(30 days)
Not Found
No
The summary describes a catheter navigation and mapping system that creates 3D models based on collected anatomical points. There is no mention of AI, ML, or any related technologies being used for analysis, interpretation, or decision-making. The testing described focuses on software verification and validation according to standard medical device software processes.
No.
The "Intended Use / Indications for Use" section explicitly states that the device is a "suggested diagnostic tool" and "provides information about the electrical activity of the heart and displays catheter location". It does not mention any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The EnSite™ X EP System is a suggested diagnostic tool."
No
The device description explicitly states it is a "catheter navigation and mapping system" and describes the use of catheters to collect anatomical data and electrical activity. This indicates the system includes hardware components beyond just software.
Based on the provided information, the EnSite™ X EP System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro - "in glass"). This system works within the body (in vivo) to map electrical activity and catheter location.
- The intended use describes a diagnostic tool for electrophysiology studies. These studies involve directly interacting with the heart's electrical system, not analyzing a sample outside the body.
- The device description details a catheter navigation and mapping system. This involves placing catheters inside the heart and using them to collect data and create 3D models.
The system is a medical device used for diagnosis, but it falls under the category of in vivo diagnostic devices rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQK
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 between all electrodes on the catheter. A surface is wrapped around the outermost points.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac chamber
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification and validation activities were performed to ensure the EnSite X v1.1.1 software release is safe and effective.
Testing:
The EnSite X EP System v1.1.1 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
- EN ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices
Types of Testing Performed:
- Software Verification at software and system level
- Preclinical Validation Testing to ensure system meets user requirements
- Installation Validation of software update
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
EnSite™ X EP System (K212061)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 Drive |
| St. Paul, MN 55119 USA | |
| Contact Person | Tabitha Payne |
| Regulatory Affairs Specialist | |
| 612-268-8558 | |
| tabitha.payne@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 (K212061) |
| 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 between all electrodes on the catheter. A surface is wrapped around
the outermost points. |
| Indications for
Use | 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. |
| Predicate Comparison | |
| Comparison | EnSite™ X v1.1.1 and the predicate EnSite™ X v1.1 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. There were no changes to the hardware and no new software features
added. 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 fixes
All risks were mitigated to acceptable levels. No new questions of safety or
effectiveness were raised. |
| Non-Clinical
Testing
Summary | Design verification and validation activities were performed to ensure the EnSite X
v1.1.1 software release is safe and effective.
Testing:
The EnSite X EP System v1.1.1 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 - EN ISO 14971:2019 Medical Devices – Application of Risk Management to
Medical Devices
Types 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 of
Equivalence | The subject and predicate device have the same intended use and the 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 Special 510(k)
provides objective evidence the subject device is at least as safe and effective as the
predicate device. Based on this, the subject device is considered to be substantially
equivalent to the predicate device. |
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