Search Results

The Fast-Cath hemostasis introducer is indicated for the introduction of various cardiovascular catheters or biopsy devices into the heart.

The Fast-Cath Transseptal Introducer is indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

Both the Fast-Cath hemostasis and transseptal introducers are used for introducing various catheters into the heart. The inner diameter measures 10F. The distal tips of the introducers are available in a variety of curve configurations to meet physician preferences for accessing different parts of the cardiac anatomy. Each introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and exchange over a guidewire. A sideport with a three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The sheaths contain radiopaque materials for visualization under fluoroscopy. A plastic dilator and stainless steel guidewire are packaged with the introducers and are designed to facilitate the introduction and passage of the introducer through the vasculature.

This 510(k) summary (K061015) describes the Fast-Cath Hemostasis Introducer and Fast-Cath Transseptal Introducer, which are catheter introducers used for introducing various catheters into the heart. The submission asserts substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided K061015 summary, explicit acceptance criteria and corresponding reported device performance metrics are not detailed. The summary states:

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

The 510(k) summary does not provide any specific information about the sample size used for any test set or the provenance of data (e.g., country of origin, retrospective or prospective). The summary merely states "Summary of Testing" and "Testing has demonstrated...", without elaborating on the nature or scope of this testing.

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

There is no mention of experts or ground truth establishment in the context of clinical or performance data for either the test set or training set. Since the submission relies on substantial equivalence to predicate devices and likely refers to bench testing, expert review to establish ground truth as one might see in diagnostic AI studies is not applicable or detailed here.

4. Adjudication Method for the Test Set

As no specific test set involving human interpretation or performance evaluation is described, adjudication methods are not applicable or mentioned.

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

An MRMC comparative effectiveness study was not performed or described. This type of study is typically relevant for diagnostic devices involving human interpretation of data, often comparing AI-assisted vs. unassisted human performance. This submission is for a medical device (catheter introducer), not a diagnostic algorithm.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study, in the context of an algorithm's performance without human intervention, was not applicable and not performed or described. The device is a physical medical instrument, not a software algorithm.

7. Type of Ground Truth Used

Given the nature of the device (catheter introducer) and the type of submission (510(k) for substantial equivalence to predicate devices), the "ground truth" used for testing would most likely relate to engineering specifications, material properties, mechanical performance, and biocompatibility standards. It would not be clinical outcomes data, pathology, or expert consensus in the same way as for diagnostic devices. These would be assessed through bench testing and possibly animal studies (though not detailed here) comparing the device's physical and functional characteristics to established standards and predicate devices.

8. Sample Size for the Training Set

There is no mention of a "training set" in this 510(k) summary. The concept of a training set is relevant for machine learning algorithms, which are not described as part of this device. The testing described would be focused on verifying physical and functional equivalence, not training a model.

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

Since no training set is discussed, the method for establishing its ground truth is not applicable or mentioned.

In summary, the provided 510(k) summary for K061015 is a standard submission for a physical medical device (catheter introducer) seeking substantial equivalence to predicate devices. It relies on a comparison of design, materials, intended use, and general performance specifications to existing, legally marketed devices. It does not provide the detailed information (such as explicit acceptance criteria, sample sizes for test/training sets, expert involvement, or adjudication methods) that would typically be associated with performance studies for diagnostic algorithms or devices where clinical efficacy and human interpretation are key endpoints. The "study" mentioned is general "testing" to demonstrate substantial equivalence, rather than a detailed clinical trial or AI performance study.

Ask a specific question about this device