(256 days)
The MedCu Antibacterial Wound Dressings with Copper-Oxide are indicated for the management of wounds and to provide a physical bacterial barrier (adhesive contour type only). The dressings are applied topically and are in direct contact with the wound. The dressings are intended to be used for indications as follows:
Over-The-Counter (OTC) use indications:
Local management of superficial wounds, minor burns, abrasions and lacerations (tears).
Prescription use indications (Rx-only):
- · Partial and full thickness wounds,
- · Pressure ulcers (stage I-IV),
- · Diabetic ulcers,
- · Venous stasis ulcers,
- · Arterial ulcers,
- · 1st and 2nd degree burns.
- · Surgical wounds,
- · Vascular access or peripheral IV sites,
- · Orthopedic external pin sites, and
- · Acute wounds such as lacerations, abrasions, and skin tears.
The MedCu Antibacterial Wound Dressings with Copper-Oxide are sterile, soft, single use, barrier wound dressings composed of an internal absorbent layer and one or two external nonwoven layers (only the adhesive contour model serves as physical barrier). The external layer(s) are made of Polypropylene nonwoven fabric and the internal layer is made of needle punch layer made of Polyester and Cellulose fibers. The wound dressings achieve at least 500% fluid absorbency.
Both the internal and external layers are impregnated with copper-oxide particles. The one or two external layers cover the internal layer from one or both sides, accordingly. The wound dressing size is of 10 cm x 10 cm or 5 cm x 5 cm (other variations may be included as well), and may be provided with or without an adhesive contour (adhesive border), which provides physical bacterial barrier. The wound dressings without an adhesive contour can be cut per wound shape. The Copper-Oxide ions are released within the wound dressing from the polymeric matrix of each layer in the presence of moisture. The MedCu ABWDs, reduced the tested bacteria by more than 4 log within the wound dressing based on in-vitro testing.
MedCu ABWDs absorb wound fluid, contain copper-oxide to inhibit bacterial growth within the dressing and serves as a *barrier against bacterial penetration.
*Note: Barrier against bacterial penetration is achieved only by the adhesive contour model.
The wound dressing is provided sterile and kept sterile in a sterilization pouch for its entire shelf life.
Body contact materials were evaluated for biocompatibility with accordance to FDA's Guidance document for Use of ISO 10993-1, Biological Evaluation of Medical Devices – Part 1 : Evaluation and Testing with a Risk Management Process, dated June 16, 2016 and the ISO 10993-1:2009 standard.
The provided text describes the MedCu Antibacterial Wound Dressings with Copper-Oxide, whose 510(k) Premarket Notification (K180643) was reviewed by the FDA. The document outlines the device's indications for use, description, and performance data used to establish substantial equivalence with predicate devices.
However, the document does not contain the following information typically associated with typical diagnostic AI/ML device approval:
- Acceptance Criteria for Performance: It describes various tests conducted but does not specify a quantitative "acceptance criterion" (e.g., sensitivity, specificity, or accuracy threshold) that the device must meet. Instead, it refers to "successfully tested," "at least 4 log reduction," and "at least 500% absorbency."
- Study That "Proves" Device Meets Acceptance Criteria: There isn't a single, clearly defined study designed to meet a pre-set performance threshold. The performance data section lists several non-clinical tests (chemical, biological, antibacterial effectiveness, bacterial barrier, absorbency, particle analysis, leachables, MEC, packaging shelf life, sterilization, pyrogenicity) that support safety and effectiveness claims and "establish substantial equivalency."
- Sample Size for Test Set: Not applicable as these are non-clinical, in-vitro, or bench tests, not clinical studies with a "test set" of patient data.
- Data Provenance: Not applicable.
- Number of Experts and Qualifications: Not applicable.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The device is a wound dressing, not a diagnostic AI/ML device, so such a study is not relevant or included.
- Standalone (Algorithm Only) Performance: Not applicable.
- Type of Ground Truth: For the "antibacterial effectiveness testing," the ground truth is the measured reduction in viable bacterial titers (colony-forming units) as compared to a control or baseline. For "biocompatibility," the ground truth is established through standard toxicological and biological assays comparing the device's effects to established safety profiles.
- Sample Size for Training Set: Not applicable as this is not an AI/ML device that requires a training set.
- How Ground Truth for Training Set Was Established: Not applicable.
