(99 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 procedures.
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 FDA 510(k) clearance letter for the EnSite™ X EP System (K251234) details the device's regulatory pathway and general testing conducted. However, it does not contain the specific information required to populate a table of acceptance criteria and reported device performance. It focuses on the regulatory aspects, substantial equivalence to a predicate device, and the general types of testing performed (e.g., software verification, amplifier design verification, system design validation) to demonstrate that the device meets user requirements and its intended use.
The document states: "Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device." However, the specific acceptance criteria (e.g., a numerical threshold for accuracy or precision) and the reported device performance values against those criteria are not presented in this public clearance letter.
Similarly, the letter does not provide details regarding:
- Sample sizes used for test sets (beyond stating "design verification" and "system design validation" were performed).
- Data provenance (country of origin, retrospective/prospective).
- Number of experts, their qualifications, or adjudication methods for establishing ground truth for any test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers.
- Whether standalone (algorithm-only) performance was assessed.
- The type of ground truth used (expert consensus, pathology, outcomes data).
- The sample size for the training set.
- How ground truth for the training set was established.
This type of detailed performance data is typically found within the confidential 510(k) submission itself, not routinely published in the public clearance letter.
Therefore,Based on the provided FDA 510(k) clearance letter for the EnSite™ X EP System, the following information can be extracted regarding the device's acceptance criteria and the study that proves it meets those criteria:
Key Takeaway: The provided FDA 510(k) clearance letter asserts that acceptance criteria were met through various design verification and validation activities, demonstrating substantial equivalence to a predicate device. However, it does not disclose the specific numerical acceptance criteria or the quantitative results of the device's performance against those criteria. The details below are based on what is stated or can be inferred from the document.
1. Table of Acceptance Criteria and Reported Device Performance
As per the provided document, specific numerical acceptance criteria and reported device performance data are not explicitly stated or detailed. The document generally states:
"Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device."
And
"System Design Validation to confirm the system could meet user requirements and its intended use after modifications"
Without specific numerical cut-offs or performance metrics (e.g., accuracy, precision, error rates), a table cannot be populated as requested. The clearance indicates that internal testing demonstrated the device met pre-defined acceptance criteria, but those criteria and the actual performance results are not publicly available in this document.
| Acceptance Criteria Category (Presumed) | Specific Acceptance Criteria (Not specified in document) | Reported Device Performance (Not specified in document) | Met? (Inferred from clearance) |
|---|---|---|---|
| System Functionality | (e.g., Catheter position display accuracy, Cardiac electrical activity waveform fidelity, 3D map creation accuracy) | (Specific quantitative results, e.g., X mm accuracy) | Yes (Implied by clearance) |
| Safety & Effectiveness | (e.g., Conformity to electromagnetic compatibility, software robustness, risk mitigation effectiveness) | (e.g., Passes all EMC tests, no critical software bugs identified) | Yes (Implied by clearance) |
| User Requirements | (e.g., System usability, interface responsiveness) | (e.g., Demonstrates ability to meet intended use) | Yes (Implied by clearance) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size Used for Test Set: Not specified in the provided document. The document mentions "Design verification activities" and "System Design Validation" but does not give the number of cases, patients, or data points used for these tests.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided document.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- (It's common for electrophysiology systems that ground truth would be established by electrophysiologists, but this document does not confirm that.)
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. (e.g., 2+1, 3+1, none)
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No indication that an MRMC comparative effectiveness study was performed or required for this 510(k) clearance. The focus of this submission is on substantial equivalence to a predicate device, which often relies on non-clinical testing for software updates or minor changes, rather than clinical efficacy studies comparing human readers with and without AI assistance.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable/Not provided, as an MRMC study is not mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: The document describes "Software Verification at unit, software and system level" and "Amplifier Design Verification," which are types of standalone-like algorithmic or component-level testing. However, the exact metrics and results for pure "algorithm-only" performance (e.g., for automated mapping or analysis features if present) are not detailed. The system is described as a "diagnostic tool" that "provides information" and "displays catheter location," implying human interaction is integral.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. Given the nature of an EP system, ground truth would likely involve a combination of:
- Validated phantom models: For physical accuracy of catheter tracking and mapping.
