← Product Code OAE · P220013 # TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C (P220013) _ABBOTT MEDICAL · OAE · May 18, 2023 · Cardiovascular · APPR_ **Canonical URL:** https://fda.innolitics.com/device/P220013 ## Device Facts - **Applicant:** ABBOTT MEDICAL - **Product Code:** OAE - **Decision Date:** May 18, 2023 - **Decision:** APPR - **Device Class:** Class 3 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Intended Use This device is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter, when used in conjunction with a compatible RF generator and three-dimensional mapping system. ## Device Story TactiFlex™ Ablation Catheter, Sensor Enabled™ is a cardiac electrophysiological mapping and ablation device. Used in conjunction with a compatible RF generator and 3D mapping system; operated by physicians in clinical settings. Device provides real-time mapping of cardiac electrical activity and delivers radiofrequency (RF) energy to ablate cardiac tissue. Enables point-by-point ablation strategy for treatment of paroxysmal atrial fibrillation. Clinical benefit includes reduction of symptomatic AF recurrence. Physician monitors procedure via 3D mapping system interface to guide catheter placement and control energy delivery, impacting clinical decision-making during electrophysiology procedures. ## Clinical Evidence PMA approval based on prospective, non-randomized, single-arm, observational, multi-center post-approval study (PAS) involving approximately 370 adult patients. Primary endpoints: rate of device-related major complications through 3 months and freedom from AF/atrial flutter/atrial tachycardia recurrence post-90-day blanking through 12 months. Secondary endpoints include early mortality, esophageal perforating complications, and serious adverse events. ## Technological Characteristics Sensor-enabled ablation catheter; compatible with 3D mapping systems and RF generators. Designed for point-by-point ablation with power limitations (max 40W on left atrial posterior wall). ## Regulatory Identification For the treatment of atrial fibrillation. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a PMA](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION May 18, 2023 Abbott Medical Bridget Neumann Regulatory Affairs Project Manager 5050 Nathan Lane North Plymouth, Minnesota 55442 Re: P220013 Trade/Device Name: TactiFlex™ Ablation Catheter, Sensor Enabled™ Product Code: OAE Filed: August 15, 2022 Amended: November 11, 2022; March 11, 2023 Dear Bridget Neumann: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) for the TactiFlex™ Ablation Catheter, Sensor Enabled™. This device is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter, when used in conjunction with a compatible RF generator and three-dimensional mapping system. We are pleased to inform you that the PMA is approved. You may begin commercial distribution of the device in accordance with the conditions of approval described below. Although this letter refers to your product as a device, please be aware that some approved products may instead be combination products. The Premarket Approval Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm identifies combination product submissions. The sale and distribution of this device are restricted to prescription use in accordance with 21 CFR 801.109 and under section 515(d)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (the act). FDA has determined that these restrictions on sale and distribution are necessary to provide reasonable assurance of the safety and effectiveness of the device. Your device is therefore a restricted device subject to the requirements in sections 502(q) and (r) of the act, in addition to the many other FDA requirements governing the manufacture, distribution, and marketing of devices. Expiration dating for this device has been established and approved at 12 months. This is to advise you that the protocol you used to establish this expiration dating is considered an approved protocol for the purpose of extending the expiration dating as provided by 21 CFR 814.39(a)(7). U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} P220013 - Bridget Neumann Page 2 Continued approval of the PMA is contingent upon the submission of periodic reports, required under 21 CFR 814.84, at intervals of one year (unless otherwise specified) from the date of approval of the original PMA. This report, identified as "Annual Report" and bearing the applicable PMA reference number, should be submitted to the address below. The Annual Report should indicate the beginning and ending date of the period covered by the report and should include the information required by 21 CFR 814.84. In addition to the above, and in order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, the Annual Report must include, separately for each model number (if applicable), the number of devices sold and distributed during the reporting period, including those distributed to distributors. The distribution data will serve as a denominator and provide necessary context for FDA to ascertain the frequency and prevalence of adverse events, as FDA evaluates the continued safety and effectiveness of the device. You must obtain approval of your post-approval study (PAS) protocol(s) within 60 days from the date of this order. Within 30 days of your receipt of this letter, you must submit a PMA supplement that includes a complete protocol of your post-approval study described below. Your PMA supplement should be clearly labeled as a "PMA Post-Approval Study Protocol" as noted below and submitted to the address below. Please reference the PMA number above to facilitate processing. If there are multiple protocols being finalized after PMA approval, please submit each protocol as a separate PMA supplement. In addition to the Annual Report requirements, you must provide the following data in post-approval study (PAS) reports for each PAS listed below. 