(78 days)
The Strada™ Carotid Guiding Sheath is indicated for the introduction of diagnostic and therapeutic devices into the human vasculature including, but not limited to, the carotid artery.
The Strada™ Carotid Guiding Sheath is designed to perform as an introducer and a guiding sheath. The device is a single-use system that consists of a delivery sheath with hemostatic valve and dilator. Upon removal of the dilator, the delivery sheath provides a pathway for diagnostic and interventional devices into the vasculature. The Strada™ Carotid Guiding Sheath is available in 80 and 90cm lengths. The sheath has an 8F outer diameter and 6F inner diameter. The distal end is straight, has a hydrophilic coating (20cm) and has a radiopaque marker approximately 2.5 mm from the tip. The device is provided sterile and non-pyrogenic.
The provided text describes a 510(k) submission for the Strada™ Carotid Guiding Sheath, focusing on demonstrating substantial equivalence to a predicate device. This type of submission relies heavily on non-clinical testing and comparison to an already cleared device, rather than extensive clinical studies with specific performance metrics for the new device.
Therefore, many of the requested elements pertaining to acceptance criteria and clinical study details (like sample sizes, expert qualifications, adjudication methods, MRMC studies, and ground truth for clinical test sets) are not applicable to this 510(k) submission, as it does not present independent clinical performance data for the Strada™ device in the same way a de novo or PMA submission might.
However, I can extract the information that is present and explain why other details are missing based on the nature of a 510(k) submission for this device.
Acceptance Criteria and Device Performance (Based on 510(k) principles):
For a 510(k) submission of this nature, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device through non-clinical testing that confirms the new device meets its own product specifications and intended uses, without raising new questions of safety or effectiveness. The performance is gauged by comparison to the established predicate.
| Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance (Strada™ Carotid Guiding Sheath) |
|---|---|
| Intended Use: Identical to predicate device | Met: "The intended use is identical to the predicate device." "The Strada™ Carotid Guiding Sheath is indicated for the introduction of diagnostic and therapeutic devices into the human vasculature including, but not limited to, the carotid artery," mirroring the predicate. |
| Technological Characteristics: Substantially equivalent to predicate device (design, material types, technology) | Met: "The device design and material types are key features that determine performance of the device. The components and material characteristics of the device are substantially equivalent to the predicate device." "The intended use, design, material types, technology, and performance of the Strada™ Sheath is identical to the predicate device." |
| Safety and Effectiveness: No new questions raised compared to predicate device | Met: "There are no differences between devices which would raise issues of safety or effectiveness." |
| Product Specifications: Meets internal product specifications | Met: "Results of the testing demonstrate that the Strada™ Sheath design meets product specifications and intended uses." (Based on non-clinical testing) |
| Non-clinical Performance: Equivalent to predicate in bench, animal, biocompatibility, shelf-life, package testing, sterilization. | Met: "Non-clinical testing of the Strada™ Carotid Guiding Sheath includes in vitro bench testing, animal evaluation, biocompatibility testing, shelf-life and package testing and sterilization validation." (Implied successful completion and equivalence.) |
Detailed Study Information (Where applicable/deduced):
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a single "test set" for performance evaluation in a clinical study. The device underwent "in vitro bench testing," "animal evaluation," "biocompatibility testing," "shelf-life and package testing," and "sterilization validation." The sample sizes for these individual non-clinical tests are not provided in the summary.
- Data Provenance: The studies are non-clinical (bench, animal, lab-based tests). There is no mention of human clinical data, and thus no country of origin or retrospective/prospective designation for human data.
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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: This was a 510(k) submission based on non-clinical testing and substantial equivalence to a predicate device. There was no clinical trial data presented that would require expert adjudication to establish ground truth for a test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable: No clinical test set requiring expert adjudication was presented in this summary.
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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:
- Not Applicable: This is a physical medical device (catheter introducer), not an AI-powered diagnostic or therapeutic device. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: See point 4. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Non-Clinical Standards: The "ground truth" for the non-clinical tests would have been established by engineering specifications, validated test methodologies, and established safety standards (e.g., ISO standards for biocompatibility, sterility, material properties, mechanical performance). For animal studies, the "ground truth" would be observed physiological responses and outcomes in animal models.
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The sample size for the training set:
- Not Applicable: This is a physical medical device. There is no concept of a "training set" in the context of machine learning for this device. The device design and manufacturing processes are "trained" through iterative R&D and testing, but these are not quantified as a "training set" in the common understanding of AI/ML.
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How the ground truth for the training set was established:
- Not Applicable: See point 7.
§ 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).