(43 days)
The SOFIA PLUS/Distal Access Catheters are indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic and therapeutic agents. It is not intended for use in coronary arteries.
The SOFIA PLUS/Distal Access Catheters are a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steam-shapeable and it has a hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. An introducer sheath and shaping mandrel are also provided.
Here's an analysis of the provided text regarding acceptance criteria and the study:
Important Note: The provided document is a 510(k) summary for a medical device (SOFIA PLUS/Distal Access Catheter). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish novel performance criteria. Therefore, the "acceptance criteria" discussed are largely based on meeting the performance of the predicate and generally recognized good manufacturing practices and testing standards for similar devices. There isn't a "device performance" in the sense of accuracy/sensitivity/specificity for a diagnostic AI, but rather functional performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied / Stated) | Reported Device Performance and Conclusions |
|---|---|---|
| Bench Testing | ||
| Simulated Use | Device performs as intended under simulated use conditions. (Implied: Achieves rating $\geq$ 3 in preparation/ease of assembly, introducer sheath interaction, introducer peel away, tracking with guidewire/microcatheter, microcatheter/guidewire lockup, lubricity and durability of hydrophilic coating, microcatheter/ guidewire removal, removal/ aspiration of clot, mechanical clot retriever, and stent delivery with no particles.) | Test articles achieved a rating $\geq$ 3 for preparation/ease of assembly, introducer sheath interaction, introducer peel away, tracking with guidewire/microcatheter, microcatheter/guidewire lockup, lubricity and durability of hydrophilic coating, microcatheter/ guidewire removal, removal/ aspiration of clot, mechanical clot retriever and stent delivery with no particles. Conclusion: Device performs as intended under simulated use conditions. |
| Equipment Interface | Device compatible with recommended accessories commonly used in intravascular procedures. (Implied: Compatible with 0.035-inch guidewire, 7F or larger guide catheter/guiding sheath, common RHVs, stopcocks, and $\leq$ 0.027-inch microcatheters.) | Test articles compatible with 0.035-inch guidewire, 7F or larger guide catheter/guiding sheath, common RHVs using insertion tool, stopcocks and $\leq$ 0.027-inch microcatheters. Conclusion: Device compatible with recommended accessories commonly used in intravascular procedures. |
| Dimensional and Physical Attributes | Device meets established dimensional and physical specifications. (Implied: Meets specified requirements for catheter OD, catheter ID, overall working length, length of distal section, length of distal tip to marker band, and total length of hub/strain relief.) | Test articles met the specified dimensional requirements for catheter OD, catheter ID, overall working length, length of distal section, length of distal tip to marker band and total length of hub/strain relief. Conclusion: Device met established dimensional and physical specifications. |
| Kink Resistance | Device resistant to kinking around small radii turns. (Implied: No kinks at 1 cm, 4 cm, 12 cm, and 25 cm from distal tip when wrapped around 0.025, 0.030, 0.040-inch pin gauges; no kinks noted during simulated use testing.) | No kinks at 1 cm, 4 cm, 12 cm and 25 cm from distal tip when wrapped around 0.025, 0.030, 0.040-inch pin gauges. No kinks noted during simulated use testing. Conclusion: Device resistant to kinking around small radii turns. |
| Tip Shapeability | Shapeability of distal tip after steam shaping – for reference. (Implied: Equivalent to competitive devices when shaped to approximately 90°.) | Tip angle of test article equivalent to competitive devices after steam shaping using mandrel with an angle of approximately 90°. Conclusion: Shapeability of distal tip after steam shaping – for reference. |
| Radio Detectability | Device radiopacity equivalent to or better than predicate and competitive devices. (Implied: Distal marker band visible under fluoroscopy.) | Distal marker band visible under fluoroscopy. (Prior test data from predicate device). Conclusion: Device radiopacity equivalent to or better than predicate and competitive devices. |
| Gauging (ISO 594-2) | Device hub meets the requirements of ISO 594-2. (Implied: Gauging pin and hub align in limit planes.) | Gauging pin and hub align in limit planes. (Prior test data from predicate device). Conclusion: Device hub meets the requirements of ISO 594-2. |
| Separation Force (ISO 594-2) | Device hub meets the requirements of ISO 594-2. (Implied: Mating parts separation force greater than 25 N.) | Mating parts separation force greater than 25 N (Prior test data from predicate device). Conclusion: Device hub meets the requirements of ISO 594-2. |
| Unscrewing Torque (ISO 594-2) | Device hub meets the requirements of ISO 594-2. (Implied: Luer remains attached after applying an unscrewing torque not less than 0.02 Nm for a minimum of 10 seconds.) | Test article luer remains attached after applying an unscrewing torque not less than 0.02 Nm for a minimum of 10 seconds (Prior test data from predicate device). Conclusion: Device hub meets the requirements of ISO 594-2. |
| Stress Cracking (ISO 594-2) | Device hub meets the requirements of ISO 594-2. (Implied: No stress cracks on test article hub.) | No stress cracks on test article hub (Prior test data from predicate device). Conclusion: Device hub meets the requirements of ISO 594-2. |
