Search Results

The Reprocessed Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The Reprocessed Steerable Introducer Set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is filtered with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise less than or equal to 90 degrees. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

The provided text describes a 510(k) submission for a Reprocessed Steerable Introducer. This document is a premarket notification to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria in the same way a novel device might.

Therefore, many of the requested elements (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth for a novel AI/diagnostic device) are not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a reprocessed device seeking 510(k) clearance, the "acceptance criteria" are primarily that the reprocessed device performs, as originally intended, equivalently to the predicate device, and that the reprocessing method is validated and does not compromise safety or efficacy. The reported "performance" focuses on demonstrating this equivalence through various tests.

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

• Sample Size: Not explicitly stated. The document refers to "Bench and laboratory testing" and that "Each individual Introducer is tested for appropriate function." This implies a sample size determined by the validation protocols for reprocessing, biocompatibility, sterilization, and function, but specific numbers are not provided in this summary.
• Data Provenance: Not applicable in the context of a clinical study. The data provenance here would relate to the in-house testing conducted by Stryker Sustainability Solutions during their reprocessing validation.

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

• Not Applicable: This is a reprocessed medical device, not a diagnostic or AI device that requires expert-established ground truth on clinical images or data. The "ground truth" here is the original design specifications and performance of the predicate device, against which the reprocessed device's performance is compared through engineering and lab testing.

4. Adjudication Method for the Test Set

• Not Applicable: There is no "adjudication method" in the sense of expert consensus on clinical cases. Performance is objectively measured against specifications through validated test methods.

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

• Not Applicable: This is not an AI/diagnostic device.

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

• Not Applicable: This is not an AI/diagnostic device.

7. The Type of Ground Truth Used

• Engineering Specifications and Predicate Device Performance: The "ground truth" for this reprocessed device is the original design specifications, material properties, and demonstrated performance characteristics of the predicate (original, new) devices. The testing aims to confirm that the reprocessed device meets these established performance benchmarks.

8. The Sample Size for the Training Set

• Not Applicable: This is not an AI/diagnostic device that uses a "training set."

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

• Not Applicable: This is not an AI/diagnostic device that uses a "training set."

Ask a specific question about this device

The Reprocessed Ultra IntraCardiac Echo Diagnostic Ultrasound rounded tip catheter is indicated for enhanced ultrasonic visualization of intracardiac structures.

The Reprocessed Ultra IntraCardiac Echo Diagnostic Ultrasound Catheter is a 9F (3mm) diameter and 9 MHz frequency IntraCardiac Echocardiography Catheter which is 110cm in lenath. The Ultra IntraCardiac Echo Catheter is constructed with an inner core and proximal connector. The catheter has a distal imaging window and an inserted rotatable imaging core with a distal ultrasound transducer. The 9F (3mm)/9MHz Ultra IntraCardiac Echo Catheter can be used with the ClearView Ultra™ DSP system only after implementation of version 4.22 software or higher, or the Galaxy™ system. Ultra IntraCardiac Echo Catheters rely on the rotational fidelity of the internal transducer and driveshaft assembly to accurately coincide with the position sensing electronics located in the Motordrive Unit (MDU). This arrangement is necessary in order to reduce the overall diameter of the catheter and to ensure that image information is displayed correctly on the screen.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of numerical acceptance criteria or specific performance metrics from benchmark tests with target values. Instead, it states a general conclusion about performance.

Study Information:

Based on the provided document, the study conducted is primarily a reprocessing validation and device performance study to demonstrate substantial equivalence to a predicate device. It is not a clinical study involving human patients to assess diagnostic accuracy or improvement with or without AI.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not specify the sample size for the test set used in the "Bench and laboratory testing." It mentions "Performance data" and lists categories of tests.
   • Data Provenance: Not specified. Given it's "bench and laboratory testing," it refers to in-vitro testing rather than patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. This was bench and laboratory testing of a reprocessed medical device, not a diagnostic accuracy study requiring expert ground truth or interpretation of images/data by medical professionals. The "ground truth" would be the expected functional performance and safety parameters of the device itself.

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

   • Not applicable, as this was not a study involving human interpretation or clinical adjudication.

4. 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, an MRMC comparative effectiveness study was not done. This device is an intracardiac echo catheter, and the study relates to its reprocessing and functional performance, not AI assistance for human readers of medical images.

5. 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 document describes a physical medical device, not an algorithm or AI system.

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

   • The "ground truth" for this study was the established specifications and performance characteristics of the original, new predicate device. The reprocessed device's performance was compared against these known, acceptable standards for safety and function. This includes:
     • Meeting biocompatibility standards.
     • Demonstrating effective reprocessing (e.g., cleanliness, decontamination).
     • Achieving terminal sterility.
     • Passing functional tests for its mechanical and electrical components (e.g., rotational fidelity, emission/reception of ultrasound energy).
     • Maintaining packaging integrity.

7. The sample size for the training set:

   • Not applicable. This is a study on a reprocessed physical medical device, not an AI or machine learning model that requires a training set.

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

   • Not applicable, as there was no training set.

Ask a specific question about this device