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K Number
K112688
Device Name
ENSITE VELOCITY SYSTEM V.3.0
Manufacturer
ST. JUDE MEDICAL
Date Cleared
2011-11-09

(55 days)

Product Code
DQK
Regulation Number
870.1425
Type
Special
Panel
CV
Reference & Predicate Devices
K101667
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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 Description

The EnSite Velocity System consists of the following:

  • Display Workstation
  • Amplifier
AI/ML Overview

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:

  1. Specific Acceptance Criteria: No quantitative or qualitative acceptance criteria are listed.
  2. Reported Device Performance: No actual performance metrics are reported.
  3. 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.
  4. Sample Sizes: No sample sizes are provided for any tests.
  5. Data Provenance: No information on the country of origin or whether data was retrospective/prospective.
  6. Number/Qualifications of Experts: No experts are mentioned in the context of establishing ground truth for testing.
  7. Adjudication Method: Not applicable as there's no mention of expert consensus.
  8. MRMC Comparative Effectiveness Study: Not mentioned as being performed.
  9. Standalone Performance Study: Not explicitly described for the algorithm itself.
  10. Type of Ground Truth: Not specified.
  11. Training Set Sample Size: No mention of a training set.
  12. 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.

§ 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).