(136 days)
The SelectFlex Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
The subject SelectFlex Neurovascular Access System Family is a line extension to expand the previously cleared device (K211893) by offering a new SelectFlex III 064 Neurovascular Access Catheter with a diameter of 6F, a 6F dilator, an introducer sheath, and a 4.5F Access Tool that can be used with the catheter to access the desired anatomy. The 4.5F Access Tool is an accessory provided with the SelectFlex III 064 Neurovascular Access Catheter and is packaged in the same sterile pouch with the SelectFlex III 064 Neurovascular Access Catheter and accessories as part of the SelectFlex Neurovascular Access System Family.
The provided text is a 510(k) Summary for a medical device (SelectFlex Neurovascular Access System Family) and does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/human-in-the-loop diagnostic system. Instead, it describes nonclinical performance testing (bench testing) and biocompatibility testing conducted to demonstrate substantial equivalence to a legally marketed predicate device.
Therefore, many of the requested items (e.g., sample sized for the test set in an AI study, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document.
However, I can extract the acceptance criteria (goals) and reported performance (results) from the nonclinical performance data section.
Here's the information based on the provided text:
1. A table of acceptance criteria and the reported device performance
For the SelectFlex Neurovascular Access System Family (including the SelectFlex III 064 Neurovascular Access Catheter, 6F Dilator, and 4.5F Access Tool where applicable):
| Test Name | Acceptance Criteria (Goal) | Reported Device Performance (Result) |
|---|---|---|
| Visual Surface Requirements | To demonstrate that the device meets the visual surface requirements. | Pass: All samples met the predetermined acceptance criteria. |
| Dimensional Verification | To demonstrate that the device meets the dimensional requirements. | Pass: All samples met the predetermined acceptance criteria. |
| Liquid Leakage Under Pressure | To demonstrate that the device passes the liquid leakage under pressure test. | Pass: All samples met the predetermined acceptance criteria. |
| Hub Aspiration Air Leakage | To demonstrate that the device passes the hub aspiration air leakage test. | Pass: All samples met the predetermined acceptance criteria. |
| Simulated Use/Usability | To demonstrate that the device passes testing specified in the simulated use test protocol. Simulated use testing includes usability assessment with multiple physicians. | Pass: All samples met the predetermined acceptance criteria. |
| Flex Fatigue | To demonstrate that the device passes the flex fatigue test. | Pass: All samples met the predetermined acceptance criteria. |
| Inflation Fatigue | To demonstrate that the device passes the inflation fatigue test. | Pass: All samples met the predetermined acceptance criteria. |
| Burst Volume | To demonstrate that the device passes the burst volume test – tested to 2x the inflation volume. | Pass: All samples met the predetermined acceptance criteria. |
| Torque Test | To demonstrate the device's ability to rotate 720 degrees (2 full revolutions) at the proximal end. | Pass: All samples met the predetermined acceptance criteria. |
| Tip Deflection | To demonstrate that the tip deflection is comparable to the predicate device. | Pass: All samples met the predetermined acceptance criteria. |
| Device Removal in Support and Tracking Modes | To demonstrate that the forces in both support and tracking modes are comparable to the predicate device. | Pass: All samples met the predetermined acceptance criteria. |
| Peak Tensile Testing | To demonstrate that the device passes the peak tensile strength testing including all bonds and joints. | Pass: All samples met the predetermined acceptance criteria. |
| Flow Rate | To demonstrate that the flow rate is comparable to the predicate device. | Pass: All samples met the predetermined acceptance criteria. |
| Corrosion Resistance | To demonstrate that the device has no visual evidence of corrosion. | Pass: All samples met the predetermined acceptance criteria. |
| Radiopacity | To demonstrate that the marker band is positioned at the distal tip of the catheter and is clearly visible under typical fluoroscopic imaging conditions. | Pass: All samples met the predetermined acceptance criteria. |
| Particulates, Coating Integrity, Lubricity, Durability | To demonstrate the quantity and size of particles generated during simulated use are comparable to the predicate and reference devices. | Pass: All samples met the predetermined acceptance criteria. |
| Static Burst | To demonstrate that the device passes static burst as specified in the test protocol. | Pass: All samples met the predetermined acceptance criteria. |
| Shelf Life | To demonstrate that the device performance is maintained over the proposed shelf-life (6 months). | Pass: All samples met the predetermined acceptance criteria. |
Biocompatibility Testing:
| Test Name | Acceptance Criteria (Goal) | Reported Device Performance (Result) | Conclusion |
|---|---|---|---|
| Cytotoxicity | Absence of reactivity | No reactivity was observed with the test article at 24 and 48 hours. | Non-cytotoxic |
| Sensitization | No evidence of sensitization | The test article extracts showed no evidence of delayed dermal contact sensitization in the guinea pig maximization test. | Non-sensitizing |
| Intracutaneous Reactivity | No irritation | The scores from test article extracts were 0 from the saline extract and 0 from the sesame seed oil extract. | Non-irritant |
| Acute Systemic Toxicity | No abnormal clinical signs/toxicity | No abnormal clinical signs indicative of toxicity were observed for 72 hours. All animals were alive at the end of 72 hours and body weight changes were within acceptable parameters. | Non-toxic |
| Material Mediated Pyrogenicity | No significant temperature rise | No rabbit temperature rise ≥ 0.5 °C. | Non-pyrogenic |
| Hemolysis - Direct Contact and Extract Method | Non-hemolytic | Blank corrected hemolytic index: 0.15, 0.13. | Non-hemolytic |
| Complement Activation | Results within acceptable range | Results within acceptable range as compared to the controls. | Not a Sc5b-9 complement activator |
| Thrombogenicity | No adverse effects/thrombus | No adverse effects or clinical signs during test period and no thrombus score ≥ 2 for either test or control device. | Non-thrombogenic |
2. Sample sized used for the test set and the data provenance
The document does not specify sample sizes for each particular test, only stating "All samples" or providing a conclusion based on the samples tested. The data provenance is "bench testing" and "biocompatibility testing," which are laboratory-based tests of the device itself, not clinical data or data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device performance and biocompatibility study, not an AI diagnostic study relying on expert ground truth. However, for "Simulated Use/Usability," it states "usability assessment with multiple physicians," but specific numbers or qualifications are not provided.
4. Adjudication method for the test set
Not applicable.
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. No AI component is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. No AI component is mentioned.
7. The type of ground truth used
For nonclinical performance, the "ground truth" is defined by established engineering and material science standards (e.g., ISO 10555-1, FDA guidance documents, ASTM D4332, AAMI TIR42, ISO 10993 series for biocompatibility). The device's physical properties and interactions are measured against these objective criteria.
8. The sample size for the training set
Not applicable. There is no AI training set as this is a device performance study.
9. How the ground truth for the training set was established
Not applicable. There is no AI 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).