(121 days)
The MicroSheath LP is a single lumen catheter intended to create a pathway for other devices in the coronary or peripheral vasculature.
The FlowCardia MicroSheath LP a single lumen catheter, 123 cm in length, with a standard luer fitting at the proximal end. The catheter is available in two tip shapes, straight and angled. The distal tip is atraumatic to help facilitate vessel navigation. A single radiopaque marker on the straight version of the MicroSheath LP and five radiopaque markers on the angled version aid in fluoroscopic visualization. The MicroSheath LP is 6F Sheath/7Fr Guide compatible.
The provided text describes a 510(k) summary for the FlowCardia MicroSheath LP Catheters, comparing it to a predicate device, the VP Sheath. The text focuses on establishing substantial equivalence rather than a clinical study with human readers or AI. Therefore, much of the requested information (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies, human reader improvement with AI) is not applicable or cannot be extracted from this document.
Here's the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Met specifications (implied by "dimensional verification") | Performed similarly to predicate devices |
| Tensile Strength | Similar to predicate device | Performed similarly to predicate devices |
| Tip Flexibility | Similar to predicate device | Performed similarly to predicate devices |
| Access and Navigation Bench Modeling | Successful creation of a pathway for other devices (implied) | Performed similarly to predicate devices |
| Critical Bend Testing | Similar to predicate device | Performed similarly to predicate devices |
| Leak and Pressure Testing | Met safety/performance standards (implied) | Performed similarly to predicate devices |
| Torque Strength | Similar to predicate device | Performed similarly to predicate devices |
| Biocompatibility | Met relevant guidance documents | Testing conducted according to relevant guidance documents. Assumed to meet. |
| Materials | Equivalent to predicate device | Equivalent to predicate device |
| Manufacturing Methods | Equivalent to predicate device | Equivalent to predicate device |
| Sterilization | Equivalent to predicate device | Equivalent to predicate device |
| Catheter Stiffness | Substantially equivalent to predicate device | Substantially equivalent to predicate device |
Note: The document primarily states that the device "met the acceptance criteria and performed similarly to the predicate devices" without explicitly listing numerical acceptance criteria for each test. The acceptance criteria are largely implied as being "similar to" or "equivalent to" the predicate device and meeting relevant guidance documents for safety and efficacy.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable or not specified. The study involved bench testing and design analysis, not a clinical test set with patient data.
- Data Provenance: Not applicable, as no human data or clinical study is described. The tests are physical and bench-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts & Qualifications: Not applicable. The ground truth for engineering and material performance tests is established through objective measurements and accepted engineering standards, not expert consensus on interpretations.
4. Adjudication method for the test set
- Adjudication method: Not applicable. There was no clinical test set requiring adjudication. The evaluation was based on objective physical and mechanical 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
- MRMC Study: No. This document describes the 510(k) clearance process for a physical medical device (catheter), not an AI-powered diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No. This is not an algorithm or AI device.
7. The type of ground truth used
- Ground Truth Type: For the physical tests, the "ground truth" would be the objective measurements of the device's physical properties (e.g., tensile strength in Newtons, precise dimensions, flexibility measurements) and their comparison to established engineering standards, regulatory requirements, and the characteristics of the predicate device. For biocompatibility, it would be compliance with biological safety standards.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. There is no AI or machine learning component described, so no training set was used.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable, as there was no training set.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).