(15 days)
The Confida™ Adaptive Sheath is intended to provide a conduit through the iliofemoral vessels for the insertion of diagnostic or interventional devices used during cardiovascular procedures, including transcatheter aortic valve replacement (TAVR).
The Confida™ Adaptive Sheath is a single-use, disposable, hydrophilically coated sheath designed to provide a flexible and hemostatic conduit for the insertion of diagnostic and interventional devices, including devices used in transcatheter aortic valve replacement (TAVR). The Confida™ Adaptive Sheath is a prescription use device, intended to be used by professionals in healthcare/hospital facilities. There is only one model of the Confida™ Adaptive Sheath, corresponding to model number CAS131830.
The Confida™ Adaptive Sheath is comprised of two components:
● Dilator component: The Dilator component includes a flexible, tapered distal tip that facilitates atraumatic tracking through the vasculature. The Dilator component contains an internal lumen able to accommodate up to a 0.035in (0.89mm) guidewire.
● Introducer Sheath component: A hydrophilic coating is applied to the sheath body to reduce the forces required for insertion into and withdrawal from the vasculature. The seal housing contains a hemostatic valve assembly designed to minimize blood loss during device use. The Introducer Sheath component contains a sideport extension with a three-way valve, providing a means for fluid to be flushed through the Introducer Sheath component during clinical use. The sheath body temporarily expands in diameter to allow the introduction and removal of devices up to 18 Fr in outer diameter, including devices used in TAVR procedures.
There are no specific accessories required for use with the Confida™ Adaptive Sheath. The Confida™ Adaptive Sheath is designed for use with guidewires up to 0.035in (.89mm) in diameter, and has been developed for use with various devices used in diagnostic and interventional procedures, including TAVR procedures.
The Confida™ Adaptive Sheath is classified as a surgically invasive device for short-term use (
The provided text describes a 510(k) premarket notification for a medical device called the "Confida™ Adaptive Sheath," and thus does not contain information about an AI/ML-based device or a comparative effectiveness study with human readers. The document details the device's technical specifications, indications for use, comparison to predicate devices, and non-clinical testing performed to establish substantial equivalence.
Therefore, many of the requested criteria, such as those related to AI/ML performance, ground truth, expert adjudication, multi-reader multi-case studies, and training/test set sample sizes for AI, are not applicable to this document.
However, based on the provided text, I can infer the acceptance criteria and the study that proves the device meets the acceptance criteria as they relate to the non-clinical performance of a medical device seeking 510(k) clearance.
Here's a breakdown of what can be extracted and what cannot:
Acceptance Criteria and Reported Device Performance (Inferred from Non-Clinical Testing):
The document states: "The results of the non-clinical testing performed for the Confida™ Adaptive Sheath show that all acceptance criteria were met."
While the specific numerical acceptance criteria values are not provided, the types of tests performed indicate the performance characteristics that were evaluated and for which criteria would have been established. The "reported device performance" is simply that it met all established acceptance criteria for each of these tests.
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Implied) |
|---|---|
| System Pressure Capability: Leak and Hemostasis | Met criteria for minimizing blood loss and maintaining integrity. |
| Dimensional Measurement | Met specified design dimensions. |
| Tensile Strength | Withstood specified tensile forces without failure. |
| Coating Integrity | Maintained coating as specified for reduced insertion forces. |
| Particulate | Did not shed particulates beyond acceptable limits. |
| Kink Resistance | Maintained lumen patency under specified bending forces. |
| Device and Delivery System Interaction Forces | Ensured smooth and proper interaction with other devices. |
| Simulated Use: System Recovery and Device Functionality | Performed as intended during simulated clinical use scenarios. |
| Usability Testing for Design Validation | Met usability requirements for healthcare professionals. |
| In Vivo Design Validation Testing (Animal Model) | Demonstrated acceptable performance and safety in a biological system. |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Pyrogen, Hemolysis, PTT, Complement Activation, Thromboresistance, Chemical Characterization) | Met ISO 10993-1:2009 standards for biological safety. |
| Sterilization Validation | Achieved specified Sterility Assurance Level (SAL). |
| Packaging and Shelf Life (Product and Package) | Maintained integrity and sterility over specified shelf life. |
Study Details (Based on Non-Clinical Testing):
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Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "non-clinical evaluations" which would involve a defined number of units or replicates for each test (e.g., number of sheaths tested for tensile strength, number of samples for biocompatibility). These numbers are not provided in this summary.
- Data Provenance: The data originates from internal testing conducted by Medtronic, Inc. The document does not specify a country of origin for the data beyond "USA" for Medtronic's address. The studies are prospective in nature, as they involve performing new tests on the device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device's non-clinical testing. "Ground truth" in this context refers to established engineering specifications, material standards (e.g., ISO 10993), and predetermined performance limits, rather than expert interpretation of medical images or conditions. The "experts" would be the engineers, scientists, and technicians conducting the tests and evaluating the results against the pre-defined criteria.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for consensus-building in interpreting complex subjective data (e.g., medical images). For non-clinical device testing, results are typically objective measurements against predefined specifications. Any discrepancies would be resolved through standard quality control and technical review processes, not a formal adjudication panel.
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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. This is not relevant to a medical device like a catheter introducer sheath and its 510(k) clearance process. An MRMC study is specific to diagnostic aids, particularly those involving AI/ML for image interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical medical instrument, not an algorithm. Standalone performance refers to AI/ML algorithms.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance evaluation is based on:
- Engineering specifications and design requirements: These define the intended dimensional, mechanical, and functional properties of the device.
- International standards (e.g., ISO 10993-1:2009 for biocompatibility): These provide established methodologies and acceptance criteria for specific tests.
- Bench testing methodologies: Standardized or validated internal methods for evaluating physical and chemical properties.
- Predicate device performance: The performance of previously cleared devices often serves as a benchmark for substantial equivalence.
- The "ground truth" for this device's performance evaluation is based on:
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The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. There is no training set.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).