(37 days)
The Halo One™ Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One™ Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.
The Halo One™ Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One™ Thin-Walled Guiding Sheath consists of a thin-walled (1F wall thickness) sheath made from braided single-lumen tubing, fitted with a female luer hub at the proximal end and has a formed atraumatic distal tip. A supplied hemostasis valve, employing a crosscut silicone membrane and incorporating a side arm terminating in a 3-way stopcock, may be connected to the sheath luer hub. The sheath is supplied with a compatible vessel dilator that snaps securely into the hemostasis valve hub. The sheath has a strain relief feature located at the luer hub and a radiopaque platinum-iridium marker located close to the distal tip. The vessel dilator is compatible with a 0.035" (0.89 mm) guidewire. The longer sheath configurations are provided with a hydrophilic coating over the distal portion of the sheath to provide a lubricious surface to ease insertion. The short sheath configuration is marketed with an appropriately sized guide wire for initial insertion of the device.
This document describes the 510(k) summary for the Halo One™ Thin-Walled Guiding Sheath. However, it does not detail specific acceptance criteria or study results in a format that allows for direct extraction into the requested table. Instead, it lists various in vitro tests performed to demonstrate substantial equivalence to the predicate device.
Here's an analysis based on the provided text, addressing the points you requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists a series of performance tests but does not explicitly state quantitative acceptance criteria or corresponding reported performance values for each. It broadly states that the device "met all predetermined acceptance criteria" and that tests "demonstrate that the technological characteristics and performance criteria... are substantially equivalent."
| Acceptance Criteria (General Description) | Reported Device Performance (General Statement) |
|---|---|
| Visual Inspection (Outer Surface) | Met predetermined acceptance criteria. |
| Simulated Use (Packaging Removal, Haemostasis Valve Connection, Sheath Inner Surface/Dilator Compatibility, Dilator Flushability, Valve Flushability, Sheath Flushability, Guidewire Compatibility, Dilator Disengagement by Hand, Tape Adhesion) | Met predetermined acceptance criteria. |
| Dimensional Testing (Sheath ID, Sheath Length, Marker Band to Tip Position, Sheath OD, Dilator OD, Dilator Extension Length) | Met predetermined acceptance criteria. |
| Radiopacity | Met predetermined acceptance criteria. |
| Penetration Force of Dilator/Sheath | Met predetermined acceptance criteria. |
| Trackability of Dilator and Sheath | Met predetermined acceptance criteria. |
| Visual Inspection (Tip Rollback-Dilator & Sheath) | Met predetermined acceptance criteria. |
| Bend Radius/Kink | Met predetermined acceptance criteria. |
| Valve Leak | Met predetermined acceptance criteria. |
| Sheath Leak | Met predetermined acceptance criteria. |
| Sheath and Dilator Tensile Forces | Met predetermined acceptance criteria. |
| Hub Torque/Stress Cracking | Met predetermined acceptance criteria. |
| Hub Stress Cracking (48 Hour Test) | Met predetermined acceptance criteria. |
| Mini Guidewire Compatibility | Met predetermined acceptance criteria. |
| Packaging (Visual Inspection, Dye Penetration, Visual Inspection of Sterile Barrier Packaging Heat Seals, Seal Strength Tensile Method) | Met predetermined acceptance criteria. |
| Cytotoxicity (ISO 10993-1) | Met predetermined acceptance criteria. |
| Sensitization (ISO 10993-1) | Met predetermined acceptance criteria. |
| Intracutaneous Reactivity (ISO 10993-1) | Met predetermined acceptance criteria. |
| Acute Systemic Toxicity (ISO 10993-1) | Met predetermined acceptance criteria. |
| Hemocompatibility (ISO 10993-1) | Met predetermined acceptance criteria. |
| Material Mediated Pyrogenicity (ISO 10993-1) | Met predetermined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for any of the individual tests. It also does not provide details on data provenance (e.g., country of origin, retrospective/prospective). The tests listed are "in vitro tests," suggesting they were conducted in a lab setting, not with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The tests described are primarily physical, chemical, and mechanical performance tests, along with biocompatibility assessments, not clinical evaluations requiring expert ground truth for interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set:
Not applicable, as this refers to adjudication of interpretations or diagnoses, which is not relevant for the types of in vitro tests performed for this device's 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The document describes a 510(k) submission, which focuses on demonstrating substantial equivalence through non-clinical performance data and biocompatibility, not clinical efficacy or comparative effectiveness against human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
Not applicable. This device is a medical instrument (a guiding sheath), not an AI algorithm.
7. Type of Ground Truth Used:
For the in vitro performance tests, the "ground truth" would be established by the specifications of the device, relevant industry standards, and regulatory guidance documents (e.g., ISO, ASTM, FDA guidance). For biocompatibility, the ground truth is adherence to the requirements of ISO 10993-1.
8. Sample Size for the Training Set:
Not applicable, as this device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as above.
§ 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).