(147 days)
For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Prelude SNAP™ Splittable Sheath Introducer is a splittable hemostatic introducer system that is intended for the introduction of various types of pacing leads and catheters. The Prelude SNAP™ Splittable Sheath Introducer system consists of a splittable sheath introducer (with or without side-port), dilator, 18g introducer needle, guide wire, and a syringe. The device is provided sterile and intended for single use only. It is for use in hospitals or healthcare facilities. The splittable sheath introducer contains a hemostasis valve to minimize blood loss and air ingress during use. The introducer is available with or without a side-port with three-way stopcock that provides means for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The splittable sheath introducer is available in two lengths: 13cm and 25cm. The dilator is designed to conform to the inner diameter of the introducer and has a tapered tip. The materials of construction are primarily polymers with the exception of the guide wire and needle cannula which are stainless steel.
The provided text describes a medical device, the "Prelude SNAP™ Splittable Sheath Introducer," and its clearance process with the FDA. It details the device's technical characteristics, intended use, and the safety and performance tests conducted. However, the document does not present a formal "acceptance criteria" table with reported device performance against the criteria that would typically be used in a study to prove the device meets these criteria. Instead, it lists the types of tests performed.
Based on the information provided, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various tests performed, implying that certain performance thresholds would have been met. However, it does not explicitly state specific acceptance criteria (e.g., "force greater than X N") or directly report the numerical results of those tests. The tests are categorized as Dimensional, Functional, Simulated Use, Visual, Sterilization validation, and Biocompatibility.
| Acceptance Criteria Category | Specific Test | Implied Acceptance Criterion (not explicitly stated in document) | Reported Device Performance (not explicitly stated as numerical values in document) |
|---|---|---|---|
| Dimensional Tests | Introducer tube outer diameter (OD) | Within specified tolerance | Compliant |
| Introducer tip inner diameter (ID) | Within specified tolerance | Compliant | |
| Introducer free length | Within specified tolerance | Compliant | |
| Dilator tube outer diameter (OD) | Within specified tolerance | Compliant | |
| Dilator tip inner diameter (ID) | Within specified tolerance | Compliant | |
| Dilator protrusion from introducer when assembled | Within specified tolerance | Compliant | |
| Functional Tests | Introducer hub break force | Above minimum threshold | Compliant |
| Introducer peel | Within specified range for effective splitting | Compliant | |
| Introducer side-port pull force | Above minimum threshold | Compliant | |
| Introducer tube to hub joint strength | Above minimum threshold | Compliant | |
| Dilator tube to hub joint strength | Above minimum threshold | Compliant | |
| Simulated Use Test | Introducer hemostasis | Minimal or no blood leakage | Compliant |
| Device insertion through introducer valve | Smooth and unobstructed | Compliant | |
| Introducer valve hemostasis (liquid leakage) | Minimal or no liquid leakage | Compliant | |
| Introducer liquid leakage | Minimal or no liquid leakage | Compliant | |
| Introducer insertion | Smooth and unobstructed | Compliant | |
| Dilator to introducer engagement | Secure and proper fit | Compliant | |
| Dilator luer functionality | Proper function of luer connection | Compliant | |
| Dilator liquid leakage | Minimal or no liquid leakage | Compliant | |
| Visual Tests | Introducer pad printing | Legible and durable | Compliant |
| Introducer soft touch pad attachment | Secure and reliable | Compliant | |
| Sterilization Validation | Sterility | Sterile per ISO 11135-1 & AAMI TIR28 | Compliant |
| Biocompatibility Testing | Cytotoxicity, Sensitization, Irritation, Acute System Toxicity, Pyrogenicity, Genotoxicity, Hemocompatibility | Biocompatible per ISO 10993 series & USP 37-NF 32 | Compliant |
Study Proving Device Meets Acceptance Criteria:
The document mentions "Performance Testing (Verification)" as the study conducted to ensure the device meets the user requirements and specifications.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide specific sample sizes for the test sets used for any of the listed tests. The data provenance (country of origin, retrospective/prospective) is also not specified. These were likely internal engineering and quality assurance tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable and hence not provided. The testing described is for a physical medical device (catheter introducer), not an AI/software device that requires expert-established ground truth for a test set. The "ground truth" for these tests would be the physical properties and performance characteristics of the device itself, measured by calibrated equipment and verified against engineering specifications.
4. Adjudication Method:
This information is not applicable for the type of testing described (physical device performance testing).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or AI algorithms where human readers interpret medical images. The Prelude SNAP™ Splittable Sheath Introducer is a physical medical device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No, a standalone (algorithm only) study was not done. This is not an AI/software device. The performance tests ("Verification") described are for the physical device itself.
7. Type of Ground Truth Used:
The ground truth used for the device's performance evaluation is based on engineering specifications, material science properties, and established international standards (e.g., ISO, AAMI, USP) for physical and biological performance of medical devices. This includes:
- Dimensional measurements: Verifying measurements against design specifications.
- Mechanical strength: Quantifying forces required for actions like hub break, peel, pull, and joint strength, compared to safety and functional requirements.
- Fluid dynamics: Assessing hemostasis and leakage under simulated use conditions.
- Sterility and Biocompatibility: Conforming to established biological safety standards.
8. Sample Size for the Training Set:
This information is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for a physical medical device.
§ 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).