(254 days)
The EnSite™ Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.
When used with the EnSite™ Array™ Catheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arthythmias that may be difficult to identify using conventional mapping systems alone.
OR
When used with an EnSite™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
The EnSite™ Velocity™ Cardiac Mapping System is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiac chamber.
The EnSite™ Velocity™ Surface Electrode Kit contains single use surface electrodes and patches for use in conjunction with St. Jude Medical's EnSite System. The kit contains the following devices:
• The electrode patches
• The Electrocardiogram (ECG) electrodes
• The system reference patch electrode
The surface electrodes transmit information from the patient to the EnSite™ System for signal conditioning and data inference.
This document is a 510(k) Pre-Market Notification for the St. Jude Medical EnSite™ Velocity™ Cardiac Mapping System v4.0.2 with EnSite™ Velocity™ Surface Electrode Kit. The submission focuses on changes to the surface electrode kit and asserts substantial equivalence to a previously cleared predicate device.
Here's an analysis of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics for the entire EnSite™ Velocity™ Cardiac Mapping System. Instead, it describes performance testing specifically for the changes made to the EnSite™ Velocity™ Surface Electrode Kit. Since the core mapping system remains the same as the predicate, the focus is on demonstrating that the revised electrode kit functions equivalently and safely.
Below is a table summarizing the tests performed on the Surface Electrode Kit and the outcome, as stated in the document:
| Test Performed on Surface Electrode Kit | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Gel Adhesion | N/A (implied to meet requirements) | Met established performance specifications |
| Electrode Impedance | N/A (implied to meet requirements) | Met established performance specifications |
| Electrode Capacitance | N/A (implied to meet requirements) | Met established performance specifications |
| Impedance Stability | N/A (implied to meet requirements) | Met established performance specifications |
| Cable Wire Resistance | N/A (implied to meet requirements) | Met established performance specifications |
| Cable Flex Life | N/A (implied to meet requirements) | Met established performance specifications |
| Current Dispersion | N/A (implied to meet requirements) | Met established performance specifications |
| Maximum Temperature | N/A (implied to meet requirements) | Met established performance specifications |
| Dielectric Strength | N/A (implied to meet requirements) | Met established performance specifications |
| Cable Pullout Force | N/A (implied to meet requirements) | Met established performance specifications |
| Biocompatibility Test | N/A (conforms to standards) | Conforms to EN ISO 10993-1, -5, -10 |
| Shelf Life Test | N/A (implied to meet requirements) | Met established performance specifications |
| Packaging Test | N/A (implied to meet requirements) | Met established performance specifications |
| Usability Test | N/A (implied to be acceptable) | Acceptable for use and meets requirements |
| Non-GLP Animal Test | N/A (implied to be acceptable) | Performed to verify device met pre-determined acceptance criteria |
Note: The document states, "All testing performed met the established performance specifications." However, the specific quantitative acceptance criteria are not provided in the publicly available summary for each test.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state a quantitative sample size (e.g., number of patients, number of electrodes) for the various tests conducted on the surface electrode kit. It refers generally to "design verification activities" and "bench and animal testing."
- Data Provenance: The document does not specify the country of origin of the data. It indicates the studies were internal design verification and validation activities conducted by St. Jude Medical. The studies appear to be prospective in nature, as they were conducted to verify the changes to the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not describe any studies that involved human experts establishing ground truth for the performance of the device, particularly for the algorithmic aspects of cardiac mapping. The testing described focuses on the physical and electrical characteristics of the surface electrode kit (gel adhesion, impedance, cable integrity, etc.) and its in-vivo compatibility in an animal model. These tests typically rely on defined engineering specifications and measurements rather than expert human interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. The tests described are objective engineering and biological evaluations, not requiring an adjudication method by human readers/experts for result interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This submission is for substantial equivalence of an updated component (surface electrode kit) of an existing cardiac mapping system. The studies focus on confirming the safety and performance of the modified electrodes compared to the predicate's electrodes, not on comparing human reader performance with and without AI assistance for diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The testing performed on the surface electrode kit (gel adhesion, impedance, material properties, etc.) and the non-GLP animal test can be considered "standalone" as they assess the physical and electrical performance of the device components independent of direct human diagnostic interpretation. The cardial mapping system itself is a diagnostic tool, but the focus of this submission's testing is on the interface with the patient via the electrodes, ensuring its technical performance.
