(69 days)
The Merit Prelude IDeal Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires.
The Prelude IDeal Hydrophilic Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath hub contains an integral hemostasis valve. A rotating suture ring is affixed to the sheath hub. The sheath tubing is coated with a hydrophilic coating and incorporates a stainless steel braid. A sidearm is affixed to the sheath hub and has a 3-way stopcock at its proximal end. The Prelude Ideal Hydrophilic Sheath Introducer is available in 7cm. 11cm, 16cm and 23cm lengths, (French sizes 4F, 5F, 6F and 7F) and is designed to accept 0.018", 0.021" and 0.025" diameter guide wires. The Prelude Ideal Hydrophilic Sheath Introducer is marketed with any of the following components, depending on the product configuration: guide wire, metal access needle, access needle with inner metal needle and outer plastic cannula and BowTie guide wire insertion device.
The provided text describes a 510(k) premarket notification for a medical device, the Prelude IDeal Hydrophilic Sheath Introducer. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI/ML algorithm's performance.
Therefore, many of the requested criteria, such as those related to AI/ML specific studies (sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training data), are not applicable to this document. The document describes traditional medical device performance testing.
Here's an analysis of what can be extracted from the document regarding acceptance criteria and performance, as well as the parts that are not applicable:
1. A table of acceptance criteria and the reported device performance
The document lists numerous performance tests performed, but it does not explicitly state specific numerical acceptance criteria for each test. Instead, it makes a general statement about the results.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| The device must meet predetermined acceptance criteria applicable to its performance. | "The results of the testing demonstrated that the subject Prelude IDeal Hydrophilic Sheath Introducer met the predetermined acceptance criteria applicable to the performance of the device." (Page 7) The document lists a comprehensive set of tests performed for this device, suggesting that the results for each of these tests were within the predefined acceptable ranges, although the ranges themselves are not specified in this summary. These tests include: |
- Bench Performance Tests: Suture Ring Rotation, 90º Tip Bend Test/Conditioning, Tensile Tip to Shaft, Sheath Assembly Leak (300kPa), Tensile Hub to Sidearm (4F only), Tensile - Valve Cap to Hub, Tensile Suture Ring to Strain Relief, Dilatory Drag through Sheath Tip and Valve, Sheath Effective Length, Kink Dual Pivot, Stiffness (Force of Deflection), Sidewall Compression, Tip Insertion Force (with coating activation), Coating Lubricity and Durability, Sheath Bend Radius, Radiopacity of Shaft and Tip, Hydrophilic Coating Uniformity and Coverage Length, Tensile - Hub to Shaft, Sheath Tip Ball Gauge Drag, Sheath Shaft Inner Diameter, Sheath Shaft Outer Diameter, Tensile Shaft, Torque Shaft to Hub, Corrosion Resistance, Particulate Evaluation (Outer Surface), Stiffness with Dilator, Catheter Insertion and Exchange, Sheath Stiffness without Dilator.
- Biocompatibility Tests (based on ISO standards): Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, Hemolysis, Thrombogenicity, Complement Activation, Chemical Characterization. |
| The device must demonstrate substantial equivalence to the predicate device regarding safety and effectiveness. | "Based on the indications for use, design, and performance testing, the subject Prelude IDeal Hydrophilic Sheath Introducer raises no new questions of safety or effectiveness compared to the predicate device and is substantially equivalent to the predicate device, the PreludeEASE Hydrophilic Sheath Introducer, K140543 and K150257, manufactured by Merit Medical Systems, Inc." (Page 7) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact sample sizes (number of devices tested) for each of the performance or biocompatibility tests. It only lists the types of tests performed.
- Data Provenance: Not specified, but generally, medical device testing for FDA clearance is conducted by the manufacturer (Merit Medical Systems, Inc. in Utah, USA) or its designated testing facilities. This is a pre-market submission, so the data is prospective in the sense that it's generated specifically for this submission.
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 a traditional medical device, not an AI/ML device that requires human expert review for establishing ground truth from medical images or data. Performance is evaluated through physical and chemical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, "ground truth" is established by:
- Engineering specifications and design requirements: The device's performance is measured against these pre-defined standards (e.g., specific tensile strength, leak rate, flexibility limits).
- International Standards (e.g., ISO): Many tests are conducted according to well-established international standards (e.g., ISO 11070 for catheter introducers, ISO 10993 series for biocompatibility) which set the benchmarks for acceptable performance.
- Predicate Device Performance: Comparative testing against the predicate device to show similar performance characteristics is implicit in demonstrating substantial equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that involves a "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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).