(113 days)
Not Found
No
The description focuses on traditional catheter navigation and mapping techniques, creating 3D models based on collected anatomical points. There is no mention of AI or ML algorithms for analysis, interpretation, or decision support.
No.
The device is described as a diagnostic tool that provides information about the electrical activity of the heart and displays catheter location during electrophysiological procedures. It is not intended to treat or prevent a disease or condition.
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."
No
The device description explicitly mentions hardware components like catheters, electrodes, and equipment (TactiSys™ Quartz Equipment), indicating it is a system with both hardware and software, not software-only.
Based on the provided information, the EnSite™ X EP System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- EnSite™ X EP System's Function: The EnSite™ X EP System is described as a "catheter navigation and mapping system." Its primary function is to display the 3-dimensional position of catheters within the heart and visualize the electrical activity of the heart in vivo (within the living body). It uses catheters inserted into the patient's heart to collect data directly from the cardiac chamber.
- Lack of Specimen Examination: The system does not process or analyze specimens (like blood or tissue) taken from the body. It interacts directly with the electrical activity and anatomy within the body.
Therefore, the EnSite™ X EP System falls under the category of a medical device used for in vivo diagnostic and procedural guidance, not an In Vitro Diagnostic device.
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.
Product codes (comma separated list FDA assigned to the subject device)
DQK
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
Not Found
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are safe and effective. Testing
The EnSite™ X EP System v1.1 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 EN ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices
Types of Testing Performed – EnSite X EP System v1.1
Software Verification at unit, software and system level
Performance Testing of updated feature functionality
Bench studies to evaluate substantial equivalence
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
EnSite™ X EP System (K202066)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 22, 2021
Abbott Medical Jamie Glaser Senior Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, Minnesota 55117
Re: K212061
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 30, 2021 Received: July 1, 2021
Dear Jamie Glaser:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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) K212061
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.
| 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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Image /page/3/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue stylized letter 'a' on the left and the word 'Abbott' in black font on the right. The blue 'a' symbol is a modern, abstract design, and the word 'Abbott' is written in a bold, sans-serif typeface.
5. 510(K) SUMMARY
| 510(k) Information | |
|---|---|
| 510(k) Number | K212061 |
| 510(k) Type | Traditional 510(k) |
| Date Prepared | 30 June 2021 |
| Submitter Information | |
| Manufacturer Name & | |
| Address | Abbott Medical |
| One St. Jude Medical Drive, | |
| St. Paul, Minnesota, 55119, USA | |
| Manufacturer of the EnSite X EP System | |
| St. Jude 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 | Jamie Glaser |
| Senior Regulatory Affairs Specialist | |
| 651-756-5091 | |
| jamie.glaser@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 (K202066) |
| 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. | |
| Predicate Comparison | |
| Comparison | EnSite™ X v1.1 and the predicate EnSite™ X v1.0.1 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 the following updates; | |
| Displays calculated waveforms of the optimal bipole (maximum voltage) | |
| independent of catheter orientation | |
| Displays activation direction arrows on maps | |
| Displays calculated wave speed maps | |
| Displays deflection direction indicators to assist in determining deflection | |
| direction | |
| Allows for exporting electrograms and electrode locations over ethernet | |
| during a live study to a 3rd party client | |
| Allows more targeted map editing using the Sandpaper tool | |
| Expands the use case for the remote support tool EnSite™ Connect | |
| (formerly SJM Connect) | |
| Displays map points in real time using EnSite™ LiveView Dynamic Display | |
| Displays catheter visualization differently under certain scenarios | |
| Fixes minor known software issues (bug fixes) | |
| 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 safe and effective. | |
| Testing | |
| The EnSite™ X EP System v1.1 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 EN ISO 14971:2019 Medical Devices – Application of Risk | |
| Management to Medical Devices | |
| Types of Testing Performed – EnSite X EP System v1.1 Software Verification at unit, software and system level Performance Testing of updated feature functionality Bench studies to evaluate substantial equivalence 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 | 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 Traditional 510(k) provides | |
| objective evidence the subject device is at least as safe and effective as the predicate | |
| device and that the subject device is substantially equivalent to the predicate device. |
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