(197 days)
The RetroFlex 3™ Introducer Sheath Set is intended for entry of interventional devices into the vascular system.
The RetroFlex 3 Introducer Sheath Set is a hydrophilic delivery system used over a compatible 0.035" guidewire for the percutaneous introduction of intravascular devices. The RetroFlex 3 houses three (3) valves (a duckbill valve, a cross-slit valve, and a disc valve) to achieve hemostasis and is fitted with a three-way stopcock to allow infusion or aspiration of fluid. Each RetroFlex 3 Introducer Sheath Set contains a sheath, an introducer (or dilator), and a loader. The loader enables a device to enter into the sheath by bypassing all of the three valves within the sheath. The loader also contains a disc valve for hemostasis. The loader allows for larger devices to enter into the vascular system. The RetroFlex 3 Introducer Sheath is for one-time use only, sold and packaged sterile.
Here's a breakdown of the acceptance criteria and study information for the RetroFlex 3™ Introducer Sheath Set, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|---|
| Physical Characteristics | Visual examination | To meet design specifications and visual quality standards. | Performed; results implied to meet criteria for substantial equivalence. |
| Dimensional verification | To meet specified sheath O.D. and I.D. as per Table 7.2. | Performed; results implied to meet criteria for substantial equivalence. | |
| Tensile strength | To withstand specified tensile forces without failure. | Performed; results implied to meet criteria for substantial equivalence. | |
| Guidewire compatibility | To allow smooth passage of a compatible 0.035" guidewire. | Performed; results implied to meet criteria for substantial equivalence. | |
| Hydrophilic coating test | To demonstrate effective and durable hydrophilic properties. | Performed; results implied to meet criteria for substantial equivalence. | |
| Sterility & Packaging | Packaging Integrity | To maintain sterility and prevent damage during storage and handling. | Performed; results implied to meet criteria for substantial equivalence. |
| Sterilization Validation | To ensure device is sterile upon packaging and remains so until use. | Performed; results implied to meet criteria for substantial equivalence. | |
| Biocompatibility | Medium Eluate Method (MEM) | No cytotoxic effects. | Performed; results implied to meet criteria for substantial equivalence. |
| Agar Overlay Method (AO) | No cytotoxic effects. | Performed; results implied to meet criteria for substantial equivalence. | |
| Blood Compatibility Test Method | No adverse blood interactions (e.g., hemolysis, coagulation). | Performed; results implied to meet criteria for substantial equivalence. | |
| Mouse Systemic Injection | No systemic toxicity. | Performed; results implied to meet criteria for substantial equivalence. | |
| Rabbit Pyrogen (Chemical-Mediated) Test | No pyrogenic response. | Performed; results implied to meet criteria for substantial equivalence. | |
| Rabbit Intracutaneous Irritation | No significant skin irritation. | Performed; results implied to meet criteria for substantial equivalence. | |
| Guinea Pig Maximization Test | No significant sensitization. | Performed; results implied to meet criteria for substantial equivalence. | |
| Complement Activation Test | No significant complement activation. | Performed; results implied to meet criteria for substantial equivalence. | |
| Thrombogenicity (porcine model) | No significant thrombosis in an in-vivo model. | Performed; results implied to meet criteria for substantial equivalence. | |
| Material/Chemical | Material Verification | To confirm materials meet specifications. | Performed; results implied to meet criteria for substantial equivalence. |
| USP Physico-Chemical Test | To meet United States Pharmacopeia standards for physical and chemical properties. | Performed; results implied to meet criteria for substantial equivalence. | |
| Overall Performance | ISO 10555-1:1997, Sec 4.5 | To comply with standard for Sterile Single Use Intravascular Catheters. | "RetroFlex 3 Introducer Sheath was verified and tested according to performance testing standards ISO 10555-1:1997, Sec 4.5." |
| Substantial Equivalence | Comparison to Predicate Devices | The RetroFlex 3 is "similar to the Edwards Introducer Sheath and the Ancure® Sheath, and are common in mode of operation, intended use, and dimensions. The devices have only slight variations to technological design and materials." | "Based on the data presented... the RetroFlex 3 Introducer Sheath Set is substantially equivalent to the predicate devices." |
Important Note: The document consistently states that tests were "performed" and that the device "met the requirements threshold to establish substantial equivalence." However, it does not provide specific numerical results or detailed pass/fail criteria for each test. The acceptance criteria are largely implied by the nature of the tests and the conclusion of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. The document lists the types of tests performed (e.g., visual examination, tensile strength, various biocompatibility tests) but does not specify the number of units or animals tested for each.
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be an in-vitro (laboratory) and animal (in-vivo for thrombogenicity, rabbit, mouse, guinea pig) study, not a clinical study involving human patients. Therefore, the retrospective or prospective nature in the context of human data does not apply.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This device notification describes engineering and laboratory performance testing and biocompatibility studies, not studies requiring expert clinical interpretation for ground truth establishment.
4. Adjudication Method for the Test Set
- Not applicable. As noted above, this was not a study involving human interpretation or clinical adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes the clearance of a medical device based on engineering and biological performance testing, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, an algorithm-only standalone performance study was not done. This being a physical medical device (an introducer sheath), it does not involve an algorithm or AI.
7. The Type of Ground Truth Used
- For engineering tests (visual, dimensional, tensile, guidewire, coating, packaging): Ground truth was established by engineering specifications, direct measurements, and compliance with recognized industry standards (e.g., ISO 10555-1:1997).
- For biocompatibility tests: Ground truth was established by standardized biological assay protocols and observations, designed to detect cytotoxicity, systemic toxicity, irritation, sensitization, pyrogenicity, complement activation, and thrombogenicity following established regulatory guidelines.
8. The Sample Size for the Training Set
- Not applicable. This document describes the clearance of a physical medical device through performance and biocompatibility testing, not the development or evaluation of an AI algorithm that would require a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there was no AI algorithm or training set involved.
§ 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).