(177 days)
Micrus Design Technology Peripheral Guiding Sheaths are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
The Micrus Design Technology Peripheral Guiding Sheaths are single lumen catheters, incorporating a Pebax body reinforced with a stainless steel wire coil. The intermediate segment is also Pebax with a stainless steel coil to reduce kinking and to promote improved torque response. They are available in 5 Fr, 6Fr, 7Fr, and 8 Fr and 45 cm, 55 cm and 90 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate device.
The provided text describes a 510(k) premarket notification for a medical device, the "Micrus Design Technology Peripheral Guiding Sheath." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical trial with acceptance criteria defined by performance metrics like sensitivity or specificity.
Therefore, many of the typical study elements for AI/ML device evaluations (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) are not applicable to this type of traditional medical device submission.
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Biocompatibility: Compliance with established safety standards. | Biocompatibility testing performed to assure compliance. |
| Mechanical Performance: Compliance with specifications (e.g., strength, durability, kink resistance, torque response). | Mechanical laboratory testing performed to assure compliance to specifications. |
| Technological Characteristics: Equivalence to predicate devices. | Technological characteristics are equivalent to the predicate device (Terumo Pinnacle Destination, Cook Shuttle/Flexor). |
| Safety and Effectiveness: Demonstration of safe and effective use for intended purpose, equivalent to predicate devices. | Non-clinical tests demonstrate that, like the predicate devices, the device is safe and effective for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This was a non-clinical, laboratory-based testing submission for a traditional hardware medical device, not a data-driven AI/ML device requiring test datasets of patient information. The testing involved mechanical and material evaluations, not diagnostic performance on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of AI/ML evaluation, refers to the definitive determination of a condition based on expert review or other definitive diagnosis. For this device, "ground truth" would relate to engineering standards and material science, likely verified by internal engineers and external testing labs, rather than medical experts interpreting cases.
4. Adjudication Method (2+1, 3+1, none) for the Test Set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of clinical data, which is not the nature of this device's testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. MRMC studies are designed for diagnostic devices to assess the impact of AI on human reader performance. This device is a catheter introducer, a tool for facilitating other procedures, not a diagnostic imaging or AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device does not have an algorithm component.
7. The Type of Ground Truth Used
The "ground truth" for this medical device's evaluation would be based on:
- Engineering Specifications: Defined parameters for mechanical strength, flexibility, torque response, etc.
- Biocompatibility Standards: Established international and national standards for material safety in contact with biological tissue.
- Predicate Device Characteristics: The performance and properties of the legally marketed predicate devices served as a benchmark for equivalence.
8. The Sample Size for the Training Set
Not applicable. This type of submission does not involve training data as it is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See answer to #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).