(70 days)
The SelectFlex 072 Neurovascular Access System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
The SelectFlex 072 Neurovascular Access System is a sterile, single-use intravascular catheter used to facilitate access to target vasculature during interventional procedures. The system is composed of a the SelectFlex 072 Catheter, a 3cc Inflation Syringe, a 7Fr Peel Away Introducer, and Hub Extension Line. The 072 SelectFlex Catheter has a usable length of 105cm. The SelectFlex 072 Catheter has variable stiffness along its length and has a dual mode stiffness mechanism on the distal portion of the catheter that is activated by the user allowing the device to transition between tracking and support modes. The distal end of the SelectFlex 072 Catheter has a hydrophilic coating.
The provided document is a 510(k) summary for the SelectFlex 072 Neurovascular Access System, asserting its substantial equivalence to a predicate device (SelectFlex 072 Neurovascular Access System K181000). The summary focuses on comparing the new device to the predicate and presenting nonclinical bench test data. It does not detail a study proving the device meets acceptance criteria for an AI/ML-based medical device. The documentation pertains to a traditional medical device (a catheter system), not an AI-enabled device.
Therefore, the following information cannot be extracted from the provided text for an AI/ML-based device:
- A table of acceptance criteria and the reported device performance: The document lists bench tests and states "PASS" for all, meaning all samples met "pre-determined acceptance criteria," but it does not specify the numerical or qualitative acceptance criteria for each test in a detailed table that would be typical for an AI/ML performance summary (e.g., sensitivity, specificity, AUC thresholds). The acceptance criteria for the new device are implicitly that they perform equivalently to the predicate device in the listed bench tests.
- Sample size used for the test set and the data provenance: No information on test set sample size or data provenance in the context of an AI/ML study is provided. The bench tests would have their own sample sizes, but these are not for an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML study requiring expert-derived ground truth.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
However, based on the document, I can provide information relevant to a traditional medical device's nonclinical performance evaluation:
1. Table of Acceptance Criteria and Reported Device Performance (Nonclinical Bench Testing):
The document states that all tests resulted in "PASS," meaning all samples met "pre-determined acceptance criteria." The specific numerical acceptance criteria themselves are not listed in this summary, only the outcome.
| Test Description | Test Method | Reported Device Performance (Result against unspecified acceptance criteria) |
|---|---|---|
| Packaging Integrity | Tested per ISO 11607-1 and -2 | PASS (All samples met the pre-determined acceptance criteria) |
| Visual Surface Requirements | Visual inspection of catheter surfaces | PASS (All samples met the pre-determined acceptance criteria) |
| Dimensional Verification | Device dimensions were measured to confirm conformance to the product specification | PASS (All samples met the pre-determined acceptance criteria) |
| Liquid Leakage Under Pressure | Tested per ISO 10555-1:2013 Annex C | PASS (All samples met the pre-determined acceptance criteria) |
| Hub Aspiration Air Leakage | Tested per ISO 10555-1 2013 for Hub Aspiration Air Leakage | PASS (All samples met the pre-determined acceptance criteria) |
| Simulated Use/Usability | Device preparation, delivery, access, was evaluated in a challenging neurovascular model. Simulated use testing includes a usability assessment with multiple physicians. | PASS (All samples met the pre-determined acceptance criteria) |
| Flex Fatigue | Tested per ISO 10555-1: 2013 for Flexural Fatigue | PASS (All samples met the pre-determined acceptance criteria) |
| Tip Deflection | The amount of tip deflection under load was evaluated and compared to the predicate device | PASS (All samples met the pre-determined acceptance criteria) |
| Inflation Fatigue | Tested per ISO 10555-1: 2013 for Inflation Fatigue - 20 inflation cycles | PASS (All samples met the pre-determined acceptance criteria) |
| Burst Volume | Tested per ISO 10555-1: 2013 for Inflation Fatigue - tested to 2x the inflation volume | PASS (All samples met the pre-determined acceptance criteria) |
