(157 days)
The VIA™ 17 Microcatheter is intended for the introduction of non-liquid interventional devices (such as coils/ stents) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral and coronary vasculature.
The VIA™ 17 Microcatheter is a sterile single lumen device designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as coils/stents. The VIATM 17 Microcatheter is available in an effective length of 154 cm and an inner diameter of 0.0175 inches. The VIA™ 17 Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic. Accessories: Each VIA™ 17 Microcatheter is provided with shaping mandrels to facilitate distal tip shaping. In intravascular procedures, the device assists the physician in: - Accessing the targeted vasculature to facilitate the delivery of interventional devices, such as coils and stents, and infusion of diagnostic agents such as contrast.
The provided text describes the 510(k) summary for the VIA™ 17 Microcatheter, focusing on its substantial equivalence to previously cleared predicate devices rather than a standalone clinical study to prove the device meets acceptance criteria in the traditional sense of AI/ML performance.
The document details rigorous nonclinical tests (bench testing, sterilization validation, packaging and shelf-life assessment, biocompatibility assessment, and simulated use testing in animals) to demonstrate this substantial equivalence. It does not describe an AI/ML device, nor does it present "accuracy," "sensitivity," or "specificity" metrics typically used for such devices.
Therefore, many of the requested categories for AI/ML device studies (such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance metrics of an AI algorithm) are not applicable to this submission.
However, I can extract information related to the acceptance criteria and the results of the nonclinical tests performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Kink Resistance | Based on measured Headway 17 kink resistance. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Tip Buckling | Based on measured Headway 17 tip buckling. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Tracking Force | Identical to VIA 21 and VIA 27/33. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Steam Shaping and Shape Retention | Based on measured Headway 17 shape retention. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Microcatheter Tensile Strength | Per ISO 10555-1:2014. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Catheter Leakage and Static Burst | Identical to VIA 21 and VIA 27/33. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Retraction | Identical to VIA 21 and VIA 27/33. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Coating Friction and Coating Integrity | Identical to VIA 21 and VIA 27/33. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Coating Adherence/Particulate | Per USP 24 . Identical to VIA 21 and VIA 27/33. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Flow Rate | Per ISO 10555-1:2014. | All units passed acceptance criteria. Flow rate was determined and documented in the instructions for use. Substantially equivalent to predicate. |
| Hub Performance | Per ISO 594-1:1986 and ISO 594-2:1998. | Test results adopted from VIA 27/VIA33 (K132652). All units passed acceptance criteria. Substantially equivalent to predicate. |
| Visual and Dimensional | Not explicitly stated as "acceptance criteria" but implied via "All units passed acceptance criteria." | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Catheter Torque to Failure | Characterization only. | Results comparable to VIA 21. Substantially equivalent to predicate. |
| Biocompatibility (various tests like Pyrogen, Sensitization, Systemic Injection, Intracutaneous Reactivity, Thromboresistance, Hemolysis, Complement Activation, Partial Thromboplastin Time, Platelet and Leukocyte Counts, MEM Elution Assay) | Applicable International Standards (e.g., ISO 10993-11:2006, ASTM F720-81 (2002), ISO 10993-10:2010, ISO 10993-4:2002 (2006), ASTM F619-03, ASTM F756-08, ASTM F2382-04, ISO 10993-5:2009). | All units passed acceptance criteria (e.g., Non-pyrogenic, Non-sensitization, Non-toxic, Non-irritant, Thromboresistance similar to control, Non-hemolytic, Comparable to control, Non-activators of coagulation pathway, Comparable to control). Pass. |
| Chemical Testing (Colorant Analysis) | 21 CFR 74.3045 (2012) | Elemental results meet requirements of 21 CFR 74.3045. Pass. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify exact sample sizes for each non-clinical bench test. It generally states "All units passed acceptance criteria" for each test, implying a sufficient number of units were tested to demonstrate compliance.
- Data Provenance: The tests are "bench testing," "simulated use testing in animals," "sterilization validation," "packaging and shelf-life assessment," and "biocompatibility assessment." This indicates lab-based, animal-based, and compliance-based testing rather than human clinical data. The country of origin for the data is not specified, but the applicant (Sequent Medical, Inc.) is based in Aliso Viejo, California, USA, suggesting the studies were conducted under US regulatory standards. The data is prospective for these tests, as they are performed specifically to evaluate the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is not applicable as the studies are non-clinical, bench, and animal tests. "Ground truth" in this context refers to the defined physical, mechanical, chemical, and biological properties measured and compared against established standards or predicate device performance, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable for non-clinical, bench testing, and animal studies.
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
- This is not applicable. The device is a microcatheter, not an AI/ML diagnostic tool that would involve human readers interpreting medical cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is based on:
- Defined physical and mechanical properties: Measured values (e.g., kink diameter, buckling force, tensile strength, flow rate, dimensions).
- Compliance with international standards: (e.g., ISO 10555-1:2014, ISO 594-1:1986, ISO 594-2:1998, USP 24 ).
- Comparison to predicate device performance: The performance of the VIA™ 17 Microcatheter was specifically compared to established performance characteristics of the VIA™ 21 Microcatheter (K150894), VIA™ and VIA™ PLUS Microcatheters (K132652), and Headway 17 Advanced Microcatheter (K101542).
- Biological responses: For biocompatibility, "ground truth" is typically defined by the absence of adverse biological reactions as per ISO 10993 series and other relevant standards.
- Simulated use in animals: This provides physiological "ground truth" for how the device performs in a living system without causing new risks.
8. The sample size for the training set
- This is not applicable as the device is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- This is not applicable as the device is not an AI/ML algorithm.
§ 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).