(179 days)
The Encirclr AL Adjustable Loop Mapping Catheter is intended for electrophysiologic mapping, recording intracardiac electrograms, and temporary pacing in the atria of the heart.
The device consists of a control handle and a closed lumen 7 French catheter shaft that transitions to a 5 French distal tip section. The distal tip section has an adjustable loop with 10 evenly spaced radiopaque active electrodes that are .75 to 1.3 mm in width, and a non-active 5 French distal tip. The catheter contains two control wires, insulated recording wires, and a nickel/titanium forming wire which has memory and elasticity that allows for adjustability of the loop. The control handle enables the user to steer the device, and adjust the diameter of the loop at the distal end of the catheter in order to fit various ostial anatomy. These catheters are available in four models (1045AL1, 1045AL2, 1060AL1, 1060AL2) with a usable length of 110 cm measuring from the strain relief to the center of the distal loop. They have curve reaches that range from 45 to 60 mm, and adjustable loop diameters that range from 14 to 28 mm (AL1's range is 14-22mm and AL2's range is 18-28mm). The catheter connects to a cable that serves as the interface between the catheter and a standard EP recording system using a Medtronic 10-pin connector cable. The catheter is supplied sterile and is intended for single-use.
The provided text details the submission of a Special 510(k) for the Encirclr™ AL Diagnostic Catheter, indicating its intended use and a comparison to a predicate device for substantial equivalence. However, the document does not contain specific acceptance criteria or the results of a study designed to prove the device meets those criteria.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: This is not present in the document. The document describes the device and states it underwent electrical and mechanical testing for comparison to a predicate, but no specific performance metrics or acceptance criteria are listed.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device is an electrophysiologic mapping catheter, not an AI diagnostic tool, so such a study would not be applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a medical device, not an algorithm.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not applicable as there is no mention of a training set for an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
The document focuses on demonstrating substantial equivalence to an existing predicate device (StableMapr EP catheter, K981642) rather than presenting a performance study against predefined acceptance criteria. The statement of technological comparison mentions: "Representative samples of the device underwent electrical and mechanical testing to demonstrate comparable functional and performance characteristics to the predicate device." Biocompatibility was assessed by analogy to existing Medtronic catheters. This suggests that the "acceptance criteria" were implied by the performance of the predicate device, and the testing aimed to show that the Encirclr™ AL performed comparably.
§ 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).