(205 days)
The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
The Headway 27 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. An introducer sheath and shaping mandrel are also provided.
The provided text describes the MicroVention, Inc. Headway 27 Microcatheter and its substantial equivalence to a predicate device (Headway 27 Microcatheter, K110813). The document primarily focuses on bench testing and biocompatibility testing to demonstrate this equivalence.
Here's an analysis of the acceptance criteria and study data based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Bench Testing Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Surface Contamination | • Liquid on surface | |
| • Particulate on external surface | ||
| • Surface defects/sharp edges | • Free from uncured hydrophilic coating. | |
| • No surface particulate > .02 mm² per tappi chart | ||
| • Free from surface defect/no sharp edges | ||
| • Embedded particulate acceptable if OD is in specification | ||
| • Free from damage | ||
| Dimensional Attributes | • Catheter effective length | |
| • Catheter lumen | ||
| • Catheter outer diameter | ||
| • Length of distal OD (2.2Fr section) | • 150 ± 2 cm | |
| • .027" (0.69 mm) | ||
| • nominal .040"/.034-.028" (1.0/.86-.71 mm) | ||
| • ≥ 6cm | ||
| Force at Break | Device shall not break during use | ≥ 1.12 lbs (5.0 N) for outer diameters from .030" to .045" (.76 to 1.1 mm) |
| Freedom from Leakage (Liquid) | (low pressure - long duration) | |
| Device shall not leak fluids | No liquid leaking from hub and catheter shaft at 46 psi (317.2 kPa) for 30 second duration | |
| Freedom from Leakage (Air) | (high pressure - short time) | |
| Device shall not leak fluids | No liquid leaking from hub and catheter shaft at 300 psi/2068 kPa (rated burst pressure) for 10 second duration | |
| Burst Pressure of Catheter | Air shall not leak into device | No air leaking into syringe for 15 seconds |
| Dynamic Burst Pressure | Microcatheter will not burst statically below rated burst pressure. | Microcatheter: will not burst below 300 psi (2068 kPa) |
| Durability and Lubricity of Hydrophilic Coating | Verification that hydrophilic coating does not delaminate during use | Rated 3 or higher (simulated use) |
| Tip Shape and Tip Retention | Not explicitly stated, but implied to retain original shape sufficiently | Tip retain better than 55% of its original shape |
| Simulated Use | Not explicitly stated, but implied to perform acceptably in tested categories | Rated 3 or higher in tested categories |
| Compatibility with Agents | Not explicitly stated, but implied to perform acceptably with applicable agents | Rated 3 or higher in tested applicable categories |
| Flow Rate | Reference data | N/A (Reference data, not performance against a specific criterion for this submission) |
| Kink Resistance | Not explicitly stated, but implied to be comparable to competitors | Equivalent to or better kink resistance than competitive |
| Catheter Stiffness | Document stiffness using Tinius Olsen - reference data only | N/A (Reference data, not performance against a specific criterion for this submission) |
| Catheter Flexural Fatigue | The catheter must have acceptable results per the following conditions: |
- Flexural fatigue: simulated use, tip shaping testing
- Hoop stress fatigue: flow rate, dynamic burst, liquid leakage | Passed |
| Catheter Particle Testing | Per USP - less than 25 particles greater than 10 microns and less than 3 particles greater than 25 micron | Passed |
| Dead Space | Reference data | N/A (Reference data, not performance against a specific criterion for this submission) |
| Torque Test | 50 rotations without catheter breakage or equivalent to competitive product catheters. | Passed |
| DMSO Test | Functional performance and chemical stability | Passed |
| Biocompatibility (Cytotoxicity MEM Elution) | Cell culture tested with test article exhibited slight reactivity (Grade 1) | Non-toxic |
| Biocompatibility (Cytotoxicity Cell Culture Agar Overlay) | Grade 2: zone limited to under specimen | Non-toxic |
| Biocompatibility (Sensitization Guinea Pig Maximization Test) | Grade 0: No visible change | Non-irritant |
| Biocompatibility (Irritation Intracutaneous Reactivity Evaluation Test) | Comparative between control and test article 10%. No reaction found. | Non-toxic effects |
| Biocompatibility (Systemic Toxicity Rabbit Pyrogen Test) | Temperature increases was 0.0℃ from baseline. | Non-pyrogenic |
2. Sample size used for the test set and the data provenance:
The document describes general bench testing and biocompatibility testing. It does not specify the sample sizes (number of units tested) for each individual bench test or the biocompatibility studies.
The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. Given the context of a 510(k) submission, this data would typically be generated by the manufacturer (MicroVention, Inc., USA) as part of their device development and validation process, likely in a controlled laboratory environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies performed are primarily physical and chemical bench tests, and in vitro and in vivo biocompatibility tests, which do not typically involve human expert interpretation for "ground truth" establishment in the way, for example, a diagnostic image review would. For "rated 3 or higher," "passed," etc., these would be based on predefined objective criteria in test protocols, not subjective expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided in the document. Adjudication methods are typically used in studies involving human interpretation or decision-making, such as clinical trials or diagnostic accuracy studies, to resolve discrepancies among multiple reviewers. The tests described are objective, physical, chemical, and biological assessments.
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 and not provided. The device in question is a microcatheter, a physical medical device used for intravascular delivery. It is not an AI-powered diagnostic or assistive technology that would involve "human readers" or "AI assistance" in the sense of an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable and not provided for the same reasons as point 5. The device is a physical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the bench tests are the pre-defined engineering specifications and performance criteria for the physical properties of the catheter (e.g., length, diameter, burst pressure, kink resistance, force at break). For the biocompatibility tests, the "ground truth" is established by standardized ISO 10993 biological evaluation test methods which define acceptable biological responses (e.g., non-toxic, non-irritant, non-hemolytic).
8. The sample size for the training set:
There is no mention of a "training set." This concept is relevant to machine learning or AI algorithms. The Headway 27 Microcatheter is a physical medical device, and its development and testing involve traditional engineering and biological validation, not machine learning model training.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this 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).