(44 days)
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.
The EnSite Velocity System consists of the following:
Display Workstation
Amplifier
The provided text describes the EnSite Velocity System EnSite Contact Force Module and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, a specific study proving those criteria were met, or detailed performance metrics in the format requested.
It primarily focuses on demonstrating substantial equivalence to a predicate device (EnSite Velocity System v.4.0, K130594) through bench testing and adherence to design control activities.
Therefore, many of the requested fields cannot be filled from the given text.
Here's a breakdown of what can and cannot be extracted:
1. Table of acceptance criteria and the reported device performance:
- Cannot be provided. The document states "Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product." However, it does not specify what those design requirements (acceptance criteria) were or the quantitative results of the bench testing.
2. Sample size used for the test set and the data provenance:
- Cannot be provided. The phrase "Bench testing" is too vague to determine sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. No information regarding human experts or ground truth establishment for a test set is mentioned. The testing described is "bench testing," implying laboratory-based or simulated environments, not involving clinical data with expert ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be provided. No adjudication method is mentioned as there's no described process involving human review of a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided. The document describes a medical device (an electrophysiology mapping system), not an AI algorithm assisting human readers. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This device is an "Electrophysiology Mapping System with console and catheter," designed to be used by clinicians ("human-in-the-loop"). It's not a standalone algorithm in the sense of an AI model generating diagnoses without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. No ground truth type is specified, as the testing mentioned is "bench testing" to confirm meeting "design requirements," not clinical validation against a gold standard.
8. The sample size for the training set:
- Cannot be provided. The device is a hardware/software system, not a machine learning model that would typically have a "training set."
9. How the ground truth for the training set was established:
- Cannot be provided. As above, no training set is mentioned as this is not an AI/ML algorithm requiring one.
Summary of available information:
The document focuses on demonstrating substantial equivalence to a predicate device (EnSite Velocity System v.4.0, K130594) through:
- Same fundamental scientific technology.
- All technological characteristics being substantially equivalent.
- Bench testing to confirm that "changes met design requirements and did not adversely affect the device's safety and effectiveness" where operational and performance differences exist.
- Compliance with Quality System Regulation design controls (21 CFR 820.30).
Essentially, the acceptance criteria are implied to be "meeting design requirements" and "not adversely affecting safety and effectiveness" compared to the predicate, verified through bench testing. Specific quantitative criteria and results are not detailed in this public disclosure summary.
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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.
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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
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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).
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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
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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
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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)
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St. Jude Medical
Section 7 - Page 1 of 1
§ 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).