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OMNI-STAT Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16French

CELOX Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, perculaneous catheters or tubes utilizing introducer sheaths up to 16French

OMNI-STAT Vascular Rapid is a chitosan-based hemostatic dressing/ pad presented in a sealed foil pouch, consisting of hemostatic granules with a bioadhesive bonded to one side of non-woven gauze and with a PU foam film backing on the other side of the gauze. The dressing is designed to control surface bleeding from vascular access sites. The granules coated side is applied directly to the access site and pressure applied until hemostasis is achieved.

OMNI-STAT Vascular Rapid achieves its principle intended action (hemostasis) by creating a physical barrier or plug to stop the flow of blood. The granules coated sides is applied directly to the access site and the point of compression, while the sheath is still in place. When the sheath is removed, and the product comes into contact with blood, with pressure applied OMNI-STAT Vascular Rapid with the bio-adhesive quickly forms a gel like plug absorbing the water from the blood.

The provided document is a 510(k) summary for the OMNI-STAT Vascular Rapid device, asserting its substantial equivalence to a predicate device (CELOX Vascular). This type of submission focuses on demonstrating equivalence to an already legally marketed device rather than proving de novo safety and effectiveness through, for example, a clinical trial with specific acceptance criteria on performance metrics like sensitivity, specificity, and AUC, as one might see for an AI/ML medical device.

Therefore, the information typically found in acceptance criteria and study results for an AI/ML device (e.g., performance metrics, sample sizes for test/training sets, ground truth establishment with expert consensus, MRMC studies) is not present in this document because it is not relevant to a 510(k) submission for this type of device.

This document describes a physical hemostatic dressing, not an AI/ML device. The "performance data" section refers to bench testing (e.g., tack adhesion, absorbency, tensile strength, packaging integrity) and evaluations of biocompatibility and sterilization, all aimed at demonstrating the new device's similarity and acceptable performance compared to the predicate, especially given a minor modification (addition of a bio-adhesive).

To directly answer your request based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" in the format of strict numerical thresholds for parameters like sensitivity or specificity because it's not an AI/ML device with such performance metrics. Instead, "acceptance criteria" are implied by the comparative testing against the predicate device and relevant standards.

• Absorbency: Performed for both subject and predicate devices. All testing on both devices "meet the defined criteria."
• Wet Tensile Strength and Elongation: Performed for both subject and predicate devices. All testing on both devices "meet the defined criteria."
• Dimension: Performed for both subject and predicate devices. All testing on both devices "meet the defined criteria."
• Packaging Integrity & Strength: Performed for both subject and predicate devices. All testing on both devices "meet the defined criteria." |
  | Biocompatibility | - ISO 10993-1 Compliance: No new testing was carried out on the subject device. Compliance was established based on "toxicology risk assessment and data from CELOX Vascular and CELOX Rapid Gauze" (predicate and reference devices). The rationale states the device "is deemed in compliance with the requirements of ISO 10993-1." |
  | Sterilization | - Validation: Assessed and evaluated in compliance with ISO 11137-1. Sterilization dose audits are carried out using VDmax25 as defined in ISO 11137-1. Achieves Sterility Assurance Level (SAL) of 10^-6, consistent with the predicate. |
  | Shelf-life | - Duration: 3 Years based on predicate stability data (Note: Predicate device has 5 Years, but the new device relies on predicate data for 3 years). |
  | Hemostasis Efficacy | - Porcine Bleeding Models: No new pre-clinical testing was deemed necessary for substantial equivalence for the modified device. Previous testing in porcine bleeding models was performed for both the predicate devices (CELOX Vascular and CELOX Rapid Gauze), and the results "demonstrate that they both support the claim with regards to the control of bleeding and hemostasis being achieved." The document implies that because the modified device is substantially equivalent in design and materials (with an improved adhesion profile), these existing efficacy data for the predicate are sufficient. |

2. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated as a single "test set" for a diagnostic performance evaluation. For bench testing (e.g., tack adhesion, absorbency), specific sample sizes are not provided in this summary but are usually defined per test protocol (e.g., n=3, 5, or 10 replicates).
• Data Provenance: Not specified regarding "country of origin." The testing was "carried out in line with Medtrade products Ltd Design Control process," implying it was conducted by or for the manufacturer (Medtrade Product Ltd, based in the UK). The data is retrospective in the sense that the testing for this device has been completed, and the results are being submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. The device is a physical hemostatic dressing, and its performance (e.g., adhesion, absorbency) is measured by objective mechanical/material tests, not by expert interpretation of images or signals that would require a "ground truth" established by experts in an AI/ML context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as there is no expert adjudication process for this type of device's performance evaluation.

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:

Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by standardized physical/chemical tests (e.g., ASTM, ISO standards for materials, sterility) and previously conducted pre-clinical studies (e.g., porcine bleeding models) for the predicate device, which established its hemostatic efficacy. It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

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