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510(k) Data Aggregation
(28 days)
Phenom Catheters
Phenom™ Catheters are intended for the introduction of interventional devices or diagnostic agents into the neuro, peripheral, and coronary vasculatures.
The Phenom™ Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to enhance navigation in the vessel. The Phenom™ 17, 21, and 27 Catheters have a hydrophilic coating that spans the distal 100cm. The Phenom™ Plus Catheters have a hydrophilic coating that spans the distal 90cm. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy. The Phenom™ Catheter is packaged with a shaping mandrel and may be accompanied with a split introducer sheath.
The provided text describes the regulatory clearance for the "Phenom Catheters" and includes performance data from bench testing. However, it does not describe any study involving AI, human readers, or the establishment of ground truth for such a study. Therefore, I cannot fulfill your request for information related to AI or human-in-the-loop performance.
The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing. There is no mention of acceptance criteria or performance metrics in the context of an AI-based device, a multi-reader multi-case (MRMC) study, or standalone algorithm performance.
Here's a breakdown of the information that is present in the document, framed against your request:
1. A table of acceptance criteria and the reported device performance
The document provides a table of "Tests" with "Test Method Summary" and "Results." The "Results" column implicitly indicates that the acceptance criteria were met for each test, as it states "The Phenom™ Catheters met the acceptance criteria for..." or "acceptable friction force," "compatible for use," etc.
| Test | Acceptance Criteria (Implied by Result) | Reported Device Performance |
|---|---|---|
| Compatibility – Guide Catheter | Compatible with guide catheters in a simulated tortuous path model. | The Phenom™ Catheters are compatible for use with a guide catheter. |
| Compatibility – Guide Wire | Compatible with guide wires in a simulated tortuous path model. | The Phenom™ Catheters are compatible for use with a guide wire. |
| Compatibility – RHV | Compatible with a standard RHV. | The Phenom™ Catheters are compatible with the standard used RHV. |
| Coating Lubricity (Friction Force) | Exhibit acceptable friction force under simulated clinical conditions. | The Phenom™ Catheters exhibit acceptable friction force under simulated clinical conditions. |
| Hub Functional & Dimensional | Met the acceptance criteria for hub functional & dimensional requirements (per ISO 80369-7:2016 and ISO 80369-20: 2015). | The Phenom™ Catheters met the acceptance criteria for hub functional & dimensional requirements. |
| Torque Strength | Exhibit acceptable torsional strength integrity. | The Phenom™ Catheters exhibit acceptable torsional strength integrity. |
| Tensile | Met the acceptance criteria for tensile strength (per ISO 10555-1:2013, Annex B). | The Phenom™ Catheters met the acceptance criteria for tensile strength. |
| Air Aspiration | Met the acceptance criteria for air aspiration (per ISO 10555-1:2013). | The Phenom™ Catheters met the acceptance criteria for air aspiration. |
| Liquid Leak | Met the acceptance criteria for liquid leak (per ISO 10555-1:2013). | The Phenom™ Catheters met the acceptance criteria for liquid leak. |
| Particulate | Met the acceptance criteria for particulate (per USP ). | The Phenom™ Catheters met the acceptance criteria for particulate. |
| Design Validation | Met user needs and intended use(s) (per ANSI/AAMI HE75:2009/(R) 2018). | The Phenom™ Catheters met the user needs and intended use(s) for which it was designed and tested. |
| Biocompatibility Tests | ||
| Cytotoxicity – MEM Elution | Exhibited slight reactivity (Grade 1). | Non-cytotoxic |
| Sensitization – Guinea Pig Maximization | Exhibited no dermal reactions (Grade 0). | Non-sensitizer |
| Irritation – Intracutaneous Study in Rabbits | Exhibited no dermal reactions (Score 0.0). | Non-irritant |
| Acute Systemic Toxicity – Systemic Toxicity Study in Mice | Exhibited no mortality or evidence of systemic toxicity. | Non-toxic |
| Material Mediated Pyrogenicity – USP Rabbit Pyrogen Study | Exhibited no temperature rise above 0.5°C. | Non-pyrogenic |
| Hemocompatibility – Platelet and Leukocyte Counts | Platelet and leukocyte counts within average normalized and control values. | Non-activator |
| Hemocompatibility – Partial Thromboplastin Time | Clotting time within control values. | Non-activator |
| Hemocompatibility – Hemolysis Direct Contact and Extract Methods | No hemolysis and within control values. | Non-hemolytic |
| Hemocompatibility – Complement Activation | Complement activation within control values. | Non-activator |
Regarding the other points of your request, the document does not provide this information because it's for a medical device (catheter) and not an AI-based system:
- 2. Sample size used for the test set and the data provenance: Not applicable. The testing described is bench testing of physical devices, not a test set of data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for data interpretation is not relevant for this type of device submission.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is not an AI system.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the catheter is its ability to perform according to engineering specifications and biocompatibility standards.
- 8. The sample size for the training set: Not applicable. This is not an AI model requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the regulatory clearance of a physical medical device (catheter) based on non-clinical performance and biocompatibility testing, not an AI software/device.
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