- Clinical expert consensus: For validating the interpretation of electrical activity and the accuracy of generated 3D maps or anatomical models.
- Reference measurements: From other validated systems or direct measurements during testing.
- The document implies ground truth was used for "Design verification" and "System Design Validation," which "confirm the system could meet user requirements."
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable/Not specified. This 510(k) is for a software update (v5.0) to an existing system (EnSite™ X EP System, predicate K242016). The document describes changes related to compatibility with new catheters and ultrasound systems, rather than the development of entirely new AI/ML algorithms requiring a "training set" in the conventional sense of deep learning. While software is involved, the primary testing discussed is verification and validation, not model training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable/Not specified, as the document does not indicate the use of a "training set" in the context of machine learning model development. The 'ground truth' concept would apply more to the test and validation steps, as discussed in point 7.
FDA 510(k) Clearance Letter - EnSite™ X EP System
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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 30, 2025
Abbott Medical
Hailey Christain
Regulatory Affairs Specialist II
One St. Jude Medical Drive
St. Paul, Minnesota 55117-9913
Re: K251234
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: April 22, 2025
Received: April 22, 2025
Dear Hailey Christain:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K251234 - Hailey Christain Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-how-report-medical-device-problems.
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K251234 - Hailey Christain Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K251234
Please provide the device trade name(s). EnSite™ X EP System
Please provide your Indications for Use below.
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 procedures.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
EnSite™ X EP System Page 8 of 39
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EnSite X EP System v5.0
510(K) SUMMARY
The 510(k) Summary was drafted in accordance with 21 CFR 807.92, and is included below.
510(k) Information
| Field | Value |
|---|---|
| 510(k) Number | K251234 |
| 510(k) Type | Traditional 510(k) |
| Date Prepared | 21 April 2025 |
Submitter Information
| Field | Value |
|---|---|
| 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 | Hailey ChristianRegulatory Affairs Specialist II612-322-3442Hailey.christian@abbott.com |
EnSite™ X EP System Device Information
| Field | Value |
|---|---|
| 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 (K242016) |
| 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 |
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Page 6
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
| Field | Value |
|---|---|
| Comparison | EnSite™ X v5.0 and the predicate EnSite™ X v3.1 have the same intended use and indications for use. They use the same fundamental scientific technology to facilitate catheter position and orientation, as well as cardiac mapping and model creation. The subject device software was revised to include the following updates:• Compatibility with ViewFlex™ X ICE Catheter, Sensor Enabled™ (Submitted under a separate 510K)• Compatibility to Shenzhen Mindray Bio-Medical Electronics Co., LTD ViewMate™ Multi Ultrasound System V2.0 (Submitted under a separate 510K).• The introduction of EnSite™ X EP System 2D ICE features.All risks were mitigated to acceptable levels. No new questions of safety or effectiveness were raised. |
Non-Clinical Testing Summary
Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device.
Testing
The EnSite™ X EP System v5.0 in scope of this submission was developed and tested in accordance with the following industry guidance documents and standards:
• Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
• IEC 62304: 2015-06 Edition 1.1, Medical Device Software - Software Life Cycle Processes
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• IEC 60601-1-2:2020-09 Edition 4.1, Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests
• ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices
Types of Testing Performed – EnSite X EP System v5.0
• Software Verification at unit, software and system level
• Amplifier Design Verification
• Display Workstation (DWS) Design Verification
• System Design Validation to confirm the system could meet user requirements and its intended use after modifications
Statement of Equivalence
All subject and predicate devices have the same intended use, and same 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. The testing completed and submitted in this Traditional 510(k) provides objective evidence the subject device is substantially equivalent to 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).