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For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal puncture.

The modified HeartSpan™ Fixed Curve Braided Transseptal Sheath consists of a dilator, guidewire, and fixed curve sheath, which are designed for catheter introduction into the cardiac anatomy. The device is provided sterile (ethylene oxide) and intended for single use only. It is for use in hospitals or healthcare facilities. The fixed curve introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side-port with threeway stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer is available in lengths ranging from 60 to 101.5 cm and curve configurations from 15° to 150° to address various anatomical features. The fixed curve introducer also includes distal perfusion holes to facilitate aspiration and minimize cavitation, a radiopaque tip marker to improve fluoroscopic visualization, an atraumatic soft tip, and a lubricious coating on the inner and outer surfaces. The dilator is designed to conform to the inner diameter of the sheath, and has a tapered tip. The materials of construction are primarily polymers with the exception of stainless steel braid reinforcement wires in the introducer shaft that are completely encapsulated in the sheath wall and do not contact the patient or bodily fluids.

The HeartSpan™ Fixed Curve Braided Transseptal Sheath is being submitted for 510(k) clearance. The following information provides details on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance testing conducted to verify product specifications and user requirements. While specific quantifiable acceptance criteria values are not explicitly stated in a table format with corresponding reported values, the text indicates that the device "meets the predetermined acceptance criteria applicable to safety and efficacy of the device."

Here's a summary of the performance tests performed, which inherently imply acceptance criteria related to these characteristics:

The document states, "The results of the testing demonstrated that the modified HeartSpan™ Fixed Curve Braided Transseptal Sheath meets the predetermined acceptance criteria applicable to safety and efficacy of the device." This general statement implies that for all the listed performance tests, the device performed within acceptable limits defined prior to testing.

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

The document does not specify the sample size used for the performance tests (e.g., number of devices tested for inner diameter, integrity, etc.).

The data provenance is from bench testing ("Performance Testing (Verification) listed below"). The document does not indicate the country of origin of the data explicitly, but as the submission is to the US FDA by a US-based company, it can be inferred to be domestically conducted. The tests are prospective in nature, as they involve testing the modified device against defined criteria.

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

This information is not applicable as the described tests are primarily device performance characteristic tests (bench testing) and biocompatibility/sterilization validations, not studies involving human interpretation or expert evaluation of clinical data. Therefore, no "ground truth" established by experts in the context of clinical outcomes or diagnostic accuracy is mentioned for these specific tests.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. The tests are direct measurements or standardized procedures against predetermined criteria.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or reported in this document. The submission focuses on technical characteristics, performance testing, and biocompatibility of the device itself, rather than evaluating its clinical effectiveness or impact on human reader performance.

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

This question is not applicable as the device is a physical medical instrument (transseptal sheath), not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to assess.

7. The Type of Ground Truth Used:

For the performance tests, the "ground truth" (or reference standard) is implicitly derived from predetermined product specifications, user requirements, and the requirements of the referenced international standards (e.g., ISO 11070:1998 for catheter introducers). For biocompatibility, the ground truth is established by the specified ISO 10993 series standards, and for sterilization, by ANSI/AAMI/ISO 11135-1. These standards define the acceptable limits and methodologies for demonstrating safety and performance.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical medical instrument and does not involve AI or machine learning models that require a "training set."

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

This information is not applicable as the device is a physical medical instrument and does not involve AI or machine learning models that require a "training set" with ground truth.

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