(121 days)
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.
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.
The provided FDA 510(k) summary (K202066) focuses on the substantial equivalence of the EnSite X EP System and associated catheters to previously cleared predicate devices. It largely relies on the similar intended use, indications for use, fundamental scientific technology, and performance of the subject devices compared to the predicate devices. The primary change described is compatibility with the EnSite™ X EP System and updated labeling.
However, the document does not contain specific acceptance criteria, reported device performance metrics, or details of a study structured to prove the device meets pre-defined acceptance criteria in the manner that would be expected for a novel AI/ML diagnostic device with a specific performance claim (e.g., sensitivity, specificity for a disease).
Instead, the non-clinical testing summary focuses on design verification activities, compliance with industry standards, and in vivo preclinical studies to evaluate substantial equivalence, and human factors evaluations. This suggests that the "acceptance criteria" here are more about demonstrating that the new system and its components function as intended and do not raise new questions of safety or effectiveness compared to the predicate(s).
Given this context, I will extract the information available and note where specific details regarding AI/ML performance studies or traditional clinical performance metrics are not present, as they do not appear to be the primary focus of this 510(k).
Acceptance Criteria and Study for K202066
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, this 510(k) does not present performance in terms of specific diagnostic metrics (e.g., sensitivity, specificity, accuracy) with numerical acceptance criteria. Instead, the "acceptance criteria" are implied by successful completion of design verification activities, adherence to standards, and performance in preclinical studies demonstrating substantial equivalence to predicate devices. The reported device performance generally refers to its ability to function as intended and similar to predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Safe and effective operation of the EnSite™ X EP System. | Demonstrated through design verification, software verification, performance testing, and in vivo preclinical studies. |
| Compliance with relevant industry guidance and standards (e.g., IEC 62304, ISO 14971). | Confirmed through adherence to listed standards and guidance documents. |
| Functional performance of each device in the EnSite™ X EP System (e.g., functional, shipment). | Met through specific performance testing. |
| Accuracy of catheter position and orientation (similar to predicate). | Demonstrated through bench and in-vivo preclinical data comparing subject, predicate, and reference devices. |
| Proper functioning of cardiac mapping and model creation (similar to predicate). | Demonstrated through bench and in-vivo preclinical data comparing subject, predicate, and reference devices. |
| Compatibility of Sensor Enabled™ Catheters with the EnSite™ X EP System. | Confirmed via labeling updates and EEPROM functional tests. |
| User interface usability as intended by defined user groups. | Verified through Human Factors Evaluations. |
| No new questions of safety or effectiveness are raised compared to predicate devices. | Concluded based on predicate comparison and non-clinical testing results. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "In vivo Preclinical Studies" for the EnSite™ X EP System and Sensor Enabled™ Catheters. However, it does not specify the sample size (e.g., number of patients, cases, or animal subjects) used for these studies, nor does it explicitly state the country of origin or whether the data was retrospective or prospective. The term "preclinical" typically refers to animal studies rather than human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the use of experts to establish ground truth for a test set in the context of diagnostic interpretation. The studies described are more focused on the functional performance and substantial equivalence of the hardware and software components rather than a diagnostic accuracy study requiring expert human interpretation as ground truth.
4. Adjudication Method for the Test Set
Since the document does not describe a diagnostic study requiring expert interpretation or ground truth establishment in a clinical sense, there is no mention of an adjudication method (e.g., 2+1, 3+1).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that an MRMC comparative effectiveness study was done. The focus is on demonstrating that the device itself performs comparably to predicate devices, which may include functional performance in in-vivo settings, but not a study of human readers' performance with and without AI assistance for improving diagnostic outcomes.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
While the EnSite™ X EP System performs functions involving data processing ("programmable diagnostic computer"), the K202066 submission does not present it as a standalone AI/ML diagnostic algorithm with specific performance metrics (e.g., sensitivity, specificity) proven in a standalone study. The system provides "information about the electrical activity of the heart and displays catheter location" and "visualization of force information." The testing described confirms the system's functional integrity and similarity to predicate devices, rather than a standalone diagnostic performance claim often associated with AI/ML algorithms.
7. Type of Ground Truth Used
For the "in vivo Preclinical Studies" and bench testing, the ground truth would likely be based on:
- Physical measurements and established physiological parameters: For evaluating catheter position, orientation, and electrical activity recording accuracy.
- Comparison to predicate device performance: Demonstrating similar outputs and behavior.
- Engineering specifications and design requirements: For functional tests of hardware and software components.
There is no mention of "pathology" or "outcomes data" being used as ground truth for the evaluations described.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set size. This indicates that the regulatory submission is likely not for a device that relies on continuously learning or adaptive AI/ML algorithms that require specific training data sets in the typical sense. The "software verification" and "system level" testing suggest traditional software development and testing, rather than a machine learning model's training and validation.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set or a machine learning component requiring one, there is no information provided on how ground truth for a training set was established.
