(30 days)
The 14F iSLEEVE™ Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of cardiovascular devices. The iSLEEVE™ Introducer Set is suitable for use in vessels > 5.5 mm diameter.
The 14F iSLEEVE Introducer Set is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction and removal of cardiovascular devices into the vascular system. The 14F iSLEEVE Introducer Set is composed of a dilator and an introducer sheath with a three-way stopcock.
The distal end of the introducer sheath is passively expandable which allows for transient sheath expansion when the compatible valve system is introduced through it. Once expanded, this region of the introducer sheath is radially compliant, which allows it to expand and collapse as needed during device delivery and removal. This reduces the time the access vessel is expanded. A hydrophilic coatinq is applied to the working end of the iSLEEVE introducer sheath which increases the lubricity to aid in delivery when activated.
A product mandrel and flushing tube are also supplied with the iSLEEVE Introducer Set.
This is a submission for a medical device (14F iSLEEVE™ Introducer Set) and therefore doesn't involve AI/ML. The provided text describes a 510(k) submission for a non-AI medical device, focusing on its substantial equivalence to a predicate device based on physical and mechanical properties. Therefore, most of your requested information (acceptance criteria for AI performance, sample size for test/training sets, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types) is not applicable to this document.
However, I can extract information related to the device's performance testing given the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Sheath to Hub Tensile Testing | Met previously established acceptance criteria (specific values not detailed) | "Testing demonstrated that the modified 14F iSLEEVE Introducer Set met the previously established acceptance criteria." |
The rest of the requested information is not applicable to this 510(k) submission as it is for a physical medical device, not an AI/ML algorithm.
Here's why the other points are not applicable:
- 2. Sample size used for the test set and the data provenance: This relates to data for AI/ML validation, not physical device testing. The "test set" here refers to physical devices, not data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a physical device. Ground truth is usually established through engineering specifications and physical measurements.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: MRMC studies are for AI-assisted image interpretation, not physical devices.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: "Standalone" in this context refers to the device itself, which performs its function physically, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical devices, ground truth often comes from engineering specifications, material properties, and in vitro/in vivo measurements that are compared against predefined performance limits. For this specific submission, the "ground truth" for the tensile strength test would be the engineering specification for how much force the sheath-to-hub connection must withstand.
- 8. The sample size for the training set: Not applicable as there is no AI/ML algorithm to train.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, this FDA clearance document pertains to a physical introducer set, and the "study that proves the device meets the acceptance criteria" refers to non-clinical performance data, specifically mechanical testing, rather than studies involving AI/ML performance metrics.
§ 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).