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The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter provides location information when used with compatible CARTO™ 3 EP Navigation Systems. This catheter is not compatible with CARTO™ 3 EP Navigation Systems prior to Version 3.x.

The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is designed to facilitate electrophysiological mapping of the heart with the CARTO® 3 EP Navigation System. It is designed for deployment in a heart chamber through an 8 Fr guiding sheath. This deflectable catheter consists of multiple 3 Fr spines on the distal tip, each spine having multiple platinum electrodes that are used for stimulation and recording. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO® 3 EP Navigation System. The catheter has two electrodes on the deflectable tip to provide for visualization of the tip when used with the CARTO® 3 EP Navigation System. Pushing forward on the catheter thumb knob deflects the tip; pulling back on the thumb knob straightens the tip. This catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid.

The provided text describes the 510(k) summary for the Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter. This document outlines the device's characteristics and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are implicitly derived from demonstrating substantial equivalence to the predicate device, the original PENTARAY® NAV eco High-Density Mapping Catheter (Biosense Webster K123837). The tests performed cover various functional, safety, and manufacturing aspects to ensure the reprocessed device performs as intended and is safe for use.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Representative samples of reprocessed devices were tested to demonstrate appropriate functional characteristics." However, it does not specify the exact sample size used for the test set for any of the non-clinical tests.

Regarding data provenance, the testing was performed by Sterilmed, Inc., the manufacturer and submitter of the 510(k). This indicates the data is prospective in the context of validating the reprocessed device. The country of origin of the data is not explicitly stated but can be inferred to be the United States, given the submission to the FDA and the company's address in Minnesota.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts

This type of information is not applicable to this submission. The tests described are non-clinical, primarily bench testing, process validation (cleaning, sterilization, packaging), and material biocompatibility. These tests rely on established scientific methods, standards (e.g., ISO, ASTM), and laboratory protocols rather than human expert interpretation of a diagnostic outcome. Therefore, there is no "ground truth" to be established by experts in the context of image interpretation or clinical diagnosis.

4. Adjudication Method for the Test Set

This is not applicable as the tests are non-clinical and do not involve human interpretation or diagnostic decision-making that would require an adjudication process.

5. 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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document is for a medical device (a reprocessed catheter), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with or without AI assistance is irrelevant here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This submission is for a physical medical device, not an algorithm or software as a medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests described, the "ground truth" is defined by established engineering specifications, performance standards (e.g., ISO, ASTM), and validated scientific methods. For example:

• Functional tests: The ground truth is whether the device meets its design specifications (e.g., electrical resistance within a certain range, correct deflection, proper bond strength).
• Sterilization: The ground truth is the absence of viable microorganisms after the sterilization process, validated through microbiological testing.
• Biocompatibility: The ground truth is the device's interaction with biological systems falling within acceptable safety limits, as defined by ISO 10993 standards and relevant biological endpoints (e.g., no cytotoxicity, no irritation).

8. The Sample Size for the Training Set

There is no training set mentioned or implied in this document. This is a submission for a reprocessed medical device, and the testing described is primarily for validation and verification, not for training a machine learning model.

9. How the Ground Truth for the Training Set was Established

As there is no training set, this question is not applicable.

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The Biosense Webster PENTARAY™ NAV eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The PENTARAY™ NAV eco High-Density Mapping Catheter provides location information when used with compatible CARTO™ 3 EP Navigation Systems. (This catheter is not compatible with CARTO™ 3 EP Navigation Systems prior to Version 3.x).

The Biosense Webster PENTARAY® Nav eco Mapping Catheter is a multi-electrode diagnostic catheter designed to facilitate electrophysiological mapping of all structures in the heart (recording and stimulation). The catheter's distal end is a flower-shaped probe with 5 spines that radiate from the center. Each spine has 4 ring electrodes that are used for stimulation and recording within the heart. The flower is available in a 30mm diameter and several ring spacing configurations to achieve optimal mapping and contact with various cardiac structures.

This document is a 510(k) summary for a medical device ([K201750](https://510k.innolitics.com/search/K201750): Pentaray Nav eco High-Density Mapping Catheter), which is submitted to the FDA for market clearance. It asserts that the device is substantially equivalent to a predicate device ([K123837](https://510k.innolitics.com/search/K123837)).

Therefore, the information you've requested regarding acceptance criteria and performance studies that would prove the device meets acceptance criteria in the context of an AI/machine learning device is not present in this document. This typically involves performance metrics like sensitivity, specificity, AUC, etc., derived from studies comparing algorithm output to ground truth.

This 510(k) specifically states:

• "The subject catheter is identical in design to the current catheter."
• "The intended use of the predicate device as a diagnostic catheter designed to facilitate mapping of structures within the heart remains the same in the subject device."
• "The purpose of this 510(k) submission is to add clarification to the precautions. There are no other changes between the subject device and the predicate device approved per K123837."
• "The PENTARAY™ NAV eco High-Density Mapping Catheter underwent bench and animal testing. The catheter passed all intended criteria in accordance with appropriate test criteria and standards."

This is a design modification submission (adding clarification to precautions) for an already cleared device, not a new device with novel AI algorithms requiring extensive clinical performance validation for its AI components with human-in-the-loop studies. The "Performance Data" section solely refers to bench and animal testing, which are standard for physical medical devices to ensure safety and functionality, not AI algorithm performance.

Therefore, I cannot provide the requested information from this document in the context of an AI/ML device. The document does not describe the kind of performance studies (e.g., MRMC, standalone algorithm performance) or the robust ground truth establishment methods typically associated with AI/ML device validation.

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