(32 days)
The Onset Medical Access Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.
The Onset Access Catheter System is a two-catheter system comprised of a Sheath and a Dilator. The Sheath has a distal region which expands when the Dilator is advanced. The Onset Access Catheter System can be used with hydrophilic guidewires up to.038 inches in diameter to access the desired anatomy. The proximal ends of the Sheath and the Dilator have a luer fitting to allow attachment of accessories and infusion of liquids through the catheter. The catheter is offered in various sizes to accommodate physician preferences and patient anatomy. A split sheath is provided in the package to provide support and facilitate the introduction of the Sheath's distal expandable region into the catheter introducer sheath. The Catheter System is provided sterile, non-pyrogenic, and is intended for single use only.
The provided document describes the "Onset Access Catheter System," a medical device. However, it does not contain the specific information required to answer the questions about acceptance criteria for an AI/ML powered device, as this is a traditional medical device (a catheter). The document focuses on demonstrating substantial equivalence to a predicate device through biocompatibility, sterilization, and bench-top testing.
The questions you've asked are typically related to the validation of AI/ML-powered medical devices, which involve performance metrics like accuracy, sensitivity, and specificity, and studies to establish ground truth. This document describes a physical medical device and its general performance and safety.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance (for AI/ML metrics)
- Sample size used for the test set and the data provenance (for AI/ML models)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (for AI/ML models)
- Adjudication method (for AI/ML models)
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance (for AI/ML models)
- If a standalone study was done (for AI/ML models)
- The type of ground truth used (for AI/ML models)
- The sample size for the training set (for AI/ML models)
- How the ground truth for the training set was established (for AI/ML models)
What the document does provide in relation to "acceptance criteria" and "study":
The document details a series of bench-top (design verification) tests and biocompatibility tests to show that the Onset Access Catheter System meets established criteria for substantial equivalence to a predicate device.
Acceptance Criteria and Reported Device Performance (Bench Tests):
| Bench Tests | Acceptance Criteria / Result |
|---|---|
| Dimensional and Visual Inspection | Met established criteria |
| Guidewire Compatibility | Met established criteria |
| Torque Response | Met established criteria |
| Torque Strength | Met established criteria |
| System Deployment Cycle Test | Met established criteria |
| Kink Resistance | Met established criteria |
| Flexibility Test | Met established criteria |
| Tensile Strength | Met established criteria |
| Catheter Leak Test (Liquid Leakage) | Met established criteria |
| Catheter Leak Test (Air Leakage) | Met established criteria |
| Dynamic Pressure Test | Met established criteria |
| Static Burst Test | Met established criteria |
| Aspiration Test | Met established criteria |
| Hub Gauging | Met established criteria |
| Corrosion Resistance | Met established criteria |
| USP Particulate Test | Met established criteria |
| Navigation and Accessibility Capabilities in vitro | Met established criteria |
| In vivo Tests | |
| System Deliverability, Compatibility, Visibility and Aspiration Performance | Met established criteria |
| Acute histopathology of treated vessels | Met established criteria |
| Biocompatibility testing | Met established criteria |
Biocompatibility Testing:
| Test | Method | Result |
|---|---|---|
| Cytotoxicity | L929 MEM Elution Test | Passed |
| Sensitization | Kligman Maximization | Passed |
| Intracutaneous Reactivity (Irritation) | Intracutaneous Injection Test | Passed |
| Systemic Toxicity (Acute) | ISO Acute Systemic Injection Test | Passed |
| Haemocompatibility | Complement Activation | Passed |
| Hemolysis | Passed | |
| Inactivated Partial Thromboplastin Time Test | Passed | |
| In vivo thrombogenicity | Passed | |
| Pyrogenicity | USP Material Mediated Rabbit Pyrogen Test | Passed |
Study Information (for this traditional device):
- Sample sizes: Not explicitly detailed for each test (e.g., number of catheters tested for torque response), but the document states "All testing was performed on units which were twice sterilized."
- Data provenance: Not applicable in the context of clinical AI/ML data; these are laboratory and animal (in vivo) tests.
- Experts/Ground Truth/Adjudication: Not applicable in the context of clinical AI/ML data. The "ground truth" for these tests is defined by established engineering and biological standards.
- MRMC / Standalone / Training Set: Not applicable as this is not an AI/ML device.
In summary, the provided text describes the performance validation of a physical medical device through standard engineering and biocompatibility testing, not the performance validation of an AI/ML algorithm.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).