(121 days)
No
The summary describes a cardiac mapping and navigation system that uses sensor data to create 3D models and display electrical activity. There is no mention of AI or ML being used for analysis, interpretation, or decision support. The focus is on data collection, visualization, and basic model creation based on collected points.
No
Explanation: The device is described as a "diagnostic tool" that "provides information about the electrical activity of the heart and displays catheter location". It is used for "recording intracardiac stimulation during diagnostic electrophysiology studies" and "electrophysiological mapping of cardiac structures." There is no indication that the device is used for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the EnSite™ X EP System "is a suggested diagnostic tool" and that the associated catheters are "used for recording intracardiac stimulation during diagnostic electrophysiology studies." The device description also highlights its capability in mapping cardiac electrical activity and displaying catheter location for understanding the heart's electrical behavior, which is essential for diagnosis.
No
The device description explicitly includes hardware components such as catheters with integrated sensors, electrodes, and a system that displays 3D position and cardiac electrical activity, indicating it is not software-only.
Based on the provided information, none of the devices described are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens derived from the human body. The descriptions clearly state that these devices are used within the human body (intracardiac) to record electrical activity, map cardiac structures, and display catheter location during electrophysiology procedures.
- The intended use and device descriptions focus on in vivo procedures. They describe the system and catheters interacting directly with the heart and its electrical signals, not analyzing samples taken from the body.
- There is no mention of analyzing blood, tissue, or other bodily fluids. The data collected is electrical activity and positional information from within the heart.
Therefore, these devices fall under the category of medical devices used for diagnostic and interventional procedures in vivo, not in vitro diagnostics.
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™ in accordance with the EnSite™ X EP System indications for use.
Advisor™ VL Circular Mapping Catheter, Sensor Enabled™:
Advisor™ VL Circular Mapping Catheter, Sensor Enabled™ is a steerable electrophysiology catheter with integrated sensors. The catheter is used for recording intracardiac stimulation during diagnostic electrophysiology studies. The cather can be used to map the atrial regions of the heart.
Advisor™ FL Circular Mapping Catheter, Sensor Enabled™:
The Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ is steerable electrophysiology catheter with integrated sensors. The catheter is used for recording intracardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.
Advisor™ HD High Density Mapping Catheter, Sensor Enabled™:
The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electricular regions of the heart.
Product codes (comma separated list FDA assigned to the subject device)
DQK, DRF, MTD
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.
Advisor™ VL Circular Mapping Catheter, Sensor Enabled™ (Advisor VL) is a variable radius, circular mapping catheter. It has an adjustable 4 French (F) distal loop size with a diameter ranging from 15mm - 25mm with models containing both ten (10) equidistant or twenty (20) paired platinum-iridium electrodes. The catheter has integrated sensors with two impedance-based navigational electrodes and two magnetic sensors located at the distal end of the shaft. The catheter is intended to be used with the EnSite Precision™ Cardiac Mapping System, or the EnSite™ X EP System.
Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ (Advisor FL, SE) is a circular mapping catheter for performing electrophysiology mapping procedures and providing pacing signals to the heart during electrophysiology procedures. The catheter handle and shaft design allows for improved maneuverability. A magnetic sensor in the distal shaft pocket provides compatibility with visualization and navigation systems. The catheter is compatible with Abbott's EnSite Precision™ Cardiac Mapping System, MediGuide™ System, or EnSite™ X EP System.
The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is a sterile, single use, irrigated, high-density mapping catheter with a 7.5F shaft and an 8F distal shaft deflectable section. It is available in a D-F bi-directional curve model that is deflected using the actuator located on the catheter handle. The catheter working length is 110 cm. The device consists of a paddle-shaped distal tip with 16 electrodes, two distal shaft ring electrodes, two magnetic sensors, polymer braided shaft, handle, fluid lumen extension with a luer, and an electrical connector. The catheter also has an introducer tool intended to compress and guide the distal paddle into, and withdraw from, the hemostasis valve of an introducer sheath. The catheter is compatible with the EnSite™ Velocity, EnSite Precision™, and EnSite™ X EP Cardiac Mapping Systems and other accessories, including the connecting cable and commercially available irrigation pumps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, atrial regions, cardiac structures
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 safety and effective.
