(48 days)
The Percutaneous Introducer is intended to allow for the percutaneous placement of devices, needles or probes, in close proximity to nerves and around or into surgical wound or non-surgical wound sites. It may be used to inject or aspirate the introduction area via the luer hub of the needle/introducer.
The Percutaneous Introducer is a single-use, disposable device consisting of a flexible polymer sheath with a molded plastic hub. The device incorporates a stainless steel needle inside the flexible cannula and is removed after the introducer is placed. The inserted stainless steel introducer needle has a sharp distal point. The flexible cannula acts as a conduit for percutaneous introduction of medical devices, such as catheters, needles, or probes. A stylet or porous plug (to prevent aspiration during insertion) comes seated in the standard 6 degree luer fitting of the proximal end of the needle hub. The Percutaneous Introducers are used for a short period of time and are supplied sterile and non-pyrogenic. The Percutaneous Introducer is available in four lengths and a 14 gauge.
This document is a 510(k) summary for a "Percutaneous Introducer" device. It outlines the device description, intended use, technological characteristics, and non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with quantitative targets and corresponding "reported device performance" in the way a clinical study might. Instead, it describes various tests performed and states that the device "meets the requirements" or "performs comparably" or has "successful results."
The tests and their reported outcomes are:
| Acceptance Criteria (Implicit from tests) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Penetration Force Test | Performs comparably to predicate device (K102460) |
| Simulated Use Penetration/ Withdrawal/ Accordion/ Peelback Test | Performs comparably to predicate device (K102460); shown to verify resistance to collapsing and accordion/ peelback during tissue penetration. |
| Tensile Strength | Performs comparably to predicate device (K102460); proven to possess the ability to withstand a minimum acceptable tensile force. |
| Material Biocompatibility: | |
| ISO 10993 compliant biocompatibility | Meets necessary biocompatibility requirements as per FDA guidance. Materials used support Substantial Equivalence. |
| Cytotoxicity (ISO10993-5:2009) | Tested with successful results. |
| Sensitization (ISO10993-10:2010) | Tested with successful results. |
| Irritation/ Intracutaneous Reactivity (ISO10993-10:2010) | Tested with successful results. |
| EtO Residuals (I-CHM-2136 Rev. 0) | Tested with successful results. |
| Pyrogenicity (ISO10993-12:2017) | Tested with successful results. |
| Rabbit Blood Hemolysis (ISO10993-12:2017) | Tested with successful results. |
| Sterility & Packaging: | |
| Packaging- Sterility | Tested with successful results. |
| Burst Testing (ASTM F 1140) | Tested with successful results. |
| Dye Penetration (ASTM F 1929) | Tested with successful results. |
| Functional Standards: | |
| ISO 594-1 (Luer Fittings) | Tested with successful results. |
| ISO 594-2 (Luer Fittings) | Tested with successful results. |
| ISO 10555-5 (Sterile, single-use intravascular catheters - introducers and dilators) | Tested with successful results. |
The study concludes that based on these results, the Percutaneous Introducer "performs comparably to, and is substantially equivalent to predicate device (K102460)."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the non-clinical tests (e.g., number of introducers tested for tensile strength, burst testing, etc.).
The data provenance is from non-clinical bench and laboratory testing, not human or animal studies. The data would originate from the manufacturing and testing facilities of Epimed International, Inc. or their contracted labs. It is inherently prospective in the sense that the tests were conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This section is not applicable in the traditional sense of clinical or diagnostic device ground truth. The "ground truth" for non-clinical performance and biocompatibility tests is established by adherence to recognized international standards (e.g., ISO, ASTM) and FDA guidance documents. The "experts" would be the qualified personnel within the testing laboratories who perform the tests according to these standards, generate the data, and interpret the results to ensure compliance. Their specific number or qualifications are not detailed here, as the focus is on adherence to standardized testing protocols.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers for diagnostic image interpretation or similar subjective assessments. The tests described are objective, standardized laboratory and bench tests where results are determined by measurement against specified criteria in the standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission is for an interventional medical device (introducer) and focuses on its physical performance, material safety, and substantial equivalence, not diagnostic accuracy or human reader performance.
6. Standalone (Algorithm Only) Performance
No, a standalone (algorithm only) performance assessment was not done because the device is a physical medical instrument (a Percutaneous Introducer), not a software algorithm or AI-driven diagnostic tool. The concept of "algorithm only performance" does not apply to this type of device.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on established international standards and regulatory guidelines. For example:
- Mechanical properties: Defined by performance criteria within ASTM and ISO standards (e.g., specific force values, absence of collapse/peelback).
- Biocompatibility: Defined by the requirements and endpoints outlined in ISO 10993 series of standards (e.g., non-cytotoxic, non-sensitizing, non-irritating).
- Sterility and Packaging: Defined by standards like ASTM F1140, ASTM F1929, and general sterility assurance principles.
- Functional standards: Defined by the specific requirements of ISO 594-1, ISO 594-2, and ISO 10555-5.
Essentially, the "ground truth" is compliance with these widely accepted benchmarks for medical device safety and performance.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI or machine learning model. Therefore, there is no "training set" in the context of an algorithm. The development and testing process involves engineering design, material selection, and verification/validation testing, not data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).