(86 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.
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.
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 document, a 510(k) premarket notification letter from the FDA regarding the EnSite™ X EP System, does not contain the detailed information typically required to answer your specific questions about device acceptance criteria and a study proving those criteria were met for an AI/ML medical device.
The document describes the device as a "Programmable Diagnostic Computer" for electrophysiology (EP) studies and notes software revisions for the subject device (EnSite™ X EP System v3.0) compared to its predicate (EnSite™ X EP System v2.0.1). However, the software updates described are primarily workflow enhancements, minor display updates, and data import/export expansions, not features that would typically involve a large-scale AI/ML performance study with specific acceptance criteria like sensitivity, specificity, or AUC as you described.
The "Non-Clinical Testing Summary" mentions "Software Verification at unit, software and system level," "Performance testing of updated feature functionality," "Preclinical Validation Testing to confirm the system could meet user requirements," and "Human Factors Evaluations." While these are tests, they are framed in the context of ensuring the updated software functions as intended and meets user requirements, rather than demonstrating a performance benefit against a specific clinical outcome with an AI algorithm.
Therefore, based solely on the provided text, I cannot extract the information required for your questions.
Here's why each point cannot be answered:
- A table of acceptance criteria and the reported device performance: The document does not provide specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for an AI algorithm, nor reported device performance against such criteria. The "acceptance criteria" mentioned are more general for software verification and validation.
- Sample sizes used for the test set and the data provenance: There is no mention of a specific test set, its size, or the provenance of any data used for performance evaluation in the context of an AI/ML algorithm.
- Number of experts used to establish the ground truth for the test set and qualifications: This information is absent as no detailed performance study with a test set requiring ground truth is described.
- Adjudication method for the test set: Not applicable, as no such test set or study is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: The document does not describe any MRMC study or any study evaluating human reader improvement with AI assistance. The device is a "Programmable Diagnostic Computer" for EP studies, not explicitly an AI-assisted diagnostic tool in the sense of image interpretation where MRMC studies are common.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned in the context of a standalone AI algorithm performance. The device itself is a system that assists in EP studies.
- The type of ground truth used: No ground truth for an AI algorithm's performance is described.
- The sample size for the training set: Not applicable, as there's no mention of an AI model's training set.
- How the ground truth for the training set was established: Not applicable, as there's no mention of an AI model's training set.
In summary, the provided document is a regulatory approval letter and a summary of the device's technical specifications and non-clinical testing. It does not elaborate on an AI/ML component meeting specific performance criteria through a clinical validation study as implied by your questions. The software changes are presented as enhancements to an existing system, rather than the introduction of a new AI-driven diagnostic capability requiring a comprehensive AI performance study.
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August 10, 2023
Abbott Medical Alyssa Timmers Senior Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, Minnesota 55117
Re: K231415
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: May 15, 2023 Received: May 16, 2023
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 mediation-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) K231415
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) Information | |
|---|---|
| 510(k) Number | K231415 |
| 510(k) Type | Traditional 510(k) |
| Date Prepared | 15 May 2023 |
| Submitter Information | |
| Manufacturer Name &Address | Abbott MedicalOne St. Jude Medical Drive,St. Paul, Minnesota, 55117, USAManufacturer of the EnSite X EP System |
| Abbott 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 | Alyssa TimmersSenior Regulatory Affairs Specialist651-756-3706alyssa.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 (K223094) |
| 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 ofconventional and Sensor Enabled™ (SE) electrophysiology catheters, as well asdisplaying 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 owncardiac chamber. The system creates a model by collecting and labeling the anatomiclocations within the chamber. A surface is created by moving a selected catheter tolocations within a cardiac structure. As the catheter moves, points are collected at andbetween 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 whomelectrophysiology studies have been indicated. | |
| The EnSite™ X EP System provides information about the electrical activity of the heartand displays catheter location during conventional electrophysiological (EP) procedures. | |
| EnSite™ X EP System Contact Force Software LicenseWhen used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System ContactForce Module is intended to provide visualization of force information from compatiblecatheters. | |
| EnSite™ X EP System Surface Electrode Kit | |
| The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EPSystem in accordance with the EnSite™ X EP System indications for use. | |
| EnSite™ X EP System, TactiFlex™ Ablation Catheter, Sensor Enabled™, SoftwareUpgrade and Software License | |
| The EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™ SoftwareModule is indicated for use with the EnSite™ X EP System in accordance with theEnSite™ X EP System indications for use. | |
| Predicate Comparison | |
| Comparison | The subject device, EnSite™ X EP System v3.0, and the predicate device, EnSite™ X EPSystem v2.0.1 have the same intended use and indications for use. They use the samefundamental scientific technology to facilitate catheter position and orientation, as well ascardiac mapping and model creation. There were no changes to the hardware. The subjectdevice software was revised to include:A display of the distance between two AutoMarks, or an AutoMark and theprojected ablation catheter distal electrode, A duplicate selection method to allow for the display of map points based on thehighest frequency, An expansion of the data able to be imported and exported between the subjectdevice and third-party systems, A workflow enhancement that allows physicians to change navigation modeswithout restarting a study, The introduction of a new AutoMark metric, A minor update to the Force Direction Indicator, A minor update to the Sandpaper tool, and Fixes to minor known software issues. All risks associated with these modifications were mitigated to acceptable levels. No newquestions of safety or effectiveness were raised. |
| Non-Clinical TestingSummary | Design verification activities were performed and met the respective acceptance criteria toensure that the devices in scope of this submission are safe and effective. |
| Testing | |
| The EnSite™ X EP System v3.0 was developed and tested in accordance with thefollowing industry guidance 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 Life CycleProcesses ISO 14971:2019 Medical Devices - Application of Risk Management to MedicalDevices | |
| Non-Clinical TestingSummary(Continued) | • ANSI AAMI IEC 62366-1:2015, Medical devices – Part 1: Application of usabilityengineering to medical devices |
| Types of Testing Performed | |
| • Software Verification at unit, software and system level | |
| • Performance testing of updated feature functionality | |
| • Preclinical Validation Testing to confirm the system could meet user requirementsand its intended use after modifications | |
| • Human Factors Evaluations to confirm the user interface of the subject device canbe used as intended by the defined user groups | |
| Statement ofEquivalence | The subject and predicate devices have the same intended use, and the same indicationsfor use. The devices operate using the same fundamental scientific technology to facilitatecatheter position and orientation, as well as cardiac mapping and model creation. Thetesting completed and submitted in this Traditional 510(k) provides objective evidence thesubject device is at least as safe and effective as 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).