(82 days)
Not Found
No
The summary describes a system for real-time 3D cardiac mapping using magnetic and impedance localization and electrograms. It focuses on data acquisition, visualization, and map construction based on user-defined criteria. There is no mention of AI, ML, or related concepts like training/test sets, performance metrics typically associated with AI/ML, or image processing which is often a domain for AI/ML in medical devices. The testing described is functional and performance-based, not related to AI/ML model validation.
No.
The device is a mapping system used for visualization and display of cardiac data, not for direct treatment or intervention.
Yes
The device is described as a "catheter-based atrial and ventricular mapping system designed to display 3D anatomical and electroanatomical maps of the human heart in real-time" and is used for "cardiac mapping and storage of cardiac electrophysiological data." This clearly indicates its function is to acquire and display information about the state of the heart, which is a diagnostic purpose.
No
The device description explicitly mentions hardware components like the "Signal Station and related accessories" and the "system Workstation computer," indicating it is not solely software.
Based on the provided information, the RHYTHMIA HDx™ Mapping System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for Use: The system is indicated for "catheter-based atrial and ventricular mapping." This involves using catheters inside the body to visualize and map the heart's electrical activity and anatomy.
- Device Description: The description explicitly states it's a "catheter-based atrial and ventricular mapping system" and is used "during electrophysiology procedures." These procedures are performed in vivo (within the living body).
- Nature of Data: The system acquires and displays "intracardiac electrograms" and "body surface ECG," which are electrical signals from the heart and body, not data derived from testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue) in vitro (in a test tube or lab setting) to diagnose a condition.
IVD devices are specifically designed to examine specimens derived from the human body in vitro to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The RHYTHMIA HDx™ Mapping System operates in vivo to map the heart's electrical activity and anatomy.
N/A
Intended Use / Indications for Use
The RHYTHMIA HDx™ Mapping System and accessories are indicated for catheter-based atrial and ventricular mapping. The mapping system allows real-time visualization of intracardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system's display screen.
Product codes
DQK
Device Description
The RHYTHMIA HDx™ Mapping System is a catheter-based atrial and ventricular mapping system designed to display 3D anatomical and electroanatomical maps of the human heart in real-time. The mapping system is intended to be used during electrophysiology procedures for cardiac mapping and storage of cardiac electrophysiological data. In addition, based on userdefined criteria, the system is able to acquire data over multiple cardiac beats. It is capable of real-time display through construction of maps using catheter magnetic and impedance localization technology and data from intracardiac and surface electrograms.
The Signal Station and related accessories provide data connection pathways for external input/output devices (e.g. catheters and recording systems) and serve as the data conduit to the system Workstation computer and software.
The subject device is reusable capital equipment that is intended to be used in an electrophysiology laboratory by physicians fully trained in cardiac electrophysiology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians fully trained in cardiac electrophysiology, in an electrophysiology laboratory.
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)
Testing was performed to verify functional performance, safety, and to support substantial equivalence determination. The subject RHYTHMIA HDx™ Mapping System with Software Version 4.0 passed all tests in accordance with appropriate test acceptance criteria and standards. As a result of hazard analysis of SW v4.0 features, no new questions of safety and effectiveness were raised.
Software Verification and Validation: Software verification testing was conducted based on 'major' level of concern in accordance with FDA Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005.
Performance Testing:
- Mapping and Visualization - Confirmed that incorporation of the new software features does not negatively impact the ability to use the subject mapping system to: (1) accurately create 3D maps of the cardiac chambers of the heart; and (2) support visualization of magnetic and impedance tracked catheters.
- Software Performance - Confirmed that the new software features meet the functional requirements.