1. The TactiFlex SE PAS is a prospective, non-randomized, single-arm, observational, multi-center study to confirm the safety and effectiveness of drug refractory paroxysmal AF (PAF) ablation with the TactiFlex™ Ablation Catheter, Sensor-Enabled™ (TactiFlex SE) when limiting radiofrequency (RF) power on the left atrial posterior wall to a maximum of 40W. Approximately 370 adult patients who intend to undergo their first atrial fibrillation ablation with the TactiFlex SE catheter to treat symptomatic PAF refractory or intolerant to at least one Class I or III antiarrhythmic medication will be enrolled and ablated using the TactiFlex SE catheter, with at least 50% of patients treated in the United States. A point-by-point ablation strategy will be required when ablating at 40W or higher. A maximum RF power setting of 40W will be allowed on the left atrial posterior wall. Follow up clinical data will be collected at 7 days, 3 months, 6 months, and 12 months post-procedure. The primary objectives of the PAS will be the following: 1) Estimating the rate of device-related major complications (i.e., major complications excluding vascular access complications) through 3 months post-ablation using the TactiFlex SE catheter. 2) Estimating freedom from atrial fibrillation/atrial flutter/atrial tachycardia recurrence post- 90-day blanking through 12 months post-ablation using the TactiFlex SE catheter in patients with symptomatic PAF refractory or intolerant to at least one Class I or III antiarrhythmic medication. The secondary objectives will include the following: 1) Estimating the rate of early mortality after PAF ablation using the TactiFlex SE catheter through 3 months post-procedure. {2} P220013 - Bridget Neumann Page 3 2) Estimating the rate of esophageal perforating complications (including but not limited to atrio-esophageal fistula and esophago-pericardial fistula) after PAF ablation using the TactiFlex SE catheter through 3 months post-procedure. 3) Estimating the rate of device-related major complications in patients who received concomitant cavo-tricuspid isthmus (CTI) ablation using the TactiFlex SE catheter. 4) Estimating the serious device or serious procedure related adverse events for catheter ablation using the TactiFlex SE catheter through 12 months post-procedure. You are also required to report any early mortality (through 3 months post-procedure) and any esophageal perforating complications to the FDA within 10 days after you first receive notice of the event. PAS Progress Reports must be submitted every six (6) months for the first year and annually thereafter, from the date of the PMA approval letter, unless otherwise specified by FDA. The Final PAS Report should be submitted no later than three (3) months after study completion (i.e., last subject's last follow-up date). From the date of study protocol approval, you must meet the following timelines for the TactiFlex SE PAS: - First subject enrolled within 6 months - 20% of subjects enrolled within 12 months - 50% of subjects enrolled within 18 months - 100% of subjects enrolled within 24 months In addition, you must submit separate periodic reports on the progress of the TactiFlex SE PAS as follows: - PAS Progress Reports every six (6) months until subject enrollment has been completed, and annually thereafter, from the date of the PMA approval letter, unless otherwise specified by FDA. - If any enrollment milestones are not met, you must begin submitting quarterly enrollment status reports every 3 months in addition to your periodic (6-month) PAS Progress Reports, until FDA notifies you otherwise. - Submit the Final PAS Report three (3) months from study completion (i.e., last subject’s last follow-up date). Each PAS report should be submitted to the address below identified as a "PMA Post-Approval Study Report" in accordance with how the study is identified above and bearing the applicable PMA reference number. Be advised that failure to comply with any post-approval requirement constitutes grounds for FDA withdrawal of approval of the PMA in accordance with 21 CFR 814.82(c) and 814.46(a)(2). Be advised that the failure to conduct any such study in compliance with the good clinical laboratory practices in 21 CFR part 58 (if a non-clinical study subject to part 58) or the institutional review board regulations in 21 CFR part 56 and the informed consent regulations in 21 CFR part 50 (if a clinical study involving human subjects) may be grounds for FDA withdrawal of approval of the PMA in accordance with 21 CFR 814.46(a)(3)-(4). {3} P220013 - Bridget Neumann Page 4 Be advised that protocol information, interim and final results will be published on the Post-Approval Studies Program Database Webpage https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm. In addition, the results from any post approval study should be included in the labeling as these data become available. Any updated labeling must be submitted to FDA in the form of a PMA Supplement. For more information on post-approval studies, see the FDA guidance document entitled, "Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order" (https://www.fda.gov/media/71327/download). This is a reminder that as of September 24, 2014, class III devices are subject to certain provisions of the final Unique Device Identification (UDI) rule. These provisions include the requirement to provide a UDI on the