(190 days)
The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are indicated for the introduction of interventional devices into the peripheral and neurovasculature.
The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are designed for the introduction of interventional devices into the peripheral and neurovasculature. The Arc™ Mini are a single lumen, flexible, variable stiffness composite catheters with a Nitinol structure. A radiopaque marker band on the distal tip of the devices is used for visualization under fluoroscopy. The distal sections of both catheters are coated with a hydrophilic coating, which is used to reduce the overall frictional force during intravascular use. The Arc™ and Arc™ Mini dimensions are included in the individual device label. The devices are supplied sterile and are intended for single-use only.
This document is a 510(k) Pre-Market Notification for the Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter. It focuses on establishing substantial equivalence to a predicate device (ReFlex™ Guide Catheter) through non-clinical testing. Therefore, it does not involve AI/ML performance criteria, human reader studies, or training/test sets as commonly understood in AI device submissions.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit from "met acceptance criteria") | Reported Device Performance |
|---|---|---|
| Lumen Patency | Mandrel of required size must pass through total length of device from proximal hub to distal tip. | All devices met acceptance criteria. |
| Dimensional Inspection | Dimensions (usable length, proximal/distal inner/outer diameters) must meet specified values. | All devices met acceptance criteria. |
| Distal Tip Buckling | Distal tip buckling force must meet specified criteria for stiffness under compressive load. | Distal tip buckling force met acceptance criteria. |
| Catheter Injection Flow Rate | Injection flow rate must meet specified criteria (ISO 10555-1, Annex E methods). | Injection flow rate met acceptance criteria. |
| Catheter Suction Flow Rate | Suction flow rate must meet specified criteria (ISO 10555-1, Annex E methods). | Suction flow rate met acceptance criteria. |
| Vacuum Resistance | Device must be resistant to vacuum collapse under static conditions with a 60cc syringe. | Device was resistant to vacuum collapse under static conditions. |
| Hub Air Aspiration Leak | Must meet ISO 10555-1, Annex D hub air aspiration leak criteria. | Hub air aspiration test met acceptance criteria. |
| Shaft Peak Tensile Force | Shaft joint peak tensile strength must meet specified criteria (ISO 10555-1, Annex B methods). | Shaft joint peak tensile force met acceptance criteria. |
| Hub Peak Tensile Force | Hub-shaft joint peak tensile strength must meet specified criteria (ISO 10555-1, Annex B methods). | Hub-shaft joint peak tensile force met acceptance criteria. |
| Coating Integrity – Baseline | (Characterization of worst-case coating defects) | Baseline coating integrity characterized with worst-case defect images. Data collected as engineering reference. (No explicit "met" here, but indicates characterization was performed) |
| Coating Lubricity/Durability | Average frictional force and durability must meet specified criteria. | Coating lubricity and durability testing met acceptance criteria. |
| Particulate Testing | Number of particulates generated under simulated use must meet specified criteria. | Number of particulates generated met acceptance criteria. |
| Coating Integrity – Simulated Use | (Characterization of worst-case coating defects after simulated use) | Post-simulated use coating integrity characterized with worst-case defect images. (No explicit "met" here, but indicates characterization was performed) |
| Kink Resistance | Device must be resistant to kinking around small radii. | Device was resistant to kinking around small radii. |
| Liquid Leakage | Must meet ISO 10555-1, Annex C liquid leakage criteria. | Liquid leakage met acceptance criteria. |
| Static/Dynamic Burst | Burst strength and performance during worst-case dynamic injections must meet specified criteria. | Static/dynamic burst testing met acceptance criteria. |
| Torque to Failure | Number of rotations to failure must meet specified criteria. | Torque to failure testing met acceptance criteria. |
| Physician Usability Testing | Compatibility with accessories, device stability, ability to aspirate, ability to inject saline or contrast, and user's ability to navigate to the M1 and M2 segment of the MCA and retrieve a mechanical thrombectomy device must meet acceptance criteria in a tortuous benchtop model. | All test results met the acceptance criteria. |
Biocompatibility Testing:
| Test | Acceptance Criteria (Implicit from "Conclusion") | Result / Conclusion |
|---|---|---|
| Plastics (USP) | Meet USP Physicochemical extraction parameters. | Passes physical chemical characteristics. |
| L929 MEM Elution Test - ISO | Non-cytotoxic (score "0" at 24, 48, and 72 ± 4 hours). | Non-cytotoxic. |
| Klingman Maximization Test - ISO (Guinea Pig Sensitization) | No sensitization response. | Non-sensitizer. |
| Intracutaneous Injection Test - ISO | Differences in mean test and control scores for dermal observations less than 1.0. | Non-irritant. |
| Acute Systemic Injection Test - ISO | No clinical signs consistent with toxicity. | Non-cytotoxic. |
| Materials Mediated Rabbit Pyrogen - ISO | No pyrogenic response (does not exceed USP limit). | Non-pyrogenic. |
| Hemolysis: Direct Contact / Indirect Extract | No significant differences between test article extract and negative control. | Non-hemolytic. |
| Complement activation C3a and SC5b-9 | Levels comparable to control device (ReFlex) and less than positive control. | Levels of the compliments C3a and SC5b complements were similar for Arc and control device. |
| Thrombosis (in vivo) — Canine (Arc / ReFlex) | Acceptable thromboresistance. | Acceptable, expected to be equivalent to ReFlex in clinical use. |
| in vitro Hemocompatibility Assay | No decrease in any blood component compared to reference material. | No adverse effect on platelet and leukocyte counts. |
| Partial Thromboplastin Time | Clotting times similar to negative control and reference material. | No adverse effect on prothrombin coagulation time of human plasma. |
| Ames bacterial Mutagenicity 4 salmonella+1e.coli | Non-mutagenic. | Non-mutagenic. |
| in vitro Mouse Lymphoma Assay with Extended Treatment | Non-mutagenic (non-genotoxic and non-clastogenic). | Non-mutagenic. |
| in vivo Mouse Micronucleus Assay | Non-mutagenic. | Non-mutagenic. |
Regarding AI/ML-specific questions (2-9):
This document describes a traditional medical device submission (catheter) focused on demonstrating substantial equivalence through bench testing, design validation, and biocompatibility testing. It does not involve software with AI/ML components for which these specific questions would be relevant. Therefore, most of these questions are not applicable.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a hardware device submission. Bench testing involved samples of the catheters, but not in the context of "test sets" for AI/ML validation. The document does not specify exact sample sizes for each bench test, but implies sufficient samples were used to meet statistical validity for the stated conclusions.
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)
- Not Applicable. No ground truth needed for AI/ML performance. Physician Usability Testing involved users, implied to be qualified, but not "experts establishing ground truth" as defined for AI/ML.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication for AI/ML performance.
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
- Not Applicable. No AI/ML component; therefore, no MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. No AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth, in the context of an AI/ML device, does not apply here. The "ground truth" for this device's performance are the established standards and specifications for mechanical performance, material properties, and biocompatibility, against which the device was tested.
8. The sample size for the training set
- Not Applicable. No AI/ML training set.
9. How the ground truth for the training set was established
- Not Applicable. No AI/ML training set or ground truth establishment.
§ 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).