(164 days)
Not Found
No
The document does not mention AI, DNN, or ML, and the description focuses on electrical coupling and catheter position, not advanced algorithmic analysis.
No.
The system is indicated as a diagnostic tool for cardiac mapping and monitoring catheter position/contact, not for treating a disease or condition.
Yes
The "Indications for Use" section explicitly states that "The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated." Additionally, the VeriSense System Software section indicates its use for "monitoring catheter tip-to-tissue electrical coupling, which may be indicative of catheter tip-to-tissue contact," which serves a diagnostic purpose during procedures.
No
The device description explicitly lists hardware components (Display Workstation and Amplifier) as part of the EnSite Velocity System.
Based on the provided information, the EnSite Velocity System and VeriSense System Software are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The descriptions and indications for use clearly state that these devices are used during cardiac electrophysiology procedures and are intended to map the heart, display catheter position, and monitor catheter tip-to-tissue electrical coupling. This is all happening in vivo (within the body).
Therefore, these devices fall under the category of in vivo diagnostic or therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Device Name: EnSite Velocity System
The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.
When used with the EnSite Array™ Catheter, the EnSite 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 the EnSite NavX™ Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology catheters in the heart.
Device Name: VeriSense System Software
VeriSense™ Technology is intended for monitoring catheter tip-to-tissue electrical coupling, which may be indicative of catheter tip-to-tissue contact during cardiac electrophysiology procedures via a proprietary Electrical Coupling Index (ECI).
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The EnSite Velocity System consists of the following:
- Display Workstation .
- . Amplifier
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product.
A final clinical report of the CONTACT AFL study (conducted under a prospective, multi-center and non-randomized IDE pivotal study (IDE# G110026)) was submitted to support approval of PMA supplement (P11016/S007) for the VeriSense System hardware and VeriSense Enabled Catheters and a summary of the clinical study applicable to the diagnostic portion (VeriSense Software) is included under this 510k as requested by the FDA via teleconference on October 11, 2012.
A summary report of the Electrical Coupling Index (ECI) Validation that was collected from the CONTACT AFL Study is included in Section 29.
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.
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).
0
12 510(k) Summary for Public Disclosure
12.1 Submitter's Name/Contact Person
Donna R. Lunak
St. Jude Medical
One St. Jude Medical Drive
St. Paul, MN 55117 USA
AUG 2 9 2013
The Establishment Registration Number is 2184149.
12.2 Common or Usual Name
Electrophysiology Mapping System with console and catheter
12.3 Proprietary Name
EnSite Velocity System VeriSense System Software Module v.1.0
12.4 Classification Name
DQK, Programmable diagnostic computer (21 CFR 870.1425), Class II, Cardiovascular Device Panel
12.5 Hardware Description
The EnSite Velocity System consists of the following:
1
- Display Workstation .
- . Amplifier
12.6 Predicate Device
The EnSite Velocity System EnSite Velocity System v.3.0 (K112688)
12.7 Indications for Use
Device Name: EnSite Velocity System
The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.
When used with the EnSite Array™ Catheter, the EnSite Velocity 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 the EnSite NavX™ Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology catheters in the heart.
Device Name: VeriSense System Software
VeriSense™ Technology is intended for monitoring catheter tip-to-tissue electrical coupling, which may be indicative of catheter tip-to-tissue contact during cardiac electrophysiology procedures via a proprietary Electrical Coupling Index (ECI).
12.8 Device Comparison to the Predicate Device
EnSite Velocity System with VeriSense System Software Module has the same indications for use and fundamental scientific technology as the predicate device, EnSite Velocity System v.3.0 (K112688). All technological characteristics of the EnSite Velocity System with VeriSense System Software Module are substantially equivalent to the predicate device, EnSite Velocity System v.3.0 (K112688).
12.9 Summary of Non-Clinical Testing -
Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product.
2
12.10 Summary of Clinical Testing
A final clinical report of the CONTACT AFL study (conducted under a prospective, multi-center and non-randomized IDE pivotal study (IDE# G110026)) was submitted to support approval of PMA supplement (P11016/S007) for the VeriSense System hardware and VeriSense Enabled Catheters and a summary of the clinical study applicable to the diagnostic portion (VeriSense Software) is included under this 510k as requested by the FDA via teleconference on October 11, 2012.
ે.
A summary report of the Electrical Coupling Index (ECI) Validation that was collected from the CONTACT AFL Study is included in Section 29.
12.11 Summary of Design Control Activities
The development of the EnSite Velocity System VeriSense System Software Module was performed in accordance with St. Jude Medical's Quality System requirements, and in compliance with Quality System Regulation design controls requirements documented in 21 CFR 820.30. A Declaration of Conformity with Design Controls follows in section 13.4. The reviewer should note that during development, the EnSite Velocity System VeriSense System Software Module was referred to as EnSite Velocity System v.4.0 Contact/VeriSense Module.
12.12 Conclusion
As in the use of the predicate device EnSite Velocity System v.3.0 (K112688). EnSite Velocity System VeriSense System Software Module has the same fundamental scientific technology as the predicate device, EnSite Velocity System v.3.0 (K112688). All technological characteristics of the EnSite Velocity System with VeriSense System Software Module are substantially equivalent to the predicate device, EnSite Velocity System v.3.0 (K112688).
Where operational and performance differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the device's safety and effectiveness.
Therefore, St. Jude Medical considers the EnSite Velocity System VeriSense System Software Module to be substantially equivalent to the predicate device. EnSite Velocity System v.3.0 (K112688).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the border of the circle. The logo is black and white.
August 29, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
St. Jude Medical Ms. Donna Lunak One St. Jude Medical Drive St. Paul, MN 55117 US
Re: K130727
Trade/Device Name: Ensite velocity system Regulation Number: 21 CFR 870.1425 Regulation Name: Electrophysiology Mapping System Regulatory Class: Class II Product Code: DOK Dated: August 5, 2013 Received: August 6, 2013
Dear Ms. Donna Lunak:
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
4
Page 2 - Ms. Donna Lunak
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.goy/MedicalDevices/Safety/ReportaProblem/default.htmfor 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 Small Manufacturers, International and Consumer Assistance 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 yours,
OwenPFaris-S
for
Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
5
7 Indications for Use
Device Name: EnSite Velocity System
Indications for Use:
The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.
-
When used with the EnSite Array™ Catheter, the EnSite 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 the EnSite NavX Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
Device Name: VeriSense System Software
Indications for Use:
VeriSense™ Technology is intended for monitoring catheter tip-to-tissue electrical coupling, which may be indicative of catheter tip-to-tissue contact during cardiac electrophysiology procedures via a proprietary Electrical Coupling Index (ECI).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by
Owen P. Faris -S
Date: 2013.08.29
10:40:54-04'00'