7. The Type of Ground Truth Used
The ground truth used for the tests on the surface electrode kit are based on:
- Engineering specifications and measurements: For tests like impedance, cable resistance, flex life, temperature, dielectric strength, and pullout force, the ground truth would be predetermined acceptable ranges or thresholds based on electrical and mechanical engineering principles.
- Biocompatibility standards: For biocompatibility, the ground truth is adherence to internationally recognized standards (EN ISO 10993 series).
- Pre-determined acceptance criteria: For the animal testing, the ground truth would be that the device "met the pre-determined acceptance criteria" which would likely involve normal physiological responses and proper functioning of the mapping system with the new electrodes.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's a hardware system (cardiac mapping system) with associated physical components (surface electrode kit). If there are internal firmware or software algorithms in the mapping system itself, their development or "training" is not detailed in this 510(k) summary, as the submission focuses on changes to the surface electrode kit.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" for an AI/ML algorithm in this submission.
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Image /page/0/Picture/1 description: The image is a logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem that features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7, 2016
St. Jude Medical Yumi Wackerfuss Senior Regulatory Specialist One St. Jude Medical Drive St. Paul, MN 55117
Re: K160186
Trade/Device Name: EnSite™ Velocity™ Cardiac Mapping System v4.0.2 with EnSite™ VelocityTM Surface Electrode Kit Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: September 08, 2016 Received: September 09, 2016
Dear Yumi Wackerfuss:
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. 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 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
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Munde Yellen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160186
Device Name
EnSite™ Velocity™ Cardiac Mapping System v4.0.2 with EnSite™ Velocity™ Surface Electrode Kit
Indications for Use (Describe)
The EnSite™ Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.
When used with the EnSite™ Array™ Catheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arthythmias that may be difficult to identify using conventional mapping systems alone.
OR
When used with an EnSite™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
| 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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6. 510(k) Summary
The 510(k) Summary is provided on the following page as required by 21 CFR 807.92(c).
| 510(k) Summary | |
|---|---|
| 510(k) Number | |
| Submitter Information: | |
| Date Prepared: | February 23 2016 |
| Manufacturer | St. Jude Medical |
| Name &Address: | One St. Jude Medical Drive |
| St. Paul, MN 55117 | |
| Establishment Registration Number: 3005188751 | |
| Contact Person: | Yumi Wackerfuss |
| Senior Regulatory Affairs Specialist | |
| Phone (651) 756-2678 | |
| Fax (651) 756-3301 | |
| ywackerfuss@sjm.com | |
| Device Information: | |
| Trade Name: | EnSite™ Velocity™ Cardiac Mapping System v4.0.2 with |
| EnSite™ Velocity™ Surface Electrode Kit | |
| Common Name: | Electrophysiology mapping system |
| Classification Name: | 870.1425, Programmable diagnostic computer |
| Product Code: | DQK |
| Class: | Class II |
| Predicate Device: | EnSite™ Velocity™ Cardiac Mapping System (version 4.0.2) |
| with EnSite™ NavX™ Surface Electrode Kit, K141050, | |
| cleared June 6, 2014 | |
| Device Description: | The EnSite™ Velocity™ Cardiac Mapping System is a |
| catheter navigation and mapping system capable of | |
| displaying the three-dimensional (3D) position of | |
| conventional electrophysiology catheters, as well as | |
| displaying cardiac electrical activity as waveform traces andas dynamic 3-D isopotential maps of the cardiac chamber. | |
| The contoured surfaces of these three-dimensional maps are | |
| based on the anatomy of the patient's own cardiac chamber. | |
| The EnSite™ Velocity™ Surface Electrode Kit contains | |
| single use surface electrodes and patches for use in | |
| conjunction with St. Jude Medical's EnSite System. The kit | |
