(161 days)
QuikClot® Hemostatic Dressing is intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.
It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.
The QuikClot Hemostatic Dressing utilizes a layered clay hemostat, kaolin USP, which is bound to medical gauze using glycerin USP. QuikClot Hemostatic Dressings are provided in a sterile, intuitive, simple to use dressing format that conforms readily to the wound. The QuikClot Hemostatic Dressing that is the subject of this submission is described in detail in K072474.
The provided text describes a 510(k) premarket notification for the QuikClot Hemostatic Dressing. The submission aims to obtain a new indication for a previously cleared device, the QuikClot eX, and asserts substantial equivalence to a predicate device, the HemCon ChitoFlex Surgical Dressing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a specific table detailing "reported device performance" against those criteria in the way a typical diagnostic or AI device study would. Instead, the "acceptance criteria" are implied by the requirements for demonstrating substantial equivalence to existing legally marketed devices, primarily focusing on safety and efficacy.
The device performance is described qualitatively and through the results of specific tests.
| Acceptance Criteria (Implied by Substantial Equivalence Review) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity, implantation effects) | Satisfied: Passed all biocompatibility tests listed in the table (Cytotoxicity: Non-cytotoxic; Intracutaneous Reactivity: Non-irritating; Sensitization: Non-sensitizing; Systemic Injection: Non-toxic; Repeat Exposure Systemic Toxicity: Non-toxic; Subcutaneous Implantation: Non-reactive). |
| Efficacy: Ability to control bleeding in traumatic wounds. | Satisfied: "In vivo testing evaluated the efficacy of the QuikClot Hemostatic Dressing versus predicate (ChitoFlex Surgical Dressing) to control bleeding in traumatic wounds. The data supports the effectiveness of QuikClot Hemostatic Dressings in achieving hemostasis in traumatic wounds." |
| Technological Characteristics: Similar composition, design, processing, and mechanism of action to predicate devices. | Satisfied: "The QuikClot Hemostatic Dressing is identical to the legally marketed QuikClot eX in composition, design and processing..." and "...substantially equivalent to the predicate device (ChitoFlex Surgical Dressing) in that both devices share the same intended use. Both devices are intended for use as a topical dressing for local management of bleeding wounds... Their mechanism of action is also similar..." |
| Intended Use: Comparable to legally marketed predicate devices. | Satisfied: The proposed indications for use are stated to be "substantially equivalent to the predicate device (HemCon ChitoFlex Surgical Dressing)." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "in vivo testing" for efficacy and various biocompatibility tests. However, it does not specify the sample sizes for these tests (e.g., number of animals or specific experimental units). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
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 applicable as the device is a hemostatic dressing, not a diagnostic device requiring expert interpretation for ground truth establishment. The efficacy and safety are assessed through biological and physiological measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the device is a hemostatic dressing and does not involve adjudication by multiple experts for interpretive results.
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 information is not applicable as the device is a hemostatic dressing and does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a hemostatic dressing and does not involve algorithms or human-in-the-loop performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety testing (biocompatibility), the "ground truth" is established through standardized laboratory assays and observations as defined by ISO 10993 series and FDA guidance (G95-1). The conclusions (e.g., "Non-cytotoxic," "Non-irritating," "Non-toxic") are direct results of these validated tests.
For efficacy, the "ground truth" for "achieving hemostasis in traumatic wounds" would be based on physiological measures, such as time to cessation of bleeding, blood loss, or other objective endpoints observed during the "in vivo testing." While the specific metrics are not detailed, it would be direct observation of physiological outcomes.
8. The sample size for the training set
This information is not applicable as the device is a medical device (hemostatic dressing) and does not involve a "training set" in the context of machine learning or AI models. The development and testing paradigm are based on traditional medical device validation.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above; there is no "training set" for this type of medical device.
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