(64 days)
The Headway 17 Advanced 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 17 Advanced Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semirigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the microcatheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheters are packaged individually with a variety of preshaped tips.
The provided document describes the MicroVention Headway 17 Advanced Microcatheter and its substantial equivalence to predicate devices, not a study evaluating acceptance criteria for an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be answered from the provided text.
The document focuses on demonstrating that the Headway 17 Advanced Microcatheter is substantially equivalent to existing devices based on various bench, animal, and biocompatibility tests. The "acceptance criteria" here are implicitly related to meeting the performance and safety specifications demonstrated by the predicate devices and relevant industry standards.
Here's the information that can be extracted or inferred from the provided text, structured to best match your request, while acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
For a device like the Headway 17 Advanced Microcatheter (a physical medical device, not an AI/ML system), "acceptance criteria" are typically defined by regulatory standards (like ISO 10555-1 and ISO 10993-1) and by demonstrating performance comparable to existing, legally marketed predicate devices. The study performed is a series of bench tests, animal studies, and biocompatibility tests to prove this.
| Acceptance Criteria Category (Implied) | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Physical and Mechanical Performance | Surface and physical attributes | Met same specifications as predicate |
| Tensile strength | Met same specifications as predicate | |
| Tip shape and retention | Met same specifications as predicate | |
| Leakage (liquid and air) | Met same specifications as predicate | |
| Static and dynamic burst pressure | Met same specifications as predicate | |
| Simulated use | Met same specifications as predicate | |
| Compatibility with devices | Met same specifications as predicate | |
| Kink resistance | Met same specifications as predicate | |
| Catheter flexural fatigue | Met same specifications as predicate | |
| Catheter stiffness | Met same specifications as predicate | |
| Hydrophilic coating | Met same specifications as predicate | |
| Particulate measurement analysis | Met same specifications as predicate | |
| Packaging testing | Met same specifications as predicate | |
| Insertion tool performance | Met specification - previously tested on predicate | |
| Flow rate | Met specification - previously tested on predicate | |
| Hub testing | Met specification - previously tested on predicate | |
| Corrosion resistance | Met specification - previously tested on predicate | |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Pass |
| Sensitization/Irritation (ISO 10993-10) | Pass | |
| Hemocompatibility (ISO 10993-4) | Pass | |
| Systemic Toxicity (ISO 10993-11) | Pass | |
| Clinical Performance (pre-market) | Acute animal study compared to predicate device | Comparable performance to predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each bench test. For the "acute animal study," the exact number of animals is not provided.
- Data Provenance: Not explicitly stated, but MicroVention, Inc. is located in Tustin, California, U.S.A. The studies are pre-market evaluations, which are inherently prospective for the specific purpose of device clearance.
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 question is not applicable to a physical device submission of this nature. "Ground truth" in this context would be defined by validated testing methodologies and compliance with established standards, not expert consensus on interpretations of data a human would use.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. The performance is measured against engineering specifications and predicate device performance, not through expert adjudication of an AI/ML output.
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 question is not applicable as the device is a physical microcatheter, not an AI-based system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical microcatheter, not an AI-based system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the bench tests: Engineering specifications and compliance with international standards (ISO 10555-1, ISO 10993-1) serve as the "ground truth" for performance.
- For the animal study: "Comparable performance to predicate device" implies that the predicate device's established safety and efficacy in an animal model served as the ground truth reference. Biocompatibility tests use Pass/Fail criteria defined by the ISO 10993 series.
8. The sample size for the training set
- This question is not applicable as the device is a physical microcatheter and does not involve AI/ML training.
9. How the ground truth for the training set was established
- This question is not applicable as the device is a physical microcatheter and does not involve AI/ML training.
§ 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).