Dual Energy THERMOCOOL SMARTTOUCH SF System
Device Facts
| Record ID | P030031S141 |
|---|---|
| Device Name | Dual Energy THERMOCOOL SMARTTOUCH SF System |
| Applicant | Biosense Webster, Inc. |
| Product Code | OAD |
| Decision Date | Jul 1, 2026 |
| Decision | APPR |
| Device Class | Class 3 |
| Attributes | Therapeutic |
Indications for Use
The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible generator, for the treatment of: When using Radiofrequency (RF) energy Only: - Type I atrial flutter in patients age 18 or older. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. - Drug refractory recurrent symptomatic persistent atrial fibrillation (defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 1 year), refractory or intolerant to at least one Class I or III antiarrhythmic medicine, when used with compatible three-dimensional electroanatomic mapping systems. When using Pulsed Field (PF) energy: - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.
Device Story
Dual Energy THERMOCOOL SMARTTOUCH SF System performs cardiac electrophysiological mapping and ablation; utilizes RF or Pulsed Field (PF) energy. Catheter provides real-time contact force measurement and location data via integration with CARTO 3 System. System includes nGEN Pump for irrigation solution delivery and sterile interface cables. Used in clinical electrophysiology labs by physicians; catheter inserted into heart to map electrical signals and deliver energy to cardiac tissue. Real-time contact force feedback assists physician in precise catheter placement; output visualized on mapping system. Benefits include treatment of symptomatic atrial arrhythmias; reduced recurrence; improved procedural control.
Clinical Evidence
Post-approval study (SmartPulse PAS) required: prospective, non-randomized, multi-center, single-arm study. Enrollment of ~276 patients undergoing de novo pulmonary vein isolation for drug-refractory paroxysmal AF. Primary endpoints: safety event-free rate at 12 months, acute procedural success, and chronic success at 12 months. Secondary endpoints include 24/36-month failure rates, procedure times, and arrhythmia recurrence.
Technological Characteristics
System comprises irrigation-enabled catheter, nGEN peristaltic pump, and interface cables. Features real-time contact force sensing and 3D electroanatomic mapping compatibility. Supports dual-energy delivery (RF and Pulsed Field).
Indications for Use
Indicated for patients age 18+ with Type I atrial flutter, drug-refractory recurrent symptomatic paroxysmal atrial fibrillation, or drug-refractory recurrent symptomatic persistent atrial fibrillation (continuous >7 days but <1 year) who are intolerant/refractory to Class I or III antiarrhythmic meds.
Regulatory Classification
Identification
For the treatment of atrial flutter.
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
July 1, 2026
Biosense Webster, Inc.
Marzieh Hemati
Senior Regulatory Affairs Program Lead
31 Technology Dr., Suite 200
Irvine, California 92618
Re: P030031/S141
Trade/Device Name: Dual Energy THERMOCOOL SMARTTOUCH™ SF System
Product Code: OAD, OAE, QZI
Filed: September 25, 2025
Amended: April 2, 2026; June 26, 2026
Dear Marzieh Hemati:
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) supplement for the Dual Energy THERMOCOOL SMARTTOUCH SF™ System. This device is indicated for:
Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter
The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible generator, for the treatment of:
When using Radiofrequency (RF) energy Only:
- Type I atrial flutter in patients age 18 or older.
- Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.
- Drug refractory recurrent symptomatic persistent atrial fibrillation (defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 1 year), refractory or intolerant to at least one Class I or III antiarrhythmic medicine, when used with compatible three-dimensional electroanatomic mapping systems.
When using Pulsed Field (PF) energy:
- Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.
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The Dual Energy THERMOCOOL SMARTTOUCH™ SF Navigation Catheter provides a real-time measurement of contact force between the catheter tip and the heart wall, as well as location information when used with the CARTO™ 3 System.
#### nGEN™ Pump
The nGEN™ Pump is a peristaltic pump designed to work with a compatible irrigation tubing set, either independently or with a compatible generator, to deliver irrigation solution to compatible irrigated catheter.
#### Sterile Interface Cable
This cable provides a means to connect a Biosense Webster electrophysiology catheter to the appropriate equipment. The cable may be reused subject to the cleaning and sterilization restrictions detailed in Instructions for Use.
Based upon the information submitted, the PMA supplement 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 available 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). The device is further restricted under section 515(d)(1)(B)(ii) of the act insofar as the labeling must specify the specific training or experience practitioners need in order to use the device. 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 all other applicable requirements, including those governing the manufacture, distribution, and marketing of devices.
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 CDRH Portal. The Annual Report should indicate the beginning and ending date of the period covered by the report and must 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, under 21 CFR 814.82(a)(9), 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.
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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 CDRH Portal. 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 SmartPulse Post-Approval Study (PAS) is a prospective, non-randomized, multi-center, single-arm study to confirm the long-term effectiveness and safety of the Dual Energy THERMOCOOL SMARTTOUCH SF™ System for the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (AF). Approximately 276 patients who intend to undergo their de novo pulmonary vein isolation procedure using the Dual Energy THERMOCOOL SMARTTOUCH SF™ System to treat symptomatic paroxysmal atrial fibrillation refractory or intolerant to at least one Class I, or III antiarrhythmic medication will be enrolled with all patients treated in the United States.
The primary objectives of the PAS will be the following:
1) Estimating the safety event free rate at 12 months post-index-procedure.
2) Estimating acute procedural success.
3) Estimating chronic success through 12 months post-index-procedure.
The secondary objectives and additional analyses will include, but not be limited to, the following:
1) Evaluating chronic treatment failure at 24 months and 36 months.
2) Estimating procedure times.
3) Estimating treatment success allowing the use of antiarrhythmic medications and/or reablation.
4) Estimating freedom from recurrence of individual types of atrial arrhythmias between 3 months and 12 months post-index-procedure.
5) Estimating chronic success through 12 months post-index procedure stratified by the presence or absence of a prior failed trial of Class I or III antiarrhythmic medication therapy (due to ineffectiveness or intolerance).
6) Analyzing lesion locations as recorded by a compatible electroanatomic mapping system.
7) Analyzing reablation parameters.
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 SmartPulse 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
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In addition, you must submit separate periodic reports on the progress of SmartPulse 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 CDRH Portal 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).
Be advised that protocol information, interim and final results will be published on the Post-Approval Studies Program Database Webpage, available at 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. Under 21 CFR 814.39, 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 Part 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 available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-udi-system.
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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. Additional information about changes that may require a PMA supplement are provided in 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.
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Part 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:
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 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 Part 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 at
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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 to the CDRH Portal and should reference the above PMA number to facilitate processing. For more information on the CDRH Portal, please visit https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-medical-device-premarket-submissions-online-cdrh-portal.
If you have any questions concerning this approval order, please contact Samson Huang at 301-796-6492 or Samson.Huang@fda.hhs.gov.
Sincerely,
HETAL B. ODOBASIC -S
Hetal Odobasic
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
