(121 days)
The Sentrant Introducer Sheath with Hydrophilic Coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions.
The Sentrant Sheath is a single-use, disposable, hydrophilic-coated catheter designed to provide a flexible and hemostatic conduit for the insertion of endovascular devices and to minimize blood loss associated with vascular procedures. The system is comprised of a dilator and an introducer sheath. The system accommodates a 0.035 in (0.89 mm) guidewire and is available in 28 and 64 cm lengths and in sizes from 12 to 26 Fr in 2 French increments. The dilator is radiopaque and has a tapered, flexible tip that facilitates atraumatic tracking through the vasculature. A female luer taper fitting is located on the distal end of the dilator grip. The proximal end of the dilator grip is threaded to allow the dilator to be secured to the sheath seal housing. The introducer sheath is comprised of a hydrophilic, coil-reinforced catheter that is attached to a rigid seal housing containing the hemostatic valve assembly. A sideport extension with a 3way valve is attached to the seal housing. A radiopaque markerband is located at the distal tip of the sheath. The device also has a suture loop for attaching it to the patient and a strain relief to minimize kinking of the catheter where it joins to the seal housing.
This acceptance criteria and study information is for the Sentrant Introducer Sheath with Hydrophilic Coating (K123990).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the performance criteria as "predetermined acceptance criteria" which were all met. The specific quantitative values for these criteria are not detailed in the summary. However, the types of tests performed indicate the areas of performance evaluated.
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Physical Dimensions | OD of Sheath Tubing | All predetermined acceptance criteria were met and results passed. |
| OD of Dilator | All predetermined acceptance criteria were met and results passed. | |
| Sheath Working Length | All predetermined acceptance criteria were met and results passed. | |
| Dilator Working Length | All predetermined acceptance criteria were met and results passed. | |
| Hydrophilic Coating Length | All predetermined acceptance criteria were met and results passed. | |
| Functional / Mechanical Performance | Guidewire Acceptance | All predetermined acceptance criteria were met and results passed. |
| Grip to Dilator Tensile Strength | All predetermined acceptance criteria were met and results passed. | |
| Seal Housing to Sheath Tubing Tensile Test | All predetermined acceptance criteria were met and results passed. | |
| Seal Cap to Seal Housing Tensile Strength | All predetermined acceptance criteria were met and results passed. | |
| Atraumatic Tip (A-Tip) Lamination Tensile Strength | All predetermined acceptance criteria were met and results passed. | |
| Sideport Torque Test | All predetermined acceptance criteria were met and results passed. | |
| Leak Test | All predetermined acceptance criteria were met and results passed. | |
| Kink Test | All predetermined acceptance criteria were met and results passed. | |
| Test for Liquid Leakage Under Pressure | All predetermined acceptance criteria were met and results passed. | |
| Biocompatibility | ISO MEM Elution, Cytotoxicity | All predetermined acceptance criteria were met and results passed. |
| ISO Maximization Sensitization | All predetermined acceptance criteria were met and results passed. | |
| ISO Intracutaneous Reactivity | All predetermined acceptance criteria were met and results passed. | |
| ISO Acute Systemic Toxicity | All predetermined acceptance criteria were met and results passed. | |
| USP Material Mediated Pyrogen | All predetermined acceptance criteria were met and results passed. | |
| ASTM In-vitro Hemolysis | All predetermined acceptance criteria were met and results passed. | |
| Complement Activation C3a and SC5b-9 | All predetermined acceptance criteria were met and results passed. | |
| ASTM Partial Thromboplastin Time | All predetermined acceptance criteria were met and results passed. | |
| In-vivo Thromboresistance | All predetermined acceptance criteria were met and results passed. | |
| Inductively Coupled Plasma Spectroscopy | All predetermined acceptance criteria were met and results passed. |
Study Proving Device Meets Acceptance Criteria
The study described is a series of bench testing and biocompatibility testing.
The type of study: Bench Testing and Biocompatibility Testing. The purpose was to evaluate its performance and verify that it meets the required performance specifications, and to assess biological compatibility per ISO10993-1.
Outcome: "All of the predetermined acceptance criteria were met and results passed."
Additional Information:
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (N-numbers) for each individual bench test or biocompatibility test.
- Data Provenance: The tests were conducted by Medtronic Vascular, the device manufacturer. No information is provided regarding data country of origin, or if the data is retrospective or prospective, though bench testing is inherently prospective for device clearance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the study involves physical, mechanical, and biological testing of a medical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation (e.g., image analysis). The "ground truth" for these tests would be the established scientific and engineering principles, and the protocols defined by international standards (e.g., ISO, ASTM, USP).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable as the study does not involve subjective assessment or interpretation requiring adjudication by multiple readers/experts. The tests are objective measurements against predefined specifications.
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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:
- This is not applicable. This device is an introducer sheath, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. The device is a physical medical device, not an algorithm or software.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench testing, the "ground truth" is defined by the predetermined performance specifications and acceptance criteria that typically align with engineering standards, material science principles, and functional requirements for such devices.
- For biocompatibility testing, the "ground truth" is established by adherence to recognized international standards such as ISO 10993-1 and other specific standards (e.g., ASTM, USP) for evaluating biological responses to medical devices.
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The sample size for the training set:
- This is not applicable as the study does not involve an AI model or machine learning, and thus no "training set."
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How the ground truth for the training set was established:
- This is not applicable as there is no training set for this type of device evaluation.
§ 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).