(57 days)
The Bioderm, Inc. foam dressing is an external wound dressing designed to help maintain a moist healing environment, manage exudate, and protect the wound from contamination. The dressing is indicated for the management of the following types of wounds:
Partial and full-thickness wounds, moderate to heavily exudating wounds such as; lower extremity ulcers including; venous stasis ulcers, arterial ulcers, or mixed etiology (venous & arterial) and post surgical incisions, pressure sores, and diabetic foot ulcers.
Partial thickness wounds such as; donor sites, abrasions, lacerations, and superficial burns.
Other indications include; a drainage dressing for tracheostomy, G-tube, J-tube, Penrose drain, chest tube, or sump drain, as well as a secondary or cover dressing for packed wounds.
The device has not changed from those approved under Bioderm, Inc. K982778 and consist of square, hydrophilic foam pads for wound care and square foam pads with a slit to fit around tracheostomy or gastrostomy tubes. The device provides a means to absorb exudate from draining wounds.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Bioderm Foam Wound Dressing:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices, particularly those seeking 510(k) clearance, the "acceptance criteria" are typically defined by demonstrating substantial equivalence to a legally marketed predicate device. This often involves showing that the new device has the same technological characteristics and similar performance. In this case, the acceptance criteria are related to the biological safety and non-toxicity of the materials.
| Acceptance Criteria (from predicate/general safety standards) | Reported Device Performance (Bioderm Foam Wound Dressing) |
|---|---|
| Non-irritant (Primary Dermal Irritation) | Considered a non-irritant |
| Non-sensitizing (Kilgman Maximization Study) | Exhibit no reaction to the challenge (0% sensitization), Grade I reaction (weak allergic potential, not considered significant) |
| No significant systemic toxicity (Systemic Injection Test) | Considered negative; no significantly greater biological reaction than control |
| Not toxic with repeated intravenous administration (14 Day Repeated Intravenous Toxicity Study) | Not toxic based on clinical observations and histopathological assessment |
| Non-cytotoxic (Cytotoxicity - Agar Diffusion Test) | No biological reactivity (Grade 0); considered non-cytotoxic |
| Non-hemolytic (Hemolysis Rabbit Blood) | Considered non-hemolytic at 0.12% Hemolysis |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document details non-clinical laboratory tests, primarily on biological samples rather than human clinical data.
- Primary Skin Irritation: Albino rabbits (specific number not given, but typically a small group for such tests).
- Kilgman Maximization Study: Not specified, but generally performed on a small group of animals (e.g., guinea pigs).
- Systemic Injection Test: Albino Swiss mice (specific number not given, but generally a small group).
- 14 Day Repeated Intravenous Toxicity Study: Not specified, but typically a small group of animals (e.g., rabbits, rodents).
- Cytotoxicity-Agar Diffusion Test: L929 mammalian cells (in vitro).
- Hemolysis Rabbit Blood: Rabbit blood (in vitro).
Data Provenance: These are pre-clinical (animal and in-vitro) studies. The sponsor is Rynel Ltd. Inc., Boothbay, Maine, and the test facility is Toxicon Laboratories. The country of origin for the animals/biological material is not explicitly stated but is presumed to be local to the test facility (USA). All tests appear to be prospective in nature, as they were specifically conducted for this evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For these non-clinical biological tests, the "ground truth" is established by adherence to standard laboratory protocols and interpretations by qualified laboratory personnel. The document does not specify the number or qualifications of individual experts who "established the ground truth" in the way clinical studies might for image interpretation. Instead, the validity relies on:
- Accredited Test Facility: Toxicon Laboratories.
- Standardized Protocols: Reference to standards like USP XXIII for cytotoxicity.
- Expert Interpretation: Implied expertise of the scientists and technicians at Toxicon Laboratories in conducting and interpreting these specific toxicology and biocompatibility assays.
4. Adjudication Method for the Test Set
Not applicable for these types of non-clinical laboratory tests. Adjudication methods like "2+1" (two readers agree, third resolves discrepancy) are relevant for human interpretation tasks (e.g., radiology reads), not for direct biological assay results.
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 submission is for a foam wound dressing, not a diagnostic imaging AI algorithm. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this device's clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (wound dressing), not an algorithm or AI-based device.
7. The Type of Ground Truth Used
The ground truth for these tests is based on direct biological and chemical measurements and observations according to established laboratory protocols and scientific standards, aimed at assessing biocompatibility and safety. This is distinct from expert consensus, pathology (though histopathology was used in one test), or outcomes data in a clinical trial.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model. There is no "training set" in the context of device development described here.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.