OptiMap™ System

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION May 28, 2025 Boston Scientific Corporation Derek Charchuk Senior Regulatory Affairs Specialist 4100 Hamline Avenue North Saint Paul, Minnesota 55112-5798 Re: K251344 Trade/Device Name: OptiMap™ System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: April 29, 2025 Received: April 30, 2025 Dear Derek Charchuk: 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" U.S. Food &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251344 - Derek Charchuk Page 2 (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 QS 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 (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-reporting-combination-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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. {2} K251344 - Derek Charchuk Page 3 For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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 Center for Devices and Radiological Health Enclosure {3} OptiMap™ System | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251344 | ? | | Please provide the device trade name(s). | | ? | | OptiMap™ System | | | | Please provide your Indications for Use below. | | ? | | The OptiMap System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} 510(k) SUMMARY K251344 # 510(k) Summary in Compliance with 21 CFR 807.92 ## I. Submitter Information Submitter Name: Boston Scientific Corporation Submitter Address: 4100 Hamline Avenue North St. Paul, Minnesota USA 55112-5798 Contact #1: Derek Charchuk Senior Regulatory Affairs Specialist Phone: (905) 696-1913 Email: derek.charchuk@bsci.com Contact #2: Mary Korte Senior Regulatory Affairs Manager Phone: (612) 965-5145 Email: mary.korte@bsci.com Date Prepared: 29-April-2025 ## II. Device Information Generic Name: OptiMap™ System Trade Name: OptiMap™ System Product Code: DQK Device Class: Class II Review Panel: Cardiovascular (DQK) Classification Regulation: (21 CFR 870.1425): Programmable diagnostic computer 510(k) Number: K251344 ## III. Predicate Device Information Predicate Device: Ablamap® System Manufacturer: Ablacon, Inc. 510(k): K230008 FDA Clearance Date: June 8th, 2023 Product Code: DQK Device Class: Class II Classification Regulation: (21 CFR 870.1425): Programmable diagnostic computer ## IV. Indications for Use The OptiMap™ System is used to analyze electrogram (EGM) signals and display results in a visual OptiMap™ System (Version 1.3 Software) Special 510(k) {5} 510(k) SUMMARY K251344 format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias. ## IV. Intended Use The OptiMap™ System is intended to be used during electrophysiology procedures on patients for whom an electrophysiology procedure has been prescribed and only by qualified medical professionals who are trained in electrophysiology. ## V. Device Description The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an Amplifier, Cart, Monitor, and Workstation that contains proprietary mapping software. Signals from a 64-electrode mapping basket catheter are transmitted to the Workstation by the Amplifier, processed by the mapping software, and the results are displayed on the Monitor. The OptiMap System utilizes proprietary algorithms to process intra-cardiac electrogram (EGM) signals from a 64-electrode unipolar mapping basket catheter. The software transforms the time domain waveform information from the electrodes into space domain information which calculates the Electrographic Flow™ (EGF™) vectors for Atrial Fibrillation. The system also has algorithms that display action potential wavefront propagation or Activation Cycle Path (ACP). The ACP maps are a reconstruction of the activation wavefront propagation and may be used to visualize organized atrial arrhythmias. The software output includes static and dynamic EGF maps that graphically depict the temporal activity and location of sources of EGF with respect to the catheter electrodes. The software displays active sources of flow and passive flow phenomena, detects spatial and temporal stability of sources of flow and detects the prevalence of sources of flow. In addition, the software output includes ACP maps displaying isochrones and a wavefront animation for each cycle. OptiMap™ System (Version 1.3 Software) Special 510(k) Page 2 {6} 510(k) SUMMARY K251344 # VI. Substantial Equivalence &amp; Comparison of Technological Characteristics Comparison of Subject OptiMap™ System (Software Version 1.3) vs. Predicate Ablamap® System | Characteristic | Subject Device: OptiMap™ System (K251344) (Cortex, Inc.) | Predicate Device: Ablamap® System (K230008) (Ablacon, Inc.) | | --- | --- | --- | | Device Classification, Classification Name, and Product Code | Class II, Programmable Diagnostic Computer (21 CFR 870.1425), DQK | Same | | Indications for Use | The OptiMap™ System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias. | Same with exception of device name | | Intended use | The OptiMap™ System is intended to be used during electrophysiology procedures on patients for whom an electrophysiology procedure has been prescribed and only by qualified medical professionals who are trained in electrophysiology. | Same with exception of device name | | System Components | Amplifier, Workstation, Monitor, Proprietary Software | Same | | Compatible Diagnostic Catheters | 64 electrode unipolar basket mapping catheters: - 50mm and 60mm sizes - 8 electrodes/splines | Same | | Electrographic Flow (EGF) Recording Duration | Reject if <55 sec or >240 sec | Same | | EGF QRS Detection | QRS complex detection and notification if >150 or <40; reject if >170 | Same | | Activation Cycle Path (ACP) Mapping | ACP algorithm is an interpolation method that leverages the spatio- temporal activation wavefront reconstruction method similarly to using EGM signals from a “basket” catheter with 64-electrode and 8 splines on 2-second segment signals. | N/A – ACP feature was not available with predicate device | | Cybersecurity | Total product lifecycle (TPLC) cybersecurity risk assessment and adoption of a Secure Product Development Framework (SPDF) per FDA Guidance: Cybersecurity in Medical Devices: Quality System | N/A | OptiMap™ System (Version 1.3 Software) Special 510(k) {7} 510(k) SUMMARY K251344 | Characteristic | Subject Device: OptiMap™ System (K251344) (Cortex, Inc.) | Predicate Device: Ablamap® System (K230008) (Ablacon, Inc.) | | --- | --- | --- | | | Considerations and Content of Premarket Submissions (September 27, 2023). | | # VII. Summary of Non-Clinical Performance Testing Software verification and validation testing was completed on the subject device demonstrating that the OptiMap System with Version 1.3 Software (including ACP functionality) successfully performed at the unit, integration and system levels. All open issues from the verification and validation activities have been resolved or documented as unresolved anomalies. The OptiMap System met the acceptance criteria listed in the test protocols, performs as designed, and is suitable for its intended use. Cybersecurity Testing was completed to align with FDA Guidance: Cybersecurity in Medical Devices – Quality System Considerations and Content of Premarket Submissions (September 27, 2023). There are no changes to the hardware design of the OptiMap System; as such, no additional physical/mechanical, electrical safety, or EMC related verification or validation activities were completed for the addition of ACP functionality or cybersecurity hardening updates. # VIII. Conclusion Based on the intended use, fundamental technological characteristics, and performance testing, the subject OptiMap™ System with Version 1.3 Software has been shown to be appropriate for its intended use and is substantially equivalent to the predicate device. OptiMap™ System (Version 1.3 Software) Special 510(k) Page 4