(67 days)
For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Prelude SNAP™™ Splittable Hydrophilic 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 Hydrophilic Sheath Introducer system consists of a splittable sheath introducer lubricated with hydrophilic coating, 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 a side-port and 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 510(k) premarket notification for a medical device called the "Prelude SNAP™ Splittable Hydrophilic Sheath Introducer." This document is from the FDA and details the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness, and substantial equivalence to a predicate device.
It's important to note that this is a medical device and not an AI/ML-based device. Hence, the acceptance criteria and study described are for a physical medical product, not an AI algorithm. Many of the requested points related to AI/ML (e.g., training set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to the information provided.
However, I can extract the relevant information regarding the acceptance criteria and studies for this physical medical device.
Acceptance Criteria and Device Performance for the Prelude SNAP™ Splittable Hydrophilic Sheath Introducer
The document states that the device was "thoroughly tested through verification of product specifications and user requirements" and that "the results of the testing demonstrated that the subject Prelude SNAP™ Splittable Hydrophilic Sheath Introducer met the predetermined acceptance criteria of the device."
The study design is based on bench testing, sterilization validation, and biocompatibility testing, referencing several international and industry standards. The acceptance criteria themselves are explicitly stated for some tests, while others are implied as meeting the requirements of the referenced standards.
Here's a summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test / Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Performance Testing | Introducer Sheath Insertion | Met predetermined criteria | Met predetermined criteria |
| Introducer Sheath Outer Diameter (O.D.) | Met predetermined criteria | Met predetermined criteria | |
| Introducer Sheath Tip Inner Diameter (I.D.) | Met predetermined criteria | Met predetermined criteria | |
| Introducer Sheath Peel Force | Met predetermined criteria | Met predetermined criteria | |
| Simulated Use Introducer Insertion (Kink and Flexibility) | Met predetermined criteria | Met predetermined criteria | |
| Introducer Sheath Coating Length | Met predetermined criteria | Met predetermined criteria | |
| Introducer Sheath Coating Adherence | Met predetermined criteria | Met predetermined criteria | |
| Introducer Sheath Coating Lubricity/Durability | Met predetermined criteria | Met predetermined criteria | |
| Particulate Testing | Met predetermined criteria | Met predetermined criteria | |
| Biocompatibility | Cytotoxicity | Complies with ISO 10993-1, 10993-7 | Met requirements of the standards (implied acceptable) |
| Biological Evaluation (general) | Complies with ISO 10993-1, 10993-7 | Met requirements of the standards (implied acceptable) | |
| Bacterial Endotoxins Test | Complies with USP 37-NF 32 , AAMI/ANSI ST72:2011 | Met requirements of the standards (implied acceptable) | |
| Pyrogen Test | Complies with USP 37-NF 32 | Met requirements of the standards (implied acceptable) | |
| Sterilization | Sterilization Validation | Complies with ISO 11135-1, AAMI TIR28 | Met requirements of the standards (implied acceptable) |
| Packaging | Performance Testing of Shipping Containers and Systems | Complies with ASTM D4169-09 | Met requirements of the standards (implied acceptable) |
| Packaging for terminally sterilized medical devices | Complies with ISO 11607-1 | Met requirements of the standards (implied acceptable) | |
| Risk Management | Application of risk management to medical devices | Complies with ISO 14971:2012 | Met requirements of the standards (implied acceptable) |
| General | Compliance with ISO 11070:1998E (Sterile single-use intravascular catheter introducers) | Met requirements of mentioned standard | Met requirements of the standard (implied acceptable) |
Note: For many tests, the document simply states "met the predetermined acceptance criteria of the device" or implies compliance with the referenced standards, rather than providing specific numerical results or thresholds. This is typical for a 510(k) summary where detailed test reports are submitted separately.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test. The studies were bench tests and laboratory validations (sterilization, biocompatibility). Data provenance would be internal laboratory testing data from Merit Medical Systems, Inc. This device is a physical product, not data-driven software, so terms like "country of origin of the data" or "retrospective/prospective" studies as they apply to clinical data are not directly applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a physical medical device is established through engineering specifications, standard test methods, and compliance with recognized industry standards (e.g., ISO, ASTM, USP). It does not involve human expert consensus in the way an AI algorithm for image interpretation would.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of human interpretations or clinical outcomes.
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
Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool. No MRMC study was performed or needed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm. Device performance is inherent to its physical design and manufacturing process, independent of human interaction beyond its intended use.
7. The type of ground truth used
The ground truth is based on engineering specifications, established performance standards (e.g., ISO, ASTM, USP), and risk analysis. For example:
- Mechanical properties: Defined by engineering design and tested against specifications (e.g., sheath diameter, peel force).
- Sterility: Verified through sterilization validation processes adhering to standards like ISO 11135-1.
- Biocompatibility: Established by testing materials in accordance with ISO 10993 series for material safety with biological systems.
- Functionality: Tested against "user requirements" and "product specifications" (e.g., insertion, kink resistance).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set for 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).