| Ease of Assembly (ISO 594-2) | Device hub meets the requirements of ISO 594-2. (Implied: Components fit together securely with no resistance observed between test article luer and reference fitting.) | Components fit together securely with no resistance observed between test article luer and reference fitting (Prior test data from predicate device). Conclusion: Device hub meets the requirements of ISO 594-2. |
| Resistance to Overriding (ISO 594-2) | Device hub meets the requirements of ISO 594-2. (Implied: Test article luer does not override reference fitting threads.) | Test article luer does not override reference fitting threads (Prior test data from predicate device). Conclusion: Device hub meets the requirements of ISO 594-2. |
| Durability/Lubricity of Hydrophilic Coating | Device tracks easily with no coating cracking or separation. (Implied: Achieves a rating of $\geq$ 3 during simulated use testing for coating durability and lubricity.) | Test article achieved a rating of $\geq$ 3 during simulated use testing for coating durability and lubricity. Conclusion: Device tracks easily with no coating cracking or separation. |
| Catheter Stiffness | Device tracks in tortuous anatomy while advancing to target site. (Implied: Stiffness equivalent to predicate and competitive devices.) | Device stiffness equivalent to predicate and competitive devices. Conclusion: Device tracks in tortuous anatomy while advancing to target site. |
| Torque Strength | Device torque strength same as predicate device. (Implied: No catheter breakage after 50 rotations.) | No catheter breakage after 50 rotations. Conclusion: Device torque strength same as predicate device. |
| Catheter Flexural Fatigue | Device integrity suitable for intended clinical use. (Implied: No flexural fatigue after repeated bending and hoop stress during testing.) | No flexural fatigue following repeated bending during simulated use testing and repeated hoop stress following pressure and air aspiration testing. Conclusion: Device integrity suitable for intended clinical use. |
| Surface Contamination | Device integrity suitable for intended clinical use. (Implied: Free from surface contaminants, particulates > 0.02 mm², embedded particulates, and has a smooth tapered distal tip.) | Test article free from surface contaminants from uncured coating surface particulates > 0.02 mm², embedded particulates. Distal tip smooth and tapered. Conclusion: Device integrity suitable for intended clinical use. |
| Force at Break (Distal and Hub) | Tensile strength test results equivalent to predicate and competitive devices. (Implied: PTFE inner layer not delaminated, catheter force at break $\geq$ 3.37 lbf for distal section and hub/catheter junction.) | PTFE inner layer not delaminated. Catheter force at break $\geq$ 3.37 lbf for distal section and hub/catheter junction. Conclusion: Tensile strength test results equivalent to predicate and competitive devices. |
| Flow Rate | Device meets specified requirements for delivery of diagnostic agents. (Implied: Flow rate at 100 psi and 300 psi with diagnostic agents equivalent to or better than competitive devices.) | Flow rate at 100 psi and 300 psi with diagnostic agents (e.g., saline, contrast media) equivalent to or better than competitive devices. Conclusion: Device meets specified requirements for delivery of diagnostic agents. |
| Static Burst Pressure | Device integrity suitable for intended clinical use and met requirements of ISO 10555-1. (Implied: No damage of pressurized catheter at 46 psi.) | No damage of pressurized catheter at 46 psi. Conclusion: Device integrity suitable for intended clinical use and met requirements of ISO 10555-1. |
| Fluid Leakage at > 46 psi | Device integrity suitable for intended clinical use and met requirements of ISO 10555-1. (Implied: No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds.) | No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds. Conclusion: Device integrity suitable for intended clinical use and met requirements of ISO 10555-1. |
| Air Leakage | Device integrity suitable for intended clinical use and met requirements of ISO 10555-1. (Implied: No air leakage at hub into syringe for 15 seconds.) | No air leakage at hub into syringe for 15 seconds. Conclusion: Device integrity suitable for intended clinical use and met requirements of ISO 10555-1. |
| Dynamic Burst | Device met labeled maximum infusion pressure of 300 psi. (Implied: Test articles did not burst at or below 300 psi.) | Test articles did not burst at or below 300 psi. Conclusion: Device met labeled maximum infusion pressure of 300 psi. |
| Particulate Test | Device met specifications for maximum allowable particles. (Implied: Less than 25 particles greater than 10 microns per ml volume and less than 3 particles less than 25 microns per ml volume.) | Less than 25 particles greater than 10 microns per ml volume and less than 3 particles less than 25 microns per ml volume. Conclusion: Device met specifications for maximum allowable particles. |
| Biocompatibility | (Note: Biocompatibility was prior test data from predicate device.) | |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic. (Implied: Cell culture treated with test article exhibits slight reactivity (Grade 1).) | Cell culture treated with test article exhibited slight reactivity (Grade 1). Conclusion: Non-cytotoxic. |
| Sensitization/Irritation (ISO 10993-10) | Weak allergic potential or sensitizing capacity. (Implied: Extracts elicit no reaction (0% sensitization) following induction phase (Grade 1).) | Extracts of the test article elicited no reaction at the challenge (0% sensitization) following the induction phase (Grade 1). Conclusion: Weak allergic potential or sensitizing capacity. |
