(212 days)
The Plato MICROCATH 27B Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents to the peripheral system. The cather is not intended for use in cither the coronary or neuro vasculature.
The Plato MICROCATH® 27B Microcatheter is a single lumen microcatheter constructed with a flexible polymer shaft of varying stiffness to aide in accessing vasculature. The catheter is designed to be used with a guide catheter and a steerable guidewire for accessing the vasculature. The proximal end of the catheter has a diameter of 3.4F, tapering to a distal OD of 3.2F, which can be inserted into a 5F guide catheter. The inner diameter is constant throughout the shaft length and accommodates up to a 0.025" guidewire. The catheter is 150 cm in length with a straight tip configuration which can be steam-shaped to the doctor's preferred shape. A steam shaping mandrel is included in the packaging. The microcatheter has hydrophilic coating on the outer distal shaft to reduce friction during manipulation in vessels and has one radiopaque tip marker to facilitate fluoroscopic visualization.
The provided document describes the FDA 510(k) summary for the Plato MICROCATH® 27B Microcatheter, focusing on demonstrating substantial equivalence to predicate devices, not on proving effectiveness for a new diagnostic or interventional AI device. Therefore, the traditional acceptance criteria, study design parameters, and concepts like 'human readers improve with AI' are not applicable to this submission.
Instead, the document details performance data collected from non-clinical testing to show that the new microcatheter is as safe and effective as existing, legally marketed predicate devices. The acceptance criteria essentially derive from established standards for medical devices and comparisons to the predicate devices.
Here's an adaptation of your requested table and information, tailored to the context of this medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Test (Acceptance Criteria Derived From) | Acceptance Criteria (Implicit/Explicit from standards; "Comparable to predicate" suggests meeting predicate's performance) | Reported Device Performance |
|---|---|---|
| Biocompatibility: | ||
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic (Scores = 0) | Non-cytotoxic. Test article scores were 0 at 48 hours. |
| Sensitization (ISO 10993-10) | Negative for dermal sensitization (Scores = 0) | Negative for dermal sensitization. Test articles sensitization scores were all 0. |
| Irritation/Intracutaneous Reactivity (ISO 10993-10) | Non-irritating (No significantly greater biological reaction than control) | Non-irritating. Extracts of the test article did not show a significantly greater biological reaction than sites injected with control article. |
| Acute Systemic Toxicity (ISO 10993-11) | Non-toxic (No toxicity or animal weight loss) | Non-toxic. Test articles showed no toxicity or animal weight loss for both cottonseed oil and saline extracts for 72 hour test period. |
| Materials-Mediated Pyrogenicity (ISO 10993-11) | Non-pyrogenic (No increases in individual temperatures) | Non-pyrogenic. No increases in individual temperatures. |
| Hemocompatibility – Hemolysis (ASTM 758-08) | Non-hemolytic (Corrected hemolysis index below threshold) | Non-hemolytic. Corrected hemolysis index was 0.15% by direct method, 0.23% by extract. |
| Partial Thromboplastin Time (ASTM F2382) | Similar activation profile to predicate (Minimal activators, minimal difference in clotting times) | Both test article and predicate were minimal activators. Difference in clotting times between test article and predicate was 3 seconds. |
| Complement Activation (ISO 10993-4) | Less than or comparable to predicate | Complement activation by the test article was less than that of the predicate device. |
| Thrombogenicity in Dogs (ISO 10993-4) | Comparable to predicate (Thrombosis grade, weight changes) | Thrombosis grade comparable to predicate. Weight changes of the implants comparable between test and control articles. |
| Functional Testing: | ||
| Visual/Dimensional Inspection | No surface defects, visible droplets, or defects causing trauma; Meets dimensional specifications | No surface defects or visible droplets of coating on catheters. All catheters met dimensional specifications. |
| Air Ingress/Negative Collapse (ISO 10555) | No air ingress, no lumen collapse | Hub fittings do not allow air ingress and no evidence of lumen collapse. |
| Kink Resistance | Resistant to kinking around small diameter turns per specification | Device was resistant to kinking around small diameter turns per specification. |
| Tensile Strength/Elongation (ISO 10555-1) | Meets minimum force breakage based on tube diameters | All catheters met minimum force breakage based on tube diameters specified in ISO 10555-1. |
| Liquid Leakage under Pressure/Leakage at Hub (ISO 10555-1) | No leakage from hub or catheter body at specified pressures | No leakage from hub or catheter body. |
| Tip Stiffness (ASTM D747-10) | Comparable to predicate devices | Tip stiffness was comparable that of the predicate devices. |
| Pressure vs. Flow Characterization | Flow rates reported in Instructions for Use at 100 and 300 psi | Flow rates reported in Instructions for Use at 1.00 and 300 psi. (Note: "1.00" might be a typo and likely meant 100 psi as per test description.) |
| Static Burst Pressure (ISO 10555-1) | Maximum peak pressures exceeded 300 psi | Maximum peak pressures all exceeded 300 psi. |
| Dynamic Flow | No leaks, breaks or occluded lumens at 750 psi | No leaks, breaks or occluded lumens at 750 psi. |
| Flexibility Fatigue and Profile | No signs of cracks or breakage post worst-case simulated use | All catheters showed no signs of cracks or breakage post worst case simulated use. |
| Shape Retention | Maintain specified tip angle post shaping/conditioning/use; Tensile strength meets original specs after shaping | All catheters maintained specified tip angle after steam shaping, water bath conditioning and simulated use of guidewires. Tensile testing after tip shaping passed minimum tensile strength requirements. |
| Torque to Failure | No signs of breakage, twists or collapsed lumens after specified number of torque turns | All catheters showed no signs of breakage, twists or collapsed lumens after specified number of torque turns. |
| Coating Lubricity and Durability | Meets specified frictional forces | All catheters met specified frictional forces. |
| Coating Integrity | Acceptable coating coverage post simulated use | All samples showed acceptable coating coverage post simulated use. |