Testing The EnSite™ X EP System and Sensor Enabled™ catheters in scope of this submission were 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 14971:2012 Medical Devices - Application of Risk Management to Medical Devices
Types of Testing Performed – EnSite™ X EP System - Software Verification at a unit, software and system level - Performance Testing of each device in the EnSite™ X EP System including functional, shipment, etc. - In vivo Preclinical Studies to evaluate substantial equivalence - Human Factors Evaluations to confirm the user interface of the subject device can be used as intended by the defined user groups
Types of Testing Performed – Sensor Enabled™ Catheters - In vivo Preclinical Studies to evaluate substantial equivalence - EEPROM Functional Tests
No additional non-clinical tests were required for the Sensor Enabled™ catheters for compatibility with the EnSite™ X EP system.
Bench and In-vivo preclinical data for the subject device, predicate device, and reference device demonstrate substantial equivalence. The testing completed and submitted in this Traditional 510(k) provides objective evidence the subject devices are at least as safe and effective as the predicate devices.
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.
K201181, K192037, K160335, K172393
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.
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 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2020
Abbott Medical Alyssa Timmers Senior Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, Minnesota 55117
Re: K202066
Trade/Device Name: EnSite X EP System Advisor VL Circular Mapping Catheter, Sensor Enabled Advisor HD Grid High Density Mapping Catheter, Sensor Enabled Advisor FL Circular Mapping Catheter, Sensor Enabled Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK
Dear Alyssa Timmers:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 25, 2020. There was an error in the Trade/Device Name section of the previous letter where Advisor FL Circular Mapping Catheter, Sensor Enabled was inadvertently omitted from the list of devices. Specifically, FDA is updating this SE Letter as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions this letter please contact Mark Fellman, OHT2: Office of Cardiovascular Devices, 301-796-6357, Mark.Fellman@fda.hhs.gov.
Sincerely,
Mark S.
Fellman -S
Mark Fellman 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
1
Image /page/1/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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 25, 2020
Abbott Medical Alyssa Timmers Senior Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul. Minnesota 55117
Re: K202066
Trade/Device Name: EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Sensor Enabled Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: October 26, 2020 Received: October 27, 2020
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/cfpmb/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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
2
requirements, including, but not limited to: registration and listing (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 (05) 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-devices/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 (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,
Mark S.
Fellman -S
for
Mark Fellman 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
3
Indications for Use
510(k) Number (if known) K202066
Device Name
EnSite™ X EP System, Advisor™ VL Circular Mapping Catheter, Sensor Enabled™, Advisor™ FL Circular Mapping Catheter, Sensor Enabled™, Advisor™ HD High Density Mapping Catheter, Sensor Enabled™
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™ in accordance with the EnSite™ X EP System indications for use.
Advisor™ VL Circular Mapping Catheter, Sensor Enabled™:
Advisor™ VL Circular Mapping Catheter, Sensor Enabled™ is a steerable electrophysiology catheter with integrated sensors. The catheter is used for recording intracardiac stimulation during diagnostic electrophysiology studies. The cather can be used to map the atrial regions of the heart.
Advisor™ FL Circular Mapping Catheter, Sensor Enabled™:
The Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ is steerable electrophysiology catheter with integrated sensors. The catheter is used for recording intracardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.
Advisor™ HD High Density Mapping Catheter, Sensor Enabled™:
The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electricular regions of the heart.
Type of Use (Select one or both, as applicable)
| Restriction Use (Part 21 CFR 601.3, Subpart D) |
|---|
| Compassionate Use (21 CFR 601.3, Subpart E) |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/1 description: The image contains the Abbott logo. The logo consists of a blue stylized letter "a" on the left and the word "Abbott" in bold black font on the right. The blue "a" symbol is made up of three horizontal lines, with rounded corners, stacked on top of each other.
