(275 days)
The Catheter Introducer Sheath is indicated for use in patients requiring access of the venous system or to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). It is intended to be used for ≤ 72 hours.
Edwards Lifesciences' Catheter Introducer Sheath is an 11 Fr. sterile, non-pyrogenic, single-use introducer made of flexible and non-flexible polymeric materials. It consists of a single lumen shaft and a hemostasis valve with a side-arm extension tube with a female luer and clamp.
The provided text describes a 510(k) premarket notification for a Catheter Introducer Sheath and does not contain information about studies proving the device meets specific acceptance criteria in the manner of a clinical trial or AI/ML performance evaluation. The document focuses on demonstrating substantial equivalence to a predicate device through functional and safety testing.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for each test performed, nor does it provide specific numerical results of device performance. Instead, it concludes: "The functional data indicate that the Catheter Introducer Sheath performs in a substantially equivalent manner when compared to the predicate device." and "All data met acceptance criteria." This implies that for each test listed below, there were pre-defined acceptance criteria, and the device successfully met them.
| Test Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility & Sterility | Cytotoxicity | Met Biocompatibility Standards | Met Acceptance Criteria |
| Sensitization | Met Biocompatibility Standards | Met Acceptance Criteria | |
| Irritation/Intracutaneous toxicity | Met Biocompatibility Standards | Met Acceptance Criteria | |
| Systemic toxicity | Met Biocompatibility Standards | Met Acceptance Criteria | |
| Genotoxicity | Met Biocompatibility Standards | Met Acceptance Criteria | |
| Haemocompatibility | Met Biocompatibility Standards | Met Acceptance Criteria | |
| Muscular toxicity | Met Biocompatibility Standards | Met Acceptance Criteria | |
| Subacute/Subchronic toxicity | Met Biocompatibility Standards | Met Acceptance Criteria | |
| In Vivo thrombogenicity | Met Biocompatibility Standards | Met Acceptance Criteria | |
| Performance / Shelf Life | Leak Testing (Valve Leak after 72-hour insertion of 7 Fr device, Assembly leak, Valve leak after 6-hour insertion of 9 Fr device, Valve leak after 6-hour insertion of 7 Fr device, Valve leak with no insertion conditioning, Valve leak after multiple insertions, Forward valve leak) | Met Leakage Standards | Met Acceptance Criteria |
| Tensile Testing | Introducer joint tensile | Met Tensile Strength Standards | Met Acceptance Criteria |
| Sideport luer tensile | Met Tensile Strength Standards | Met Acceptance Criteria | |
| Sideport tubing to body | Met Tensile Strength Standards | Met Acceptance Criteria | |
| Compatibility & Additional Testing | 9 Fr balloon catheter insertion force | Met Catheter Insertion Force Standards | Met Acceptance Criteria |
| 9 Fr balloon catheter retraction force | Met Catheter Retraction Force Standards | Met Acceptance Criteria | |
| Dilator insertion force | Met Dilator Insertion Force Standards | Met Acceptance Criteria | |
| Contamination guard connection | Met Connection Integrity Standards | Met Acceptance Criteria | |
| Introducer sheath and dilator transition | Met Transition Smoothness Standards | Met Acceptance Criteria | |
| Valve retention force | Met Valve Retention Standards | Met Acceptance Criteria | |
| Sideport infusion with empty introducer | Met Infusion Performance Standards | Met Acceptance Criteria | |
| Sideport infusion post clamping | Met Infusion Performance Standards | Met Acceptance Criteria | |
| Sideport infusion with 10 Fr device | Met Infusion Performance Standards | Met Acceptance Criteria | |
| Fluoroscopic visibility | Met Visibility Standards | Met Acceptance Criteria | |
| Kink testing | Met Kink Resistance Standards | Met Acceptance Criteria | |
| Packaging Testing | All Packaging Tests | Met Packaging Integrity Standards | Met Acceptance Criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the functional or safety tests. It also does not mention any test sets in the context of clinical data, or the provenance (country of origin, retrospective/prospective) of any data beyond the physical device testing. The "tests" described are laboratory-based, not patient-based clinical trials.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable to the provided document. The "ground truth" here is established by engineering and material standards, and the results of laboratory tests are presumably interpreted by qualified engineers and scientists involved in the testing and regulatory submission, not by medical experts establishing diagnostic ground truth.
4. Adjudication Method
Not applicable. The tests performed are laboratory-based and would involve measurements against established standards, not interpretation by multiple human readers requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a 510(k) submission for a physical medical device (catheter introducer sheath), not an AI/ML-driven diagnostic or assistive technology. Therefore, no MRMC study, human reader improvement effect size, or human-in-the-loop performance is relevant or discussed.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This submission is for a physical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the tests described is based on established engineering standards for medical device performance, material science specifications, biocompatibility guidelines (e.g., ISO standards), and internal performance specifications derived from the predicate device characteristics. For example, "Valve leak" would have a maximum allowable leakage rate, which is the ground truth for that test.
8. Sample Size for the Training Set
Not applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned.
§ 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).