Search Results
Found 1 results
510(k) Data Aggregation
(103 days)
The React™ 71 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
The React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with various durable polymer outer layers. A lubricious, polytetrafluoroethylene liner and Engage™ inner layer is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinum-iridium marker band which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. The proximal end of the React™ 71 Catheter is designed with a green thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is coated with a Surmodics Serene™ Coating.
The provided document describes the React™ 71 Catheter. Based on the content, here's a breakdown of the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various tests, their methods, and states that the React™ 71 Catheter "met the acceptance criteria" or similar statements for each. Specific quantitative acceptance criteria are generally not provided in this summary, but the results confirm compliance.
| Test Description | Test Method Summary | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | |||
| Cytotoxicity (Elution Method) | The test article extract showed no evidence of causing cell lysis or toxicity and had a Grade 0 (No Reactivity). | Grade < 2 (Mild Reactivity) | Met (Grade 0: No Reactivity), considered non-cytotoxic. |
| Sensitization (Guinea Pig Maximization Test) | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. | No evidence of sensitization | Met, does not elicit a sensitization response. |
| Irritation (Intracutaneous Reactivity) | The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.2 for the Sodium Chloride and Sesame Oil test article extracts, respectively. | Difference in mean score ≤ a specified threshold (implied to be low) | Met, considered a non-irritant. |
| Acute Systemic Toxicity (Systemic Toxicity) | There was no mortality or evidence of systemic toxicity from the extracts injected into mice. | No mortality or systemic toxicity | Met, does not indicate signs of toxicity. |
| Hemocompatibility (Hemolysis) | The hemolytic index for the test article in direct contact with blood was 0.8%, and the hemolytic index for the test article extract was 0.0%. | Hemolytic index below a specified threshold | Met (0.8% and 0.0%), considered non-hemolytic. |
| Hemocompatibility (Complement Activation) | The concentration of SC5b-9 in the test article was not statistically higher than the activated normal human serum control or the negative control. | SC5b-9 concentration not statistically higher than controls | Met, not considered a potential activator of the complement system. |
| Hemocompatibility (Thrombogenicity – Canine Model) | The control article had a mean score of 2.0. The test article had a mean score of 1.7 after four (4) hours (±30 minutes) without systemic anticoagulation. | Lower thrombogenic potential than predicate/control | Met, demonstrates lower thrombogenic potential compared to ACE 68 Reperfusion Catheter. |
| Pyrogenicity (Material Mediated) | Not a single animal showed a temperature rise of 0.5°C or more above its baseline temperature. The total rise of the rabbits' temperature during the three (3) hours was 0.0°C. | Temperature rise < 0.5°C above baseline | Met, considered non-pyrogenic. |
| Bench Performance (Leveraged Testing) | |||
| Ethylene Oxide Residual | Evaluated per ISO 10993-7. | Met acceptance criteria for residuals | Met the acceptance criteria. |
| Ethylene Chlorohydrin Residual | Evaluated per ISO 10993-7. | Met acceptance criteria for residuals | Met the acceptance criteria. |
| Bioburden Recovery | Evaluated per ISO 11737-1. | Met acceptance criteria for recovery | Met the acceptance criteria. |
| Bacterial Endotoxin | Evaluated per ANSI/AAMI ST72 and USP <161>. | Met acceptance criteria for endotoxin levels | Met the acceptance criteria. |
| Packaging Visual Inspection | Evaluated per ASTM F1886. | Met acceptance criteria for visual integrity | Met the acceptance criteria. |
| Bubble Leak | Evaluated per ASTM F2096. | Met acceptance criteria for leak integrity | Met the acceptance criteria. |
| Seal Strength | Evaluated per ASTM F88. | Met acceptance criteria for seal strength | Met the acceptance criteria. |
| Bench Performance (Conducted Testing) | |||
| Bioburden | Evaluated per ISO 11737-1. | Met acceptance criteria for bioburden | Met the acceptance criteria. |
| Visual Inspection | Inspected under x2.5 magnification. | Met acceptance criteria for visual integrity | Met the acceptance criteria. |
