(122 days)
The SureFlex™ Steerable Guiding Sheath Kit is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
The SureFlex™ Steerable Guiding Sheath Kit is a single-use device which is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The kit contains a steerable sheath, a dilator, and a guidewire. The steerable sheath is comprised of a stainless steel braided nylon tube with a soft, pebax distal tip. A platinum/iridium marker band is positioned near the distal tip to ensure precise tracking and placement of the sheath during procedures. The sheath is finished at the proximal end with a hemostasis valve and 2.distal side ports with a 3-way stopcock for the injection or aspiration of fluids. The steerable sheath comes in small, medium, and large curve options which can be deflected 90° counter-clockwise and 180° clockwise. The dilator is comprised of an HDPE tube with a tapered tip and has a male luer hub connector at the proximal end for connection to the sheath. The guidewire is stainless steel and coated with PTFE.
Here's a breakdown of the acceptance criteria and the study information for the SureFlex™ Steerable Guiding Sheath Kit, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes various tests performed to demonstrate the substantial equivalence of the SureFlex™ Steerable Guiding Sheath Kit to its predicate devices. The acceptance criteria are implied by the successful completion of these tests, indicating the device "meets the requirements" or "can withstand" certain stresses.
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | Meets requirements |
| Sensitization | Meets requirements | |
| Irritation or Intracutaneous Reactivity | Meets requirements | |
| Systemic Toxicity (Acute) | Meets requirements | |
| Hemocompatibility (including Hemolysis and Thrombosis) | Meets requirements | |
| Mechanical Testing | Torque Transmission and Strength of Union Torque Test | Can withstand without failure |
| Freedom from Liquid Leakage through Hemostasis Valves | Can withstand without failure | |
| Freedom from Air Leakage through Hemostasis Valve | Can withstand without failure | |
| Freedom from Liquid Leakage | Can withstand without failure | |
| Freedom from Air Leakage | Can withstand without failure | |
| Strength of Union Pull Test | Can withstand without failure | |
| Tip Transition | Can withstand without failure | |
| Snap Fit | Can withstand without failure | |
| Valve Insertion Force | Can withstand without failure | |
| Physical Testing | Surface Defects | Passed |
| Range of Motion + Geometry | Passed | |
| Curve Retention + Integrity Test | Passed | |
| Corrosion Resistance | Passed | |
| Friction Testing | Passed | |
| Handle Lubricity | Passed | |
| Tip Stiffness | Passed | |
| Bench Testing | Compatibility for use with 8.5F devices in a clinical setting | Determined to be compatible |
| Radiopacity and Particulate Testing | Radiopacity | Performed (implies successful demonstration) |
| Particulate | Performed (implies successful demonstration) |
Study Details
Based on the provided K122926 document, the "study" described is a series of performance tests to demonstrate substantial equivalence, rather than a clinical trial or a specific comparative effectiveness study with human readers.
Here's a breakdown of the requested information based on the document:
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for any of the individual tests. The document mentions "The SureFlex™ Steerable Guiding Sheath Kit" passing various tests, implying that representative samples of the device were tested.
- Data Provenance: Not specified. These are laboratory/bench tests, not clinical data from specific countries. The testing was conducted by Baylis Medical Company Inc., which is based in Mississauga, Ontario, Canada.
- Retrospective or Prospective: Not applicable as these are laboratory performance tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for these performance tests is based on established engineering and biocompatibility standards and specifications, not expert consensus on medical images or patient outcomes.
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Adjudication method for the test set:
- Not applicable. The results are based on objective measurements and compliance with predetermined specifications/standards for each test.
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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 document describes the pre-market submission for a physical medical device (guiding sheath kit) and its mechanical, physical, and biocompatibility properties, not an AI-powered diagnostic device. Therefore, questions regarding "human readers" or "AI assistance" are not relevant to this submission.
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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 is a physical medical device, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for these performance tests is based on engineering specifications, industry standards, and regulatory requirements for medical devices (e.g., biocompatibility standards, mechanical strength requirements, fluid leakage limits).
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI-driven device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).