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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.

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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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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. The catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

The catheter provides location information when used with the 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 F guiding sheath. This deflectable catheter consists of multiple 3F spines on its 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 device includes an irrigation lumen for connection to a source of continuous anticoagulant fluid.

This catheter interfaces with standard recording equipment and the Carto 3 EP Navigation System via interface cables with the appropriate connectors.

The provided FDA 510(k) summary (K190785) describes the substantial equivalence of a reprocessed medical device (Reprocessed PentaRay Nav eco High-Density Mapping Catheter) to an original predicate device. It addresses device safety and effectiveness through various tests.

However, this document does not describe a study involving an AI/Machine Learning device or a diagnostic algorithm that would typically have acceptance criteria related to accuracy, sensitivity, specificity, or human-in-the-loop performance. The testing described focuses on the physical and functional integrity, sterility, and biocompatibility of the reprocessed catheter.

Therefore, many of the requested points related to AI/ML device performance (like sample size for test/training sets, expert ground truth, MRMC studies, effect size of AI assistance, standalone performance, etc.) are not applicable to the information provided in this 510(k) summary.

The acceptance criteria and "study" described herein pertain to the reprocessing of a physical medical device, not a diagnostic algorithm.

Here's an interpretation based on the provided document:

Acceptance Criteria and Study for Reprocessed PentaRay Nav eco High-Density Mapping Catheter

The "study" described in the 510(k) summary for the Reprocessed PentaRay Nav eco High-Density Mapping Catheter (K190785) is not a study of an AI/Machine Learning diagnostic algorithm. Instead, it is a demonstration of the substantial equivalence of a reprocessed medical device to its original predicate device, focusing on its safety and effectiveness after reprocessing.

The acceptance criteria are implied by the battery of functional, safety, and performance tests conducted to ensure the reprocessed device performs as intended and is as safe and effective as the new device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with numerical performance targets for an AI/ML diagnostic system. Instead, the acceptance criteria are implicitly linked to the successful completion and passing of the various tests for the reprocessed catheter, ensuring it meets the original device's specifications and performance.

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

• Sample Size: The document does not specify the exact number of reprocessed catheters used for each of the functional and safety tests. This information is typically detailed in the study reports submitted to the FDA but is summarized and not fully elaborated in the 510(k) summary. Given these are physical device tests, a statistically representative sample of reprocessed units would have been tested for each protocol.
• Data Provenance: The tests are performed "Bench and laboratory testing" by Innovative Health, LLC. This is likely internal testing conducted in a controlled laboratory environment.
  • Country of Origin: United States (based on the company and FDA filing location).
  • Retrospective or Prospective: These are prospective tests performed on reprocessed devices to validate the reprocessing procedure and the device's performance post-reprocessing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: This pertains to the validation of a reprocessed physical device, not an AI/ML algorithm requiring expert interpretation for ground truth. Ground truth for these tests would be established by objective measurements against engineering specifications (e.g., electrical resistance values, dimensional tolerances, sterilization test results).

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods like "2+1" or "3+1" are typical for diagnostic imaging studies where multiple readers interpret cases and a consensus or tie-breaking mechanism is needed to establish ground truth. For the physical device testing described, the "ground truth" is determined by objective measurement against established engineering and safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: An MRMC comparative effectiveness study is not relevant here as the device is not a diagnostic imaging aid or an AI algorithm intended for human-in-the-loop performance evaluation. The study is about the safety and function of a reprocessed catheter.

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

• Not Applicable: This is not an algorithm. The "standalone" performance relates to the catheter's ability to perform its intended function (mapping, recording, stimulation) independently when used with compatible equipment. The "Functional testing" and "Electrical Safety Testing" sections would cover aspects of this.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Results: The "ground truth" for the reprocessed catheter's performance and safety is derived from:
  • Predicate Device Specifications: The performance and safety parameters of the original, legally marketed predicate device (PentaRay NAV eco High-Density Mapping Catheter, K123837).
  • Industry Standards: Compliance with relevant national and international standards (e.g., ISO for biocompatibility, sterilization, packaging; IEC for electrical safety).
  • Defined Pass/Fail Criteria: Each test (e.g., electrical continuity, leak test, visual inspection) would have pre-defined quantitative or qualitative acceptance criteria.

