(88 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, ML, or related concepts in the intended use, device description, or testing summaries. The system appears to rely on traditional geometric modeling and data visualization techniques.
No.
The "Intended Use" section clearly states that the EnSite™ X EP System is a "suggested diagnostic tool" and "provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures." It is used for diagnosis and information display, not for direct therapeutic treatment.
Yes
Explanation: 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 also mentions that it "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 describes the use of catheters to collect data and create 3D maps, indicating it includes hardware components beyond just software. The testing section also mentions electrical safety testing, further suggesting hardware is part of the system.
Based on the provided text, the EnSite™ X EP System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's 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 procedures. This is an in vivo (within the living body) diagnostic process, not an in vitro (outside the living body) diagnostic process.
- Device Description: The description details a catheter navigation and mapping system that displays the 3D position of catheters and cardiac electrical activity as waveform traces and 3D maps. This is all related to real-time monitoring and mapping within the patient's heart.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples (blood, tissue, etc.) outside of the body, which is a defining characteristic of IVD devices.
Therefore, the EnSite™ X EP System is an in vivo diagnostic and therapeutic support system, not an IVD.
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
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 v2.0.1 used with the EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade and License 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
- IEC 60601-1: 2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
Types of Testing Performed:
- Software Verification at a software and system level to test the new software features added for the display of the TactiFlex™ Ablation Catheter, Sensor Enabled™ Force Number Refresh Rate Force Direction Indicator
- 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
- Electrical Safety Testing to ensure the system when used with the TactiFlex™ Ablation Catheter, Sensor Enabled™ continues to comply with safety standards
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EnSite™ X EP System (K221213)
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 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.
December 27, 2022
Abbott Medical Alyssa Timmers Senior Regulatory Affairs Specialist One St. Jude Medical Device St. Paul, Minnesota 55117
Re: K223094
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: September 29, 2022 Received: September 30, 2022
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
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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,
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) K223094
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) Summary
The 510(k) Summary was drafted in accordance with 21 CFR 807.92 and is included below.
| 510(k) Information | |
|---|---|
| 510(k) Number | K223094 |
| 510(k) Type | Traditional 510(k) |
| Date Prepared | 29 September 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 | 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 (K221213) |
| 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 devices are:
EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor
Enabled™, Software Upgrade, v2.0 andEnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor
Enabled™, Software License. |
| | The subject devices are intended to be installed on the EnSite™ X EP System with
version 2.0.1 software. The predicate device is EnSite X EP System v2.0 with the
Contact Force License, catalog number ENSITE-CF-01 (included in the predicate
submission). |
| | The subject device adds a new indication for use specific for the EnSite™ X EP
System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade. The
predicate intended use and indications for use have not changed with this addition.
The addition of this intended use is not critical to the intended diagnostic use of the
device as it refers to use of the subject device in accordance with the indications for
use of the predicate device. |
| | The subject device adds additional user selectable settings for Force Number
Refresh Rate as compared with the predicate which has a fixed setting for this. This
feature is available when either a TactiCath™ Contact Force Ablation Catheter,
Sensor Enabled™ or TactiFlex™ Ablation Catheter, Sensor Enabled™ are
connected. |
| | The predicate device displays force direction by a graphical representation and the
Force Cone feature, while the subject device uses those features and adds Force
Direction Indicator arrows displayed at the catheter tip at the 3D location of the
catheter. This feature is only available when a TactiFlex™ Ablation Catheter, Sensor
Enabled™ is connected. |
| | The subject and predicate device 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 device software was modified
to enable compatibility with Abbott's ablation catheter, TactiFlex™ Ablation Catheter,
Sensor Enabled™. 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 their respective acceptance
criteria to ensure that the devices in scope of this submission are safe and effective. |
| | Testing |
| | The EnSite™ X EP System v2.0.1 used with the EnSite™ X EP System TactiFlex™
Ablation Catheter, Sensor Enabled™, Software Upgrade and License 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 IEC 60601-1: 2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 +
A1:2012, Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance. |
| Types of Testing Performed | |
| | Software Verification at a software and system level to test the new
software features added for the display of the TactiFlex™ Ablation
Catheter, Sensor Enabled™ Force Number Refresh Rate Force Direction Indicator 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 Electrical Safety Testing to ensure the system when used with the
TactiFlex™ Ablation Catheter, Sensor Enabled™ continues to comply
with safety standards |
| Statement of Equivalence | The subject and predicate devices have the same intended use, and similar
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 non-clinical and clinical testing completed and submitted in
this Traditional 510(k) provides objective evidence the subject device is as safe, as
effective, and performs as well as or better than the legally marketed device
predicate. |
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