Search Results

The Reprocessed DECANAV™ Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, in the Coronary Sinus. In addition, the Reprocessed DECANAV™ Catheter is used with compatible Carto® 3 EP Navigation Systems to provide catheter tip location information.

The Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. In addition, the Reprocessed WEBSTER® Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and coronary sinus.

The Reprocessed DECANAV™ Catheter is a sterile, single patient use device designed to be used with the CARTO® 3 EP Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The catheter has a high torque shaft with a deflectable tip section containing an array of platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals. The Reprocessed DECANAV™ Catheter has a single proximal electrode that can be used for unipolar recording signals. The Reprocessed DECANAV™ Catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in curve types D and F. Pushing the thumb knob forward causes the catheter tip to bend (curve); when the knob is pulled back, the tip straightens. The plane of the curved tip can be rotated during use. The Reprocessed DECANAV™ Catheter interfaces with standard recording equipment and CARTO® 3 EP Navigation System equipment via interface cables with the appropriate connectors.

The Reprocessed WEBSTER® Duo-Decapolar Catheter (DDP) is a sterile, single patient use device designed to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording. Tip deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumb knob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. The catheter interfaces with standard recording equipment via interface cables with the appropriate connectors.

The provided text describes the 510(k) summary for reprocessed electrophysiology catheters, which are medical devices, not AI/ML-enabled software. Therefore, the questions related to AI/ML device performance, such as sample size for test sets (data provenance), number of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, and training set information (sample size, ground truth establishment), are not applicable to this document.

The document discusses acceptance criteria and device performance in the context of demonstrating substantial equivalence for reprocessed medical devices to their predicate devices.

1. A table of acceptance criteria and the reported device performance

The document lists several tests performed to demonstrate appropriate functional characteristics and substantial equivalence to predicate devices. It states that "Performance testing shows the Reprocessed DECANAV™ and Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheters perform as originally intended." and "Results demonstrated substantial equivalence to the predicate devices."

Specific acceptance criteria (e.g., numerical thresholds for compliance) are not explicitly detailed in this summary. However, the types of tests conducted serve as the basis for determining if the reprocessed devices meet acceptable performance comparable to the original predicate devices.

2. Sample size used for the test set and the data provenance

The document states: "Representative samples of reprocessed devices were tested to demonstrate appropriate functional characteristics." It does not specify the exact sample size for each test or the total test set.

• Data provenance: Not explicitly stated, but the testing was conducted by Sterilmed, Inc. or its contractors in the context of their reprocessing efforts. This would be considered internal data from the reprocessing process. The data is retrospective in the sense that it evaluates the reprocessed devices after manufacturing, but the tests themselves are prospective studies on those samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The device is a reprocessed electrophysiology catheter. Performance is assessed through engineering and biocompatibility tests against established specifications and comparison to the original (OEM) device, not through expert human review of interpretative data like medical images.

4. Adjudication method for the test set

This question is not applicable, as the performance evaluation relies on objective engineering and biological test results, not expert human interpretation or adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

This question is not applicable. MRMC studies are typically used to evaluate the diagnostic accuracy of imaging systems or AI algorithms by comparing performance with and without an AI assist. This document is for a reprocessed medical device.

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

This question is not applicable. This is not an AI/ML-enabled device.

7. The type of ground truth used

The "ground truth" for the performance of these reprocessed catheters is established by:

• Engineering specifications and performance characteristics of the original equipment manufacturer (OEM) predicate devices. The reprocessed devices are tested to ensure they meet these specifications.
• Compliance with recognized standards for medical device reprocessing, safety, and performance (e.g., ISO 10993 for biocompatibility, ASTM standards for packaging and shelf-life, and internal functional performance criteria designed to mimic intended use).
• Visual inspection for physical integrity.

Essentially, the ground truth is the performance and safety profile of the new, original predicate device.

8. The sample size for the training set

This question is not applicable. This is not an AI/ML-enabled device, so there is no training set in the context of machine learning.

9. How the ground truth for the training set was established

This question is not applicable, as there is no training set for an AI/ML algorithm.

Ask a specific question about this device

The Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. In addition, the Webster Duo-Decapolar catheter is designed to facilitate electrogram mapping in the atrial reqion of the heart and the coronary sinus.

The Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter has been designed for electrophysiological mapping of heart. The catheters have a hightorque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording.

The tip deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumbknob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high-torque shaft allows the plan of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

The provided text describes a 510(k) premarket notification for a Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel performance against clinical acceptance criteria with a study designed to evaluate such. As such, the information typically found in a clinical study report regarding acceptance criteria and performance against those criteria (especially for AI/software devices) is not present in this document.

