(108 days)
The Z6 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation electrophysiological testing of the human heart.
The Z6 Stimulator is a cardiac pulse generator designed for use in an Electrophysiology Laboratory during electrophysiological studies. The system operates in conjunction with ECC Recording devices to deliver electrical stimulus to the patient's heart through up to four simultaneously operable output channels. The Z6 Stimulator is controlled by a CPU based Workstation with Windows XP. This provides programmability and flexibility with regard to the stimulus program and allows access to system users. Additionally, the system features a graphical interface with a Windows XP look and feel.
Each of the four independent output channels of the Z6 Stimulator is capable of generating between 0.1 and 25 mAs of current to the patient, with voltages up to 20 Volts. The System is capable of delivering pulses on all channels simultaneously. The duration of the pulses can be programmed to be between 0.5 and 10 ms, maintaining timing accuracy (> +/- 0.15 ms).
The provided document, K070743, is a 510(k) premarket notification for the Z6 Stimulator, a programmable cardiac electrophysiological stimulator. The purpose of this notification is to demonstrate that the Z6 Stimulator is substantially equivalent to a legally marketed predicate device, the Micropace Pty Ltd. EPS320 Clinical Stimulator.
Here's an analysis of the acceptance criteria and the study presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document uses the specifications of the predicate device, the Micropace EP320 Stimulator, as the acceptance criteria for the Z6 Stimulator's performance. The "Non-clinical Testing" section explicitly states that the Z6 Stimulator's output pulses were compared to these specifications and "found to be within the specifications."
| Acceptance Criteria (Based on Micropace EP320) | Z6 Stimulator Reported Performance |
|---|---|
| Output Pulse Timing Accuracy | Within specifications |
| Output Pulse Amplitude Accuracy | Within specifications |
| Isolated Stimulus Channels: 2 | 4 (Improved, exceeding criteria) |
| Pulse Amplitude: 0.1-25 mA | 0.1-25 mA |
| Pulse Duration: 0.5-10 ms | 0.5 to 10 ms |
| Interstimulus Interval: 30-9900 ms | 30-10000 ms (Improved) |
| Number of Extra Stimuli: 6 | 8 (Improved, exceeding criteria) |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a sample size for the test set. The non-clinical testing appears to be a technical verification comparing the Z6 Stimulator's output characteristics against the published specifications of the predicate device.
- The data provenance is not explicitly stated as country of origin or retrospective/prospective. As it's a technical verification of the device itself rather than patient data, these categories might not be applicable in the traditional sense. It's an internal validation of the Z6 Stimulator's hardware and software performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not applicable to this type of submission. The ground truth for this technical verification is the published specifications of the predicate device, which are objective engineering parameters. Clinical expert consensus is not used for this.
4. Adjudication Method for the Test Set:
- This is not applicable. The "test set" here refers to the device's output parameters which are objectively measured and compared to numerical specifications. There is no need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This submission focuses on the substantial equivalence of device specifications, not on clinical effectiveness in human readers. The Z6 Stimulator is a tool used by clinicians, not an AI diagnostic tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, in spirit. The non-clinical testing for the Z6 Stimulator is inherently a "standalone" evaluation of the device's functional performance (timing, amplitude accuracy) against established specifications. It's the performance of the device itself, independent of a human operator's cognitive input in interpreting results.
7. The Type of Ground Truth Used:
- Engineering specifications and published data of the predicate device. The Z6 Stimulator's output pulses (timing and amplitude accuracy) were compared against the "specifications of the EP320 Stimulator output pulses."
8. The Sample Size for the Training Set:
- Not applicable. This submission is for a medical device (a stimulator), not an AI algorithm that requires a "training set" in the machine learning sense. The device is designed based on engineering principles and validated against specifications.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As stated above, there is no "training set" in the context of this device and submission.
§ 870.1750 External programmable pacemaker pulse generator.
(a)
Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.(b)
Classification. Class II (performance standards).