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510(k) Data Aggregation
(357 days)
Reprocessed PentaRay Nav eco High-Density Mapping Catheter
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.
| Acceptance Criteria (Implicitly from substantial equivalence to predicate) | Reported Device Performance |
|---|---|
| Functional Characteristics: | Performance testing demonstrates that the Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter performs as originally intended. Specific tests included: Electrical Resistance and Isolation, Electrical Leakage, Leak test, Planarity, Curvature and Spine Spacing, CCS Calibration, Auto ID/EEPROM Reset Verification, Connector Cycling, Tip Stiffness, Tip Side Force, Tip Buckle, Fluid Integrity, Deflection Fatigue, Torsional Strength, Flexation Fatigue, Shaft Rotation Fatigue, Shaft and Connector Bond Strength, Micro Lumen Inspection, Final Rinse and blow out. |
| Cleaning and Sterilization Validation: | Process validation testing was performed to validate cleaning and sterilization. |
| Ethylene Oxide Residual Testing: (to ISO 10993-7 standard) | Testing performed to ISO 10993-7. |
| Packaging Validation: (to ASTM D4169, ASTM F88, ASTM F2096 standards) | Testing performed to ASTM D4169, ASTM F88, ASTM F2096. |
| Shelf-life Validation: (to ASTM 1980-07 standard) | Testing performed to ASTM 1980-07. |
| Biocompatibility: (per ISO 10993-1 for external communicating device, short duration contact with circulating blood ( |
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(90 days)
Reprocessed PentaRay Nav eco High-Density Mapping Catheter
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.
| Test Category | Specific Test | Implied Acceptance Criteria | Reported Device Performance (Implied) |
|---|---|---|---|
| Functional Testing | Visual Inspection | Device must be free from visible damage, defects, or residual soil after reprocessing. | Met: Device is visually inspected. |
| Dimensional Verification | Reprocessed device dimensions (e.g., usable length, French size) must conform to specifications (e.g., matching the predicate device dimensions listed). | Met | |
| Electrical Continuity and Resistance | Electrical components (electrodes) must have proper continuity and resistance within specified ranges to ensure accurate electrophysiological mapping (recording/stimulation). | Met | |
| Simulated Use | Device must perform as intended in a simulated clinical environment, demonstrating proper deflection, navigation, and signal acquisition capabilities with the compatible Carto 3 EP Navigation Systems. | Met | |
| Leak/Occlusion | The irrigation lumen and other internal pathways must be free from leaks or occlusions to ensure proper fluid delivery and prevent complications. | Met | |
| Inner Lumen Occlusion | The inner lumen (presumably for the irrigation) must be clear and unobstructed. | Met | |
| Mechanical Characteristics | Device must maintain structural integrity, flexibility, and mechanical performance comparable to the new device (e.g., tensile strength, bending properties, durability during deployment) after reprocessing. | Met | |
| Safety Testing | Biocompatibility | Materials of the reprocessed device must remain biocompatible after reprocessing, ensuring no cytotoxicity, sensitization, or irritation when in contact with tissues. (Typically, ISO 10993 standards are followed. The acceptance criterion is biocompatibility as per relevant standards). | Met |
| Electrical Safety Testing (Dielectric and Current Leakage) | Electrical insulation must remain intact, and current leakage must be below specified limits to prevent patient or user harm (e.g., electrical shock). (Acceptance criteria are usually specific limits defined by IEC 60601-1 or similar standards). | Met | |
| Sterilization Validation | The device must achieve a specified sterility assurance level (SAL), typically 10^-6, after sterilization. (Acceptance criterion is successful validation of the sterilization process, demonstrating killing of microorganisms to the target SAL). | Met | |
| Cleaning Validation | The reprocessing procedure must effectively remove all clinically relevant soil and contaminants from the device to prevent patient infection or foreign body reactions. (Acceptance criterion is residual soil levels below specified thresholds, validated by methods like protein, hemoglobin, or TOC analysis). | Met | |
| Other | Packaging Validation | The packaging must maintain sterility, protect the device from damage, and be suitable for transport and storage until point of use. (Acceptance criterion is successful validation of packaging integrity and barrier properties per relevant ISO standards). | Met |
| Maximum Reprocessing Cycles | The device must remain safe and effective only for the validated number of reprocessing cycles (in this case, "no more than one (1) time"). The tracking system must effectively reject devices reaching this limit. | Met: Device marked and tracked. | |
| Equivalence to Predicate | The overall performance, safety, and effectiveness of the reprocessed device must be demonstrated to be "as safe and effective as the predicate devices," implying that all tested parameters are comparable and within clinically acceptable ranges for its intended use. | Concluded as such by the submitter. |
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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