(27 days)
The Short Introducer Sheaths are used to facilitate placing a catheter through the skin into a graft. The dilator is an accessory device which is used by placing it into the sheaths to create an occlusion and further provide support to the wall of the indwelling system.
The Rex Medical Short Introducer Sheaths, offered in both 6F and 7F sizes, are vascular access devices consisting of a central lumen, angled side arm extension, and a hemostasis valve. The device is used under identical indications for use as the predicate device, as other substantially equivalent 510(K) cleared devices.
The provided 510(k) summary for K032569 describes a medical device, the "Short Introducer Sheaths," and its substantial equivalence to a predicate device. However, it does not include the detailed information requested regarding specific acceptance criteria, and a study demonstrating that the device meets those criteria, particularly within the context of AI/ML performance evaluation.
The document focuses on demonstrating substantial equivalence through non-clinical bench testing, comparing the new device to a legally marketed predicate device (Rex Medical Inner-Lock Locking Introducer Sheath, K#022170). The submission clearly states "Discussion of Clinical Tests Performed: Not Applicable." This means there was no human-in-the-loop study, standalone algorithm study, or any clinical trial involving patients to generate performance data for AI/ML criteria.
Therefore, I cannot fulfill the request for information on acceptance criteria, a study proving the device meets them, sample sizes, expert qualifications, or AI-specific details, as that information is not present in the provided text.
Based on the provided document, here's what can be extracted regarding the non-clinical testing discussed:
1. A table of acceptance criteria and the reported device performance
The document states: "Test methodology and acceptance criteria were derived form ISO 11070. Sterile single-use intravascular catheter introducers."
However, specific numerical acceptance criteria (e.g., maximum force to insertion, burst pressure, flow rate thresholds) and the reported performance values against these criteria are not provided in this summary. The summary only mentions that the tests were performed and the conclusion was that there are "no differences in their technological characteristics, thereby not raising any new question of safety or effectiveness."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing was non-clinical bench testing, so "data provenance" in the sense of patient data is not applicable.
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 information is not provided. The "ground truth" for non-clinical bench testing would be physical measurements and engineering specifications, not expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. This concept is typically relevant for clinical studies or studies involving human review of data.
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
No, an MRMC comparative effectiveness study was not done. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This is a medical device, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench testing, the "ground truth" would be established by "Test methodology and acceptance criteria were derived form ISO 11070. Sterile single-use intravascular catheter introducers." This implies engineering and technical specifications for physical performance (e.g., dimensions, material properties, mechanical strength).
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device and no training set was used.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device and no training set was used.
Summary of Device and Equivalence:
- Device Name: Rex Medical Short Introducer Sheaths
- Intended Use: To facilitate placing a catheter through the skin into a graft. The dilator is an accessory device used by placing it into the sheaths to create an occlusion and further provide support to the wall of the indwelling system.
- Predicate Device: Rex Medical Inner-Lock Locking Introducer Sheath (K#022170)
- Basis for Equivalence: Non-clinical bench testing demonstrating that despite minor design differences (elimination of retention feature, single lumen design, slightly different wall thickness, bore ID, and sheath length, and a modified distal cap), there are "no differences in their technological characteristics, thereby not raising any new question of safety or effectiveness."
- Testing Standard Referenced: ISO 11070. Sterile single-use intravascular catheter introducers.
- Clinical Testing: Not Applicable.
- Materials: Identical to predicate device, with a color additive added to the base extrusion of the Short Introducer Sheath. Materials of the predicate device were tested according to ISO 10993-1 (Biological Evaluation of Medical Devices).
§ 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).