(211 days)
The HemCon® Bandage is intended as an external temporary wound treatment for the control of severely bleeding wounds for emergency use. In addition, the HemCon® Bandage also controls bleeding in patients following hemodialysis. The HemCon® Bandage OTC is intended for the local management of bleeding such as laceration and minor bleeding.
The HemCon® Bandage and the HemCon® Bandage OTC are each applied to the wound and held in place until it adheres to the wound and hemostasis is achieved. Then, an outer bandage is applied to secure the dressing on the wound site. The HemCon® Bandage and the HemCon® Bandage OTC are manufactured from chitosan, a material consisting of cellulosic polymer, poly[ß(1->4)-2-amino-2-deoxy-D-dlucopyranose]. These devices are packaged in a foil package and provided sterile. They are sterilized by gamma irradiation at a dose adequate to ensure a SAL of 10 %.
This document is a 510(k) summary for the HemCon® Bandage and HemCon® Bandage OTC. It refers to previous submissions for performance data and states that the current devices are identical to predicate devices in intended use, material, performance, sterilization method, and method of application. This means a new study specifically for this 510(k) submission was not required as equivalence was based on prior data and minor modifications.
Therefore, many of the requested details about a new study (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a new study) are not applicable to this specific 510(k) submission.
However, I can extract information regarding acceptance criteria and reported performance from the provided text, as well as details about the previous studies that established equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance (from predicate device data) |
|---|---|---|
| Hemostasis | Achieve hemostasis for severely bleeding wounds (emergency use). | HemCon® Bandage: Controls severely bleeding wounds. Controls bleeding in patients following hemodialysis. |
| Hemostasis | Achieve hemostasis for local management of laceration and minor bleeding. | HemCon® Bandage OTC: Controls bleeding in laceration and minor bleeding. |
| Antibacterial | Demonstrate antibacterial properties. | HemCon® Bandage & OTC: Demonstrated antibacterial barriers by AATCC Test Method 100-2004 with Staphylococcus aureus and Klebsiella pneumonia. |
| Biocompatibility | Be biocompatible. | HemCon® Bandage & OTC: Complete biocompatibility data presented in referenced predicate device submissions. |
| Sterility | Achieve sterility with a SAL of 10^-6. | HemCon® Bandage & OTC: Sterilized by gamma irradiation at a dose adequate to ensure a SAL of 10^-6. Validation study conducted according to ISO 11137, Method IIB. |
| Safety & Effectiveness | Equivalent to predicate devices. | HemCon® Bandage & OTC: Expected to achieve the same safety and effectiveness as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This 510(k) submission states, "Performance data for the HemCon® Bandage and the HemCon® Bandage OTC have been previously submitted in the referenced predicate device submissions."
Therefore, for this specific submission K043050, a new test set was not used. The data provenance and sample sizes would be found in the predicate submissions (K023298 for HemCon® Bandage and K030946 for HemCon® Bandage OTC), which are not provided in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this 510(k) submission, as it relies on previously submitted data.
4. Adjudication Method for the Test Set
Not applicable for this 510(k) submission, as it relies on previously submitted data.
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 device is a hemostatic bandage, not an AI-powered diagnostic device involving human readers.
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
Based on the description of the device (hemostatic bandage), the ground truth for performance in the predicate device studies would likely involve:
- Clinical outcomes data: Direct observation of hemostasis (cessation of bleeding) in human or animal subjects for the hemostatic claims.
- Laboratory test results: For antibacterial properties (AATCC Test Method 100-2004) and biocompatibility.
- Sterilization validation data: For sterility claims (ISO 11137).
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not a machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
N/A