RHYTHMIA HDx™ Mapping System

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August 29, 2024 Boston Scientific Corporation Liliana Omar Principal Regulatory Affairs Specialist 4100 Hamline Avenue North St. Paul, Minnesota 55112-5798 Re: K241227 Trade/Device Name: RHYTHMIA HDx™ Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: July 30, 2024 Received: July 30, 2024 Dear Liliana Omar: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Aneesh S. Deoras -S Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality {2}------------------------------------------------ Enclosure {3}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K241227 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) | | |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | 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." {4}------------------------------------------------ # 510(K) SUMMARY #### SUBMITTER INFORMATION Boston Scientific Corporation 4100 Hamline Avenue North St. Paul, MN, 55112 Phone: 612-965-5145 Contact Person: Liliana Omar Date Prepared: 01 May 2024 #### DEVICE INFORMATION Device Name: RHYTHMIA HDx™ Mapping System Classification: Class II Product code: DQK Regulation: 870.1425 Programmable diagnostic computer Primary Predicate: RHYTHMIA HDx™ Mapping System, K192438 Secondary Predicate: RHYTHMIA HDx™ Mapping System, K162793 # DEVICE DESCRIPTION The RHYTHMIA HDx™ Mapping System is a diagnostic medical device designed for 3D cardiac mapping, catheter navigation and display of cardiac electrophysiological data collected during an Electrophysiology (EP) study. Based on user-defined criteria, the Mapping System can acquire data over multiple cardiac beats. The maps are constructed using magnetic and impedance-based localization technology and data from intracardiac and surface electrograms. Maps may be displayed as anatomical maps and electroanatomical maps in different formats. When used in conjunction with a magnetically tracked mapping catheter, the Mapping System can acquire data leading to high resolution map creation. The Mapping System allows real-time and recorded visualization of intracardiac catheter location(s). The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system's display screen. The Mapping System consists of reusable capital equipment, intended to be used in an electrophysiology laboratory by licensed medical practitioners fully trained in cardiac electrophysiology and Boston Scientific Mapping Specialists. {5}------------------------------------------------ The Mapping System includes a dedicated Signal Station (SiS) and related accessories which provide data connection pathways for external input/output devices (e.g., catheters and recording systems) and serve as the data conduit to the System's Workstation computer and software. ### 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. ### TECHNOLOGICAL CHARACTERISTICS Substantial equivalence of the RHYTHMIA HDx Mapping System with Software v6.0 was established based on the comparison of the subject and predicate devices intended use, design features and performance testing. The subject device has the same intended use, the same principle of operation, the same indications for use, includes the same system components (hardware), and general feature functionality as the predicates. The RHYTHMIA HDx Mapping System with Software v6.0 includes the following enhancements: - General compatibility with the Magnetically Tracked FARAWAVE NAV PFA Catheter, using . the same technological characteristics as the existing compatibility with the INTELLAMAP ORION catheter. - Improved compatibility with the Magnetically Tracked FARAPOINT PFA Catheter using the . same technological characteristics as the existing compatibility with linear ablation catheters. - Sheath detection visualization within the heart chamber, enhancement using the same technoloqy and principle as that used for the catheter localization. - . Import of CT or MRI cardiac images via a network connection from a PACS Server (also referred to as DICOM Server). The subject device allows segmentation of the imported images to improve efficiency of PACS import workflow. These images are used for visual reference only. - . Field Tag™ is similar to the existing AutoTaq included in the primary predicate device. Field Tags are the tagging visualization when using the FARAWAVE NAV PFA catheter prior to and after ablation. - . Catheter shadows allow the user to visualize the location of the last ablation and decide the next workflow step. - Ablation statistics is the presentation of some information already collected by subject and . primary predicate. There were non-significant changes to the hardware unrelated to the software update. These changes do not raise questions of safety and effectiveness of the subject device. {6}------------------------------------------------ ## Performance Data Testing was conducted to verify functional performance and substantial equivalence. Successful testing results provide objective evidence that the proposed changes do not raise new questions of safety and effectiveness. The testing consisted of: - . Software/Firmware and Cybersecurity Verification and Validation testing confirmed that the subject device meets the design input requirements and specifications. - . Design Verification testing confirmed that the subject device hardware continues to meet the performance specifications. - . EMC and Electrical Safety testing demonstrated conformity with the electrical safety and EMC performance requirements and specifications, according to the methods and criteria of the recognized consensus standards 60601-1 and 60601-1-2 and BSC design input requirements and specifications. - . Usability validation testing demonstrated that the subject device meets the user needs specifications. - . Design validation testing demonstrated that all test articles evaluated in the study performed as intended for their intended use specifications and were found to be Clinically Acceptable by the appropriate end users. # Conclusion The RHYTHMIA HDx Mapping System with Software v6.0 is substantially equivalent to the legally marketed devices. This conclusion is reached as the subject and predicate devices have the same intended use and the successful testing results demonstrate that the minor differences in the technological characteristics do not raise questions of safety and effectiveness.