| Torque Test | Tested per ISO 10555-1: 2013 for Torque Testing | PASS (All samples met the pre-determined acceptance criteria) |
| Flow Rate | Tested per ISO 10555-1: 2013 for Flow rate compared to the predicate device | PASS (All samples met the pre-determined acceptance criteria) |
| ISO 80369-7: Small Bore Connectors | Tested per ISO 80369-7 (dimensional, leakage, resistance to separation, etc.) | PASS (All samples met the pre-determined acceptance criteria) |
| Corrosion Resistance | Tested per ISO 10555-1 Annex A for corrosion resistance | PASS (All samples met the pre-determined acceptance criteria) |
| Particulate Count | Effluent tested per AAMI TIR42, USP 788 using multiple insertion and withdrawal cycles | PASS (All samples met the pre-determined acceptance criteria) |
| Coating Integrity, Lubricity, Durability | Tested in consideration of FDA CTQ for Hydrophilic Coated vascular catheters | PASS (All samples met the pre-determined acceptance criteria) |
| Peak Tensile Testing | Tested per ISO 10555-1 for tensile strength including all bonds/joints | PASS (All samples met the pre-determined acceptance criteria) |
| Device Removal | Removal force in both modes was compared to a reference device | PASS (All samples met the pre-determined acceptance criteria) |
| Radiopacity | Radiopacity was evaluated during simulated use testing confirming visualization under fluoroscopy | PASS (All samples met the pre-determined acceptance criteria) |
| Shelf Life | Accelerated aging studies were completed to confirm the stability of the product and package. All testing noted above was performed on aged product to support the shelf life claim | PASS (All samples met the pre-determined acceptance criteria) |
| Cytotoxicity | Tested in accordance with ISO 10993-5, Neutral Red Uptake Method | Pass (Noncytotoxic according to the predetermined acceptance criteria) |
| Intracutaneous Irritation | Tested in accordance with ISO 10993-10 | Pass (Test requirements for intracutaneous reactivity were met) |
| Sensitization | Tested in accordance with ISO 10993-10, Kligman Maximization Test | Pass (did not elicit a sensitization response) |
| Systemic Toxicity | Tested in accordance with ISO 10993-11 | Pass (Test requirements for systemic toxicity were met) |
| Material Mediated Pyrogenicity | Tested in accordance with ISO 10993-11 and USP 40 Pyrogen Test | Pass (Nonpyrogenic, met the predetermined acceptance criteria) |
| Hemolysis | Tested in accordance with ASTM F756-17 and ISO 10993-4 (direct and indirect methods) | Pass (Non-hemolytic, met the predetermined acceptance criteria) |
| In Vitro Hemocompatibility | Tested in accordance with ISO 10993-4 (Direct Contact Method) | Pass (Not expected to result in adverse effects in vivo) |
| Complement Activation | Tested in accordance with ISO 10993-4 (SC5b-9 Complement Activation) | Pass (Does not activate the complement system) |
| Un-activated Partial Thromboplastin Time | Tested in accordance with ISO 10994-4 and ASTM F2382-04 | Pass (Does not have an effect on coagulation of human plasma) |
| Thrombogenicity | Tested in accordance with ISO 10994-4 | Pass (Demonstrates similar thromboresistance characteristics as control) |
| Bacterial Endotoxin | Tested in accordance with USP 40, NF 35, 2017. Bacterial Endotoxins Test | PASS (All samples met the pre-determined acceptance criteria) |
2. Sample sized used for the test set and the data provenance:
The document mentions "All samples met the pre-determined acceptance criteria" for various bench tests, but does not specify the sample size (n) for each test set used in the nonclinical bench testing. Data provenance is not applicable in the context of clinical data for an AI/ML device, as these are bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
For the "Simulated Use/Usability" test, the document states it "includes a usability assessment with multiple physicians." The specific number and qualifications of these physicians are not provided. This is not establishing "ground truth" in an AI/ML context, but rather assessing usability.
4. Adjudication method for the test set:
Not applicable in the context of bench testing for a traditional medical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, this type of study was not conducted as this is a non-AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used:
Not applicable, as this is not an AI/ML device. For the bench tests, the "ground truth" is defined by established international and national standards (e.g., ISO, ASTM, USP) and the device's own specifications.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
§ 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).