Given these limitations from the provided text, I can only populate the table with the performance data and claims mentioned, and clarify that other requested information is not present or relevant for this type of device according to the document.
1. Table of Acceptance Criteria and Reported Device Performance
As specific acceptance criteria (e.g., "must achieve X% sensitivity") are not explicitly stated in the document for the overall device performance, the table reflects the performance claims or results reported from the non-clinical tests.
| Acceptance Criterion (Implicit/Claimed) | Reported Device Performance (from K180643) |
|---|---|
| Biocompatibility | Successfully evaluated for biocompatibility with accordance to FDA's Guidance document for Use of ISO 10993-1, Biological Evaluation of Medical Devices – Part 1 and ISO 10993-1:2009 standard, including: Exhaustive extractions, FTIR, GC-MS, ICP-OES, UPLC-MS, Cytotoxicity, Skin irritation and Intracutaneous reactivity, Acute systemic toxicity, Sensitization (Maximization), Wound healing study on large animal (porcine). |
| Antibacterial Effectiveness | Achieves more than 4 log reduction of viable titers of 6 bacteria (E. coli, E. faecalis, E. aerogenes, K. pneumoniae, S. epidermis, and MRSA) within the wound dressing, based on in-vitro testing per AATCC 100, following real-time aging. |
| Bacterial Barrier Effectiveness | Demonstrated for the device intended use duration (adhesive contour model only). |
| Absorbance Capacity | Achieves at least 500% absorbency of the wound dressing weight. (Reported 2 layers: ~79.4 oz/yd²; 3 layers: ~75.6 oz/yd²). Note: The 500% absorbency is a general claim, while the oz/yd² are specific measurements provided in the comparative table. |
| Copper-Oxide Particle Integrity | Analyzed for size, shape, and distribution using ICP, SEM, EDS, and DLS. Confirmed copper oxide particles were not released (leachables) using DLS method. Minimal Effective Concentration (MEC) study evaluated for 4 log reduction. |
| Shelf Life | Packaging shelf life validated using accelerated aging method according to ISO 11607-1. |
| Sterilization | Validated using EtO half cycle method according to ISO 11135:2014, including EtO/ECH residuals according to ISO 10993-7:2008. |
| Pyrogenicity | Pyrogenicity test conducted using LAL method and Material-Mediated Pyrogen study. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of typical AI/ML diagnostic device test sets. The document describes non-clinical laboratory tests (e.g., in-vitro antibacterial tests, chemical analyses, biological evaluations on material, pig wound healing study). Specific sample sizes for each of these non-clinical tests (e.g., number of bacterial replicates, number of animals in the wound healing study) are not detailed in the provided summary.
- Data Provenance: The tests are described as in-vitro and laboratory-based studies performed by the manufacturer (MedCu Technologies, Ltd.). The wound healing study was conducted on a "large animal (porcine)." No human clinical data or geographical origin of patient data is mentioned in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. This device is a wound dressing, and the performance evaluation relies on laboratory test standards and biological assays, not interpretation by human experts to establish a "ground truth" for a diagnostic task.
4. Adjudication Method for the Test Set
- Not applicable. (No expert adjudication involved for this type of non-clinical testing).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is a medical device (wound dressing), not a diagnostic AI/ML system that would typically involve human readers interpreting medical images or data.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
- Not applicable. This is a medical device (wound dressing), not an AI/ML algorithm.
7. The Type of Ground Truth Used
- Biocompatibility: Ground truth is established by standardized biological and chemical assays that measure cellular response, toxicity, irritation, sensitization, and systemic effects according to ISO and FDA guidelines. For the wound healing study, the ground truth would be the observation of wound healing processes in the animal model.
- Antibacterial Effectiveness: The ground truth is the direct measurement of viable bacterial titers (colony-forming units, CFU) after exposure to the device, compared to control groups. A reduction of "more than 4 log" signifies a 99.99% reduction in bacteria.
- Bacterial Barrier: Ground truth is the measured ability of the dressing to prevent bacterial passage.
- Absorbency: Ground truth is the direct measurement of fluid absorption by weight.
- Material Characterization (Copper Oxide particles, leachables): Ground truth is established by analytical chemistry techniques (ICP, SEM, EDS, DLS) and direct measurement of concentrations or particle properties.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/ML device.
N/A