(59 days)
The Reprocessed Achieve Catheter Connecting Cable is designed for use only with the Achieve family of mapping catheters. It is intended to provide connection of the catheter to a standard ECG interface box.
The Reprocessed Achieve Catheter Connecting Cable provides conduction from the proximal end of the mapping catheter to standard shielded ECG pins that connect standard EP recording and pacing equipment. The cable is designed for use with the Achieve family of mapping catheters.
The provided text is a 510(k) summary for the Innovative Health LLC's Reprocessed Achieve Catheter Connecting Cable. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report of a device's performance against specific acceptance criteria in a clinical or AI-related context.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or not explicitly detailed in this type of FDA submission. This is because the device being described is a reprocessed cable, and the 510(k) emphasizes functional and safety testing to show equivalence to a predicate device, not necessarily a clinical outcomes study with AI components.
However, I can extract information related to the bench and laboratory testing that was conducted.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria with reported numerical device performance as would be found in a detailed study report. Instead, it lists the types of functional and safety testing performed to ensure the reprocessed device is "as safe and effective as the predicate device."
Types of Testing Performed:
- Cleaning Validation
- Sterilization Validation
- Functional Testing
- Visual Inspection
- Dimensional Verification
- Electrical Continuity Testing
- High Potential (HiPOT) Testing
- Packaging Validation
The "performance" implied is that the device passed these validations and tests, demonstrating its equivalence. Specific quantitative performance metrics or acceptance thresholds are not provided in this summary. For example, instead of stating "Electrical Continuity: Resistance
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).