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510(k) Data Aggregation
(76 days)
Kodiak Dual Port Coaxial Introducer Kit
The Kodiak™ Dual Port Coaxial Introducer Kit is indicated to introduce therapeutic or diagnostic devices into the vasculature.
The Kodiak™ Dual Port Coaxial Introducer Kit is intended to introduce therapeutic or diagnostic devices into the vasculature. The Kit Model 381416000 contains a coaxial 16F and 14F braided reinforced sheaths with a fluoropolymer coating, an embedded radiopaque marker band, and an over molded hub assembly containing two hemostasis valves and side port with stopcock. It also contains a removable Y-connector with two 7F (ID) ports with hemostasis valves, a 14F dilator, a 16ga blunt flushing needle, and a high-pressure Luer adapter. After percutaneous access is established and a working guidewire is placed, the introducer system is inserted over the guidewire and advanced under imaging. Therapeutic or diagnostic devices are inserted through the system. The Kodiak™ Dual Port Coaxial Introducer Kit is a single use device.
The provided text is a 510(k) Summary for the Kodiak™ Dual Port Coaxial Introducer Kit, which is a medical device for introducing therapeutic or diagnostic devices into the vasculature. The document details the device's characteristics and performance testing to demonstrate substantial equivalence to a predicate device.
It is important to note that this document does not contain information about an AI/ML powered device. Therefore, many of the requested criteria regarding AI/ML studies (like multi-reader multi-case studies, standalone algorithm performance, training set details, ground truth establishment methods for AI) are not applicable.
Below is the information that can be extracted relevant to the performance of the Kodiak™ Dual Port Coaxial Introducer Kit as a non-AI medical device:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Performance Testing | System Leak | Not explicitly stated in the provided text, but implied to be compliance with applicable standards/protocols designed to ensure product safety and clinical function. | "shown to meet the acceptance criteria" |
| Tensile Strength | Not explicitly stated | "shown to meet the acceptance criteria" | |
| Tip Strength | Not explicitly stated | "shown to meet the acceptance criteria" | |
| Radiopacity | Not explicitly stated, but would likely involve the device being sufficiently visible under fluoroscopy. | "shown to meet the acceptance criteria" | |
| Kink Testing | Not explicitly stated, but would likely involve maintaining lumen patency and structural integrity when bent to a certain degree. | "shown to meet the acceptance criteria" | |
| Dimensional | Not explicitly stated, but would refer to conformity to specified measurements (e.g., length, diameter) as detailed in the device description. | "shown to meet the acceptance criteria" | |
| Functional Fit | Not explicitly stated, but would relate to the proper interaction and assembly of components (e.g., sheath with guidewire, dilator, Y-connector). | "shown to meet the acceptance criteria" | |
| Simulated Use | Not explicitly stated, but would involve simulating real-world clinical scenarios to ensure the device performs as intended without failure. | "shown to meet the acceptance criteria" | |
| Luer Testing | Not explicitly stated, but refers to the integrity and leak-proof nature of Luer connections according to ISO standards. | "shown to meet the acceptance criteria" | |
| Power Injection Testing | Not explicitly stated, but would involve testing the device's ability to withstand pressures from power injection without rupture or leakage. | "shown to meet the acceptance criteria" | |
| Tip Buckling | Not explicitly stated, but would relate to the resistan ce of the introducer tip to buckle or deform during insertion. | "shown to meet the acceptance criteria" | |
| Particulate | Not explicitly stated, but would involve testing for the absence of unacceptable levels of particulates that could be introduced into the patient. | "shown to meet the acceptance criteria" | |
| Packaging Integrity | Not explicitly stated, but would involve ensuring the sterile barrier and physical protection of the device until point of use. | "shown to meet the acceptance criteria" | |
| Biocompatibility Testing | Cytotoxicity (ISO 10993-5) | Not explicitly stated, but would be based on ISO 10993-5 guidelines for cytotoxicity testing. | "shown to meet the acceptance criteria" |
| Sensitization (ISO10993-10) | Not explicitly stated, but based on ISO 10993-10 guidelines. | "shown to meet the acceptance criteria" | |
| Irritation/Intracutaneous Reactivity (ISO10993-23) | Not explicitly stated, but based on ISO 10993-23 guidelines (formerly ISO 10993-10). | "shown to meet the acceptance criteria" | |
| Acute Systemic Toxicity (ISO10993-11) | Not explicitly stated, but based on ISO 10993-11 guidelines. | "shown to meet the acceptance criteria" | |
| Pyrogenicity (ISO 10993-11) | Not explicitly stated, but based on ISO 10993-11 guidelines. | "shown to meet the acceptance criteria" | |
| Hemolysis Direct/Indirect (ISO 10993-4) | Not explicitly stated, but based on ISO 10993-4 guidelines. | "shown to meet the acceptance criteria" | |
| Thromboresistance (ISO 10993-4) | Not explicitly stated, but based on ISO 10993-4 guidelines, ensuring the device does not promote thrombus formation. | "shown to meet the acceptance criteria" | |
| Partial Thromboplastin Time (ISO 10993-4) | Not explicitly stated, but based on ISO 10993-4 guidelines, assessing interactions with the coagulation system. | "shown to meet the acceptance criteria" | |
| Complement Activation (ISO 10993-4) | Not explicitly stated, but based on ISO 10993-4 guidelines, assessing interactions with the complement system. | "shown to meet the acceptance criteria" | |
| Platelet and Leukocyte Count (ISO 10993-4) | Not explicitly stated, but based on ISO 10993-4 guidelines, assessing effects on blood cellular components. | "shown to meet the acceptance criteria" |
The document states, "A series of testing was conducted in accordance with protocols based on requirements outlined in guidance and industry standards and the testing below was shown to meet the acceptance criteria that was determined to demonstrate substantial equivalence."
Study Information (for non-AI device)
-
Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes (number of units tested) for each individual performance or biocompatibility test. It only states that "a series of testing was conducted." The data provenance is internal testing performed by the device manufacturer, Argon Medical Devices, Inc. The data would be prospective for the purpose of this 510(k) submission, as these are tests specifically conducted for this new device. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a non-AI medical device. The "ground truth" for its performance is established by objective physical and chemical testing against engineering specifications and international standards, not by expert interpretation of data. -
Adjudication method for the test set:
Not applicable for this type of device testing. Results are typically quantitative measurements compared against predefined acceptance limits. -
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 non-AI medical device. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a non-AI medical device. -
The type of ground truth used:
For performance testing, the "ground truth" refers to the objective physical and chemical properties and functional capabilities of the device as measured by standardized test methods against established specifications and international standards (e.g., ISO 10993 for biocompatibility, Luer connector standards, internal engineering specifications). -
The sample size for the training set:
Not applicable. This is a non-AI medical device, so there is no "training set." -
How the ground truth for the training set was established:
Not applicable. This is a non-AI medical device, so there is no "training set" or corresponding ground truth establishment process in the context of AI/ML.
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