Here's an analysis based on the document:

1. A table of acceptance criteria and the reported device performance:

This document does not contain a table of acceptance criteria and reported device performance in the context of clinical efficacy or diagnostic accuracy. The testing described is primarily for functional and safety testing to demonstrate that the reprocessed device performs comparably to the original device.

The "acceptance criteria" here are implied by the battery of tests performed to ensure the reprocessed device is safe and effective and functions like the new device. These include:

• Biocompatibility: The reprocessed device must be biocompatible.
• Cleaning Validation: The cleaning process must effectively remove contaminants.
• Sterilization Validation: The sterilization process must render the device sterile.
• Functional Testing:
  • Visual Inspection: Device appearance must meet specifications.
  • Dimensional Verification: Dimensions must be within specified tolerances.
  • Electrical Continuity and Resistance: Electrical properties must be within specifications.
  • Simulated Use: The device must perform as expected under simulated use conditions.
  • Mechanical Characteristics: Mechanical properties (e.g., tip deflection) must be maintained.
• Electrical Safety Testing:
  • Dielectric and Current Leakage: Electrical safety must be within acceptable limits.
• Packaging Validation: Packaging must maintain device integrity and sterility.

The document states, "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Webster Duo-Decapolar Diagnostic EP Catheters." It then lists the above tests, implying that the device "met" the unstated acceptance criteria for each of these tests to conclude that it is "as safe and effective as the predicate devices."

2. Sample size used for the test set and the data provenance:

The document does not detail the sample sizes for the functional and safety tests. Studies for reprocessed medical devices typically involve testing a representative sample size of reprocessed units. No information on data provenance (e.g., country of origin, retrospective/prospective) is provided, as these are lab-based performance tests, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided. The testing described is laboratory-based mechanical, electrical, and material testing, not human-interpretation-based evaluation requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not described here.

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:

This is not applicable and no such study was done. This device is a reprocessed electrophysiology catheter, not an AI or software device.

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

This is not applicable as the device is not an algorithm or software.

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

The "ground truth" for the performance claims of this reprocessed device is the established performance specifications and accepted safety and efficacy profiles of the original, new Webster Duo-Decapolar Diagnostic EP Catheter (K101991), and the performance standards for the specific functional and safety tests (e.g., electrical resistance limits, sterilisation assurance levels, biocompatibility standards). The reprocessed device is deemed safe and effective if it meets these engineering and performance standards, thereby being substantially equivalent.

8. The sample size for the training set:

This is not applicable. There is no training set mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

This is not applicable. There is no training set.

Ask a specific question about this device

The Reprocessed Webster Duo-Decapolar EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. In addition, the Webster Duo-Decapolar catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.

The Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter has been designed for electrophysiological mapping of heart. The catheters have a hightorque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording.

The tip deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumbknob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high-torque shaft allows the plan of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

I am sorry, but the provided text from the FDA 510(k) filing for the Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter does not contain the information required to describe acceptance criteria and a study proving a device meets those criteria, as typically seen for AI-enabled medical devices.

This 510(k) pertains to a reprocessed medical device (a catheter), which means it's a device that has been cleaned, disinfected, sterilized, and functionally tested after prior use to be used again. The documentation focuses on demonstrating that the reprocessed device is substantially equivalent to a new, legally marketed predicate device in terms of design, materials, function, intended use, and safety/effectiveness through bench and laboratory testing.

Here's why the requested information about AI model performance, expert ground truth, multi-reader multi-case studies, and training/test set details is not present in this document:

• This is not an AI-enabled device. The device is a physical catheter used for electrophysiological mapping of the heart. Its function is based on physical properties, electrical contacts, and mechanical manipulation, not on artificial intelligence algorithms analyzing data.
• The "study" refers to bench and laboratory testing. The document lists "Functional and Safety Testing" which includes biocompatibility, cleaning validation, sterilization validation, visual inspection, dimensional verification, electrical continuity and resistance, simulated use, mechanical characteristics, electrical safety testing, and packaging validation. These are standard tests for physical medical devices and do not involve AI performance metrics.
• "Acceptance Criteria" here would relate to physical and electrical specifications. For example, "dimensional verification" might have an acceptance criterion for the catheter's length or diameter, or "electrical continuity" might have a resistance range. These are not framed as AI model performance metrics like sensitivity, specificity, or AUC.
• Ground truth, experts, and adjudication are irrelevant. They are used to establish the correctness of an AI model's output in interpreting medical data (e.g., images, signals). For a reprocessed catheter, the "ground truth" is its physical and electrical integrity compared to a new device.