| contains the following devices | |
| • The electrode patches | |
| • The Electrocardiogram (ECG) electrodes | |
| • The system reference patch electrode | |
| 510(k) Summary | |
| The surface electrodes transmit information from the patientto the EnSite™ System for signal conditioning and datainference. | |
| Intended Use:(Indications for Use) | The EnSite™ Velocity Cardiac Mapping System is asuggested diagnostic tool in patients for whomelectrophysiology studies have been indicated.When used with the EnSite™ Array™ Catheter, theEnSite™ Velocity™ Cardiac Mapping System is intendedto be used in the right atrium of patients with complexarrhythmias that may be difficult to identify usingconventional mapping systems alone. OR When used with an EnSite™ Velocity™ SurfaceElectrode Kit, the EnSite™ Velocity™ Cardiac MappingSystem is intended to display the position of conventionalelectrophysiology (EP) catheters in the heart. |
| Comparison toPredicate Devices | The proposed EnSite™ Velocity Cardiac Mapping Systemwith EnSite™ Velocity™ Surface Electrode Kit has the sameintended use and fundamental scientific technology as thepredicate device, the EnSite™ Velocity™ Cardiac MappingSystem with EnSite™ NavX™ Surface Electrode Kit,K141050. Changes from predicate include : Electrode patches change from rectangular to circular shape Change in conductive hydrogel type Replacement of ECG electrode with a market released 3M ECG electrode Change in manufacturer Change in product name from EnSite™ NavX™ Surface Electrode Kit to EnSite™ Velocity™ Surface Electrode Kit |
| Summary on Non-Clinical Testing | The proposed EnSite™ Velocity Cardiac Mapping Systemwith EnSite™ Velocity™ Surface Electrode Kit has the sameindications for use as the predicate device. The technologicalcharacteristic of the device is the same as predicate device.Design verification activities for functional testing wereperformed with their respective acceptance criteria to ensurethat electrode patch modifications do not affect the safety oreffectiveness of the device. All testing performed met theestablished performance specifications.Bench and animal testing was performed to verify the devicemet the pre-determined acceptance criteria. The followingtests were performed. |
| 510(k) Summary | |
| Performance Test: Gel Adhesion Electrode impedance Electrode Capacitance Impedance Stability Cable Wire Resistance Cable Flex Life Current dispersion Maximum Temperature Dielectric Strength Cable Pullout Force Biocompatibility Test Shelf Life Test Packaging Test Usability Test: Non-GLP Animal Test The changes to the Surface Electrode Kit were evaluated through design verification and validation to show that the proposed EnSite™ Velocity™ Surface Electrode Kit is acceptable for use and meets requirements.The EnSite™ Velocity™ Surface Electrode Kit conforms to the following standards: EN ISO 14971 (2012) Medical Devices - Applications of risk management to medical devices IEC 60601-1 (2005 + CORR.1 (2006) + CORR.2 (2007) + Ed 3.1 EN: 2012 + CORR1: 2012) Medical electrical equipment- Part 1: General requirements for basic safety and essential performance IEC 60601-1-2 (2007) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: electromagnetic disturbances - requirements and tests EN ISO 10993-1:2009 Biological Evaluation of medical device – Part 1: Evaluation and testing within a risk management process EN ISO 10993-5:2009 Biological Evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity EN ISO 10993-10:2013 Biological Evaluation of medical devices – Part 10: Test for irritation and sensitization Risk ManagementThe changes to the Surface Electrode Kit were evaluated | |
| 510(k) Summary | |
| through review of risk management to ensure no new hazards have been introduced by this change. The risk analysis was completed and risk controls were implemented to mitigate identified hazards. | |
| Statement ofEquivalence | The proposed EnSite™ Velocity Cardiac Mapping Systemwith EnSite™ Velocity™ Surface Electrode kit have the sameindications for use as the predicate device. The technologicalcharacteristics for the device are the same as the predicatedevice. Based on this and the data provided in this pre-market notification, the subject device and predicate devicehave been shown to be substantially equivalent. |
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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).