(18 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 .
This 510(k) summary (K101667) describes a resubmission for the EnSite Velocity System with PRT, which is a modification to the previously cleared EnSite Velocity System (K093942). As such, the submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo study with acceptance criteria for a novel device. The document states that the new device has the same indications for use, intended use, and fundamental scientific technology as the predicate and that all technological characteristics are substantially equivalent.
Therefore, the provided document does not contain a detailed study proving the device meets specific performance acceptance criteria in the way one might expect for a new device submission. Instead, it relies on demonstrating that the changes made did not adversely affect the device's safety and effectiveness compared to the already cleared predicate.
Here's a breakdown of the information as requested, extrapolated from the provided text where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, specific quantitative acceptance criteria or a dedicated performance study for this modified device (EnSite Velocity System with PRT) are not included in this 510(k) summary. The summary focuses on equivalence to a predicate device. The "performance" assessment is based on ensuring the changes did not degrade performance.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence to Predicate Device | Bench testing confirmed that changes met design requirements and did not affect safety or effectiveness. Differences between proposed and predicate device do not adversely affect safety and effectiveness. |
| Meeting Design Requirements | Changes introduced met design requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "bench testing," which implies some form of in-vitro or simulated testing, but details on sample size (e.g., number of test cases, number of runs) are not provided.
- Data Provenance: The testing was "bench testing," indicating it was likely conducted in a laboratory setting by St. Jude Medical. No information on country of origin for data or whether it was retrospective or prospective clinical data is mentioned, as this was not a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This type of detail is not applicable to the "bench testing" described. Bench testing typically involves engineering verification against specifications or design requirements, not expert-adjudicated ground truth as would be used in a clinical study of diagnostic accuracy.
4. Adjudication Method for the Test Set
- Not applicable. This information is relevant for clinical studies involving human observers or diagnoses, where consensus among experts is often established. Bench testing does not involve adjudication in this sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC comparative effectiveness study was not conducted for this 510(k) submission. This type of study would typically be performed for new diagnostic algorithms where human reader performance is a key metric, often with and without AI assistance to measure improvement (effect size). This submission focuses on engineering changes and equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The EnSite Velocity System is a tool used by interventional electrophysiologists. Its function is to map cardiac activity and display catheter positions. It is inherently a "human-in-the-loop" device. Therefore, a standalone (algorithm only) performance assessment as might be done for an AI diagnostic algorithm is not applicable in the context described. The "bench testing" was likely verification of the system's ability to accurately perform its technical functions.
7. The Type of Ground Truth Used
- For the "bench testing" mentioned, the ground truth would typically be engineering specifications, known physical properties, or pre-defined validation targets established during the device's design and development. For instance, if a change affected how catheter position is displayed, ground truth could be the known, reference position of the catheter in a phantom or simulated environment. It would not be expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Not applicable. The EnSite Velocity System, as described in this summary, is an electrophysiology mapping system, not an AI/machine learning device that relies on a "training set" in the conventional sense. The "PRT" refers to "Positional Reference Tool," which is an engineering-level feature, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As explained above, there is no "training set" for this type of device.
In summary, this 510(k) summary pertains to a modification of an existing device and leverages the concept of "substantial equivalence" to a predicate device. The "study" described is limited to "bench testing" to ensure the modifications do not negatively impact safety or effectiveness, rather than a comprehensive de novo clinical performance study with specific acceptance criteria, expert adjudication, or AI performance metrics.
§ 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).