(30 days)
Not Found
No
The description focuses on traditional catheter navigation and mapping techniques, without mentioning AI or ML algorithms for data analysis, mapping, or other functions.
No
The device is described as a "diagnostic tool" and provides "information about the electrical activity of the heart and displays catheter location". It is a "catheter navigation and mapping system" used to display "3-dimensional (3-D) position" and "cardiac electrical activity". These functions are for diagnosis and information gathering, not for treating 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." It further elaborates that it "provides information about the electrical activity of the heart."
No
The device description explicitly mentions hardware components like catheters and surface electrodes, indicating it is a system that includes both hardware and software.
Based on the provided information, the EnSite™ X EP System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is a "suggested diagnostic tool in patients" and "provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures." This describes a system used in vivo (within the living patient) to gather physiological data and guide procedures.
- Device Description: The description details a "catheter navigation and mapping system" that displays the position of catheters and cardiac electrical activity as waveforms and 3D maps. This is consistent with an in vivo system used for electrophysiology studies.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) outside the body to diagnose diseases or conditions. The EnSite™ X EP System does not process or analyze biological specimens in this manner.
Therefore, the EnSite™ X EP System is an in vivo diagnostic and procedural guidance system, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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
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 substantially equivalent to the predicate device.
Software Verification at unit, software and system level
Performance Testing of updated feature functionality
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.
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 9, 2024
Abbott Medical Alexandra Agre Principal Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, Minnesota 55117-9913
Re: K242016
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: July 10, 2024 Received: July 10, 2024
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.
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"
1
(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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-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 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.
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-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
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Enclosure
3
Indications for Use
510(k) Number (if known) K242016
Device Name EnSite™ X EP System
Indications for Use (Describe) |
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-------------------------------- |
EnSite™ X EP System |
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--------------------- |
The EnSite™ X EP System is a |
---|
------------------------------ |
X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been The EnSite 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/4/Picture/2 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 bold font on the right. The blue "a" is a geometric shape with rounded corners, and the word "Abbott" is in a sans-serif typeface.
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 | K242016 |
510(k) Type | Special 510(k) |
Date Prepared | 10 July 2024 |
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 |
Principal Regulatory Affairs Specialist | |
612-322-3442 | |
alexandra.agre@abbott.com | |
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 (K231415) |
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 v3.1 and the predicate EnSite™ X v3.0 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 software was revised to include the following updates: |
Compatibility with Advisor™ HD Grid X, Sensor Enabled™ Farawave catheter visualization Minor software updates (bug fixes) and enhancements 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 v3.1 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 IEC 60601-1-2:2020-09 Edition 4.1, Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests ISO 14971:2019 Medical Devices - Application of Risk Management to Medical Devices |
Types of Testing Performed – EnSite X EP System v3.1 | Software Verification at unit, software and system level Performance Testing of updated feature functionality |
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. |
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Special 510(k)
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