| Dimensional Measurements | Proximal ID, distal ID, proximal OD, distal OD, usable length, total length, coating length, and distal tip length measured. | Met acceptance criteria for specified dimensions | Met the acceptance criteria. |
| Tip Buckling | Evaluated for maximum compressive force. | Met acceptance criteria for tip buckling force | Met the acceptance criteria. |
| Kink Resistance | Evaluated for maximum kink diameter. | Met acceptance criteria for kink diameter | Met the acceptance criteria. |
| Particulate | Evaluated per USP <788>. | Met acceptance criteria for particulate levels | Met the acceptance criteria. |
| Coating Lubricity | Evaluated for average frictional forces. | Met acceptance criteria for frictional forces | Met the acceptance criteria. |
| Tensile Strength | Evaluated per ISO 10555-1. Annex B. | Met acceptance criteria for tensile strength | Met the acceptance criteria. |
| Liquid Leak | Evaluated per ISO 10555-1. Annex C. | Met acceptance criteria for liquid leak | Met the acceptance criteria. |
| Corrosion Resistance | Evaluated per ISO 10555-1. Annex A. | Met acceptance criteria for corrosion | Met the acceptance criteria. |
| Hub Aspiration Resistance | Evaluated per ISO 10555-1. Annex D. | Met acceptance criteria for hub air aspiration | Met the acceptance criteria. |
| Radiopacity | Markerband length and wall thickness measured; confirmed via fluoroscopy. | Met acceptance criteria for radiopacity | Met the acceptance criteria. |
| Luer Standards | Evaluated per ISO 594-1 and ISO 80369-7. | Met acceptance criteria for luer standards | Met the acceptance criteria. |
| Compatibility | Inspected for visual damage when delivering and retrieving interventional devices. | Met acceptance criteria for no visual damage/functionality | Met the acceptance criteria. |
| Torque to Failure | Evaluated for transmission of proximal torque to the distal tip. | Withstood typical clinical torsional forces | Was able to withstand torsional forces typical of clinical use. |
| Dynamic Pressure | Evaluated for the amount of pressure it can withstand. | Withstood typical clinical pressures | Was able to withstand pressures typical of clinical use. |
| Coating Integrity | Evaluated for coating coverage and lubricity. | Remained coated and lubricious | Remained coated and lubricious. |
| Usability | Evaluated for maneuverability and flexibility against a predicate device. | Met acceptance criteria for maneuverability and flexibility. | Met the acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test. For the biocompatibility study on thrombogenicity, it mentions a "Canine Model" with "four (4) hours (±30 minutes) without systemic anticoagulation," and comparing a "control article" to the "test article." This implies a very small comparative animal study, rather than a large test set for AI evaluation.
The provenance of data (e.g., country of origin, retrospective/prospective) is not provided as the tests are primarily bench and animal studies (biocompatibility) conducted in controlled laboratory settings for device performance and safety.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a medical device submission based on product performance and biocompatibility testing, not an AI/software submission requiring expert ground truth for classification or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. As this is not an AI/software submission involving human interpretation or adjudication for ground truth, this information is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No. This is a medical device submission for a catheter, not an AI system that would typically undergo MRMC studies.
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. The "standalone" performance here refers to the device's physical and biological performance in bench and animal tests.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed is based on established scientific and engineering standards and methods. For example:
- Biocompatibility: In vitro and in vivo testing (e.g., cell cultures, guinea pigs, mice, canine model) following ISO 10993 standards.
- Performance Data – Bench: Standardized laboratory tests (e.g., ISO, ASTM, USP) for physical, mechanical, and material properties.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no concept of a "training set" as understood in AI/machine learning. The device design and manufacturing processes are refined through engineering development, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model. For the device itself, the "ground truth" for its design and performance requirements is established through regulatory standards, predicate device characteristics, and engineering specifications.
Ask a specific question about this device
Page 1 of 1