Therefore, I cannot populate the requested table or answer the specific questions about AI model validation because the provided text describes a reprocessed physical medical device, not an AI-enabled one.

Ask a specific question about this device

The catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. In addition, the Webster Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.

The Biosense Webster. Duo-Decapolar Catheter, manufacturing part number D-1171-35. is designed for electrophysiological mapping of cardiac structures. The catheter has a high-torque 7 Fr shaft with a tip section containing 10 pairs of platinum-iridium electrodes that can easily be seen under fluoroscopy. The 10 pairs of electrodes are arranged in two sets of five with a spacing of 60 mm between the sets. The electrode spacing within each set is 2-8-2 mm. The D-1171-35 catheter facilitates simultaneous local electrograms due to the greater number of electrodes and its deflection capabilities. All of the electrodes may be used for recording and stimulation purposes.

Tip deflection is controlled at the proximal end by a tubular hand piece in which a piston slides. The piston in the handpiece is attached to an internal puller wire which changes the radius of the curvature. When the piston is pushed forward with the thumbknob, the radius of the curvature is reduced; when the thumbknob is pulled back, the radius of the curvature is increased until the tip section straightens. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

The catheter has a bifurcated Pigtail Connector Subassembly at the proximal end of the hand piece that houses a pair of 10-pin circular connectors. This connector provides a means for the catheter to connect to an interface cable and allow interface of the catheter with standard recording equipment.

The provided text describes a medical device, the Webster Duo-Decapolar Catheter, and its performance data in the context of a 510(k) premarket notification. However, it does not include a table of acceptance criteria or a detailed study proving the device meets those criteria, nor does it contain information about AI integration, human readers, or an MRMC study.

Here's a breakdown of the available information based on your requested categories:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in a table format. The text generally indicates that the device "passed all testing in accordance with appropriate test criteria and standards."
• Reported Device Performance: The device "underwent extensive bench (mechanical, electrical and simulated use) testing." It was also "assessed to be safe and effective for use in the coronary sinus based on an animal study performed with the similarly designed Webster CS Catheter with EZ Steer Technology." Specific numerical performance metrics or detailed results are not provided.

2. Sample sized used for the test set and the data provenance:

• Test Set (Animal Study): Not explicitly stated, but it refers to "an animal study." The provenance is also not specified (e.g., country of origin, retrospective or prospective).
• Test Set (Bench Testing): Not applicable for sample size in the traditional sense, as it refers to mechanical, electrical, and simulated use testing of the device itself rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This information is not provided in the text.

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:

• An MRMC study, AI assistance, or human reader improvement data are not mentioned in the provided text. The device is an electrophysiology mapping catheter, not an AI-powered diagnostic tool.

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

• This is not applicable as the device is a physical medical instrument, not an algorithm.

7. The type of ground truth used:

• For the animal study, the ground truth would likely be established through direct observation and measurements during the animal procedures, with efficacy and safety assessments based on physiological responses and potentially post-mortem analysis. However, the exact methodology is not detailed.
• For bench testing, the ground truth would be based on engineering specifications and established test standards for mechanical and electrical properties.

8. The sample size for the training set:

• A "training set" in the context of algorithm development is not applicable to this device. The development process involved "extensive bench (mechanical, electrical and simulated use) testing" which served to refine and validate the device's design.

9. How the ground truth for the training set was established:

• As above, a "training set" for an algorithm is not applicable. The device's design was likely validated against engineering specifications and performance expectations derived from predicate devices and clinical understanding of electrophysiology catheters.

Ask a specific question about this device

Ask a specific question about this device

The DECap™ is a non-vented cap that is intended to seal male or female luer locks that are part of typical medical devices such as manifolds, stopcocks or sets.

The DECap™ is a non-vented cap.

The provided document is a 510(k) clearance letter for a medical device called "DECap™". It primarily focuses on the regulatory approval for marketing the device based on its substantial equivalence to a legally marketed predicate device.

Unfortunately, this document does not contain the detailed information necessary to answer your request regarding acceptance criteria and the specifics of a study proving the device meets those criteria.

The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976...".

This means the device was cleared because it was shown to be substantially equivalent to an existing device, not necessarily through a new study with explicit acceptance criteria for its performance. The 510(k) pathway often relies on demonstrating that a new device is as safe and effective as a predicate device, which can involve performance data but doesn't always require a comprehensive study against pre-defined acceptance criteria in the same way a PMA (Premarket Approval) might.

Therefore, I cannot provide the requested information from this document. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, or details of a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone algorithm performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device