| Sensitization/Irritation (Intracutaneous) | Non-irritant. (Implied: Extracts do not show significantly greater biological reaction than control sites.) | Extracts of the test article did not show a significantly greater biological reaction than the sites injected with the control article. Conclusion: Non-irritant. |
| Hemocompatibility (Rabbit Blood) | Non-hemolytic. (Implied: Hemolysis index $\leq$ acceptable limits, e.g., 5% based on ISO standards; reported values are 0.13% direct, 0.0% indirect.) | The hemolysis index was 0.13% (direct contact) and 0.0% (indirect contact). Conclusion: Non-hemolytic. |
| Hemocompatibility (UPTT) | No effect on coagulation. (Implied: No statistically significant difference in UPTT compared to controls.) | No statistically significant difference found between the Unactivated Partial Thromboplastin Time (UPTT) of the plasma exposed to the test article and that of the plasma exposed to either the negative control or the untreated control. Conclusion: No effect on coagulation. |
| Hemocompatibility (Complement Activation) | No effect on complement activation. (Implied: C3a and SC5b-9 levels $\leq$ negative and untreated controls.) | C3a and SC5b-9 levels $\leq$ negative and untreated controls. Conclusion: No effect on complement activation. |
| Hemocompatibility (Thrombogenicity Study) | No significant thrombosis. (Implied: Minimal thrombosis observed.) | Minimal thrombosis observed with a Grade 0 in two out of two test sites and two out of two control sites. Conclusion: No significant thrombosis. |
| Systemic Toxicity (Systemic Injection) | No toxic effects. (Implied: Extracts do not induce significantly greater biological reaction than control extracts.) | Extracts of test article did not induce a significantly greater biological reaction than the control extracts when injected in Swiss Albino mice. Conclusion: No toxic effects. |
| Systemic Toxicity (Rabbit Pyrogen Test) | Non-pyrogenic. (Implied: Temperature increases (maximum) $\leq$ acceptable limits, e.g., 0.5°C; reported value 0.03°C.) | The temperature increases (maximum) was 0.03°C from baseline. Conclusion: Non-pyrogenic. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size for each bench test. Instead, it refers to "test articles" being evaluated. For the thrombogenicity study, it mentions "two out of two test sites and two out of two control sites" which implies a very small sample size for that specific animal study.
- Data Provenance: The studies are retrospective in the sense that they are laboratory bench tests and some animal biocompatibility tests for a new device intended to demonstrate equivalence to an already marketed device. The location of the testing is not explicitly stated, but MicroVention, Inc. is a U.S. company (Tustin, California), suggesting a U.S. origin for the tests. Some data (e.g., Radio Detectability, ISO 594-2 tests, Biocompatibility) are explicitly noted as "Prior test data from predicate device," meaning they were established from the previously approved SOFIA Distal Access Catheter (K142014/K131482).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This document describes technical device performance testing, not diagnostic or clinical performance requiring expert ground truth in the traditional sense of medical image interpretation (e.g., radiologists). The "ground truth" for these tests is defined by established engineering specifications, medical device standards (e.g., ISO 594-2, ISO 10555-1, ISO 10993 series), and comparisons to predicate and competitive devices. The evaluations (e.g., rating of ease of assembly, observation of kinks) would have been performed by qualified laboratory personnel following test protocols, but specific "experts" or their qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements or performance evaluations against defined criteria, not observations requiring adjudication by multiple human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is focused on the physical and biological performance of an intravascular catheter, not on the interpretation of medical images or an AI's diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are all "standalone" in the sense that they evaluate the device's physical and biocompatible properties directly against predetermined criteria, without human interaction as part of a diagnostic or interpretive loop. The "standalone" here means device-only testing, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these performance tests includes:
- Engineering Specifications: Defined dimensional requirements, force thresholds, flow rates, etc.
- International Standards: Compliance with ISO standards (e.g., ISO 594-2 for luer connectors, ISO 10555-1 for catheters, ISO 10993 series for biocompatibility).
- Predicate Device Performance: Comparison to the performance of the legally marketed predicate device (SOFIA Distal Access Catheter).
- Competitive Device Performance: Comparison to the performance of other devices in the market.
- Visual/Qualitative Assessment: Graded ratings (e.g., for simulated use, coating durability), and observations for the presence/absence of kinks, cracks, leakage, etc., performed by trained technicians according to protocols.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (catheter), not an AI/ML algorithm. Therefore, there is no "training set." The materials and design are "trained" through iterative engineering and manufacturing processes, but not in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as outlined in point 8.
§ 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).