(242 days)
The Intri24 Sheath is indicated to provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
The Intri24 Sheath is a single-use, sterile medical device for use in the peripheral vasculature. The Intri24 Sheath is an introducer sheath consisting of a short single lumen catheter with a hydrophilic coating, proximal hemostasis valve, and stopcock with flush port. A radiopaque marker is positioned near the distal tip of the sheath to aid with fluoroscopic visualization. The Intri24 Dilator is compatible with a 0.035" guidewire and has a tapered leading edge which aids insertion and positioning of the Intri24 Sheath.
The provided text is a 510(k) summary for a medical device called the "Intri24 Sheath." It details the device's characteristics, indications for use, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.
However, the nature of the device (a catheter introducer sheath) means that the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are based on physical and functional performance tests rather than AI model performance or diagnostic accuracy. Therefore, the questions related to AI-specific metrics (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance, and effect size for human readers) are not applicable to this type of device submission.
The "study" that proves the device meets acceptance criteria in this context refers to the non-clinical testing performed.
Here's how to interpret the provided information in the context of the device:
1. A table of acceptance criteria and the reported device performance:
The document describes various non-clinical tests performed and states that "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." While the specific numerical acceptance criteria values are not provided in this summary, the types of tests conducted represent the areas where acceptance criteria would be set.
| Acceptance Criteria Category (Test Type) | Reported Device Performance |
|---|---|
| Material & Physical Properties | |
| Visual and Dimensional Inspection | Met acceptance criteria |
| Dye Staining | Met acceptance criteria |
| Lubricity and Durability | Met acceptance criteria |
| Kink Radius and Dilator Retraction Force | Met acceptance criteria |
| Tensile, Compression, and Torque Testing | Met acceptance criteria |
| Functional Performance | |
| Guidewire Compatibility | Met acceptance criteria |
| Insertion Force | Met acceptance criteria |
| Locking Cap Force | Met acceptance criteria |
| Leak Testing | Met acceptance criteria |
| Simulated Use | Met acceptance criteria |
| Flowrate Testing | Met acceptance criteria |
| Vacuum Testing | Met acceptance criteria |
| Sheath Burst | Met acceptance criteria |
| Push-Button Force | Met acceptance criteria |
| Placement Resistance Testing | Met acceptance criteria |
| Biocompatibility | |
| L-929 MEM Elution | Successfully passed |
| Kligman Maximization | Successfully passed |
| Intracutaneous Injection | Successfully passed |
| Systemic Injection | Successfully passed |
| Pyrogen | Successfully passed |
| Blood Hemolysis | Successfully passed |
| Complement Activation | Successfully passed |
| Thromboresistance | Successfully passed |
| Platelet and Leukocyte Count | Successfully passed |
| Partial Thromboplastin Time | Successfully passed |
| Sterility & Packaging | |
| Pouch Seal Visual Inspection and Dye Penetration | Met acceptance criteria |
| Pouch, Peel, Seal Strength | Met acceptance criteria |
| Sterilization Validation | Met acceptance criteria |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes for each non-clinical test. This information would typically be detailed in the full test reports, not necessarily in a 510(k) summary. For physical device testing, sample sizes are often determined by statistical methods or industry standards (e.g., ISO, ASTM) to provide sufficient confidence in the results.
- Data Provenance: The data is from non-clinical (benchtop) testing conducted by Inari Medical, Inc. The country of origin for the data is implicitly the USA (based on the company's address in Irvine, California, and the FDA submission). It is a prospective generation of data through controlled laboratory experiments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: For this type of physical medical device, "ground truth" is established by direct measurement against engineering specifications and industry standards, not by expert consensus on, for example, diagnostic images. The performance metrics are objectively measurable (e.g., force, flow rate, dimensions).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: Adjudication methods like 2+1 or 3+1 are used for consensus-based ground truth in AI/imaging studies. Here, the "ground truth" is determined by established measurement techniques and calibrated equipment.
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 device is a catheter introducer sheath, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Measurement/Engineering Specifications/Industry Standards: The "ground truth" for this device's performance is derived from its design specifications, established industry standards (such as ISO 10993 for biocompatibility), and physical measurements using calibrated equipment.
8. The sample size for the training set:
- Not Applicable: There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable: There is no "training set" or corresponding ground truth establishment process for this device as it is not an AI/machine learning 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).