(57 days)
The Introducer Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.
Do not use this device for neural placements.
The Introducer Sheath is intended for establishing a percutaneous access that facilitates the introduction of intravascular devices. The Introducer Sheath is composed of the Guiding Sheath and the Dilator. The Introducer Sheath is available in multiple effective lengths and curve shape configurations.
This document is an FDA 510(k) premarket notification letter for an "Introducer Sheath" device, which is a Class II medical device. The letter determines substantial equivalence to a legally marketed predicate device.
The provided document does NOT describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI-powered device or a study involving human readers. Instead, it details the non-clinical bench performance testing for a physical catheter introducer sheath.
Therefore, many of the requested information points, such as AI-specific acceptance criteria, human reader studies, or ground truth establishment for a training set, are not applicable to this document.
However, I can extract the information that is relevant to the physical device performance testing.
Here's an analysis of the provided information:
This document describes the regulatory approval of a physical medical device (an Introducer Sheath), not an AI/Software as a Medical Device (SaMD) or a study involving diagnostic image analysis.
As such, the information requested regarding AI acceptance criteria, human reader studies (MRMC), standalone algorithm performance, ground truth for AI, and training/test set sample sizes for AI is not present in this document. The document focuses on the mechanical, material, and sterility performance of a physical device.
Information relevant to the physical device's performance testing:
1. A table of acceptance criteria and the reported device performance
The document states: "Performance tests were conducted to ensure that the Introducer Sheath met the applicable design and performance requirements throughout its shelf life." and "The tests results indicate that the Introducer Sheath passed all the tests and it conforms to 150 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires."
Explicit Acceptance Criteria (implied by passing tests and conformity to standards):
| Performance Aspect | Acceptance Criteria (Implied by conformity to ISO 11070:2014 and passing "all tests") | Reported Device Performance |
|---|---|---|
| Physical Properties | ||
| Dilator Appearance | Conforms to visual inspection | Passed |
| Dilator Dimensional (OD/ID, working length) | Within specified tolerances | Passed |
| Dilator Luer compatibility | Compatible with Luer fittings | Passed |
| Dilator Guidewire compatibility | Compatible with guidewires | Passed |
| Dilator Tensile strength | Meets strength requirements | Passed |
| Sheath Appearance | Conforms to visual inspection | Passed |
| Sheath Dimensional (OD/ID, working length, curve geometry) | Within specified tolerances | Passed |
| Sheath Luer compatibility | Compatible with Luer fittings | Passed |
| Sheath Guidewire compatibility | Compatible with guidewires | Passed |
| Valve liquid/air leak test | No significant leakage | Passed |
| Sheath Tensile strength | Meets strength requirements | Passed |
| Sheath Torque strength | Meets torque requirements | Passed |
| Sheath Simulated use | Functions as intended in simulated environment | Passed |
| Sheath Kink resistance | Resists kinking | Passed |
| Particulate matter | Meets particulate matter limits | Passed |
| Radiopacity | Visible under fluoroscopy | Passed |
| Biocompatibility | ||
| Cytotoxicity | Non-toxic to cells (per ISO 10993-1) | Passed |
| Sensitization | Not a sensitizer (per ISO 10993-1) | Passed |
| Irritation | Non-irritating (per ISO 10993-1) | Passed |
| Acute Systemic & Pyrogenicity | No acute systemic toxicity and non-pyrogenic (per ISO 10993-1) | Passed |
| Hemocompatibility | Biocompatible with blood (per ISO 10993-1) | Passed |
| Sterilization | ||
| Sterility Assurance Level (SAL) | 10^-6 (per ISO 11135:2014 via overkill half-cycle) | Achieved |
| Residual EO/ECH | Do not exceed average daily dose of 4 mg (EO) / 9 mg (ECH) per ISO 10993-7:2008 (after 24h aeration) | Met |
| Shelf-Life | Maintained performance for 24 months | Confirmed for 24 months |
| Packaging & Transport | Integrity maintained | Passed |
| Labeling/Identification | Conforms to requirements | Passed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "Performance tests" and "tests results" but does not specify the sample sizes (e.g., number of units tested for each physical property) or the provenance (country of origin, retrospective/prospective) of the data. This is typically detailed in the full test reports that support the 510(k) submission, but not in the summary letter itself.
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)
Not applicable. This is for a physical device, not an AI diagnostic tool or an imaging study requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is for a physical device, not an AI diagnostic tool or an imaging study requiring expert adjudication.
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
No. This is for a physical device. Clinical studies (including MRMC) were explicitly not included: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical device, the "ground truth" is defined by established engineering and material science standards (e.g., ISO 11070:2014, ISO 10993 series for biocompatibility) and internal design specifications. There isn't "ground truth" in the diagnostic sense (like pathology for AI).
8. The sample size for the training set
Not applicable. This is for a physical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable. This is for a physical device, not an AI model.
§ 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).