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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 & 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
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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
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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
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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)
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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™ CardiacMapping 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 catheternavigation and mapping system is capable of displaying the 3-dimensional (3-D)position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, aswell 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'sown cardiac chamber. The system creates a model by collecting and labeling theanatomic locations within the chamber. A surface is created by moving a selectedcatheter to locations within a cardiac structure. As the catheter moves, points arecollected at and between all electrodes on the catheter. A surface is wrapped aroundthe outermost points. | |
| Indications for Use | EnSite™ X EP System |
| The EnSite™ X EP System is a suggested diagnostic tool in patients for whomelectrophysiology studies have been indicated. | |
| The EnSite™ X EP System provides information about the electrical activity of theheart 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 SystemContact Force Module is intended to provide visualization of force information fromcompatible catheters. | |
| EnSite™ X EP System Surface Electrode Kit | |
| The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ XEP 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 foruse as the predicate device. The EnSite™ X EP System operates using the samefundamental scientific technology to facilitate catheter position and orientation, aswell as cardiac mapping and model creation with some differences. The subjectdevice enables the use of a magnetic-primary catheter navigation mode or animpedance-based catheter navigation mode. The predicate device does not have amagnetic-primary catheter navigation mode but has an impedance-based catheternavigation mode and allows for magnetic field scaling. The reference device utilizesa magnetic-primary or impedance for catheter navigation. No new questions ofsafety 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 avariable radius, circular mapping catheter. It has an adjustable 4 French (F) distalloop size with a diameter ranging from 15mm - 25mm with models containing bothten (10) equidistant or twenty (20) paired platinum-iridium electrodes. The catheterhas integrated sensors with two impedance-based navigational electrodes and twomagnetic sensors located at the distal end of the shaft. The catheter is intended to beused with the EnSite Precision™ Cardiac Mapping System, or the EnSite™ X EPSystem. |
| Indications for Use | Advisor™ VL Circular Mapping Catheter, Sensor Enabled™ is a steerableelectrophysiology catheter with integrated sensors. The catheter is used for recordingintracardiac signals and cardiac stimulation during diagnostic electrophysiologystudies. The catheter can be used to map the atrial regions of the heart. |
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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.
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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 acircular mapping catheter for performing electrophysiology mapping procedures andproviding pacing signals to the heart during electrophysiology procedures. Thecatheter handle and shaft design allows for improved maneuverability. A magneticsensor in the distal shaft pocket provides compatibility with visualization andnavigation 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 steerableelectrophysiology catheter with integrated sensors. The catheter is used forrecording intracardiac signals and cardiac stimulation during diagnosticelectrophysiology studies. The catheter can be used to map the atrial regions of theheart. | ||
| Predicate Comparison | The subject and predicate devices have the same intended use and similar indicationfor use statements. There are slight differences in verbiage, however the overallintent remains the same. The subject and predicate device have identical devicedesign, fundamental scientific technology and device functionality. The onlydifference between the subject and predicate device are the labeling updates toindicate compatibility with the EnSite™ X EP System. No new questions of safetyor 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, singleuse, irrigated, high-density mapping catheter with a 7.5F shaft and an 8F distal shaftdeflectable section. It is available in a D-F bi-directional curve model that isdeflected using the actuator located on the catheter handle. The catheter workinglength is 110 cm. The device consists of a paddle-shaped distal tip with 16electrodes, two distal shaft ring electrodes, two magnetic sensors, polymer braidedshaft, handle, fluid lumen extension with a luer, and an electrical connector. Thecatheter also has an introducer tool intended to compress and guide the distal paddleinto, and withdraw from, the hemostasis valve of an introducer sheath. |
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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™, andEnSite™ X EP Cardiac Mapping Systems and other accessories, including theconnecting cable and commercially available irrigation pumps. | |
|---|---|
| Indications for Use | The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated formultiple electrode electrophysiological mapping of cardiac structures in the heart,i.e., recording or stimulation only. This catheter is intended to obtain electrograms inthe 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, fundamentalscientific technology and device functionality. The only difference between thesubject and predicate device are the labeling updates to indicate compatibility withthe 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 TestingSummary | Design verification activities were performed and met their respective acceptancecriteria to ensure that the devices in scope of this submission are safety andeffective.TestingThe EnSite™ X EP System and Sensor Enabled™ catheters in scope of thissubmission were developed and tested in accordance with the following industryguidance documents and standards:- Guidance for the Content of Premarket Submissions for Software Contained inMedical Devices- IEC 62304: 2015-06 Edition 1.1, Medical Device Software - Software LifeCycle Processes- EN ISO 14971:2012 Medical Devices - Application of Risk Management toMedical DevicesTypes 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 includingfunctional, shipment, etc.- In vivo Preclinical Studies to evaluate substantial equivalence- Human Factors Evaluations to confirm the user interface of the subject devicecan be used as intended by the defined user groupsTypes of Testing Performed – Sensor Enabled™ Catheters- In vivo Preclinical Studies to evaluate substantial equivalence- EEPROM Functional TestsNo additional non-clinical tests were required for the Sensor Enabled™ catheters forcompatibility with the EnSite™ X EP system. |
| Statement of Equivalence for EnSite™ X EP System and Sensor Enabled™ Catheters | |
| Statement ofEquivalence | All subject and predicate devices have the same intended use, and similar indicationsfor use. All devices operate using the same fundamental scientific technology tofacilitate catheter position and orientation, as well as cardiac mapping and modelcreation with some differences. Bench and In-vivo preclinical data for the subjectdevice, predicate device, and reference device demonstrate substantial equivalence.The testing completed and submitted in this Traditional 510(k) provides objectiveevidence the subject devices are at least as safe and effective as the predicatedevices. |
§ 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).