(108 days)
The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.
The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is a single use introducer designed to facilitate insertion of a device into the vasculature. The Peel-Away Sheath/Dilator Introducer Assembly is a unit comprised of a peel-away sheath introducer and a dilator. The Peel-Away sheath has a non-tapered body with a tapered tip to provide a smooth transition from the dilator. The Peel-Away sheath is a radiopaque polyethylene extruded sheath body with a molded polyethylene hub. The hub is designed with wings and a thin-wall peel groove on both sides that facilitate splitting the hub and sheath after a catheter is placed through the sheath. The sheath hub is also designed to allow the dilator to lock into the sheath during the insertion procedure. The polyethylene dilator has a tapered tip and an ergonomic hub that locks into the sheath hub during the insertion procedure. The dilator hub also features a Luer lock connection on the proximal end. The Peel-Away sheath/dilator introducer is available in 3 Fr. - 7 Fr. configurations with usable lengths of 7 and 10 cm.
1. Acceptance Criteria and Device Performance:
The provided document describes a 510(k) submission for a non-AI medical device (Arrow GlideThru Peel-Away Sheath/Dilator Introducer). Therefore, the concept of "acceptance criteria" and "reported device performance" in the context of AI models (e.g., accuracy, sensitivity, specificity) is not directly applicable here.
Instead, the device's performance is demonstrated through a set of nonclinical bench tests, and the acceptance criterion is "substantially equivalent functionality to the predicate device."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional equivalence to predicate device (Xentek K000313) in: | Bench testing demonstrated "substantially equivalent functionality" to the predicate device. |
| - Tensile strength | The results of comparison testing demonstrated that the GlideThru is comparable to the predicate device in: |
- Tensile strength |
| - Biocompatibility | Testing completed. While specific quantitative results aren't provided, the conclusion states "substantially equivalent functionality," implying successful completion and acceptable results for biocompatibility. |
| - Sheath surface free from extraneous matter | Testing completed. Implied to meet acceptance criteria as "substantially equivalent functionality" is concluded. |
| - Radiodetectability | The results of comparison testing demonstrated that the GlideThru is comparable to the predicate device in: - Radiopacity |
| - Luer testing | Testing completed. Implied to meet acceptance criteria. |
| - Simulated Use testing | Testing completed. Implied to meet acceptance criteria. |
| - Penetration/Insertion force | The results of comparison testing demonstrated that the GlideThru is comparable to the predicate device in: - Penetration/Insertion force |
| - No new safety or effectiveness issues compared to predicate device | The FDA's conclusion explicitly states: "Any differences between the subject and predicate sheath introducers do not raise new issues of safety or effectiveness. The Arrow GlideThru™ Peel-Away Sheath/Dilator Introducer is substantially equivalent to the Xentek Medical, Inc. Tearaway Introducer Sheath." This confirms the device met the overarching acceptance criteria for 510(k) clearance. |
2. Sample size used for the test set and the data provenance:
Not applicable. This is a medical device, not an AI model, and the testing involved bench tests on the device itself, not a 'test set' of data in the AI sense. The document does not specify exact sample sizes for each bench test, but it confirms that these nonclinical tests were performed.
The data provenance is from nonclinical bench testing performed by Arrow International, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device does not use an AI model, so there is no "ground truth" established by experts in the context of AI model evaluation. The "ground truth" for the device's performance is derived from physical measurements and observations during bench testing against predefined specifications or comparison with the predicate device.
4. Adjudication method for the test set:
Not applicable. There is no human adjudication process for a "test set" in the context of this device. The evaluation is based on objective measurements from bench testing.
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 not an AI-assisted device, so no MRMC study or evaluation of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the device's performance is established through objective physical measurements and observations from nonclinical bench testing comparing the subject device to a legally marketed predicate device (Xentek Medical, Inc. Tearaway Introducer Sheath K000313). This includes:
- Tensile strength measurements
- Evaluation of biocompatibility (as per relevant standards, though specific details are not provided in this summary)
- Visual inspection for extraneous matter
- Radiodetection tests
- Luer connection tests
- Simulated use scenarios
- Penetration/Insertion force measurements
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no AI model and thus no training set, this question is not relevant.
§ 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).