8. The Sample Size for the Training Set

• Not Applicable: This device is not an AI/ML algorithm that requires a "training set." The reprocessing procedure itself is the "process" being validated, and its parameters are established through rigorous engineering and validation studies, not machine learning.

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

• Not Applicable: As there is no AI/ML training set, this question is irrelevant to the provided document. The "ground truth" for developing the reprocessing procedure (if one were to draw a very loose analogy) would be the established performance and safety of the new device, which the reprocessed device must match.

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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 PENTARAY® High-Density Mapping Catheter family is a 7 Fr, multi-electrode electrophysiological mapping catheter designed for diagnostic electrogram mapping and pacing in all chambers (atria and ventricles) of the heart. Six proposed PENTARAY® NAV eco High-Density Mapping Catheters (D-1282-07-S to D-1282-12-S) will be similar to six predicate PENTARAY® NAV High-Density Mapping Catheters (D-1282-01-S to D-1282-06-S), modified only to implement an "eco" Handle. The modification to implement this "eco" Handle involves removing the Printed Circuit Board (PCB) that is associated with the Magnetic Location Sensor from the Handle Extension and connecting this catheter to an existing "eco" Interface Cable and a short, reusable cable component that now contains this PCB. This cable containing the PCB (known as the Dongle) is associated with the CARTO® 3 Electrophysiology (EP) Navigation System. This "eco" Handle is the only modification of the predicate catheters to create the six proposed Biosense Webster PENTARAY NAV eco Catheter models.

The working tip of the six proposed PENTARAY NAV eco Catheters is identical to the predicate catheters. The proposed catheters will continue to have five flexible spines, each with four ring electrodes for a total of 20 electrodes. There will continue to be three different electrode spacing configurations (4-4-4, 2-6-2, or 1-8-1 mm) and two different curves (F or D) in order to accommodate different clinical situations. The tip of the shaft of both the predicate and proposed catheters house a Magnetic Location Sensor that provides magnetic location information when used with the CARTO® 3 EP Navigation System. In addition to the 20 spine electrodes, two additional Ring Electrodes are located near the tip of the shaft for a total of 22 ring electrodes that provide location information via ACL technology when used with the CARTO 3 EP Navigation System. The shafts of the proposed and predicate catheters are the same as are the distal ends of the Handle. All the modifications are in the proximal portion of the Handle where the changes described in the previous paragraph were effected.

This document describes a 510(k) premarket notification for the PENTARAY® NAV eco High-Density Mapping Catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the PENTARAY® NAV High-Density Mapping Catheter.

The key information regarding the acceptance criteria and the study performed is as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated in terms of a specific numerical count for a "test set" in the context of a clinical study. The device's performance was evaluated through bench testing and a single animal test.
• Data Provenance: The bench testing and animal testing were conducted internally by the manufacturer (Biosense Webster, Inc.). No information on country of origin for any external data, or whether it was retrospective or prospective, is provided as no human clinical trials were performed.

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

Not applicable. No clinical test set requiring expert ground truth establishment was conducted. The evaluation relied on engineering bench tests and an animal study.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring human expert adjudication was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not performed. The submission explicitly states, "No clinical testing was deemed necessary." The device is a hardware mapping catheter, not an AI diagnostic tool that would typically be evaluated with MRMC studies.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The PENTARAY® NAV eco is a medical device (catheter), not a standalone algorithm. Its performance is evaluated as an integrated system with the CARTO® 3 EP Navigation System.

7. Type of Ground Truth Used

• For Bench Testing: Engineering specifications and established industry standards for catheter performance served as the ground truth.
• For Animal Test (ECG signal quality): The quality of ECG signals obtained using the predicate device likely served as the comparative "ground truth" to ensure no degradation with the modified device.

8. Sample Size for the Training Set

Not applicable. This device is a hardware catheter, not an AI algorithm that requires a training set.

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

Not applicable, as there was no training set for an AI algorithm.

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