(16 days)
The Endologix AFX Introducer System is intended for use to facilitate the introduction of guidewires, catheters, and other medical devices into the vasculature and minimize blood loss associated with such introduction.
The Endologix AFX Introducer System, Model S17-45 consists of an Introducer Sheath (45cm working length), Dilator, and a peel-away wire straightener. The AFX Introducer System is a single-use sterile device that is compatible with a standard 0.035" guidewire.
This document describes a Special 510(k) submission for the Endologix AFX Introducer System, Model S17-45, which involves a minor modification to an already cleared device. Therefore, the information provided focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo clinical study with extensive acceptance criteria and performance metrics typically associated with novel devices or significant device changes.
1. Table of Acceptance Criteria and Reported Device Performance
| Evaluation | Applicable Test Standard(s) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Functional/Mechanical Qualification | BS EN ISO 10555-1:2009 | Device meets performance requirements for introducer catheters as per standard. | Demonstrated substantial equivalence to predicate device through successful completion of tests outlined in the standard. |
| EO Gas Sterilization Validation | ANSI/AAMI/ISO 11135-1: 2007 | Device is sterile after processing as per standard. | Sterilization process was validated and found compliant with the standard. |
| EO Gas Sterilization Validation | AAMI TIR 28: 2009 | Ensures proper ethylene oxide sterilization practices for healthcare products. | Sterilization process was validated and found compliant with the standard. |
| Biocompatibility Testing | ISO 10993-1: 2009 | Device materials are biocompatible and do not pose unacceptable biological risks. | Biocompatibility was demonstrated in accordance with the standard. |
| Overall Substantial Equivalence | N/A | Modified device performs as safely and effectively as the predicate device (K111747) for its intended use. | "The descriptive characteristics of the proposed device are sufficient to ensure equivalence to the predicate device... the evaluations listed... have been performed on the modified AFX Introducer System to support the determination of substantially equivalence." (FDA cleared the device, indicating this criterion was met). |
Explanation of Implied Acceptance Criteria: For a Special 510(k) submission involving a minor modification to an already cleared device, the "acceptance criteria" are primarily based on demonstrating that the modification does not negatively impact the safety and effectiveness of the device compared to the predicate. This is typically achieved by performing specific tests against recognized standards and ensuring the modified device continues to meet the performance characteristics established for the predicate. Specific numerical performance metrics are usually not presented as "acceptance criteria" in this context unless the modification specifically impacts a measurable performance claim.
Study Type: This is not a clinical study on patient outcomes or a comparative effectiveness study in the traditional sense. It's a bench testing and validation study designed to demonstrate that the changes (replacement of a butyl rubber valve with a silicone valve, modification of hemostasis valve housing, and addition of a peel-away wire straightener) to the AFX Introducer System maintain the device's substantial equivalence to its predicate device (K111747).
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample sizes used for each individual test (e.g., number of devices tested for functional or mechanical qualification). This is typical for such submissions as the focus is on confirming adherence to established standards rather than statistical clinical significance.
- Data Provenance: The data provenance is from bench testing conducted by Endologix, Inc. to assess various aspects of the modified device against recognized industry standards. The country of origin of the data is Endologix, Inc. (Irvine, CA, USA). The data is prospective in the sense that the tests were specifically performed after the device modification to validate its performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable in the context of this submission. "Ground truth" for bench testing is established by the specifications of the device and the requirements of the applicable test standards. The tests are designed to objectively measure specific characteristics.
- Qualifications of Experts: The testing would have been conducted by trained engineers and technicians at Endologix, Inc., with expertise in medical device testing and quality assurance, and familiarity with the relevant ISO and AAMI standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where expert consensus is needed to establish a "true" diagnosis or outcome for a patient. In bench testing, the results are objectively measured against pre-defined criteria from the standards. Any discrepancies would be handled through a formal investigation process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers (e.g., radiologists) perform with and without an AI assistant across multiple cases. The submission is for a physical medical device (introducer system) and does not involve AI or human interpretation of outputs that would warrant an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, a standalone (algorithm only) performance study was not done. This concept applies to AI/ML software devices. The Endologix AFX Introducer System is a physical medical device and does not inherently have an "algorithm-only" or "human-in-the-loop" component in this context.
7. The Type of Ground Truth Used
- Ground truth for bench testing: The "ground truth" for the tests performed (Functional/Mechanical Qualification, Sterilization Validation, Biocompatibility) is defined by the requirements and specifications within the referenced international consensus standards (BS EN ISO 10555-1:2009, ANSI/AAMI/ISO 11135-1: 2007, AAMI TIR 28: 2009, ISO 10993-1: 2009) and the design specifications of the Endologix AFX Introducer System. The tests were performed to demonstrate compliance with these objective standards.
8. The Sample Size for the Training Set
- Not applicable. This submission is for a physical medical device. The concept of a "training set" is relevant for AI/ML models.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for this 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).