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510(k) Data Aggregation
(219 days)
Slinky Catheter
The Slinky Catheter is indicated for general intravascular use. including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents and therapeutic devices. It is not intended for use in coronary arteries.
The Slinky® Catheter is a single lumen, variable stiffness catheter with a coil and braid reinforcement. It has a radiopaque marker at the distal tip for enhanced fluoroscopic visualization, a lubricious inner, and a hydrophilic coating on the distal 35 cm to enhance lubricity and vascular navigation. The Slinky® Catheter is provided sterile via Ethylene Oxide (EO) sterilization, non-pyrogenic, and is for single use only.
This document describes the premarket notification (510(k)) for the Anoxia Medical, Inc. Slinky Catheter. The primary purpose of the submission is to demonstrate substantial equivalence to a predicate device, the SOFIA PLUS/Distal Access Catheters (K150366). The document does not describe a study involving an AI component or the improvement of human readers with AI assistance. Instead, it focuses on the engineering and biocompatibility performance of the Slinky Catheter.
Since the prompt asks for details related to AI performance, multi-reader multi-case (MRMC) studies, and the use of expert consensus for ground truth in an AI context, and the provided text describes a medical device (a catheter) and its physical and biological performance, I will interpret the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, adapting the categories to fit the provided information on a physical medical device rather than an AI or software product.
Here's an analysis based on the provided text for the Slinky Catheter, focusing on its performance criteria and the studies conducted:
1. A table of acceptance criteria and the reported device performance
The document provides a table of various tests, their methods, and conclusions. The "Conclusions" column effectively serves as the "reported device performance" and implicitly indicates that the acceptance criteria were met, as all conclusions state the device performed as intended, met established criteria, or was comparable to the predicate.
| Test | Test Method Summary | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Bench Performance Testing | |||
| Simulated Use | Test articles used by three trained interventional neuroradiologists in a tortuous anatomical bench test model, demonstrating compatibility with ancillary devices. | Device to perform as intended under simulated use conditions. | Device performed as intended under simulated use conditions. |
| Particulate Test | Test articles tracked multiple times through tortuous anatomical model with ancillary devices. Inspected for coating anomalies pre- and post-testing. | Particulate generation of subject device to be similar to predicate device. | Particulate generation of the subject device was similar to the predicate device. |
| Product Compatibility | Simulated use testing by three physicians using full-length silicone anatomical tortuous path model. Included use with worst-case ancillary devices. | Device to be compatible with ancillary devices. | The device was found to be compatible with ancillary devices. |
| Dimensional and Visual Attributes | Physical and dimensional attributes evaluated and measured. | Device to meet established dimensional and visual specifications. | Device met the established dimensional and visual specifications. |
| Kink Resistance | Distal, mid, and proximal sections wrapped around varying size pin gauges. | Device to meet established kink resistance criteria. | Device met the established kink resistance criteria. |
| Radio Detectability | Distal marker band and catheter body visibility evaluated under fluoroscopy. | Device radiopacity to be comparable to predicate device. | Device radiopacity comparable to the predicate device. |
| Catheter Hub | Hub functionality evaluated during simulated use, freedom from leakage, flow rate, dynamic burst, particulate, and other bench testing. | Device hub to meet requirements of ISO 80369-7. | Device hub meets the requirements of ISO 80369-7. |
| Durability/Lubricity of Hydrophilic Coating | Coating evaluated after simulated use for defects and friction force. | Device to meet established friction and lubricity criteria; friction force similar to predicate. | Device met the established friction and lubricity criteria. The friction force was similar to the predicate. |
| Tip Flexibility | Device tip stiffness characterized on a cantilever bend test. | Tip stiffness to be similar to predicate. | The tip stiffness was similar to the predicate. |
| Torque Strength | Devices pre-conditioned by simulated use and torqued to failure inside a tortuous anatomical model with distal tip fixed. | Device torque strength to be same as predicate device. | Device torque strength is the same as the predicate device. |
| Force at Break (Distal and Hub) | Catheter force at break averaged 8 lbf for hub and 5-6 lbf for mid and distal segments, exceeding acceptance criteria from withdrawal force measurements. | Tensile strength to meet acceptance criteria determined from withdrawal force measurements. | Tensile strength meets the test acceptance criteria. |
| Flow Rate | Characterized at 100 psi with diagnostic agents (e.g., saline, contrast media). | Device to meet specified requirements for delivery of diagnostic agents. | Device meets the specified requirements for delivery of diagnostic agents. |
| Static Burst Pressure | Device withstand static pressure above labeled 100 psi maximum with margin of safety. | Device integrity to be suitable for intended clinical use and meet requirements of ISO 10555-1. | Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1. |
| Freedom from Leakage | Testing followed methods and criteria defined in EN ISO 10555-1 after pre-conditioning by simulated use. | Device integrity to be suitable for intended clinical use and meet requirements of ISO 10555-1. | Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1. |
| Air Leakage | No air leakage at hub into syringe for 15 seconds. | Device integrity to be suitable for intended clinical use and meet requirements of ISO 10555-1. | Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1. |
