(30 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.
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.
I apologize, but the provided text does not contain the detailed information necessary to answer your request regarding the acceptance criteria and the study that proves the device meets those criteria.
The document is an FDA 510(k) clearance letter and an accompanying 510(k) summary for the EnSite™ X EP System. While it states that "Design verification and validation activities were performed to ensure the EnSite X v1.1.1 software release is safe and effective" and lists some "Types of Testing Performed" (Software Verification, Preclinical Validation Testing, Installation Validation), it does not provide:
- A table of specific acceptance criteria and detailed device performance metrics. The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with quantitative results against specific criteria.
- Sample sizes used for testing.
- Data provenance (country of origin, retrospective/prospective).
- Information on experts used for ground truth (number, qualifications).
- Adjudication methods.
- Details on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone performance data (algorithm only).
- Specific type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set (as this is a software update for an existing system, deep learning training data might not be relevant in the same way as for a novel AI device).
- How ground truth for the training set was established.
The document states that the software updates include "Patch input signals switched from driven to undriven signals," "Composite signal respiration waveform," "Bio Impedance Scaling algorithm updates," "Respiration Gating algorithm updates," and "Metal distortion threshold changes," along with "Additional bug fixes." The testing described is general software verification and preclinical validation to ensure user requirements are met and risks are mitigated, rather than a clinical performance study with specific quantitative acceptance criteria.
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November 11, 2021
Abbott Medical Tabitha Payne Regulatory Affairs Specialist 5050 Nathan Ln N Plymouth, Minnesota 55442
Re: K213364
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: October 8, 2021 Received: October 12, 2021
Dear Tabitha Payne:
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 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 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 (OS) 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,
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) K213364
Device Name EnSite™ X EP System
Indications for Use (Describe)
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.
| 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) Summary | |
|---|---|
| 510(k) Information | |
| 510(k) Number | K213364 |
| 510(k) Type | Special 510(k) |
| Date Prepared | 30 September 2021 |
| Submitter Information | |
| Manufacturer | Abbott Medical |
| Name &Address | One St. Jude Medical DriveSt. Paul, MN 55119 USA |
| Contact Person | Tabitha PayneRegulatory Affairs Specialist612-268-8558tabitha.payne@abbott.com |
| EnSite™ X EP System Device Information | |
| Trade Name | EnSite™ X EP System |
| Common Name | Programmable Diagnostic Computer |
| Class | II |
| ClassificationName | 870.1425, computer, diagnostic, programmable |
| Product Code | DQK |
| Predicate Device | EnSite™ X EP System (K212061) |
| DeviceDescription | 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 forUse | 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. |
| Predicate Comparison | |
| Comparison | EnSite™ X v1.1.1 and the predicate EnSite™ X v1.1 have the same intended useand indications for use. They use the same fundamental scientific technology tofacilitate catheter position and orientation, as well as cardiac mapping and modelcreation. There were no changes to the hardware and no new software featuresadded. The subject device software was revised to include the following updates:- Patch input signals switched from driven to undriven signals- Composite signal respiration waveform- Bio Impedance Scaling algorithm updates- Respiration Gating algorithm updates- Metal distortion threshold changes- Additional bug fixesAll risks were mitigated to acceptable levels. No new questions of safety oreffectiveness were raised. |
| Non-ClinicalTestingSummary | Design verification and validation activities were performed to ensure the EnSite Xv1.1.1 software release is safe and effective.Testing:The EnSite X EP System v1.1.1 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 LifeCycle Processes- EN ISO 14971:2019 Medical Devices – Application of Risk Management toMedical DevicesTypes of Testing Performed:- Software Verification at software and system level- Preclinical Validation Testing to ensure system meets user requirements- Installation Validation of software update |
| Statement ofEquivalence | The subject and predicate device have the same intended use and the sameindications for use. All devices operate using the same fundamental scientifictechnology to facilitate catheter position and orientation, as well as cardiac mappingand model creation. The testing completed and submitted in this Special 510(k)provides objective evidence the subject device is at least as safe and effective as thepredicate device. Based on this, the subject device is considered to be substantiallyequivalent 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).