(55 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.
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.
The EnSite Velocity System consists of the following:
- Display Workstation
- Amplifier
The provided text is a 510(k) summary for the EnSite Velocity System v.3.0. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study reporting on the device's performance against specific acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The document states:
- "Bench testing and animal study testing (Appendix S) were performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product."
- "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."
However, it does not provide any details on:
- Specific Acceptance Criteria: No quantitative or qualitative acceptance criteria are listed.
- Reported Device Performance: No actual performance metrics are reported.
- Study Details: There is no description of the methodology, results, or statistical analysis of any study. "Bench testing and animal study testing" are mentioned, but no specifics are given.
- Sample Sizes: No sample sizes are provided for any tests.
- Data Provenance: No information on the country of origin or whether data was retrospective/prospective.
- Number/Qualifications of Experts: No experts are mentioned in the context of establishing ground truth for testing.
- Adjudication Method: Not applicable as there's no mention of expert consensus.
- MRMC Comparative Effectiveness Study: Not mentioned as being performed.
- Standalone Performance Study: Not explicitly described for the algorithm itself.
- Type of Ground Truth: Not specified.
- Training Set Sample Size: No mention of a training set.
- Ground Truth for Training Set: Not applicable.
This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on intended use, fundamental scientific technology, and the claim that differences do not adversely affect safety or effectiveness, rather than reporting a detailed study against pre-defined acceptance criteria.
{0}------------------------------------------------
K11 2688 1/3
NOV - 9 2011
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.
12.2 Predicate Device
EnSite Velocity System with PRT (K101667)
12.3 Common or Usual Name
Electrophysiology Mapping System with console and catheter
12.4 Proprietary Name
EnSite Velocity System
Consisting of:
.
EnSite Electrophysiology Workstation – Model EE3000 EnSite ElectrophySiblogy Workstation - Model Size Array™ – Model EC1000) EnSite NavX Surface Electrode Kit - Model EN0010
12.5 Classification Name
DQK, Programmable diagnostic computer (21 CFR 870.1425), Class II, Circulatory Systems Device Panel
12.6 Hardware Description
The EnSite Velocity System consists of the following:
- Display Workstation
- Amplifier
32 Page 32 of 3060
{1}------------------------------------------------
12.7 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.
12.8 Device Comparison to the Predicate Device
The EnSite Velocity System v.3.0 has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the EnSite Velocity System v.3.0 are substantially equivalent to the predicate device.
Summary of Non-Clinical Testing 12.9
Bench testing and animal study testing (Appendix S) were 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 v.3.0 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.
12.11 Conclusion
The EnSite Velocity v.3.0 has the same indications for use, intended use and fundamental scientific technology as the predicate device. All technological characteristics of the EnSite Velocity v.3.0 are substantially equivalent to the predicate device.
510(k): EnSite Velocity System v.3.0
{2}------------------------------------------------
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 v.3.0 to be substantially equivalent to the predicate device.
510(k): EnSite Velocity System v.3.0
. '
{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
St. Jude Medical c/o Donna R. Lunak Regulatory Specialist One St. Jude Medical Drive Saint Paul MN 55117
NOV - 9 2011
Re: K112688
Trade/Device Name: EnSite Velocity System V.3.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: October 18, 2011 Received: October 19, 2011
Dear Ms. 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 intestate 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, Or to 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 1 ct 1 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.
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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.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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Division of Cardiology Devices
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 The EnSile Velooky - toolsy studies are indicated.
-
When used with the EnSite Array™ Catheter, the EnSite System is intended to . When used with the Enone Anaj - Guinbicomplex arrhythmias that may be de used in the fight atham or preptional mapping systems alone.
OR -
When used with the EnSite NavX Surface Electrode Kith, the EnSite System is t When used with the EnSite Navx Sundos Liostract Chical Castleters in the heart.
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)
| Division Sign-Off |
|---|
| Division of Cardiovascular Devices |
510(k): EnSite Velocity System v.3.0
510(k) Number
13
§ 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).