(100 days)
The Captiva Blood Containment Device is intended for blood containment during vascular access procedures. Upon entering the vessel, the Captiva Blood Containment Device provides visualization of flashback and containment of blood within a sealed chamber. It also allows placement of a guidewire through the device for subsequent catheterization.
The CaptivaTM Blood Containment Device is designed to contain the flow of a patient's blood during vascular access procedures, thereby helping to reduce the healthcare professionals' exposure to bloodborne pathogens while controlling patient blood loss. It also provides for vascular access by maximum 0.038 inch guidewires.
The provided document describes the Captiva™ Blood Containment Device and its substantial equivalence to a predicate device, the Novoste™ PulsePlus Blood Containment Device. This is a 510(k) summary, which focuses on demonstrating equivalence rather than providing a detailed technical study report with specific acceptance criteria directly quantifiable. Therefore, some information requested may not be explicitly present as a rigorous clinical trial or AI model validation would detail.
Here's an attempt to extract and infer the requested information based on the available text:
Acceptance Criteria and Device Performance
The document states: "The Captiva™ Blood Containment Device has met all pre-determined acceptance criteria." and "The performance data indicate that the applicant and the predicate devices have substantially equivalent values." It also mentions "No new safety and effectiveness issues arise as a result of the proposed device modifications." This implies the acceptance criteria were based on demonstrating equivalence to the predicate device in terms of safety and efficacy for its intended use.
Table of Acceptance Criteria and Reported Device Performance (Inferred):
| Acceptance Criteria (Inferred from "Substantially Equivalent" and Intended Use) | Reported Device Performance |
|---|---|
| Ability to contain blood during vascular access procedures | The device is designed to contain the flow of a patient's blood during vascular access procedures, helping to reduce healthcare professionals' exposure to bloodborne pathogens while controlling patient blood loss. Performance data indicate substantial equivalence to the predicate device in achieving this function. |
| Ability to provide visualization of flashback | Upon entering the vessel, the Captiva Blood Containment Device provides visualization of flashback. Performance data indicate substantial equivalence to the predicate device in achieving this function. |
| Ability to allow placement of a guidewire (maximum 0.038 inch) | The device allows for vascular access by maximum 0.038 inch guidewires and allows placement of a guidewire through the device for subsequent catheterization. Performance data indicate substantial equivalence to the predicate device in achieving this function. |
| Use of medical grade, biocompatible materials for blood containment | Both the predicate and applicant devices utilize medical grade, biocompatible materials for blood containment. No new safety and effectiveness issues are identified, suggesting the materials meet required standards. |
| Non-deleterious effects of modifications | The document states: "There is no indication that the proposed modifications have any deleterious effects on applicant device performance and no new safety and efficacy questions arise when the applicant device is used as intended." This confirms the device modifications do not negatively impact safety or efficacy. |
| Robustness for intended use | The document states: "the modified design of the applicant device is sufficiently robust for its intended use." This ensures the device can withstand the stresses of its intended application. |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "pre-clinical tests" and "performance data" that indicate substantial equivalence. It does not provide specific numbers of units tested.
- Data Provenance: Not explicitly stated. The tests are described as "pre-clinical," suggesting laboratory or bench testing rather than human clinical data. There is no information about the country of origin.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. This device, being a physical blood containment device, would not typically have "ground truth" established by experts in the way an AI diagnostic algorithm would. The safety and efficacy are likely evaluated against predetermined engineering and performance specifications and comparison to the predicate device.
- Qualifications of Experts: Not applicable.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This concept is typically relevant for studies involving human interpretation or subjective assessments, often in diagnostic imaging or clinical trials, which is not described here. Device performance is likely measured against objective metrics.
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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:
- MRMC Study: No. This is not an AI-assisted diagnostic device or an imaging device. Therefore, a multi-reader multi-case study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The concept of "ground truth" in the context of an AI algorithm is not directly applicable here. For this device, the "ground truth" would be related to material properties, functional performance (e.g., ability to contain fluid, allow guidewire passage), and biocompatibility testing, compared against established standards and the characteristics of the predicate device. The "truth" is whether it performs its stated function safely and effectively, and is substantially equivalent to a legally marketed predicate device.
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The sample size for the training set:
- Sample Size: Not applicable. This is a physical device, not a machine learning model. There is no "training set" in the context of AI.
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How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable. As there is no training set for an AI model, this question is not relevant.
§ 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).