(213 days)
Under the supervision of a healthcare professional CHG Antibacterial Foam Patch is intended for use as: A hydrophilic foam patch that is used to absorb exudates and to cover the peri-wound area of a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, midline catheters, drains, chest tubes, externally placed orthopaedic pins, and epidural catheters.
The Medtrade Product Ltd CHG Antibacterial Foam Patch consists of a hydrophilic Polyurethane absorbent foam with chlorhexidine gluconate (CHG) and a thin Polyurethane backing. The foam material absorbs up to eight times its own weight in fluid. The CHG present in the dressing inhibits or kills microorganisms on the surface of the dressing.
The provided documentation describes a 510(k) submission for the Medtrade Products Ltd CHG Antibacterial Foam Patch. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials to establish novel performance criteria. Therefore, the device performance is primarily assessed against the predicate device's established uses and through in-vitro and bench testing to show it meets its own specifications and is safe and effective for its intended use.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured/tested for) | Reported Device Performance (Results) |
|---|---|
| Antibacterial Activity (In-vitro) | |
| Reduces/inhibits microbial colonization in the dressing | Demonstrated |
| Log 4 reduction of specific organisms over 7 days | Demonstrated for: |
- Staphylococcus aureus (MRSA) NCTC 13142
- Escherichia coli ATCC 8739
- Pseudomonas aeruginosa ATCC 9027
- Enterococcus faecalis NCTC 12201
- Staphylococcus aureus ATCC 6538 |
| Biocompatibility | In compliance with BS EN ISO 10993-1 (Biological Evaluation of Medical Devices) |
| Sterilization | Performed in compliance with harmonized standards |
| Manufacturing Quality | Meets all established specifications; manufactured under GMP; risk analysis (BS EN ISO 14971) performed and controls implemented |
| Absorption Capacity | Hydrophilic foam absorbs up to eight times its own weight in fluid |
Note on "Acceptance Criteria" for a 510(k): For a 510(k) submission like this, the "acceptance criteria" are typically demonstrating that the device is as safe and effective as the predicate device, and that its in-vitro and bench testing results meet its own internal specifications and relevant standards. There isn't a "clinical study" in the traditional sense with specific clinical endpoints and acceptance thresholds for clinical performance in humans, as you might see in a PMA or a more novel device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for specific tests. The antibacterial data refers to "organisms" which implies laboratory strains, not human patient samples.
- Data Provenance: The antibacterial and bench testing are in-vitro (laboratory) and bench studies, meaning they are not derived from human patients or a specific country of origin in a clinical context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not applicable and not provided. The testing described is in-vitro (lab-based antibacterial efficacy) and bench testing (physical properties, biocompatibility, sterilization). These types of tests do not involve human experts establishing a "ground truth" through interpretation (e.g., radiologists reviewing images). Instead, results are determined by laboratory measurements and adherence to specified standards.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided. As noted above, the testing is in-vitro and bench testing, not clinical with expert review of cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with/without AI Assistance
- No. This is a medical device (foam patch), not an AI/imaging device. Therefore, MRMC studies and AI assistance are not relevant to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No. This question applies to AI algorithms. This device is a physical medical dressing.
7. The Type of Ground Truth Used
- Antibacterial Testing: The "ground truth" would be the direct measurement of microbial reduction (e.g., Log reduction) in laboratory conditions following established microbiological protocols.
- Biocompatibility: Adherence to the requirements of the standard BS EN ISO 10993-1.
- Sterilization: Compliance with harmonized standards.
- Absorption: Direct measurement of fluid absorption capacity.
8. The Sample Size for the Training Set
- This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical medical product undergoing in-vitro and bench testing.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reasons as above.
N/A