(44 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, deep learning, or neural networks. The description focuses on conventional cardiac mapping technology.
No
The document states that the device is a "suggested diagnostic tool" and is used to "display the position of conventional electrophysiology (EP) catheters in the heart" and "provide visualization of force information," but it does not mention any therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated." It further describes its use in identifying complex arrhythmias and displaying catheter positions, all of which are diagnostic functions.
No
The device description explicitly lists hardware components (Display Workstation, Amplifier) as part of the system, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "suggested diagnostic tool in patients for whom electrophysiology studies are indicated." It focuses on mapping and displaying the position of catheters within the body (in the heart and right atrium) to aid in identifying and understanding complex arrhythmias.
- Device Description: The components listed (Display Workstation, Amplifier) are typical of systems used for physiological monitoring and mapping in vivo.
- Lack of IVD Characteristics: IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not mention analyzing any such samples.
The EnSite Velocity System is an in vivo diagnostic device, meaning it is used to diagnose conditions within the living body.
N/A
Intended Use / 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.
- 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.
When used with the St. Jude Medical Contact Force hardware, the EnSite Velocity System EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.
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, heart
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.
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
JUN 0 6 2014
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
The Establishment Registration Number is 2184149.
Common or Usual Name 12.2
Electrophysiology Mapping System with console and catheter
12.3 Proprietary Name
EnSite Velocity System EnSite Contact Force Module
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:
- . Display Workstation
- Amplifier .
12.6 Predicate Device
The EnSite Velocity System EnSite Velocity System v.4.0 (K130594)
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.
1
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.
When used with the SJM Contact Force hardware, the EnSite Velocity System EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.
12.8 Device Comparison to the Predicate Device
EnSite Velocity System with EnSite Contact Force Module has the same fundamental scientific technology as the predicate device, EnSite Velocity System v.4.0 (K130594). All technological characteristics of the EnSite Velocity System with EnSite Contact Force Module are substantially equivalent to the predicate device, EnSite Velocity System v.4.0 (K130594).
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.
12.10 Summary of Design Control Activities
The development of the EnSite Velocity System EnSite Contact Force 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 13.3. The reviewer should note that during development, the EnSite Velocity System EnSite Contact Force Module was referred to as Project Gamma.
12.11 Conclusion
As in the use of the predicate device EnSite Velocity System v.4.0 (K130594). EnSite Contact Force Module has the same fundamental scientific technology as the predicate device, EnSite Velocity System v.4.0 (K130594). All technological characteristics of the EnSite Velocity System with EnSite Contact Force Module
2
are substantially equivalent to the predicate device, EnSite Velocity System v.4.0 (K130594).
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 EnSite Contact Force Module to be substantially equivalent to the predicate device, EnSite Velocity System v.4.0 (K130594).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2014
Donna Lunak Sr.Regulatory Specialist St. Jude Medical One St. Jude Medical Drive St. Paul, Minnesota 55117
Re: K141050
Trade/Device Name: Ensite velocity system Regulation Number: 21 CFR 870.1425 Regulation Name: Electrophysiology Mapping System Regulatory Class: Class II Product Code: DQK Dated: April 22, 2014 Received: April 23, 2014
Dear 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 CFR
4
Page 2 - Donna Lunak
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
forbram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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.
ଠାର -
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: EnSite Contact Force Module
Indications for Use:
When used with the St. Jude Medical Contact Force hardware, the EnSite Velocity System EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ x (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)
Image /page/5/Picture/16 description: The image shows a signature and a date stamp. The date on the stamp is 2014.06.06, and the time is 15:23:31. The time zone offset is +04'00'.
St. Jude Medical
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