(65 days)
Not Found
No
The description mentions "mathematical algorithms" to solve the cardiac inverse problem and provide various analyses and displays. While this involves complex calculations, there is no mention of AI, ML, training sets, or learning processes, which are characteristic of AI/ML technologies. The performance studies focus on verification against specifications and standards, not on evaluating the performance of a learning model.
No.
The device is intended for the acquisition, analysis, display, and storage of cardiac electrophysiological data and maps for analysis by a physician, which are diagnostic functions. It does not provide any treatment or therapy.
Yes
The device is intended for "acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician," which directly supports clinical analysis and diagnosis of cardiac conditions.
No
The device description explicitly mentions a "Sensor Array placed on the torso" and the performance studies include "Hardware Verification compliance" and "Firmware Verification," indicating the system includes hardware components beyond just software.
Based on the provided information, the Medtronic CardioInsight® Cardiac Mapping System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- CardioInsight Function: The CardioInsight system works by acquiring and analyzing electrical signals from the body surface (ECG) and combining them with anatomical information from a CT scan to create 3D maps of the heart's electrical activity. It does not analyze biological specimens (blood, tissue, etc.) in a laboratory setting.
- Intended Use: The intended use is for "acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician." This focuses on the electrical and anatomical aspects of the heart, not the analysis of biological samples.
Therefore, the CardioInsight system falls under the category of a medical device used for diagnostic purposes, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DQK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
real-time chest ECG signals (measured by a Sensor Array placed on the torso) and CT scan data.
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / patient's bedside or in the EP lab.
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)
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.
Performance testing for the proposed system included the following:
Hardware Verification compliance with dimensions, cart functionality and mechanical safety as well as the amplifier mechanical and electrical functionality and electrical safety.
Labeling Verification to applicable requirements
Electrical Safety compliance per ANSI/AAMI ES 60601-1:2005/A1:2012 IEC 60601-1:2005/A1:2012 EN 60601 1:2006/A1:2013 All excluding: excluding biocompatibility (cl. 11.7), usability (cl. 1 and 15.1), and EMC (cl. 17)
EMC/EMI compliance per AAMI / ANSI / IEC 60601-1-2:2007/(R)2012
Mechanical Safety compliance per ANSI/AAMI ES 60601-1:2005/A1:2012 IEC 60601-1:2005/A1:2012 EN 60601 1:2006/A1:2013 All excluding: excluding biocompatibility (cl. 11.7), usability (cl. 1 and 15.1), and EMC (cl. 17)
with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and AAMI / ANSI / IEC 62304:2006, Medical Device Software - Software Life Cycle Processes. The software in this system is considered moderate level of concern as failure could contribute to a hazard leading to non-serious injury.
Algorithm Testing and Integration – verified the algorithms met requirements and functioned as intended and when integrated performed as expected.
Firmware Verification – demonstrated that the firmware met requirements
Packaging Validation was performed and demonstrated that the packaging and the system met the environmental conditioning and simulated shipping per the applicable sections of ASTM D4332-14 and ASTM D4169.
Usability Testing
System Verification and Validation testing for functionality and performance in a simulated environment.
Preclinical and clinical testing were not required for the CardioInsight Cardiac Mapping System.
Testing demonstrated that the CardioInsight Cardiac Mapping System met the requirements and functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ECVUE MAPPING SYSTEM. (K150990)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Summary
| Prepared: | October 4, 2016 |
|---|---|
| Applicant: | Medtronic (Owner/Operator) |
| CardioInsight Technologies | |
| 11000 Cedar Avenue Suite 210 | |
| Cleveland, OH 44106 | |
| Establishment Registration No.: 3006526833 | |
| Primary Contact: | Laurie Lewandowski |
| Regulatory Affairs Specialist (consultant) | |
| Telephone: 612-770-4038 | |
| Email: laurie.a.lewandowski@medtronic.com | |
| Alternate Contact: | Kristyn Benson |
| Director, Regulatory Affairs | |
| Telephone 763-526-2523 | |
| Email: Kristyn.m.benson@medtronic.com | |
| Medtronic Inc./AF Solutions | |
| 8200 Coral Sea Street NE | |
| Mounds View, MN 55112 | |
| Fax: 763.367.9903 | |
| Trade Name: | Medtronic CardioInsight® Cardiac Mapping System |
| Common Name: | Electrophysiological cardiac mapping system |
| Classification Name: | Programmable diagnostic computer, |
| Classification & | |
| Panel: | Class II |
| Cardiovascular | |
| Product Code: | DQK |
| Regulation: | 21 CFR 870.1425 |
| Predicate Device(s): | ECVUE MAPPING SYSTEM. (K150990) |
4
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.
| System
Component | or
Model Number |
|-----------------------------------------|--------------------------------------------|
| CardioInsight Cardiac
Mapping System | CIT 200 |
| Work Station
Computer | 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/Ground
Reference 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.