| Particulates | Comparable numbers of particles to predicate in each size range | The test and predicate catheters had comparable numbers of particles in each size range. |
| Chemical Compatibility | No signs of degradation, corrosion, or physical decomposition after exposure to agents | All catheters showed no signs of degradation, corrosion or physical decomposition. |
| Latex Content (ASTM D6499-07) | No detectable traces of latex found | No detectable traces of latex found. |
| Corrosion Resistance (ISO 10555-1) | No signs of corrosion on metallic components | No signs of corrosion on metallic components of catheters. |
| Radiopacity | Acceptable radiopacity (evaluated by physicians) | Both test and predicate catheters had acceptable radiopacity. |
| MRI Compatibility | Labeled MRI Unsafe (as applicable for conducting/magnetic materials) | Catheters are labeled MRI Unsafe on IFU. |
| Simulated Use | Comparable Likert scores to predicate in Guidewire tracking and guide catheter movement; Interventional devices successfully deployed | Catheters and predicate devices had comparable Likert scores in terms of Guidewire tracking and guide catheter movement. Interventional devices successfully deployed. |
| Cadaver Testing | Comparable performance and access time to predicate in designated target; Ability to deploy/retrieve interventional devices | Test and predicate devices both exhibited comparable performance with similar access time to the designated target. |
| Packaging Testing (ASTM F88-00, F2096-04) | Minimum seal strength met, no bubbles under leak test conditions | All sterile barrier pouches met minimum seal strength and showed no bubbles under leak test conditions. |
| Shelf Life Testing | Continued to meet specifications post accelerated aging and room temperature storage | Shelf life testing in progress. Expiration date will be advanced as aging data are available to demonstrate package and product continues to meet specifications. |
2. Sample Size Used for the Test Set and Data Provenance
This document primarily reports on non-clinical bench and lab testing, and some limited biological/simulated use testing. The "test set" here refers to the number of devices or samples tested for each specific non-clinical performance attribute.
- Sample Sizes: Not explicitly stated for each test, but implied by the nature of bench testing where multiple samples are typically used to ensure reliability. For example, "all catheters" met specifications implies multiple catheters were tested. For animal studies (thrombogenicity) and cadaver studies, the sample size would be small (e.g., number of dogs, cadavers). For Radiopacity and Simulated Use, "physicians," plural, suggests more than one device per observer.
- Data Provenance: The data is primarily from bench-top laboratory testing and in vitro studies, in accordance with ISO and ASTM standards. Some tests involve animal models (e.g., thrombogenicity in dogs) and human cadavers. The context implies these studies were conducted by the manufacturer or their contracted labs. No specific country of origin for the data is mentioned, but the submission is to the U.S. FDA, and the company is US-based. This is all prospective testing, specifically designed to demonstrate compliance for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Experts: The document mentions "physicians" evaluated radiopacity and participated in cadaver testing. For simulated use, "physicians" also provided Likert scores.
- Number: Not explicitly stated how many physicians were involved in these evaluations. The plural "physicians" indicates more than one.
- Qualifications: Not explicitly stated in terms of years of experience or specific subspecialty (e.g., interventional radiologist), but given the context of medical device evaluation, it is implied that these are qualified medical professionals with expertise relevant to microcatheters and their use.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly detailed. For tests involving "physicians" (Radiopacity, Simulated Use, Cadaver Testing), it is stated that comparisons were made or scores obtained. The document does not specify if there was a formal adjudication process (e.g., 2+1, 3+1), rather it presents the aggregate findings or an overall determination of "comparable" or "acceptable."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study (often used for diagnostic imaging AI) is not applicable to a premarket notification for a physical medical device like a microcatheter. The comparison is primarily against established performance standards and a predicate device's existing characteristics. The "simulated use" and "cadaver testing" involve human readers/users (physicians) providing feedback, but this is to assess usability and performance in a simulated environment, not an MRMC study comparing AI with and without human assistance.
- Effect Size of Human readers with/without AI: Not applicable, as this is not an AI device.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This submission is for a physical medical device (microcatheter), not an algorithm or AI product. The performance evaluations are intrinsic to the device itself and its interaction with biological and simulated environments.
7. The Type of Ground Truth Used
The concept of "ground truth" as it applies to diagnostic or AI studies is not directly applicable here. Instead, the basis for comparison and acceptance is:
- Established Industry Standards: ISO 10993 (biocompatibility), ISO 10555 (intravascular catheters), ASTM standards.
- FDA Guidance: FDA guidance for Short-Term and Long-Term Intravascular Catheters, FDA Special Controls Document for PTCA Catheters.
- Predicate Device Performance: Direct comparison to the ev3 Marksman™ Catheter (K111490, K091559) and the Scientia Vascular, LLC Plato MICROCATH 27 (K121734). The goal is to demonstrate that the new device is "substantially equivalent" in safety and effectiveness.
- Expert Observational Consensus: For aspects like radiopacity and simulated use feedback from physicians.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device, so there is no "training set." The device design and materials are based on engineering principles and prior device knowledge.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI model, this question does not apply. The "ground truth" for the device's design and expected performance comes from established engineering principles, regulatory standards, and the performance characteristics of predicate devices.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).