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510(k) Data Aggregation
(107 days)
The React™ 68 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
The React™ 68 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with a durable polymer outer layer. A lubricous, polytetrafluoroethylene liner is used to create a structure that has both proximal stiffness and distal flexibility, and an encapsulated radiopaque distal platinum-iridium markerband which is used for visualization under fluoroscopy. The React™ 68 Catheter is introduced into the vasculature through the split y-introducer sheath. The proximal end of the React™ 68 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The React™ 68 Catheter is designed with a hydrophilic coating.
This is a 510(k) premarket notification for the React™ 68 Catheter. The document focuses on demonstrating substantial equivalence to predicate devices through design comparisons and extensive bench testing. Animal and clinical studies were not deemed necessary for this submission.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes numerous functional, biocompatibility, and sterilization-related tests. The "Acceptance Criteria" for each test are implicitly that the device "met the acceptance criteria" or demonstrated results within acceptable limits for safe and effective use. The "Reported Device Performance" is the stated outcome of each test.
| Test Description | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility: | ||
| Cytotoxicity (Elution Method) | No evidence of cell lysis/toxicity (grade < 2) | Grade of 0 (no reactivity), considered non-cytotoxic |
| Sensitization (Guinea Pig Maximization) | No evidence causing delayed dermal contact sensitization | No evidence of causing delayed dermal contact sensitization |
| Irritation (Intracutaneous Reactivity) | Difference between test/control scores of 0 | Difference of 0.0 for NaCl and sesame oil extracts, considered non-irritant |
| Acute Systemic Toxicity (Systemic Toxicity) | No mortality or evidence of systemic toxicity | No mortality or evidence of systemic toxicity |
| Hemocompatibility (Hemolysis) | Hemolytic index within acceptable limits | Hemolytic index of 0.9% (direct), 0.0% (extract) |
| Hemocompatibility (Complement Activation) | Test article not statistically higher than controls | Test article not statistically higher than controls, not a potential activator of complement system |
| Hemocompatibility (Thrombogenicity) | Minimal thrombus formation | Minimal thrombus formation after 4 hours |
| Pyrogenicity (Material Mediated) | No animal temperature rise $\ge$ 0.5°C over baseline | No animal showed a temperature rise of 0.5°C or more |
| Performance Data – Bench (Microbial): | ||
| Ethylene Oxide Residual | Met ISO 10993-7 acceptance criteria | Met the acceptance criteria for ethylene oxide residual |
| Ethylene Chlorohydrin Residual | Met ISO 10993-7 acceptance criteria | Met the acceptance criteria for ethylene chlorohydrin residual |
| Bioburden | Met ISO 11737-1 acceptance criteria | Met the acceptance criteria for bioburden |
| Bacterial Endotoxin | Met ANSI/AAMI ST72 and USP <161> acceptance criteria | Met the acceptance criteria for bacterial endotoxin |
| Performance Data – Bench (Performance): | ||
| Visual Inspection | Met acceptance criteria | Met the acceptance criteria for visual inspection |
| Dimensional Measurements | Met acceptance criteria for all measured dimensions | Met the acceptance criteria for dimensional measurements |
| Tip Buckling | Met acceptance criteria for maximum compressive force | Met the acceptance criteria for tip buckling |
| Kink Resistance | Met acceptance criteria for maximum kink diameter | Met the acceptance criteria for kink resistance |
| Particulate | Met USP <788> acceptance criteria | Met the acceptance criteria for particulate evaluation |
| Coating Lubricity | Met acceptance criteria for average friction forces | Met the acceptance criteria for coating lubricity |
| Tensile Strength | Met ISO 10555-1 Annex B acceptance criteria | Met the acceptance criteria for tensile strength at hub and shaft |
| Liquid Leak | Met ISO 10555-1 Annex C acceptance criteria | Met the acceptance criteria for liquid leak |
| Corrosion Resistance | Met ISO 10555-1 Annex A acceptance criteria | Met the acceptance criteria for corrosion resistance |
| Hub Aspiration Resistance | Met ISO 10555-1 Annex D acceptance criteria | Met the acceptance criteria for hub air aspiration |
| Compatibility | Met acceptance criteria for visual damage during use | Met the acceptance criteria for delivering and retrieving interventional devices |
| Radiopacity | Met acceptance criteria (markerband/wall thickness, fluoroscopy) | Met the acceptance criteria for radiopacity |
| Luer Standards | Met ISO 594-1 and ISO 80369-7 acceptance criteria | Met the acceptance criteria for luer standards |
| Torque Strength | Able to withstand typical clinical torsional forces | Able to withstand torsional forces typical of clinical use |
| Dynamic Pressure | Able to withstand typical clinical pressures | Able to withstand pressures typical of clinical use |
| Coating Integrity | Coating remained covered and lubricious | Remained coated and lubricous |
| Usability | Met acceptance criteria for maneuverability and flexibility | Met the acceptance criteria for usability |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes for each specific test within the bench testing. However, such tests would typically involve a statistically relevant number of units to ensure reliability. The data provenance is from bench testing conducted by the manufacturer, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The data is prospective as it was generated specifically for this submission. The country of origin of the data is not explicitly stated but can be inferred as the United States given the FDA submission and the company's address in Irvine, CA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a physical catheter, and its performance is evaluated through objective, standardized physical and chemical tests (e.g., ISO standards, USP, visual inspection, dimensional measurements). There is no "ground truth" derived from expert interpretation in the context of diagnostic performance testing of, for example, medical images.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth for this type of device's performance is established through objective laboratory testing against predetermined specifications and international standards, not through adjudications of expert opinions.
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. This is a physical medical device (catheter) and not an AI or imaging diagnostic device. Therefore, MRMC studies are irrelevant.
6. 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.
7. The Type of Ground Truth Used
The "ground truth" for the React™ 68 Catheter's performance is defined by its compliance with:
- Industry Standards: Such as ISO 10993 (Biocompatibility), ISO 11737-1 (Bioburden), ANSI/AAMI ST72 (Bacterial Endotoxin), USP <161>/<788> (Bacterial Endotoxin/Particulate), ISO 10555-1 (Catheter testing), ISO 594-1/80369-7 (Luer standards).
- Predicate Device Performance: Demonstrating substantial equivalence to legally marketed predicate devices in terms of materials, dimensions, and functional characteristics.
- Engineering Specifications: Internal design requirements for dimensions, material properties, and functional performance (e.g., tip buckling, kink resistance, lubricity, tensile strength).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no "training set" for this device.
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