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QuikClot® Radial® is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 7 Fr. in (a) patients on druq/induced anti-coagulation treatment and (b) patients not on druq/induced anti-coaqulation treatment.

The QuikClot® Radial® consists of a rolled hemostatic dressing to be used in conjunction with Tegaderm™, Coban™, or equivalent adhesive bandage (not supplied). The roll is a soft, white, sterile, hydrophilic, kaolin-impregnated gauze. Kaolin is a hemostatic agent that functions to stop bleeding in anti-coagulated patients, and is used in the same form and amount as in the predicate device. The kaolin is bound to the gauze in the same manner as in the predicate device. The QuikClot® Radial® is configured in 0.75" diameter x 1.5" length. The device is packaged for aseptic removal in a peelable foil pouch. The dressing is a single-use device that has suface contact with breached or compromised skin for a limited duration (≤24 hours).

The provided text describes the 510(k) premarket notification for the QuikClot® Radial® device, which is a hemostatic dressing. However, it does not contain specific acceptance criteria or a detailed study report that would typically lay out acceptance criteria and then demonstrate performance against them. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's a breakdown of the information provided, specifically addressing your numbered points, and highlighting what is not present in the document:

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

This information is not present in the provided document in the form of a table of specific acceptance criteria. The document states that the device achieved "successful hemostasis without occurrence of re-bleeding or radial artery occlusion" and that the "mean time to achieve successful hemostasis was significantly shorter" in one study. These are performance observations, but not defined acceptance criteria against which the device was measured for regulatory clearance in this specific document.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Sizes:
  • Study 1: 30 patients
  • Study 2: 20 patients
• Data Provenance: The studies were described as "confirmatory clinical studies performed by the company." The provenance (country of origin) is not explicitly stated. They were prospective studies as patients were "randomized into cohorts."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not present in the document. The studies assessed clinical outcomes directly, observed by the study personnel, rather than relying on a separate ground truth established by experts.

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

This information is not present in the document. Clinical studies typically have protocols for assessing outcomes, but the specific adjudication method for the test set is not detailed here.

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

This is not applicable as the device is a hemostatic dressing, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant.

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

This is not applicable as the device is a hemostatic dressing. The device is used by humans but it does not have a "standalone" algorithmic performance in the way an AI diagnostic tool would. Its performance is intrinsic to its physical and chemical properties and how it interacts with the patient's physiology.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the clinical studies appears to be the directly observed clinical outcomes data related to hemostasis, re-bleeding, and radial artery occlusion. In Study 1, it also included the "mean time to achieve successful hemostasis."

8. The sample size for the training set

This is not applicable as the device is a physical hemostatic dressing, not an AI or machine learning algorithm that requires a training set.

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

This is not applicable as the device is a physical hemostatic dressing, not an AI or machine learning algorithm.

Summary of Device Performance (from the document, without explicit acceptance criteria):

• Study 1 (30 patients):
  • Achieved successful hemostasis without re-bleeding or radial artery occlusion in all patients treated with QuikClot® Radial®.
  • Mean time to achieve successful hemostasis was significantly shorter for QuikClot® Radial® compared to the standard of care (TR Band).
  • No major complications reported.
• Study 2 (20 patients):
  • Achieved successful hemostasis without re-bleeding or radial artery occlusion in all patients treated with QuikClot® Radial®.
  • No major complications reported.

In essence, the document confirms the device's safety and efficacy based on two small clinical studies and its substantial equivalence to an existing predicate device with a history of clinical data. It emphasizes that differences between the subject and predicate devices do not raise new safety or effectiveness concerns.

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QuikClot Interventional-A Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 7 Fr. in patients on drug/induced anti-coagulation treatment.

The QuikClot Interventional-A Hemostatic Bandage that is the subject of this submission is described in detail in K090620 in that it is made of a soft, white, kaolin-impregnated gauze. QuikClot® Interventional-A Hemostatic Bandage may be provided in a kit form that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® bandage (K973036) or equivalent. The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by l 1/2"wide by 1/2" thick multi-layer pad.

Here's an analysis of the acceptance criteria and supporting studies for the QuikClot Interventional-A Hemostatic Bandage, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative format typical for regulatory submissions (e.g., "sensitivity must be > X%", "specificity must be > Y%"). Instead, it presents performance metrics from pre-clinical animal studies and clinical studies. The implicit acceptance criterion is that the device demonstrates efficacy in controlling bleeding in anticoagulated patients, comparable to or superior to control methods, with an acceptable safety profile.

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