device label and packages (21 CFR 801.20), format dates on the device label in accordance with 21 CFR 801.18, and submit data to the Global Unique Device Identification Database (GUDID) (21 CFR 830 Subpart E). Additionally, 21 CFR 814.84 (b)(4) requires PMA annual reports submitted after September 24, 2014, to identify each device identifier currently in use for the subject device, and the device identifiers for devices that have been discontinued since the previous periodic report. It is not necessary to identify any device identifier discontinued prior to December 23, 2013. Combination Products may also be subject to UDI requirements (see 21 CFR 801.30). For more information on these requirements, please see the UDI website, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-udi-system. Before making any change affecting the safety or effectiveness of the PMA device, you must submit a PMA supplement or an alternate submission (30-day notice) in accordance with 21 CFR 814.39. All PMA supplements and alternate submissions (30-day notice) must comply with the applicable requirements in 21 CFR 814.39. For more information, please refer to the FDA guidance document entitled, "Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process" https://www.fda.gov/media/81431/download. You are reminded that many FDA requirements govern the manufacture, distribution, and marketing of devices. For example, in accordance with the Medical Device Reporting (MDR) regulation, 21 CFR 803.50 and 21 CFR 803.52 for devices or post-marketing safety reporting (21 CFR 4, Subpart B) for combination products, you are required to report adverse events for this device. Manufacturers of medical devices, including in vitro diagnostic devices, are required to report to FDA no later than 30 calendar days after the day they receive or otherwise becomes aware of information, from any source, that reasonably suggests that one of their marketed devices: 1. May have caused or contributed to a death or serious injury; or 2. Has malfunctioned and such device or similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Additional information on MDR, including how, when, and where to report, is available at https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems and on combination product post-marketing safety reporting is available at (see {4} P220013 - Bridget Neumann Page 5 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products). In accordance with the recall requirements specified in 21 CFR 806.10 for devices or the post-marketing safety reporting requirements (21 CFR 4, Subpart B) for combination products, you are required to submit a written report to FDA of any correction or removal of this device initiated by you to: (1) reduce a risk to health posed by the device; or (2) remedy a violation of the act caused by the device which may present a risk to health, with certain exceptions specified in 21 CFR 806.10(a)(2). Additional information on recalls is available at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industry-guidance-recalls. CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. CDRH will notify the public of its decision to approve your PMA by making available, among other information, a summary of the safety and effectiveness data upon which the approval is based. The information can be found on the FDA CDRH Internet Home Page located at https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/pma-approvals. Written requests for this information can also be made to the Food and Drug Administration, Dockets Management Branch, (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The written request should include the PMA number or docket number. Within 30 days from the date that this information is placed on the Internet, any interested person may seek review of this decision by submitting a petition for review under section 515(g) of the act and requesting either a hearing or review by an independent advisory committee. FDA may, for good cause, extend this 30-day filing period. Failure to comply with any post-approval requirement constitutes a ground for withdrawal of approval of a PMA. The introduction or delivery for introduction into interstate commerce of a device that is not in compliance with its conditions of approval is a violation of law. You are reminded that, as soon as possible and before commercial distribution of your device, you must submit an amendment to this PMA submission with a copy of all final labeling. Final labeling that is identical to the labeling approved in draft form will not routinely be reviewed by FDA staff when accompanied by a cover letter stating that the final labeling is identical to the labeling approved in draft form. If the final labeling is not identical, any changes from the final draft labeling should be highlighted and explained in the amendment. All required documents should be submitted, unless otherwise specified, to the address below and should reference the above PMA number to facilitate processing. U.S. Food and Drug Administration Center for Devices and Radiological Health Document Control Center - WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 {5} P220013 - Bridget Neumann Page 6 If you have any questions concerning this approval order, please contact Anita Khatiwara at 240-402-1710 or Anita.Khatiwara@fda.hhs.gov. Sincerely, # Hetal B. Patel -S Hetal Odobasic 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 --- **Source:** [https://fda.innolitics.com/device/P220013](https://fda.innolitics.com/device/P220013) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a PMA](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com