(29 days)
The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
The AXERA is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.
Here's a breakdown of the acceptance criteria and the study information for the AXERA Access System, based on the provided text:
Important Note: The provided document is a 510(k) summary for a modification to an existing device (AXERA Access System, K113110). Therefore, the data presented focuses on demonstrating that the modified device still meets the safety and effectiveness criteria, often using bench testing. Clinical data for the original device serves as a foundation for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Device functionality | Met all performance testing acceptance criteria. |
| Deployment forces (heel, needle, plunger) | Met all performance testing acceptance criteria. | |
| Release forces (heel) | Met all performance testing acceptance criteria. | |
| Flex conditioning (latchwire) | Met all performance testing acceptance criteria. | |
| Resistance of latchwire to damage by flexing | Met all performance testing acceptance criteria. | |
| Tensile strength of multiple joints (latchwire, anchor, heel, plunger, needle) | Met all performance testing acceptance criteria. | |
| Compressive strength (handle/anchor) | Met all performance testing acceptance criteria. | |
| Torque loading (handle/anchor) | Met all performance testing acceptance criteria. | |
| Material/Environmental | Corrosion resistance testing | Met all performance testing acceptance criteria. |
| (Previously Performed) | Tensile testing of multiple joints (plunger, plunger tube) | (Implicitly met as part of original device approval) |
| Compressive strength testing (plunger lockout) | (Implicitly met as part of original device approval) | |
| Biocompatibility testing | (Implicitly met as part of original device approval) | |
| Clinical Performance | Short term safety and clinical performance | Established (for original device, and carried over to modified device). |
| Long term safety, ability to access and re-access | Retrospectively studied in a smaller cohort of patients (for original dev). |
Study Details Proving Device Meets Acceptance Criteria
The provided document describes a "Special 510(k): Device Modification", meaning the primary focus is on demonstrating that changes to an already cleared device do not introduce new safety or effectiveness concerns. The "study" for this modification primarily consisted of bench testing.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for each individual bench test. The text mentions "test units" without specifying the number per test.
- Data Provenance: The bench tests were performed by Arstasis, Inc. (the manufacturer) as part of their device modification review process. The studies were conducted after sterilization of test units. No information on country of origin for the data is provided, but it would presumably be from the manufacturer's testing facilities. The studies for the modification are prospective in nature (tests performed on modified devices).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable for the bench testing described in this document. Bench tests rely on engineering specifications and measurement devices, not human expert interpretation for ground truth.
- For the clinical investigations mentioned (likely for the original device), details about experts are not provided in this summary.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- This question is not applicable for the bench testing described. Adjudication methods are typically used in clinical studies or image-based evaluations involving human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
- No, an MRMC comparative effectiveness study was not done. The AXERA Access System is a medical device (catheter introducer), not an AI-assisted diagnostic tool, so this type of study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The AXERA Access System is a physical medical device, not an algorithm. Bench testing evaluates the physical device's performance against predefined engineering criteria, which is a standalone evaluation of the device itself.
7. The Type of Ground Truth Used:
- For the bench testing of the modified device: Engineering specifications and predefined acceptance criteria based on the device's intended function and safety requirements.
- For the prior clinical investigations (mentioned for the original device): The text refers to "short term safety and clinical performance" and "long term safety, as well as the ability to access and re-access." Without further detail, this would likely involve clinical outcomes data (e.g., successful access, hemostasis, complication rates) assessed by clinical professionals.
8. The Sample Size for the Training Set:
- This question is not applicable. The AXERA Access System is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- This question is not applicable. (See point 8.)
§ 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).