(223 days)
The Flip Introducer access kit is used to facilitate placing a guide catheter through the skin into a vein or artery, including but not limited to the radial artery.
The Flip Introducer access kit is used to gain vascular access and allow placement of a guide catheter (not included). The Flip Introducer access kit contains the following components:
- . 21G x 4 cm percutaneous entry needle
- . 0.018" x 180 cm guidewire with a Nitinol mandrel and curved tungsten tip
- . Flip Introducer
The Flip Introducer functions as a dilator to gain vascular access, allowing sheathless delivery of a guide catheter into a vein or artery to perform a percutaneous catheterization procedure. The Flip introducer consists of a hollow PEEK extruded tube with a tapered distal end that has a radiopaque marker band and a hydrophilic-coated Pebax funnel. A tuohy borst is provided on the proximal end of the device. The Flip Introducer is 130 cm long and compatible with 0.018" guidewires. The Flip Introducer is available in two sizes for use with 6F and 7F guide catheters.
The provided text describes the "Flip Introducer access kit," a medical device used for vascular access. The submission focuses on demonstrating substantial equivalence to a predicate device through mechanical and biocompatibility testing.
Here's an analysis of the acceptance criteria and study information based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
The document mentions that "Verification test results met the specified acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each test. Instead, it lists the types of tests performed.
| Test Category | Specific Test Conducted | Reported Device Performance | Acceptance Criteria (from text) |
|---|---|---|---|
| Mechanical Tests | Fluoroscopy visualization | Met acceptance criteria | Not explicitly stated (e.g., "clearly visible under standard fluoroscopy conditions") |
| Dilator length | Met acceptance criteria | Not explicitly stated (e.g., "within +/- X mm of specified length") | |
| Dilator shaft OD | Met acceptance criteria | Not explicitly stated (e.g., "within +/- X mm of specified diameter") | |
| Dilator/guidewire compatibility | Met acceptance criteria | Not explicitly stated (e.g., "smooth passage of guidewire without kinking") | |
| Dilator insertion force | Met acceptance criteria | Not explicitly stated (e.g., "requires less than X N force to insert") | |
| Dilator prolapse | Met acceptance criteria | Not explicitly stated (e.g., "no prolapse when subjected to X force") | |
| Dilator bond strength | Met acceptance criteria | Not explicitly stated (e.g., "bond withstands X N tensile force") | |
| Biocompatibility Tests | Cytotoxicity | Met acceptance criteria (as recommended by ISO 10993-1) | Not explicitly stated (e.g., "non-cytotoxic, passes ISO 10993-5") |
| Sensitization | Met acceptance criteria (as recommended by ISO 10993-1) | Not explicitly stated (e.g., "non-sensitizing, passes ISO 10993-10") | |
| Irritation/Intracutaneous Reactivity | Met acceptance criteria (as recommended by ISO 10993-1) | Not explicitly stated (e.g., "non-irritating, passes ISO 10993-10") | |
| Acute Systemic Toxicity | Met acceptance criteria (as recommended by ISO 10993-1) | Not explicitly stated (e.g., "non-systemically toxic, passes ISO 10993-11") | |
| Hemocompatibility | Met acceptance criteria (as recommended by ISO 10993-1) | Not explicitly stated (e.g., "hemocompatible, passes ISO 10993-4") |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide any information regarding sample sizes for the mechanical or biocompatibility tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). These tests are typically conducted in a controlled lab environment.
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)
This section is not applicable to the type of studies described. The "Flip Introducer access kit" is a physical medical device, and its performance is evaluated through objective mechanical and biological tests, not through expert interpretation of data like in an AI-based diagnostic tool. Therefore, there's no "ground truth" established by human experts in the context of this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the studies are mechanical and biocompatibility tests, not clinical studies requiring adjudication of human reader interpretations. The results would be based on predefined metrics and instrumental readings.
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
This is not applicable. The device is a physical medical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" (in the sense of expert consensus, pathology, or outcomes data) is not applicable to the studies performed for this device. The "ground truth" for these tests are the objective measurements and pass/fail criteria for each mechanical and biocompatibility parameter.
8. The sample size for the training set
This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this 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).