| 510(k) Information | |
|---|---|
| 510(k) Number | K202066 |
| 510(k) Type | Bundled Traditional 510(k) |
| Date Prepared | 24 July 2020 |
| Submitter Information | |
| Manufacturer Name & | Abbott Medical |
| Address | 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 | |
| Abbott Medical | |
| 5050 Nathan Lane North | |
| Plymouth, Minnesota, 55442, USA | |
| Manufacturer of the Sensor Enabled™ Diagnostic Catheters | |
| 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™ Velocity Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac |
| Mapping System v2.2 (K201181) | |
| Reference Device | Carto 3 EP Navigation System (K180238) |
| 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 | The EnSite™ X EP System has the same intended use, and similar indications for |
| use as the predicate device. The EnSite™ X EP System operates using the same | |
| fundamental scientific technology to facilitate catheter position and orientation, as | |
| well as cardiac mapping and model creation with some differences. The subject | |
| device enables the use of a magnetic-primary catheter navigation mode or an | |
| impedance-based catheter navigation mode. The predicate device does not have a | |
| magnetic-primary catheter navigation mode but has an impedance-based catheter | |
| navigation mode and allows for magnetic field scaling. The reference device utilizes | |
| a magnetic-primary or impedance for catheter navigation. No new questions of | |
| safety or effectiveness were raised. | |
| Advisor™ VL Circular Mapping Catheter, Sensor Enabled™ | |
| Trade Name | Advisor™ VL Circular Mapping Catheter, Sensor Enabled™ |
| Common Name | Diagnostic Electrophysiology Catheter |
| Class | II |
| Classification Name | 870.1220, Electrode recording catheter or electrode recording probe |
| Product Code | DRF |
| Predicate Device | Advisor™ VL Circular Mapping Catheter, Sensor Enabled™ (K192037) |
| Device Description | Advisor™ VL Circular Mapping Catheter, Sensor Enabled™ (Advisor VL) is a |
| variable radius, circular mapping catheter. It has an adjustable 4 French (F) distal | |
| loop size with a diameter ranging from 15mm - 25mm with models containing both | |
| ten (10) equidistant or twenty (20) paired platinum-iridium electrodes. The catheter | |
| has integrated sensors with two impedance-based navigational electrodes and two | |
| magnetic sensors located at the distal end of the shaft. The catheter is intended to be | |
| used with the EnSite Precision™ Cardiac Mapping System, or the EnSite™ X EP | |
| System. | |
| Indications for Use | Advisor™ VL Circular Mapping Catheter, Sensor Enabled™ is a steerable |
| electrophysiology catheter with integrated sensors. The catheter is used for recording | |
| intracardiac signals and cardiac stimulation during diagnostic electrophysiology | |
| studies. The catheter can be used to map the atrial regions of the heart. |
5
Image /page/5/Picture/1 description: The image shows the logo for Abbott. The logo consists of a blue symbol on the left and the word "Abbott" in black on the right. The symbol is a stylized letter "a" in blue. The word "Abbott" is in a bold, sans-serif font.
6
Image /page/6/Picture/1 description: The image contains the Abbott logo. On the left is a blue, stylized letter 'A' inside a rounded square. To the right of the logo is the word "Abbott" in bold, black font. The logo and text are aligned horizontally.
subject and predicate device are the labeling updates to indicate compatibility with
the EnSite™ X EP System. No new questions of safety or effectiveness were raised.
| Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ | |||
|---|---|---|---|
| Trade Name | Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ | ||
| Common Name | Diagnostic Electrophysiology Catheter | ||
| Class | II | ||
| Classification Name | 870.1220, Electrode recording catheter or electrode recording probe | ||
| Product Code | DRF | ||
| Predicate Device | Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ (K160335) | ||
| Device Description | Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ (Advisor FL, SE) is a | ||
| circular mapping catheter for performing electrophysiology mapping procedures and | |||
| providing pacing signals to the heart during electrophysiology procedures. The | |||
| catheter handle and shaft design allows for improved maneuverability. A magnetic | |||
| sensor in the distal shaft pocket provides compatibility with visualization and | |||
| navigation systems. The catheter is compatible with Abbott's EnSite Precision™ | |||
| Cardiac Mapping System, MediGuide™ System, or EnSite™ X EP System. | |||
| Indications for Use | The Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ is steerable | ||
| electrophysiology catheter with integrated sensors. The catheter is used for | |||
| recording intracardiac signals and cardiac stimulation during diagnostic | |||
| electrophysiology studies. The catheter can be used to map the atrial regions of the | |||
| heart. | |||
| Predicate Comparison | The subject and predicate devices have the same intended use and similar indication | ||
| for use statements. There are slight differences in verbiage, however the overall | |||
| intent remains the same. The subject and predicate device have identical device | |||
| design, fundamental scientific technology and device functionality. The only | |||
| difference between the subject and predicate device are the labeling updates to | |||
| indicate compatibility with the EnSite™ X EP System. No new questions of safety | |||
| or effectiveness were raised. | |||
| Advisor™ HD Grid High Density Mapping Catheter, Sensor Enabled™ | |||
| Trade Name | Advisor™ HD High Density Mapping Catheter, Sensor Enabled™ | ||
| Common Name | Catheter, Intracardiac Mapping, High-Density Array | ||
| Class | II | ||
| Classification Name | 870.1220, Electrode recording catheter or electrode recording probe | ||
| Product Code | DRF & MTD | ||
| Predicate Device | Advisor™ HD High Density Mapping Catheter, Sensor Enabled™ (K172393) | ||
| Device Description | The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is a sterile, single | ||
| use, irrigated, high-density mapping catheter with a 7.5F shaft and an 8F distal shaft | |||
| deflectable section. It is available in a D-F bi-directional curve model that is | |||
| deflected using the actuator located on the catheter handle. The catheter working | |||
| length is 110 cm. The device consists of a paddle-shaped distal tip with 16 | |||
| electrodes, two distal shaft ring electrodes, two magnetic sensors, polymer braided | |||
| shaft, handle, fluid lumen extension with a luer, and an electrical connector. The | |||
| catheter also has an introducer tool intended to compress and guide the distal paddle | |||
| into, and withdraw from, the hemostasis valve of an introducer sheath. |
7
Image /page/7/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue stylized "a" on the left and the word "Abbott" in black on the right. The "a" is made up of three horizontal lines, with the top and bottom lines being shorter than the middle line.
| | The catheter is compatible with the EnSite™ Velocity, EnSite Precision™, and
EnSite™ X EP Cardiac Mapping Systems and other accessories, including the
connecting cable and commercially available irrigation pumps. |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for
multiple electrode electrophysiological mapping of cardiac structures in the heart,
i.e., recording or stimulation only. This catheter is intended to obtain electrograms in
the atrial and ventricular regions of the heart. |
| Predicate Comparison | The subject and predicate device have the same intended use and indications for use.
The subject and predicate device have identical device design, fundamental
scientific technology and device functionality. The only difference between the
subject and predicate device are the labeling updates to indicate compatibility with
the EnSite™ X EP System. No new questions of safety or effectiveness were raised. |
| | Non-Clinical Testing Summary for EnSite™ X EP System and Sensor Enabled™ Catheters |
| 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 safety and
effective.
Testing
The EnSite™ X EP System and Sensor Enabled™ catheters in scope of this
submission were 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 14971:2012 Medical Devices - Application of Risk Management to
Medical Devices
Types of Testing Performed – EnSite™ X EP System - Software Verification at a unit, software and system level
- Performance Testing of each device in the EnSite™ X EP System including
functional, shipment, etc. - In vivo Preclinical Studies to evaluate substantial equivalence
- Human Factors Evaluations to confirm the user interface of the subject device
can be used as intended by the defined user groups
Types of Testing Performed – Sensor Enabled™ Catheters - In vivo Preclinical Studies to evaluate substantial equivalence
- EEPROM Functional Tests
No additional non-clinical tests were required for the Sensor Enabled™ catheters for
compatibility with the EnSite™ X EP system. |
| | Statement of Equivalence for EnSite™ X EP System and Sensor Enabled™ Catheters |
| Statement of
Equivalence | All subject and predicate devices have the same intended use, and similar 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 with some differences. Bench and In-vivo preclinical data for the subject
device, predicate device, and reference device demonstrate substantial equivalence.
The testing completed and submitted in this Traditional 510(k) provides objective
evidence the subject devices are at least as safe and effective as the predicate
devices. |