(254 days)
No
The document describes a cardiac mapping system that displays 3D position and electrical activity. It does not mention any AI or ML capabilities, and the "Mentions AI, DNN, or ML" section explicitly states "Not Found". The performance studies focus on traditional device performance metrics.
No
The device is described as a "diagnostic tool" and a "mapping system" used to display the position of catheters and cardiac electrical activity, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated." It also describes how the system is intended to "identify" complex arrhythmias and "display the position of conventional electrophysiology (EP) catheters in the heart," all of which are diagnostic functions.
No
The device description explicitly mentions hardware components like catheters, surface electrodes, and patches, which are integral to its function. The performance studies also include testing of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The EnSite™ Velocity™ Cardiac Mapping System is a system used in vivo (within the living body) to map the electrical activity and position of catheters within the heart. It uses surface electrodes and potentially an intracardiac catheter (EnSite™ Array™ Catheter) to gather information directly from the patient's heart.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The system is interacting directly with the patient's body.
Therefore, the EnSite™ Velocity™ Cardiac Mapping System falls under the category of a medical device used for in vivo diagnostic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DQK
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, specifically the right atrium.
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)
Non-Clinical Testing: Design verification activities for functional testing were performed with their respective acceptance criteria to ensure that electrode patch modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications. Bench and animal testing was performed to verify the device met the pre-determined acceptance criteria. The following tests were performed: 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.
Risk Management: The changes to the Surface Electrode Kit were evaluated 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EnSite™ Velocity™ Cardiac Mapping System with EnSite™ NavX™ Surface Electrode Kit, K141050
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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
1
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 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 | |
| 510(k) Summary | |
| The surface electrodes transmit information from the patient | |
| to the EnSite™ System for signal conditioning and data | |
| inference. | |
| Intended Use: | |
| (Indications for Use) | 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 | |
| arrhythmias that may be difficult to identify using | |
| conventional mapping systems alone. OR When used with an EnSite™ Velocity™ Surface | |
| Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping | |
| System is intended to display the position of conventional | |
| electrophysiology (EP) catheters in the heart. | |
| Comparison to | |
| Predicate Devices | The proposed EnSite™ Velocity Cardiac Mapping System |
| with EnSite™ Velocity™ Surface Electrode Kit has the same | |
| intended use and fundamental scientific technology as the | |
| predicate device, the EnSite™ Velocity™ Cardiac Mapping | |
| System 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 System |
| with EnSite™ Velocity™ Surface Electrode Kit has the same | |
| indications for use as the predicate device. The technological | |
| characteristic of the device is the same as predicate device. | |
| Design verification activities for functional testing were | |
| performed with their respective acceptance criteria to ensure | |
| that electrode patch modifications do not affect the safety or | |
| effectiveness of the device. All testing performed met the | |
| established performance specifications. | |
| Bench and animal testing was performed to verify the device | |
| met the pre-determined acceptance criteria. The following | |
| tests 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 Management | |
| The 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 of | |
| Equivalence | The proposed EnSite™ Velocity Cardiac Mapping System |
| with EnSite™ Velocity™ Surface Electrode kit have the same | |
| indications for use as the predicate device. The technological | |
| characteristics for the device are the same as the predicate | |
| device. Based on this and the data provided in this pre- | |
| market notification, the subject device and predicate device | |
| have been shown to be substantially equivalent. |
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