device.
The CardioInsight Cardiac Mapping System uses the same technology, and Comparison of has the same intended use, fundamental technology, principal of operation and Technological Characteristics performance as the predicate device. Modifications were made for processing capacity and usability.
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| Characteristic | MedtronicCardioInsight CardiacMapping System(Proposed System) | CardioInsightECVUE MappingSystem(Predicate System) |
|---|---|---|
| Intended Use | Identical | For individualsundergoing an EP Study |
| Indications for Use | Identical | The CardioInsightECVUE MappingSystem is intended foracquisition, analysis,display and storage ofcardiacelectrophysiological dataand maps for analysis bya physician |
| System | Cart,Monitor,Core Processor,Keyboard,Mouse,Isolation Transformer,Cabling,Sensor Array,Second Monitor connection | Cart,Monitor,Core Processor,Keyboard,Mouse,Isolation Transformer,Cabling,Sensor Array,Printer,UPS |
| Principal of Operation | Identical | Electrocardiographicpotentials aremeasured from thetorso sensors on thesurface of the body. ACT scan is segmentedto obtain the 3-dimensional locationof each sensor and thedetailed anatomy of theepicardial surface ofthe heart. From thesedata, the system usesmathematicalalgorithms to use thegeometricalinformation totransform themeasured body surfacesignals intoepicardial signals viasolving the cardiacinverse problem |
| Characteristic | MedtronicCardioInsight CardiacMapping System(Proposed System) | CardioInsightECVUE MappingSystem(Predicate System) |
| Software / Firmware /Algorithm | Equivalent functionality –improved usability,reducing manual inputrequired and fixing bugsOTS software | Create patient recordsSegment heart and vestelectrodesAcquire sensor arraysignalsCreate and review maps |
| Off the Shelf Software | Updated to latest versions.Added additional Off theShelf Software to supportfunctionality• Fellow Oak DICOM• Boost C++ Libraries• DevExpress• WPF ComponentsLibrary• Parallel Studio XEComposer | Entity FrameworkSQL Server ExpressOpenInventor 64-bit.NET Framework |
| Performance testing was completed on the CardioInsight Cardiac MappingSystem which verified that the System complies with the safety andspecifications and performs as designed; it is suitable for its intended use. | ||
| Performance testing for the proposed system included the following: | ||
| Hardware Verification compliance with dimensions, cart functionality andmechanical safety as well as the amplifier mechanical and electricalfunctionality and electrical safety.Labeling Verification to applicable requirementsElectrical Safety compliance perANSI/AAMI ES 60601-1:2005/A1:2012IEC 60601-1:2005/A1:2012EN 60601 1:2006/A1:2013All excluding: excluding biocompatibility (cl. 11.7), usability (cl. 1and 15.1), and EMC (cl. 17)EMC/EMI compliance perAAMI / ANSI / IEC 60601-1-2:2007/(R)2012 | ||
| Mechanical Safety compliance perANSI/AAMI ES 60601-1:2005/A1:2012IEC 60601-1:2005/A1:2012EN 60601 1:2006/A1:2013All excluding: excluding biocompatibility (cl. 11.7), usability (cl. 1and 15.1), and EMC (cl. 17) | ||
| with FDA's Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices" and AAMI / ANSI / IEC 62304:2006, MedicalDevice Software - Software Life Cycle Processes. The software in this systemis considered moderate level of concern as failure could contribute to a hazardleading to non-serious injury.Algorithm Testing and Integration – verified the algorithms met requirementsand functioned as intended and when integrated performed as expected. | ||
| Firmware Verification – demonstrated that the firmware met requirementsPackaging Validation was performed and demonstrated that the packaging andthe system met the environmental conditioning and simulated shipping per theapplicable sections of ASTM D4332-14 and ASTM D4169.Usability TestingSystem Verification and Validation testing for functionality and performancein a simulated environment. | ||
| Preclinical and clinical testing were not required for the CardioInsight CardiacMapping System.Testing demonstrated that the CardioInsight Cardiac Mapping System met the | ||
| requirements and functioned as intended. | ||
| Discussion | Minor differences in technology, update of hardware due to obsolescence,removal of the printer that was not used, removal of the UPS for portabilityand not necessary for function of current system and the addition of anoptional second monitor do not change the fundamental technology.Modifications to the software, firmware and algorithms were made forusability, reducing the manual interaction required. Updates were made tofirmware for bug fixes, off the shelf software to update to the latest versionsand additions to support functionality. Indications for use, principals ofoperations and fundamental technology do not change with thesemodifications. | |
| Conclusion | The data presented in this submission demonstrate that the MedtronicCardioInsight Cardiac Mapping System is substantially equivalent to thepredicate device identified in intended use, device design, fundamentaltechnology and performance. |
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Performance Data
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§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).