(265 days)
The L-Cath Single and Dual Lumen Catheters and the L-Cath Midline Catheters are indicated for short or long term peripheral access to the central venous system for the administrations, and nutrients; the sampling of blood; and monitoring blood pressure and temperature intravenously.
The L-Cath™ Single and Dual Lumen and L-Cath™ Midline Catheters are sterile, single use devices, sold as standalone devices which includes the following accessories:
• Trim Tool
• Tape measure
• Stylet (include in the final catheter assembly as applicable)
• Polyurethane catheter
These catheters are also sold as a component in a Basic Kit (catheter and introducer packaged together) which includes the following:
- BD Introsyte Autoguard Introducer or Splittable Introducer ●
- Stylet (include in the final catheter assembly as applicable)
- Trim Tool
- Tourniquet
- Tape measure
The provided text describes a 510(k) premarket notification for Argon Medical Devices' L-Cath™ Single and Dual Lumen Catheters and L-Cath™ Midline Catheters. This document focuses on demonstrating substantial equivalence to an existing predicate device (BD L-Cath™ Midline Catheter, BD Cath™ Single Lumen, BD Cath™ Dual Lumen Peripherally Inserted Central Catheters PICC, K091670), rather than proving the device meets clinical acceptance criteria based on studies involving AI or human readers.
Therefore, many of the requested criteria in your prompt (e.g., acceptance criteria for device performance in terms of AI metrics, sample sizes for test/training sets in an AI study, number of experts, adjudication methods, MRMC studies, standalone AI performance, ground truth establishment) are not applicable to this type of regulatory submission. This document details the engineering and biocompatibility aspects of the device to show it functions safely and effectively similarly to devices already on the market.
However, I can extract the relevant information from the provided text regarding the performance testing conducted to support the substantial equivalence claim.
Here's a breakdown of the requested information based on the provided text, highlighting what is applicable and what is not:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This submission is a 510(k) for substantial equivalence, not a clinical study proving performance against AI-related metrics. The "acceptance criteria" here refer to engineering, biocompatibility, and sterilization performance standards, demonstrating the modified device is as safe and effective as its predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The subject device met all the predetermined acceptance criteria derived from the above listed reference standards and internal test protocols and demonstrated substantially equivalent performance compared to the predicate device." While specific numerical acceptance criteria (e.g., "pressure burst must exceed X psi") are not explicitly detailed in a table, the document lists the types of performance tests conducted and confirms successful completion.
| Acceptance Criteria Category (Implied) | Performance Test Conducted (Reported) | Device Performance (Reported) |
|---|---|---|
| Mechanical/Physical Performance | Catheter – Joint Leak Test | Met acceptance criteria (Substantially equivalent to predicate) |
| Catheter – Dimensional | Met acceptance criteria (Substantially equivalent to predicate) | |
| Catheter – Pressure Burst | Met acceptance criteria (Substantially equivalent to predicate) | |
| Catheter – Durometer | Met acceptance criteria (Substantially equivalent to predicate) | |
| Catheter – Radiopacity | Met acceptance criteria (Substantially equivalent to predicate) | |
| Stylet – Retaining force | Met acceptance criteria (Substantially equivalent to predicate) | |
| Luer Functional Mechanical Bonds – Pull force | Met acceptance criteria (Substantially equivalent to predicate) | |
| Particulates | Met acceptance criteria (Substantially equivalent to predicate) | |
| Material Durability | Met acceptance criteria (Substantially equivalent to predicate) | |
| Supplemental Testing for Design Change (Luer Lock material change) | ||
| Luer Integrity (Functional) Report 2023-042-RPT | Met acceptance criteria | |
| ISO 80369-7 Compliance | Met acceptance criteria | |
| Luer Integrity (Functional); Functional Leak Test Report 2023-134-RPT | Met acceptance criteria | |
| Biocompatibility | Pyrogenicity (ISO 10993-11) | Met acceptance criteria (Substantially equivalent to predicate) |
| Cytotoxicity (ISO 10993-5) | Met acceptance criteria (Substantially equivalent to predicate) | |
| Hemocompatibility (ISO 10993-4) | Met acceptance criteria (Substantially equivalent to predicate) | |
| Irritation/Sensitization (ISO 10993-10) | Met acceptance criteria (Substantially equivalent to predicate) | |
| Systemic Toxicity (ISO 10993-11) | Met acceptance criteria (Substantially equivalent to predicate) | |
| Ethylene oxide Residuals (ISO 10993-7) | Met acceptance criteria (Substantially equivalent to predicate) | |
| Local effects after implantation (ISO 10993-7) | Met acceptance criteria (Substantially equivalent to predicate) | |
| Supplemental Testing for Material Change (Luer lock material) | ||
| Systemic Toxicity (10993-17) Report 2022-026-RPT | Met acceptance criteria | |
| Genotoxicity (10993-3) | Met acceptance criteria | |
| Sterilization | 100% EtO | Met acceptance criteria (SAL 10-6) |
| ISO 11135:2014 & AAMI TIR28:2016 compliance | Met acceptance criteria |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in terms of number of units tested for each criterion, but implied to be sufficient for demonstrating compliance with ISO standards and internal protocols.
- Data Provenance: The tests were conducted internally by Argon Medical Devices, as indicated by the company providing the summary. The regulatory context implies these are laboratory tests, not clinical data from patients. They are likely prospective bench and lab tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a medical device 510(k) submission based on engineering and biocompatibility testing, not an AI performance study requiring human expert ground truth for image or diagnostic interpretation. The "ground truth" here is established by validated test methods and reference standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
5. 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
- Not Applicable. This is not an AI-assisted diagnostic device. Clinical testing (human studies) was explicitly stated as "not required for the determination of substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering and Biocompatibility Test Standards: The "ground truth" for the device's performance is established by recognized international standards (e.g., ISO 10993 series for biocompatibility, ISO 80369-7 for luer connectors, ISO 11135 for sterilization) and internal validated test protocols designed to assess the device's physical properties and safety characteristics.
8. The sample size for the training set
- Not Applicable. This document describes a medical device, not an AI algorithm. There is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of the Study Proving Acceptance:
The study presented in this 510(k) summary is a series of bench testing, laboratory analyses (biocompatibility), and sterilization validations designed to demonstrate that the modified L-Cath™ catheters are substantially equivalent to the previously cleared predicate devices. The primary change was the material used in the Luer Lock assembly.
The "study" involved:
- Performance Testing: Assessing mechanical characteristics like leak integrity, dimensions, pressure burst, durometer, radiopacity, retaining force, pull force, particulates, and material durability. These tests were stated to be the "SAME as K091670" (the predicate's testing) with additional supplemental testing specific to the Luer Lock material change (Luer Integrity, ISO 80369-7 Compliance).
- Biological Comparison (Biocompatibility Testing): Evaluation of potential biological risks including pyrogenicity, cytotoxicity, hemocompatibility, irritation/sensitization, systemic toxicity, ethylene oxide residuals, and local effects after implantation. Supplemental testing (Systemic Toxicity, Genotoxicity) was performed due to the Luer Lock material change.
- Sterilization Validation: Confirmation that the device can be consistently sterilized to meet a sterility assurance level (SAL) of 10-6, in accordance with ISO 11135:2014 and AAMI TIR28:2016.
The conclusion is that the modified device "met all the predetermined acceptance criteria derived from the above listed reference standards and internal test protocols and demonstrated substantially equivalent performance compared to the predicate device." This means the tests confirmed the new device performs within acceptable limits, similar to the predicate, and does not raise new questions of safety or effectiveness.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”