EnSite™ X EP System
Device Facts
| Record ID | K262006 |
|---|---|
| Device Name | EnSite™ X EP System |
| Applicant | Abbott Medical |
| Product Code | DQK · Cardiovascular |
| Decision Date | Jul 15, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1425 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
EnSite™ X EP System The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures. EnSite™ X EP System Contact Force Software License When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force Module is intended to provide visualization of force information from compatible catheters. EnSite™ X EP System Surface Electrode Kit The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.
Device Story
Catheter navigation and mapping system; displays 3D position of electrophysiology catheters; displays cardiac electrical activity as waveform traces and 3D isopotential/isochronal maps. System creates 3D models by collecting/labeling anatomic locations within cardiac chambers; surface created by moving catheter to collect points. Used in clinical EP procedures by physicians. Subject device adds Pulsed Field Ablation Index software license to existing EnSite X platform. Output provides visualization of cardiac anatomy and electrical activity to assist clinical decision-making during ablation or diagnostic procedures.
Clinical Evidence
Bench testing only. Software verification performed at unit, software, and system levels in accordance with IEC 62304 and ISO 14971 standards. No clinical data provided.
Technological Characteristics
Programmable diagnostic computer; 3D catheter navigation and mapping; software-based modeling; connectivity with TactiSys™ Quartz Equipment for contact force visualization. Complies with IEC 62304 (software lifecycle) and ISO 14971 (risk management).
Indications for Use
Indicated for patients undergoing electrophysiology studies requiring cardiac electrical activity monitoring and catheter visualization. Applicable to all age groups including neonates, infants, children, adolescents, and adults.
Regulatory Classification
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.
Predicate Devices
- EnSite™ X EP System (K260212)
Submission Summary (Full Text)
{0}
**U.S. FOOD & DRUG**
ADMINISTRATION
July 15, 2026
Abbott Medical
Alexandra Agre
Regulatory Affairs Manager
One St. Jude Medical Dr.
St. Paul, Minnesota 55117
Re: K262006
Trade/Device Name: EnSite™ X EP System
Regulation Number: 21 CFR 870.1425
Regulation Name: Programmable Diagnostic Computer
Regulatory Class: Class II
Product Code: DQK
Dated: June 15, 2026
Received: June 15, 2026
Dear Alexandra Agre:
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.
{1}
K262006 - Alexandra Agre
Page 2
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" (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 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).
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 Management System Regulation (QMSR) (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.
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-
{2}
K262006 - Alexandra Agre
Page 3
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,
# 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
Enclosure
{3}
| 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. | K262006 | ? |
| Please provide the device trade name(s). | | ? |
| EnSite™ X EP System | | |
| Please provide your Indications for Use below. | | ? |
| EnSite™ X EP SystemThe EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures.EnSite™ X EP System Contact Force Software LicenseWhen used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force Module is intended to provide visualization of force information from compatible catheters.EnSite™ X EP System Surface Electrode KitThe EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use. | | |
| Please select the types of uses. | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | Neonates/Newborns (Birth to < 29 days old)Infants (29 days old to < 2 years old)Children (2 years old to < 12 years old)Adolescents (12 years old to < 22 years old)Adults (22 years old and greater) | ? |
{4}
EnSite X EP System Pulsed Field Ablation Index
Special 510(k)
ABBOTT
## 510(k) SUMMARY
The 510(k) Summary was drafted in accordance with 21 CFR 807.92 and is included below.
| 510(k) Information | |
| --- | --- |
| 510(k) Number | K262006 |
| 510(k) Type | Special 510(k) |
| Date Prepared | 15 June 2025 |
| Submitter Information | |
| **Manufacturer Name & Address** | Abbott Medical One St. Jude Medical Drive, St. Paul, Minnesota, 55117, USA Manufacturer of the EnSite X EP System |
| | Abbott Medical Costa Rica Ltda. Edificio #44 Calle 0, Ave. 2 Zona Franca Coyol El Coyol Alajuela, Costa Rica 1897-4050 Manufacturer of the EnSite X EP System Surface Electrode Kit |
| **Contact Person** | Alexandra Agre Regulatory Affairs Manager 612-322-3442 alexandra.agre@abbott.com |
| EnSite™ X EP System Device Information | |
| Trade Name | EnSite™ X EP System |
| Common Name | Programmable Diagnostic Computer |
| Class | II |
| Classification Name | 870.1425, computer, diagnostic, programmable |
| Product Code | DQK |
| Predicate Device | EnSite™ X EP System (K260212) |
| Device Description | The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber. The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points. |
| Indications for Use | **EnSite™ X EP System** The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures. **EnSite™ X EP System Contact Force Software License** |
K262006
Page 1 of 2
{5}
EnSite X EP System Pulsed Field Ablation Index
Special 510(k)
[LOGO]
ABBOTT
| | When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force Module is intended to provide visualization of force information from compatible catheters. **EnSite™ X EP System Surface Electrode Kit** The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use. |
| --- | --- |
| **Predicate Comparison** | |
| **Comparison** | EnSite™ X EP System with the Pulsed Field Ablation Index Software License and the predicate EnSite™ X v6.0 have the same intended use and indications for use. They use the same fundamental scientific technology to facilitate catheter position and orientation, as well as cardiac mapping and model creation. There were no changes to the hardware. The subject device adds a software license which implements the new feature, Pulsed Field Ablation Index. All risks were mitigated to acceptable levels. No new questions of safety or effectiveness were raised. |
| **Non-Clinical Testing Summary** | Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device. **Testing** The EnSite™ X EP System in scope of this submission was developed and tested in accordance with the following industry guidance documents and standards: - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - IEC 62304: 2015-06 Edition 1.1, Medical Device Software - Software Life Cycle Processes - ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices **Types of Testing Performed – EnSite X EP System Pulsed Field Ablation Index** - Software Verification at unit, software and system level |
| **Statement of Equivalence** | All subject and predicate devices have the same intended use, and same indications for use. All devices operate using the same fundamental scientific technology to facilitate catheter position and orientation, as well as cardiac mapping and model creation. The testing completed and submitted in this Special 510(k) provides objective evidence the subject device is substantially equivalent to the predicate device. |
K262006
Page 2 of 2