5
Image /page/5/Picture/0 description: The image contains the Medtronic logo. The logo features a stylized graphic of a human figure in motion, depicted in a circular frame. Below the graphic is the word "Medtronic" in a bold, sans-serif typeface, with the letters in a dark blue color.
| Characteristic | Medtronic
CardioInsight Cardiac
Mapping System
(Proposed System) | CardioInsight
ECVUE Mapping
System
(Predicate System) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Identical | For individuals
undergoing an EP Study |
| Indications for Use | Identical | The CardioInsight
ECVUE Mapping
System is intended for
acquisition, analysis,
display and storage of
cardiac
electrophysiological data
and maps for analysis by
a 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 | Electrocardiographic
potentials are
measured from the
torso sensors on the
surface of the body. A
CT scan is segmented
to obtain the 3-
dimensional location
of each sensor and the
detailed anatomy of the
epicardial surface of
the heart. From these
data, the system uses
mathematical
algorithms to use the
geometrical
information to
transform the
measured body surface
signals into
epicardial signals via
solving the cardiac
inverse problem |
| Characteristic | Medtronic
CardioInsight Cardiac
Mapping System
(Proposed System) | CardioInsight
ECVUE Mapping
System
(Predicate System) |
| Software / Firmware /
Algorithm | Equivalent functionality –
improved usability,
reducing manual input
required and fixing bugs
OTS software | Create patient records
Segment heart and vest
electrodes
Acquire sensor array
signals
Create and review maps |
| Off the Shelf Software | Updated to latest versions.
Added additional Off the
Shelf Software to support
functionality
• Fellow Oak DICOM
• Boost C++ Libraries
• DevExpress
• WPF Components
Library
• Parallel Studio XE
Composer | Entity Framework
SQL Server Express
OpenInventor 64-bit
.NET Framework |
| 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. | | |
| Performance testing for the proposed system included the following: | | |
| Hardware Verification compliance with dimensions, cart functionality and
mechanical safety as well as the amplifier mechanical and electrical
functionality and electrical safety.
Labeling Verification to applicable requirements
Electrical Safety compliance per
ANSI/AAMI ES 60601-1:2005/A1:2012
IEC 60601-1:2005/A1:2012
EN 60601 1:2006/A1:2013
All excluding: excluding biocompatibility (cl. 11.7), usability (cl. 1
and 15.1), and EMC (cl. 17)
EMC/EMI compliance per
AAMI / ANSI / IEC 60601-1-2:2007/(R)2012 | | |
| Mechanical Safety compliance per
ANSI/AAMI ES 60601-1:2005/A1:2012
IEC 60601-1:2005/A1:2012
EN 60601 1:2006/A1:2013
All excluding: excluding biocompatibility (cl. 11.7), usability (cl. 1
and 15.1), and EMC (cl. 17) | | |
| | with FDA's Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices" and AAMI / ANSI / IEC 62304:2006, Medical
Device Software - Software Life Cycle Processes. The software in this system
is considered moderate level of concern as failure could contribute to a hazard
leading to non-serious injury.
Algorithm Testing and Integration – verified the algorithms met requirements
and functioned as intended and when integrated performed as expected. | |
| | Firmware Verification – demonstrated that the firmware met requirements
Packaging Validation was performed and demonstrated that the packaging and
the system met the environmental conditioning and simulated shipping per the
applicable sections of ASTM D4332-14 and ASTM D4169.
Usability Testing
System Verification and Validation testing for functionality and performance
in a simulated environment. | |
| | Preclinical and clinical testing were not required for the CardioInsight Cardiac
Mapping 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 portability
and not necessary for function of current system and the addition of an
optional second monitor do not change the fundamental technology.
Modifications to the software, firmware and algorithms were made for
usability, reducing the manual interaction required. Updates were made to
firmware for bug fixes, off the shelf software to update to the latest versions
and additions to support functionality. Indications for use, principals of
operations and fundamental technology do not change with these
modifications. | |
| Conclusion | The data presented in this submission demonstrate that the Medtronic
CardioInsight Cardiac Mapping System is substantially equivalent to the
predicate device identified in intended use, device design, fundamental
technology and performance. | |
6
Image /page/6/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular graphic above the word "Medtronic" in a bold, blue font. The graphic features a stylized human figure in motion, depicted in a light gray color. The figure appears to be rotating or moving through different positions within the circle.
Performance Data
7
Image /page/7/Picture/0 description: The image contains the Medtronic logo. The logo features a circular graphic with three stylized human figures in different poses, 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, reflecting the company's presence in the medical technology industry.