| Dynamic Burst | Devices pre-conditioned by simulated use. Test devices connected to pressurized fluid source, starting with 250 psi and increased every 10 seconds up to 600 psi. | Device to meet labeled maximum infusion pressure of 100 psi. | Device met labeled maximum infusion pressure of 100 psi. |
| Peak Tensile Force | Devices pre-conditioned by simulated use. Tensile testing conducted per methods defined in EN ISO 10555-1. | Device to meet acceptance criteria determined from withdrawal force testing. | Device met acceptance criteria determined from withdrawal force testing. |
| Biocompatibility Testing | |||
| Cytotoxicity (ISO 10993-5) - MEM Elution Assay | Cell culture observed for cytotoxic reactivity following exposure to test extract with Grade , ISO 10993-11) | Study animals observed for individual temperature rise following intravenous injection of test extracts. | Non-pyrogenic. |
| Hemolysis (ASTM F756, ISO10993-4) – Direct and Indirect (extract) Hemolysis | Difference between hemolytic indexes of subject device and negative control evaluated after exposure to test extracts and direct exposure to test article. | Non-hemolytic. | Direct contact - Non-hemolytic; Indirect contact - Non-hemolytic |
| SC5b-9 Complement Activation Assay (ISO 10993-4) | Using an enzyme immunoassay, SC5b-9 concentration following exposure of test article extracts to normal human serum (NHS) compared to SC5b-9 of control article exposed to NHS. | Not considered to be a potential activator of the complement system. | Not considered to be a potential activator of the complement system |
| Thrombogenicity (ASTM F2382) - Partial Thromboplastin Time | Thrombogenicity potential of test article compared to control articles. | Acceptable results. | Acceptable results |
| Platelet and Leukocyte Count (ASTM F2888-19, ISO 10993-4) In vitro Blood Loop | (Test Method Summary Blank) | (Implied acceptable performance for blood compatibility) | (Conclusions blank, but generally implied to be acceptable based on overall summary) |
| Sterilization and Shelf-Life | |||
| Sterilization | Validated process to achieve a minimum sterility assurance level (SAL) of 10^-6. | SAL of 10^-6. | Achieved minimum sterility assurance level (SAL) of 10^-6. |
| Shelf-Life | Studies conducted to demonstrate product and packaging remain functional and sterile. | Product and packaging remain functional and sterile for 12 months. | Demonstrates functionality and sterility for 12 months. |
2. Sample size used for the test set and the data provenance
- Sample Size for Bench Tests:
- Simulated Use, Product Compatibility, Torque Strength, Dynamic Burst, Peak Tensile Force, Freedom from Leakage, Durability/Lubricity: Not explicitly stated as a number, but "Test articles" and "Devices" implies multiple units were used for each test.
- Simulated Use, Product Compatibility: "Test articles were used by three trained interventional neuroradiologists."
- Sample Size for Biocompatibility Tests: Not explicitly stated as numbers (e.g., how many guinea pigs, how many cell cultures). The phrase "Study animals" is used.
- Data Provenance: The document does not specify the country of origin for the data. The tests performed are standard bench tests and regulated biocompatibility studies, following ISO and ASTM standards. The studies were conducted in accordance with 21 CFR Part 58 Good Laboratory Practices, which are US regulations. It's a prospective test in the sense that these tests are performed on the manufactured device models to demonstrate their performance characteristics for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For Simulated Use and Product Compatibility bench testing: three trained interventional neuroradiologists were used. Their specific years of experience are not mentioned, but they are identified as "trained interventional neuroradiologists."
- For other tests, "ground truth" is established by adherence to specified test methods (e.g., ISO, ASTM standards) and their quantitative or qualitative pass/fail criteria, rather than expert consensus on, for example, image interpretation.
4. Adjudication method for the test set
- The document does not describe an adjudication method in the context of multiple expert readers or interpretations. For the "Simulated Use" and "Product Compatibility" tests where three neuroradiologists participated, it's not stated how disagreements, if any, were resolved; however, the conclusion states the device "performed as intended" and "was found to be compatible," suggesting a consensus or successful outcome observed by all. This is not a formal adjudication process as would be seen in an imaging study.
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
- No, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (a catheter), not an AI or software device. Therefore, the concept of human readers improving with AI assistance is not applicable to this document. The "three trained interventional neuroradiologists" participated in simulated use bench testing to evaluate the physical interaction and performance of the catheter in a model, not to read images or interpret data generated by the device in terms of AI output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical catheter, not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the catheter's performance is established through bench testing against established engineering and biocompatibility standards (ISO, ASTM) and comparison to the predicate device's characteristics.
- For dimensional and physical properties: direct measurement and adherence to specifications.
- For functional properties (e.g., kink resistance, torque strength, flow rate): performance against defined quantitative criteria or qualitative observations (e.g., performs as intended).
- For biocompatibility: results from standardized biological assays performed on animal models, cell cultures, or blood samples, with pass/fail criteria defined by the ISO 10993 series and other relevant standards.
- For simulated use: observation by trained physicians against expected performance.
- The overall "ground truth" for regulatory clearance is substantial equivalence to the predicate device, demonstrated by meeting comparable performance characteristics through these tests.
8. The sample size for the training set
- This question is not applicable. This document describes performance testing for a physical medical device, not the development or validation of an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as above.
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