(91 days)
QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.
QuikClot Control+® Hemostatic Dressing is a prescription use non-absorbable device containing kaolin (hemostatic agent) bound to gauze. The hemostatic dressings are x-ray detectable and are provided as a single-use sterile device available in various sizes. The device is available in single or multipacks.
This document is a 510(k) summary for the QuikClot Control+ Hemostatic Dressing, which is a device used for temporary control of internal organ space bleeding and severely bleeding wounds. The summary focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to the requested information about acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance specifications but doesn't present them in a direct table format with explicit acceptance criteria values alongside reported performance values. Instead, it states that the device "meets the required specifications" generally. Here's a reconstructed table based on the provided text:
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Biocompatibility (ISO 10993-1) | Device showed acceptable performance for prolonged patient contact (>24 hours to 30 days) as an external communicating device with tissue/bone/dentin contact, covering: |
| - Cytotoxicity | Met (L929 Neutral Red Uptake Method) |
| - Irritation | Met (Intracutaneous Injection) |
| - Sensitization | Met (Guinea Pig Maximization Sensitization Test) |
| - Systemic Injection (Acute Systemic Toxicity) | Met (Intravenous Injection and Intraperitoneal Injection) |
| - Implantation (Rabbit) | Met (4-week sub-cutaneous, 1-week muscle, 4-week muscle, 4-week bone, 8-week bone) |
| - Genotoxicity | Met (Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay, Chromosomal Aberration Study, Peripheral Blood Micronucleus Study) |
| - Carcinogenicity | Met (Clonal Transformation Assay using SHE Cells for 7-days) |
| - Repeat Exposure System Toxicity | Met (6-month animal survival study using custom test for Kaolin) |
| - Systemic Intravenous Injection | Met (for Kaolin Extract) |
| - Systemic Intraperitoneal Injection | Met (for Kaolin Extract) |
| - Pyrogen Test | Met |
| X-Ray Detectability | Meets required specifications. |
| Bench Testing | Meets required specifications and acceptance criteria for: |
| - Tensile Strength | Met |
| - Elongation | Met |
| - Clotting | Met |
| - Kaolin Release | Met |
| Preclinical Animal Study (Safety & Effectiveness) | Demonstrated the safety and effectiveness of QuikClot Control+. Observations included hemostasis, blood chemistry (hematology, serum, coagulation), and macroscopic/microscopic tissue/organ examinations (adhesion, thromboembolism, kaolin migration). The results supported substantial equivalence. |
| Stability | Testing supports a 39-month expiration date. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Bench Testing: Not specified for each test (tensile strength, elongation, clotting, kaolin release).
- Biocompatibility Tests: Sample sizes are inherent to the specific ISO 10993 tests mentioned (e.g., L929 cells for cytotoxicity, guinea pigs for sensitization, rabbits for implantation, mice for genotoxicity). Specific numbers are not provided in this summary.
- Preclinical Animal Study: "Three GLP large animal (swine), to include a survival model" and "one non-GLP study." The specific number of animals per GLP study is not detailed beyond "three."
- Data Provenance: The studies are preclinical (animal studies) and bench tests. The document does not specify country of origin for the studies, but they were conducted under GLP (Good Laboratory Practice) for the animal studies, indicating a controlled and ethical environment. They are inherently prospective for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies described are preclinical animal studies and bench tests, not human reader studies requiring expert adjudicated ground truth. The "ground truth" for these studies is derived from direct measurements, observations, and histological/pathological analyses by qualified laboratory personnel and veterinarians within the study protocols.
4. Adjudication Method for the Test Set
This is not applicable as the studies are preclinical animal studies and bench tests, not clinical studies involving human interpretation or adjudication.
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
There is no mention of an MRMC comparative effectiveness study or any AI component in this document. The device is a hemostatic dressing, not an AI-powered diagnostic or assistive tool.
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 physical hemostatic dressing and does not involve any algorithm or AI.
7. The Type of Ground Truth Used
- For Biocompatibility: Laboratory results (e.g., cell viability, tissue reactions, genetic mutations) from established ISO 10993 standard test methods.
- For Bench Testing: Direct physical measurements (e.g., tensile strength, elongation), in vitro clotting assays, and chemical analysis for kaolin release.
- For Preclinical Animal Study:
- Physiological observations: Direct assessment of hemostasis (cessation of bleeding).
- Laboratory analyses: Blood chemistry (hematology, serum, coagulation panel results).
- Pathological examinations: Macroscopic and microscopic tissue/organ examinations by veterinary pathologists for adhesion, thromboembolism, and kaolin migration.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical medical device and does not involve machine learning or a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is a physical medical device and does not involve machine learning or a training set.
§ 878.4454 Non-absorbable, hemostatic gauze for temporary internal use.
(a)
Identification. A non-absorbable, hemostatic gauze for temporary internal use is a prescription device intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must:
(i) Demonstrate that the device is able to achieve hemostasis;
(ii) Demonstrate that the device can be radiographically detected; and
(iii) Assess pertinent safety endpoints including vascular obstruction and adhesion formation.
(2) The device must be demonstrated to be biocompatible.
(3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed:
(i) In vitro clot assessment;
(ii) Particulate release testing;
(iii) Physical characterization, including swelling percent and particulate size;
(iv) Chemical characterization;
(v) Radiopacity testing; and
(vi) Mechanical integrity testing, including tensile strength and tear strength.
(4) Performance data must demonstrate the sterility of the device.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Labeling must include the following:
(i) Instructions for use, including an instruction to remove all visible device components by irrigation;
(ii) The maximum amount of time the device may be left within the body;
(iii) A shelf life;
(iv) A contraindication for intravascular use of the device; and
(v) A warning regarding the potential for adhesion formation.