- Summative Usability - Confirmed system level functionality under expected use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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November 27, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
Boston Scientific Corporation Lee Margolin Senior Regulatory Affairs 125 Cambridgepark Drive Cambridge, Massachusetts 02140
Re: K192438
Trade/Device Name: RHYTHMIA HDx™ Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: September 5, 2019 Received: September 6, 2019
Dear Lee Margolin:
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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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 medical devices and radiation-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,
Nicole Gillette Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices 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)
Device Name
RHYTHMIA HDx™ Mapping System
Indications for Use (Describe)
The RHYTHMA HDx™ Mapping System and accessories are indicated for catheter-based atrial and ventricular mapping. The mapping system allows real-time visualization of intracardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system's display screen.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY 510(K) SUMMARY COMPLYING WITH 21 CFR 807.92
I. SUBMITTER
Boston Scientific Corporation 125 Cambridgepark Drive, Suite 600 Cambridge, MA 02140 Phone: 617-218-3823 Fax: 617-218-3850 Contact Person: Lee Margolin Date Prepared: August 30, 2019
II. DEVICE Name of Device: RHYTHMIA HDx™ Mapping System
III. Common or Usual Name: Cardiac Mapping System Classification Name: Programmable diagnostic computer (21 CFR 870.1425) Regulatory Class: Class II Product Code: DQK
IV. PREDICATE DEVICES
Primary Predicate: RHYTHMIA HDx™ Mapping System Boston Scientific Corporation (K173837, S.E. 07/25/2018) Secondary Predicate: CARTO® 3 EP Navigation System version 6.0, Biosense Webster, Inc. (K180238, S.E. 06/01/2018)
DEVICE DESCRIPTION V.
The RHYTHMIA HDx™ Mapping System is a catheter-based atrial and ventricular mapping system designed to display 3D anatomical and electroanatomical maps of the human heart in real-time. The mapping system is intended to be used during electrophysiology procedures for cardiac mapping and storage of cardiac electrophysiological data. In addition, based on userdefined criteria, the system is able to acquire data over multiple cardiac beats. It is capable of real-time display through construction of maps using catheter magnetic and impedance localization technology and data from intracardiac and surface electrograms.
The Signal Station and related accessories provide data connection pathways for external input/output devices (e.g. catheters and recording systems) and serve as the data conduit to the system Workstation computer and software.
The subject device is reusable capital equipment that is intended to be used in an electrophysiology laboratory by physicians fully trained in cardiac electrophysiology.
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INDICATIONS FOR USE V.
The RHYTHMIA HDx™ Mapping System and accessories are indicated for catheter-based atrial and ventricular mapping. The mapping system allows real-time visualization of intracardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system's display screen.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
Substantial equivalence of the RHYTHMIA HDx™ Mapping System with Software Version 4.0 was established in terms of design features, performance testing, and indications for use as compared to the predicates RHYTHMIA HDx™ Mapping System and CARTO® 3 EP Navigation System Version 6.0. The subject device system has a similar design to the primary predicate device to include the same primary system components, operating principle, catheter tracking methods, and same intended use while incorporating the same feature functionality as the secondary predicate feature.
The technological differences between the subject device and the predicate RHYTHMIA HDxTM Mapping System include the following software enhancements:
- AutoTag provides an ablation workflow which includes automatic tag placement. .
- Stability Filtering provides a filter to compensate for respiration when calculating a ● catheter's position.
- Minor bug fixes.
VII. PERFORMANCE DATA
Testing was performed to verify functional performance, safety, and to support substantial equivalence determination. The subject RHYTHMIA HDx™ Mapping System with Software Version 4.0 passed all tests in accordance with appropriate test acceptance criteria and standards. As a result of hazard analysis of SW v4.0 features, no new questions of safety and effectiveness were raised.
Software Verification and Validation
Software verification testing was conducted based on 'major' level of concern in accordance with FDA Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005.
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Performance Testing
- Mapping and Visualization - Confirmed that incorporation of the new software features does not negatively impact the ability to use the subject mapping system to: (1) accurately create 3D maps of the cardiac chambers of the heart; and (2) support visualization of magnetic and impedance tracked catheters.
- Software Performance Confirmed that the new software features meet the functional ● requirements.
- . Summative Usability - Confirmed system level functionality under expected use conditions.
VIII. CONCLUSIONS
The software hazard analysis, verification and performance testing demonstrated that the RHYTHMIA HDx™ Mapping System with Software Version 4.0 performs as intended. This data supports that the subject device is substantially equivalent to identified predicate devices.