(86 days)
Not Found
No
The document describes a catheter navigation and mapping system that creates 3D models based on collected anatomical points. There is no mention of AI or ML in the intended use, device description, or performance studies. The system appears to use traditional geometric modeling techniques.
No
The device is described as a "diagnostic tool" that provides information about the electrical activity of the heart and displays catheter location, which are diagnostic functions. It does not exert a therapeutic effect.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated." It further elaborates that the system "provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures," which are diagnostic activities.
No
The device description explicitly states it is a "catheter navigation and mapping system" and mentions the use of "conventional and Sensor Enabled™ (SE) electrophysiology catheters," indicating the system includes hardware components beyond just software. The intended use also mentions "displaying catheter location."
Based on the provided information, the EnSite™ X EP System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the system as a "suggested diagnostic tool" that provides information about the electrical activity of the heart and displays catheter location. This is related to in vivo procedures (within the living body) rather than in vitro procedures (testing samples outside the body).
- Device Description: The description details a catheter navigation and mapping system that displays the position of catheters and cardiac electrical activity. This is consistent with a system used during a medical procedure on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body, which are hallmarks of IVD devices.
The system is used during an electrophysiology study on a patient to gather information about the heart's electrical activity and guide catheters, which is an in vivo diagnostic process.
N/A
Intended Use / Indications for Use
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.
EnSite™ X EP System, TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade and EnSite™ X EP System, TactiFlexTM Ablation Catheter, Sensor EnabledTM, Software License:
The EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™ Software Module is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.
Product codes
DOK
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart / Cardiac chamber
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Testing Summary:
Design verification activities were performed and met the respective acceptance criteria to ensure that the devices in scope of this submission are safe and effective.
Testing:
The EnSite™ X EP System v3.0 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
- ANSI AAMI IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical devices
Types of Testing Performed:
- Software Verification at unit, software and system level
- Performance testing of updated feature functionality
- Preclinical Validation Testing to confirm the system could meet user requirements and its intended use after modifications
- Human Factors Evaluations to confirm the user interface of the subject device can be used as intended by the defined user groups
Key Metrics
Not Found
Predicate Device(s)
EnSite™ X EP System (K223094)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 10, 2023
Abbott Medical Alyssa Timmers Senior Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, Minnesota 55117
Re: K231415
Trade/Device Name: EnSite™ X EP System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: May 15, 2023 Received: May 16, 2023
Dear Alyssa Timmers:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231415
Device Name EnSite™ X EP System
Indications for Use (Describe) 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.The EnSite™ X EP System TactiFlex™ Ablation Catheter Sensor Enabled™ Software Module is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.
EnSite™ X EP System, TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade and EnSite™ X EP System, TactiFlexTM Ablation Catheter, Sensor EnabledTM, Software License:
The EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™ Software Module is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 510(k) Information | |
|---|---|
| 510(k) Number | K231415 |
| 510(k) Type | Traditional 510(k) |
| Date Prepared | 15 May 2023 |
| 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 | Alyssa Timmers |
| Senior Regulatory Affairs Specialist | |
| 651-756-3706 | |
| alyssa.timmers@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 (K223094) |
| 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 | |
| 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. | |
| EnSite™ X EP System, TactiFlex™ Ablation Catheter, Sensor Enabled™, Software | |
| Upgrade and Software License | |
| The EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™ Software | |
| Module is indicated for use with the EnSite™ X EP System in accordance with the | |
| EnSite™ X EP System indications for use. | |
| Predicate Comparison | |
| Comparison | The subject device, EnSite™ X EP System v3.0, and the predicate device, EnSite™ X EP |
| System v2.0.1 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 software was revised to include: | |
| A display of the distance between two AutoMarks, or an AutoMark and the | |
| projected ablation catheter distal electrode, A duplicate selection method to allow for the display of map points based on the | |
| highest frequency, An expansion of the data able to be imported and exported between the subject | |
| device and third-party systems, A workflow enhancement that allows physicians to change navigation modes | |
| without restarting a study, The introduction of a new AutoMark metric, A minor update to the Force Direction Indicator, A minor update to the Sandpaper tool, and Fixes to minor known software issues. All risks associated with these modifications 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 the respective acceptance criteria to |
| ensure that the devices in scope of this submission are safe and effective. | |
| Testing | |
| The EnSite™ X EP System v3.0 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 | |
| Non-Clinical Testing | |
| Summary | |
| (Continued) | • ANSI AAMI IEC 62366-1:2015, Medical devices – Part 1: Application of usability |
| engineering to medical devices | |
| Types of Testing Performed | |
| • Software Verification at unit, software and system level | |
| • Performance testing of updated feature functionality | |
| • Preclinical Validation Testing to confirm the system could meet user requirements | |
| and its intended use after modifications | |
| • Human Factors Evaluations to confirm the user interface of the subject device can | |
| be used as intended by the defined user groups | |
| Statement of | |
| Equivalence | The subject and predicate devices have the same intended use, and the same indications |
| for use. The 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 Traditional 510(k) provides objective evidence the | |
| subject device is at least as safe and effective as the predicate device. |
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