(19 days)
The Wingman Extendable Tip Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
The Wingman Extendable Tip Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature. The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.
The provided text describes a 510(k) summary for the Wingman Extendable Tip Support Catheter, focusing on demonstrating substantial equivalence to a predicate device. It details the device's characteristics and the performance testing conducted.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists several tests conducted and states that the updated device "met all specified criteria." However, specific numerical acceptance criteria (e.g., minimum tensile strength value, maximum torque value, cytotoxicity limits, etc.) are not explicitly provided in this document. The table below represents the tests performed and the general performance statement provided.
| Test Performed | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Simulated Use | (Implied: Device functions as intended in a simulated clinical environment) | Met all specified criteria |
| Tensile Strength | (Implied: Withstands expected tensile forces) | Met all specified criteria |
| Torque | (Implied: Withstands expected torsional forces during use) | Met all specified criteria |
| Dimensional verification | (Implied: Conforms to design specifications) | Met all specified criteria; visual inspections performed |
| Visual inspections | (Implied: No visual defects that would impact safety or performance) | Met all specified criteria; visual inspections performed |
| Biocompatibility: Cytotoxicity | (Implied: Non-toxic to cells) | Met all specified criteria |
| Biocompatibility: Irritation | (Implied: Non-irritating to tissues) | Met all specified criteria |
| Biocompatibility: Sensitization | (Implied: Does not induce allergic reactions) | Met all specified criteria |
| Biocompatibility: Acute Systemic Toxicity | (Implied: Does not cause acute systemic harm) | Met all specified criteria |
| Biocompatibility: Materials Mediated Pyrogens | (Implied: Does not induce fever from material components) | Met all specified criteria |
| Biocompatibility: Hemocompatibility | (Implied: Compatible with blood, does not cause adverse blood reactions) | Met all specified criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for any of the tests conducted. The data provenance (country of origin, retrospective/prospective) is also not mentioned.
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 section is not applicable to the provided document. The tests performed are related to the physical and biological characteristics of a medical device (catheter), not to diagnostic image interpretation or expert-driven clinical assessment where ground truth would be established by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. The type of testing performed (simulated use, tensile strength, biocompatibility, etc.) does not involve adjudication by multiple experts in the sense of clinical decision-making.
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 section is not applicable. The document describes the technical and biological testing of a physical medical device (catheter), not an AI-powered diagnostic tool, and therefore no MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical catheter, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests described (e.g., tensile strength, torque, biocompatibility), the "ground truth" or reference values are typically established by recognized industry standards, internal design specifications, and regulatory requirements (e.g., ISO standards for medical devices, ASTM standards for material properties, or specific FDA guidance documents for biocompatibility). The document implies that these tests were conducted against such "specified criteria." It is not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
This section is not applicable. The device is a physical catheter, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
§ 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).