(113 days)
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 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.
The provided text does not contain details about acceptance criteria or a study proving the device meets those criteria for the EnSite™ X EP System's AI software.
The document is a 510(k) summary for the EnSite™ X EP System, specifically for version 2.0. It primarily focuses on demonstrating substantial equivalence to a predicate device (EnSite™ X v1.1.1). While it mentions "software was revised to include the following updates" which sound like new features (e.g., "Displays activation time based on the Near Field Detection Method," "Displays peak frequency maps," "Automatically assesses activation times for outliers using the Outlier Filter"), it does not provide any specific quantitative acceptance criteria or detailed study results related to the performance of these new software features or any embedded AI/algorithmic components.
The "Non-Clinical Testing Summary" broadly states that "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." It lists types of testing performed such as "Software Verification at unit, software and system level," "Performance Testing of updated feature functionality," and "Preclinical studies to evaluate substantial equivalence," and "Preclinical Validation Testing to confirm the system could meet user requirements and its intended use after modifications." However, it does not elaborate on the specific acceptance criteria for these tests, nor does it provide any data (e.g., accuracy, sensitivity, specificity, or inter-reader agreement statistics) to demonstrate how these criteria were met.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided document. The document primarily focuses on regulatory approval based on "substantial equivalence" rather than a detailed performance study of specific AI algorithm metrics.
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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 MedicalOne St. Jude Medical Drive,St. Paul, Minnesota, 55117, USAManufacturer of the EnSite™ X EP SystemAbbott Medical Costa Rica Ltda.Edificio #44 Calle 0, Ave. 2Zona Franca CoyolEl Coyol Alajuela, Costa Rica 1897-4050Manufacturer of the EnSite™ X EP System Surface Electrode Kit |
| Contact Person | Alexandra AgreSenior Regulatory Affairs Specialist651-756-4147alexandra.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. Acatheter 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 aswaveform traces and as three-dimensional (3D) isopotential and isochronalmaps of the cardiac chamber.The contoured surfaces of the 3D maps are based on the anatomy of thepatient's own cardiac chamber. The system creates a model by collecting andlabeling the anatomic locations within the chamber. A surface is created bymoving a selected catheter to locations within a cardiac structure. As thecatheter moves, points are collected at and between all electrodes on thecatheter. A surface is wrapped around the outermost points. |
| Indications for Use | EnSite™ X EP SystemThe EnSite™ X EP System is a suggested diagnostic tool in patients forwhom electrophysiology studies have been indicated.The EnSite™ X EP System provides information about the electrical activity ofthe heart and displays catheter location during conventionalelectrophysiological (EP) procedures. |
| K221213 | |
| 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 informationfrom compatible catheters. | |
| EnSite™ X EP System Surface Electrode KitThe EnSite™ X EP Surface Electrode Kit is indicated for use with theEnSite™ X EP System in accordance with the EnSite™ X EP Systemindications for use. | |
| Predicate Comparison | |
| Comparison | EnSite™ X v2.0 and the predicate EnSite™ X v1.1.1 have the same intendeduse and indications for use. They use the same fundamental scientifictechnology to facilitate catheter position and orientation, as well as cardiacmapping and model creation. There were no changes to the hardware. Thesubject 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 oreffectiveness were raised. | |
| Non-Clinical TestingSummary | Design verification activities were performed and met their respectiveacceptance criteria to ensure that the devices in scope of this submission aresafe and effective. |
| Testing | |
| The EnSite™ X EP System v2.0 in scope of this submission was developedand tested in accordance with the following industry guidance documents andstandards: 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 ofEquivalence | All subject and predicate devices have the same intended use, and sameindications for use. All devices operate using the same fundamental scientifictechnology to facilitate catheter position and orientation, as well as cardiacmapping and model creation. The non-clinical and clinical testing completedand submitted in this Traditional 510(k) provides objective evidence thesubject device is at least as safe and effective and performs as well or betterthan the predicate device. |
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§ 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).