(25 days)
The AirGuard™ Valved Introducer is indicated for use in the percutaneous insertion of catheters in the venous system.
AirGuard™ Valved Introducers have a PTFE sheath and are available in 15Fr and 16.5Fr sizes, and in lengths of 13cm and 18cm.
This document describes the 510(k) premarket notification for the AirGuard™ Valved Introducer (K042036). This is a traditional 510(k) for a medical device and therefore does not include a study related to Artificial Intelligence (AI) or machine learning. The requested information regarding acceptance criteria and study data would typically pertain to a clinical trial or performance study, which is not the primary focus of this type of regulatory submission concerning substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request, highlighting what is present and what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding reported device performance values in the way one might expect from a clinical trial or a detailed engineering performance report. Instead, it states:
| Criterion Type | Acceptance Statement |
|---|---|
| Biocompatibility | Met the requirements of ISO-10993 and FDA Modified ISO 10993 Test Profile. |
| Design Verification | Met all requirements of in-house protocols, applicable standards, and comparable to predicate device. |
| Substantial Equivalence | All test results confirm the subject device to be substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission references "in-house protocols" and "biological evaluation of medical devices Part 1: Evaluation and testing" for non-clinical performance data, but does not specify sample sizes or data provenance for these evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this 510(k) submission. This filing is for a medical device (catheter introducer), not an AI/ML algorithm that requires expert-established ground truth for image analysis or diagnosis. The "ground truth" for a device like this would be its physical and functional performance according to engineering specifications and biological safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this 510(k) submission as it does not involve expert adjudication of results. Testing would likely follow standard engineering and biological assessment methodologies.
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
This is not applicable. This submission is for a physical medical device (catheter introducer) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This submission is for a physical medical device and does not involve any algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be established through objective measurements and validated testing against industry standards and safety regulations. These include:
- AAMI/ANSI/ISO-10993-1: 1997, Biological evaluation of medical devices Part 1: Evaluation and testing: This standard defines the acceptable biological response of the device when in contact with the body. The "ground truth" here is meeting the established safety thresholds for biocompatibility.
- AAMI/ANSI/ISO 11135:1994, Medical devices – Validation and routine control of ethylene oxide sterilization: Establishes sterility assurance levels.
- ISO 11070:1998(E), Sterile single-use intravascular catheter introducers: Defines performance and safety requirements for catheter introducers.
- In-house protocols: These would cover functional performance characteristics like air/blood leakage reduction, peelability, and material integrity, with acceptance criteria defined by the manufacturer and validated through testing.
8. The sample size for the training set
This is not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. This is not an AI/ML device and does not have a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document states that "Design verification testing was conducted in conformance to in-house protocols, and performed or evaluated based on the following standards:"
- AAMI/ANSI/ISO-10993-1: 1997, Biological evaluation of medical devices Part 1: Evaluation . and testing, and the FDA Modified ISO 10993 Test Profile
- AAMI/ANSI/ISO 11135:1994, Medical devices – Validation and routine control of elhylene oxide sterilization
- ISO 11070:1998(E), Sterile single-use intravascular catheter introducers
The results from this testing are summarized as:
- "Results from biocompatibility testing met the requirements of ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and the FDA Modified ISO 10993 Test Profile for externally communicating, direct blood-contacting, limited-exposure devices."
- "All test results confirm the subject device to be substantially equivalent to the predicate device."
- "AirGuard Valved Introducers met all performance criteria of design verification as specified by applicable standards, test protocols and/or customer inputs."
The "study" in this context is a series of non-clinical, bench performance tests and evaluations against established industry standards and internal protocols to demonstrate the device's safety and effectiveness, and critically, its substantial equivalence to the predicate device (MedAmicus FlowGuard™Peelable Introducer, K040150). The primary acceptance criterion for a 510(k) is demonstrating this substantial equivalence.
§ 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).