(113 days)
Not Found
No
The summary describes a catheter navigation and mapping system that creates 3D models based on collected anatomical points. There is no mention of AI or ML algorithms being used for analysis, interpretation, or decision-making. The testing described focuses on software verification and performance testing of updated features, not on the evaluation of AI/ML model performance.
No
The device is described as a "suggested diagnostic tool" and a "catheter navigation and mapping system" that provides information about the heart's electrical activity and catheter location. Its intended use is for diagnosis and visualization, not for treating a condition.
Yes
The device is explicitly stated as a "suggested diagnostic tool" and provides "information about the electrical activity of the heart," which are functions consistent with a diagnostic device.
No
The device description explicitly states it is a "catheter navigation and mapping system" and describes the use of catheters to collect anatomical locations and electrical activity. This indicates the system includes hardware components beyond just 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 for whom electrophysiology studies have been indicated." It provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures. This indicates it's used directly on the patient during a medical procedure, not for testing samples in vitro (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 for real-time guidance and mapping within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or performing tests on these samples outside the body, which are hallmarks of IVD devices.
The system is used in vivo (within the living body) to assist in electrophysiology procedures, making it a medical device, but 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
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)
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 v2.0 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 v2.0:
Software Verification at unit, software and system level
Performance Testing of updated feature functionality
Preclinical studies to evaluate substantial equivalence
Preclinical Validation Testing to confirm the system could meet user requirements and its intended use after modifications
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EnSite™ X EP System (K213364)
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 and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 18, 2022
Abbott Alexandra Agre Senior Specialist, Regulatory Affairs One St. Jude Medical Drive St. Paul, Minnesota 55117
Re: K221213
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: July 15, 2022 Received: July 18, 2022
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 (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.
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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 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 medical devices and radiation-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.
for 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) K221213
Device Name EnSite™ X EP System
Indications for Use (Describe) EnSite™ X EP System
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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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The 510(k) Summary was drafted in accordance with 21 CFR 807.92, and is included below.
| 510(k) Information | |
|---|---|
| 510(k) Number | K221213 |
| 510(k) Type | Traditional 510(k) |
| Date Prepared | 26 April 2022 |
| 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
Senior Regulatory Affairs Specialist
651-756-4147
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 (K213364) |
| 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. |
| K221213 | |
| 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 v2.0 and the predicate EnSite™ X v1.1.1 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 activation time based on the Near Field Detection Method Displays peak frequency maps Displays multiple metrics on a single map using the Emphasize feature Automatically assesses activation times for outliers using the Outlier Filter Displays a model using only model points collected during expiration Updates work panel layouts 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 v2.0 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 v2.0 Software Verification at unit, software and system level Performance Testing of updated feature functionality Preclinical studies to evaluate substantial equivalence Preclinical Validation Testing to confirm the system could meet user requirements and its intended use after modifications |
| 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 non-clinical and clinical testing completed
and submitted in this Traditional 510(k) provides objective evidence the
subject device is at least as safe and effective and performs as well or better
than the predicate device. |
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