(260 days)
The transGlideXT Expandable Introducer is intended to be inserted into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and/or devices introduced into the femoral iliac arteries.
The transGlideXT Expandable Introducer (also referred to as "transGlideXT") is the next generation expandable Mesh Introducer consisting of a polymer braid which expands to accommodate catheters and/or devices with profiles up to 22F. The Mesh Introducer, with an indwelling Dilator (also referred to as "Mesh Assembly"), is inserted into the femoral artery, over a 0.035" guidewire (or smaller). The device is introduced at a small diameter of 12F inner diameter (ID) and is designed with a hydrophilic coating on the outer diameter (OD) and ID along the 30 cm usable length, thus facilitating passage through the femoral artery and passage of the commercial catheter and/or device. The proximal 11 cm of the Mesh usable length is sealed to prevent blood loss at the access site. Once at the target location, the Dilator is removed and the Mesh Introducer provides a bearing surface for the commercial catheter and/ or device, which is designed to reduce the axial forces applied to the artery wall while the commercial catheter and/or device is being inserted.
The transGlideXT Expandable Introducer is a sterile, non-pyrogenic, single-use prescription device. The transGlideXT Expandable Introducer does not supply but recommends use with commercially available 0.035" (or smaller) Guidewires.
The TransAortic Medical, Inc. transGlideXT Expandable Introducer (K181817) aims to establish substantial equivalence to its predicate device, the transGlide Expandable Introducer (K152194). The device is intended to be inserted into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and/or devices introduced into the femoral iliac arteries.
Here's an analysis of the acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical acceptance criteria and performance data in a direct table format. However, it outlines various performance tests conducted and states that the results confirmed safety and functionality comparable to the predicate.
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (MEM Elution), Sensitization (Magusson-Kligman), Irritation (Intracutaneous Toxicity), Systemic Toxicity (Systemic Injection), Hemocompatibility (Thrombogenicity, Complement Activation, Partial Thromboplastin Time, Hemolysis), Pyrogenicity (Material Mediated Pyrogen, Bacterial Endotoxins-LAL) | All biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, pyrogenicity) were performed. The implicit acceptance criterion is that the device demonstrates biocompatibility comparable to or better than the predicate device. The results are not explicitly stated, but the conclusion of substantial equivalence implies these criteria were met. |
| Bench Testing | Visual Inspection and Dimensional Verification | Performed. Implied compliance with design specifications. |
| Flush Testing | Performed. Implied proper fluid dynamics. | |
| Simulated Use (Advancement, Dilator Removal, Retraction & Inspection) | Performed. Implied successful device operation during simulated clinical scenarios. | |
| Leak Testing (BS EN ISO 11070:2014) | Performed. Implied structural integrity and prevention of leakage. | |
| Bend/Kink Resistance Testing | Performed. Implied resistance to kinking during use. | |
| Radiopacity Testing | Performed. Implied visibility under fluoroscopy. | |
| Interventional Device Advancement and Removal | Performed. Implied compatibility with other interventional devices. | |
| Hydrophilic Coating Lubricity | Performed. Implied smooth advancement through vessels. | |
| Hydrophilic Coating Durability | Performed. Implied coating integrity over time. | |
| Hydrophilic Coating Particulate Characterization | Performed. Implied minimal particulate shedding. | |
| Hub to Sheath Rotation | Performed. Implied proper rotational functionality of components. | |
| Tensile Tests (BS EN ISO 11070:2014) | Performed. Implied mechanical strength. | |
| Corrosion Testing (BS EN ISO 11070:2014) | Performed. Implied resistance to degradation in biological environment. | |
| Packaging Validation (BS EN ISO 11607-:2009 + A1:2014) | Performed. Implied maintenance of sterility and integrity during storage and transport. | |
| Sterilization Validation (ANSI/AAMI/ISO 11135:2014, ANSI/AAMI/ISO 10993-7:2008/(R) 2012) | Performed. Implied effective sterilization to a specified sterility assurance level (SAL). | |
| Shelf Life | Performed. Implied maintenance of device properties over its specified shelf life. | |
| Animal Studies | In vivo chronic and acute studies in ovine model | Safety Acceptance Criteria: Met based on pathology and histopathology results. Performance Observations: Functional and safe for intended use, comparable to predicate. The specific numerical acceptance criteria for these studies are not detailed but are stated as "consistent with the animal testing performed and submitted for the predicate (K152194)." |
2. Sample Sizes and Data Provenance:
- Test Set (Animal Studies): The document states "A series of in vivo evaluations were performed." The exact number of animals in the ovine model is not specified, but it implies multiple animals were used for both acute and chronic studies.
- Data Provenance: Prospective animal study conducted in an ovine (sheep) model. The country of origin is not explicitly stated.
3. Number of Experts and their Qualifications for Ground Truth - Test Set:
- The document mentions "pathology and histopathology results" were used for safety acceptance criteria in the animal study. This implies that veterinary pathologists were involved in establishing the ground truth.
- The exact number and specific qualifications (e.g., years of experience) of these experts are not provided.
4. Adjudication Method for the Test Set:
- The document does not specify an adjudication method for the animal study (e.g., use of multiple independent evaluators with a specific tie-breaking rule). It simply states that pathology and histopathology results were used to determine if safety criteria were met. This suggests a standard pathology review process rather than a complex adjudication method for comparing interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is typically used for diagnostic imaging devices to evaluate human reader performance with and without AI assistance. The transGlideXT is an introducer device, and its evaluation focuses on physical performance, biocompatibility, and procedural safety/effectiveness rather than diagnostic accuracy.
- Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.
6. Standalone Performance Study:
- Yes, the performance testing described (biocompatibility, bench testing, and animal studies) represents a standalone evaluation of the device's performance. The device's functionality, safety, and performance characteristics were assessed independently, comparing them against established standards and the predicate device, rather than only in conjunction with human-in-the-loop performance.
7. Type of Ground Truth Used:
- For the animal studies, the ground truth was established through pathology and histopathology results. This involves microscopic examination of tissues to identify and characterize any device-related adverse effects or tissue reactions.
- For bench testing, the ground truth is based on engineering specifications and established test standards (e.g., BS EN ISO 11070:2014, ANSI/AAMI/ISO 11135:2014).
8. Sample Size for the Training Set:
- This information is not applicable to the type of device and study described. The transGlideXT Expandable Introducer is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of machine learning. The studies described are physical performance validations.
9. How Ground Truth for the Training Set Was Established:
- This information is not applicable as there is no training set for an AI/machine learning algorithm.
§ 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).