(268 days)
The Agile Devices Angler™ Steerable, Deflectable Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the sub-selective region has been accessed, the microcatheter can be used for the controlled infusion of diagnostic agents and delivery of embolic or therapeutic devices. Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area.
The Agile Devices Angler™ Steerable, Deflectable Microcatheter is a variable stiffness, single lumen microcatheter designed to access small tortuous vasculature. It has a steerable articulating deflectable tip and has a hydrophilic polymer coating over the distal 80cm which gives lubricity when wet. Tip deflection is controlled using a manual steering mechanism / handle external to the body. On-plane bi-directional tip deflection is achieved via coaxial movement of the inner versus the outer shaft which bends a distal covered flat wire. Material injection is achieved via syringe connection to the proximal end of the catheter.
The Agile Devices Angler™ Steerable, Deflectable microcatheter has a maximum outside diameter of 0.0394" (3F). It has an inside diameter of 0.021" and has two radiopaque marker bands on the distal tip and at the deflection point to facilitate fluoroscopic visualization. It is compatible with guiding catheters with I.D. down to 0.047". The microcatheter lumen is compatible with steerable guidewires up to 0.018", and particles up to 500um or embolic spheres up to 700μm, with a burst pressure rating up to 1000 psi.
Here's a breakdown of the acceptance criteria and study information for the Agile Devices Angler™ Steerable, Deflectable Microcatheter, based on the provided text:
Important Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets novel acceptance criteria through a large-scale clinical study in the way an AI/ML device might. Therefore, many of the typical questions for AI/ML device studies (like sample sizes for test/training sets, expert qualifications for ground truth, MRMC studies, standalone performance with metrics like sensitivity/specificity/AUC) are not applicable or not clearly delineated in this type of submission. This device is a physical medical instrument, not an AI algorithm.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here refers to pre-defined test acceptance criteria for bench testing and pre-clinical testing for a physical medical device to demonstrate its performance characteristics are comparable to predicate devices and meet relevant standards. It does not refer to clinical endpoints or diagnostic performance metrics typically associated with AI.
| Test Category | Specific Test | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|---|
| In Vitro Bench Testing | Visual Inspections and Dimensional verifications | Met pre-defined test acceptance criteria | All tests met the pre-defined test acceptance criteria. |
| Tensile Bond Strength at Tip and Handle Connections | Met pre-defined test acceptance criteria | All tests met the pre-defined test acceptance criteria. | |
| Torque Strength (Revolutions to Failure) | Met pre-defined test acceptance criteria | All tests met the pre-defined test acceptance criteria. | |
| Radio-Detectability | Met pre-defined test acceptance criteria | All tests met the pre-defined test acceptance criteria. | |
| Kink Resistance | Met pre-defined test acceptance criteria | All tests met the pre-defined test acceptance criteria. | |
| Liquid Leakage | Met pre-defined test acceptance criteria | All tests met the pre-defined test acceptance criteria. | |
| Luer Testing to ISO 80369-7 & ISO 80369-20 | Met pre-defined test acceptance criteria | All tests met the pre-defined test acceptance criteria. | |
| Tip Flexibility / Softness | Met pre-defined test acceptance criteria | All tests met the pre-defined test acceptance criteria. | |
| Tip Deflection Angle and Multiple Deflection Fatigue | Met pre-defined test acceptance criteria | All tests met the pre-defined test acceptance criteria. | |
| Resistance to Override | Met pre-defined test acceptance criteria | All tests met the pre-defined test acceptance criteria. | |
| Power Injection (for Flowrate and Device Burst Pressure) | Met pre-defined test acceptance criteria | All tests met the pre-defined test acceptance criteria. | |
| Coating Tests: Length, Coating Integrity and Particulate | Met pre-defined test acceptance criteria | All tests met the pre-defined test acceptance criteria. | |
| Pushability / Trackability and Torque Response | Met pre-defined test acceptance criteria | All tests met the pre-defined test acceptance criteria. | |
| Shelf Life and Sterility Testing | Package integrity (dye penetration, pouch peel) | Confirm proper operation following aging & shipping | All package and device integrity tests passed. |
| Device integrity (after aging & shipping) | Confirm proper operation following aging & shipping | All package and device integrity tests passed. | |
| Sterilization Validation | Sterility Assurance Level (SAL) per ISO 11135 | SAL of 10^-6 | Achieved SAL of 10^-6. |
| Endotoxin levels per USP 40-NF35:2017 <85> | Below 2.15 EU/Device | Confirmed endotoxin levels well below the limit. | |
| Sterilization residuals evaluated per ISO 10993-7 | Compliance with ISO 10993-7 | Evaluated according to ISO 10993-7. * (Implied compliance)* | |
| Biocompatibility | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility, SC5b-9 Complement Active Assay, ASTM Partial Thromboplastin Time, In Vivo Thromboresistance Study | Compliance with ISO 10993-1:2018 (Circulating Blood, Externally Communicating, ≤ 24 hours). | All listed tests were performed to confirm biocompatibility. * (Implied compliance)* |
Study Details (for a physical medical device)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The text does not specify exact sample sizes for each individual bench test. The testing involved "Agile Devices Angler™ Steerable, Deflectable Microcatheters" but the precise number of units tested for each specific test is not detailed.
- Data Provenance: The studies are "In Vitro Bench Testing" and "Shelf Life and Sterility Testing" and "Biocompatibility" (which included an in vivo thromboresistance study in canines). This is primarily laboratory and animal testing, not human clinical data, so country of origin of patient data is not applicable. The data is prospective as it was generated specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical medical device undergoing bench and pre-clinical testing, "ground truth" is established by adherence to recognized standards (e.g., ISO, ASTM, USP) and predefined engineering specifications. This doesn't involve expert consensus on medical images or clinical outcomes in the same way an AI device would.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or uncertain outcomes. For bench testing, test results either meet a pre-defined objective criterion or they do not.
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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. This is a physical medical device (microcatheter), not an AI diagnostic algorithm. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench and pre-clinical testing mentioned:
- Bench Testing: Engineering specifications, physical measurements, and performance against established industry standards (e.g., ISO 10555-1) served as the "ground truth" or acceptance criteria.
- Sterilization Validation: Demonstrated sterility per ISO 11135 and endotoxin levels per USP standards.
- Biocompatibility: Performance against biological safety requirements outlined in ISO 10993. For the in vivo thromboresistance study, observed biological reactions in canines compared to controls would serve as the basis for evaluation.
- For the bench and pre-clinical testing mentioned:
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The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set for a physical device, this question is not relevant.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).