SHA · Solid Wound Dressing With Permanently Bound Antimicrobial Agent

General, Plastic Surgery · 21 CFR 878.4013 · Class 2

Overview

Identification

Amferia Wound Dressing is a solid wound dressing with a permanently bound antimicrobial agent. It is intended to cover and protect dry-to-low exuding wounds (e.g., abrasions, skin tears, lacerations, incisions and surgical wounds, superficial and partial-thickness burns, pressure ulcers, arterial ulcers) and to maintain an appropriate moisture balance within the wound. The device consists of a solid wound dressing containing an antimicrobial permanently bound to the substrate surface, provided sterile, and intended for use only on external cutaneous (skin) wounds.

Classification Rationale

FDA has determined that the device should be classified into Class II. Class II (special) controls, in combination with the general controls of the FD&C Act, provide reasonable assurance of the safety and effectiveness of the device type.

Special Controls

In combination with the general controls of the FD&C Act, the wound dressing with permanently bound antimicrobial agent is subject to the following special controls: - (1) The device must not contain antimicrobials considered by FDA to be medically important. Medically important antimicrobials are antimicrobials that are important for therapeutic use in humans and associated with a high level of antimicrobial resistance concern (AMR). Medically important antimicrobials include the following classes: Allylamines, Aminocyclitols, Aminoglycosides, Aminomethylcyclines, Amphenicols, Antifolates, Ansamycins, Azoles, Betalactams both with and without Beta-lactamase inhibitors, Carbapenems, Cephalosporins, Cephamycins, Cyclic Polypeptides, Dihydrofolate Reductase Inhibitors, Echinocandins, Fluorocyclines, Fluoroquinolones, Fosfomycins, Fusidanes, Glycopeptides, Glycylcyclines, Heterocyclic compounds, Hydroquinolones, Lincosamides, Lipoglycopeptides, Lipopeptides, Macrolides and Ketolides, Macrocyclic peptides, Monobactams, Nitrofurans, Nitroimidazoles, Oxazolidinones, Penems, Penicillins, Phosphonic Acid Derivatives, Pleuromutilins, Polyenes, Polymyxins, Pseudomonic acids, Quinolones, Rifampin, Riminofenazines, Streptogramins, Sulfonamides, Sulfones, or Tetracyclines. - (2) Performance testing and technological characteristics must demonstrate the functionality of the device to achieve the intended use, including: - (i) The physical and chemical characteristics of the solid wound dressing must be established. The following must be provided: - (A) Identity, quantification, and purpose of each component in the finished product; - (B) Description of the process by which the antimicrobial is bound to the substrate, including the resulting type of bonding (e.g. covalent, ionic, etc.); - (C) Specifications and characterization of each component in the finished product; and - (D) Final release specifications for the manufactured solid wound dressing. - (ii) Performance data must demonstrate that components are present in appropriate amounts to perform as intended under anticipated conditions of use, including evaluation of expected worst-case conditions. - (iii) The device must be demonstrated to be sterile. - (iv) The device must be demonstrated to be biocompatible. - (v) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including evaluation of expected worst-case conditions. - (vi) Performance data must support the shelf life of the device by demonstrating package integrity and product functionality over the identified shelf life. - (3) Antimicrobial characterization and performance testing must address the following: - (i) The technological characteristics of the device must indicate the purpose of the antimicrobial and performance data must demonstrate it is present in appropriate amounts to perform as intended under anticipated conditions of use and storage conditions. If the antimicrobial is present as a microbial barrier to cover and protect a wound, microbial barrier testing must demonstrate elimination of passage of microorganisms through the solid wound dressing. If the antimicrobial is present to inhibit microbial growth within the solid wound dressing being used to cover and protect a wound, antimicrobial effectiveness testing must demonstrate inhibition of microbial growth within the solid wound dressing during use. This testing must include: - (A) Establishment of the Minimum Effective Concentration (MEC) of the antimicrobial in the context of the final solid wound dressing; - (B) Identification of the period of effectiveness (i.e., maximum product use life) based on concentration of antimicrobial, leachability data, and performance under expected worst-case simulated use conditions; and - (C) For the tests conducted, evaluation with clinically relevant microbial species, including available strains of challenge organisms containing specific antimicrobial resistance mechanisms as part of expected worst-case scenario performance testing. - (ii) Performance test data must demonstrate that the antimicrobial is bound to the dressing substrate and does not leach from the dressing. This testing must include: - (A) Extraction studies exposing the dressing to justified conditions to evaluate the leachability of the antimicrobial (e.g. prolonged extraction in solvents of different polarity at elevated temperatures); and - (B) Assessment of the potential for substrate and/or coating degradation leading to leaching of the antimicrobial. - (iii) Evaluation and identification, based on literature review, of any probable risks for probable contributions to the development and spread of antimicrobial resistance (AMR) must be provided, and must include: - (A) Identification of the antimicrobial, proposed mechanism(s) of action, and expected spectrum of activity; and - (B) An AMR assessment for each antimicrobial, including the following characterization elements based on literature review: - (1) Known resistance mechanisms; - (2) Transmissibility of resistance mechanisms; - (3) List of resistant microbial species; and - (4) Potential for coselection (e.g., via coresistance or cross-resistance) for medically important antimicrobial resistance mechanisms. (4) Any statements in labeling must be clear such that they may be understood by the end user, supported by appropriate evidence, and consistent with the intended use of covering and protecting a wound, absorbing exudate, and maintaining appropriate moisture balance within the wound. The labeling must include: - (i) Instructions regarding the proper placement, sizing, duration of use for the solid wound dressing, frequency of use, and removal of the solid wound dressing, if applicable; - (ii) A list of each ingredient or component within the solid wound dressing; - (iii) A warning statement regarding any known incompatibilities with other potential therapies; - (iv) Instructions to monitor for signs of infection; - (v) A statement regarding the potential retention of material in the wound or the surrounding area and any applicable instructions for removal of this material; - (vi) A contraindication for any known sensitivity to components within the product; - (vii) A shelf life (i.e., maximum period the unopened solid wound dressing is stable while stored on the shelf under a specified range of environmental conditions); - (viii) A maximum use life per application of solid wound dressing (i.e., period the solid wound dressing is recommended for use prior to removal); - (ix) A statement regarding when to discontinue use of the solid wound dressing after multiple reapplications based on biocompatibility and performance testing; - (x) A statement of the role of the antimicrobial in the device. All statements regarding the antimicrobial must be consistent with and placed in the context of the role as a protectant; - (xi) A warning statement regarding the potential for selection of antibiotic resistant organisms if the wound dressing contains an antimicrobial that may indirectly select for organisms with medically important antimicrobial resistance mechanisms; and - (xii) A statement that the antimicrobial is not intended to affect wound bioburden.

Recent Cleared Devices (1 of 1)

Top Applicants

• Amferia AB — 1 clearance