Search Results

OTC: Hy-Chlo™ Wound Solution is intended for removal of foreign objects such as dirt, for cleansing of minor cuts, lacerations, abrasions and wounds.

Professional Use: Hy-Chlo™ Wound Solution is intended to be used under the supervision of healthcare professional in the cleansing of acute, chronic and/or open wounds such as Stage I-IV pressure ulcers, diabetic foot and leg ulcers, surgical wounds, first and second degree burns and grafted and donor sites.

Hy-Chlo™ Wound Solution is an aqueous, clear, colorless solution that cleans open wounds. The solution delivers sodium hypochlorite as a preservative with sodium bicarbonate as a pH modifier. Hy-Chlo™ Wound Solution will be supplied in heat sealed, impervious, mold extruded HDPE bottles. A permanent affixed label will be on each bottle.

This document describes the 510(k) summary for the Hy-Chlo™ Wound Solution, a medical device for wound cleansing.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for Hy-Chlo™ Wound Solution appear to be demonstrated through various tests evaluating safety, efficacy in wound healing, antimicrobial properties, and physical characteristics. While explicit numerical acceptance criteria are not always stated, the reported performance indicates that the device met the implied safety and effectiveness standards for its intended use.

2. Sample Sizes Used for Test Set and Data Provenance

Due to the nature of the device (wound solution) and the pre-clinical nature of the studies, the "test set" does not refer to a dataset in the typical AI context but rather to the animal models and in-vitro samples used for various biological and physical tests.

• Animal Studies:
  • Wound Healing Study (Pigs): "young adult pigs" (specific number not provided). Provenance: Not specified (likely laboratory animal studies).
  • Dermal Irritation Study (Rabbits): "rabbits" (specific number not provided). Provenance: Not specified (likely laboratory animal studies).
  • Sensitization Study (Guinea Pigs): "guinea pigs" (specific number not provided). Provenance: Not specified (likely laboratory animal studies).
• In-vitro Studies:
  • Cytotoxicity: Mammalian cell line (L-929). Provenance: Laboratory (in-vitro).
  • Preservative Testing: Specific microbial cultures (S. aureus, E. coli, P. aeruginosa, C. albicans, S. aureus (MRSA), A. Brasiliensis, mold, yeast). Provenance: Laboratory (in-vitro).
• Physical Testing:
  • Force Measurement: Not specified, but involved measuring force from the container. Provenance: Laboratory.

All studies appear to be prospective in nature, as they were specifically conducted for the purpose of demonstrating device safety and effectiveness.

3. Number of Experts and Qualifications for Ground Truth

This document does not describe studies that require expert adjudication or establishing "ground truth" in the context of medical imaging or diagnostic algorithms. The studies performed were pre-clinical (in-vivo animal studies, in-vitro laboratory tests, and physical testing). The assessment of outcomes (e.g., irritation, healing, microbial growth) would have been performed by trained laboratory personnel/scientists/veterinarians, but a specific number or qualification of "experts" for ground truth establishment for a test set, as might be found in an AI/imaging study, is not applicable here.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, the studies are not of a type that would involve adjudication by experts on a test set in the conventional sense for AI devices. Outcomes were determined by direct observation, laboratory measurements, and standard testing protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic or screening devices, especially those involving human interpretation of medical images, to assess the impact of an AI system on human reader performance. The Hy-Chlo™ Wound Solution is a topical wound cleansing solution, not an imaging or diagnostic device requiring human-in-the-loop performance evaluation in that manner.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Hy-Chlo™ Wound Solution is a physical chemical solution, not a software algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this device. Its performance is inherent in its chemical composition and physical properties.

7. Type of Ground Truth Used

The "ground truth" for the performance of Hy-Chlo™ Wound Solution was established by:

• Direct Observation of Biological Responses: In-vivo studies (e.g., wound healing, dermal irritation, sensitization) provided direct evidence of the device's effect on living tissues.
• Laboratory Assay Results: In-vitro cytotoxicity and preservative effectiveness studies yielded quantitative and qualitative results from established laboratory protocols.
• Physical Measurements: Measurement of force generated by the spray mechanism.
• Adherence to Standards: Compliance with USP protocols for preservative testing and ISO 10993 for biocompatibility, as well as OPPTS Guidelines for dermal irritation, constitute the benchmarks against which performance was measured.

8. Sample Size for the Training Set

Not applicable. This device is a chemical solution, not an AI/ML algorithm that requires a training set. The safety and effectiveness were demonstrated through pre-clinical laboratory and animal studies, not through machine learning.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Ask a specific question about this device