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Rx Indications:
Under the supervision of a healthcare professional, ELECTROCYN soma is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic wounds including stage I-IV pressure ulcers, stasis ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin and diabetic foot ulcers. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.

OTC Indications:
ELECTROCYN soma is intended for OTC use in the management of skin abrasions, minor irritations, cuts, and intact skin.

ELECTROCYN soma contains purified water - 99.9%, hypochlorous acid (HOCl) + sodium hypochlorite (NaOCl) + sodium chloride (NaCl) ~ 0.1% and packed in HDPE bottles.

The provided text is a 510(k) summary for the device ELECTROCYN soma. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. The document includes non-clinical testing results but explicitly states that no clinical studies were included in the submission. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement in ground truth.

Specifically, the document focuses on demonstrating that ELECTROCYN soma is substantially equivalent to Microcyn Antimicrobial Skin and Wound Cleanser (K172622) based on product code, Rx/OTC classification, indications for use, technology, sterility claim, mechanism of action, and delivery system, all of which are stated as "Same."

The non-clinical testing section details biocompatibility and performance tests conducted to evaluate the device's safety and effectiveness, but these are not presented as meeting specific clinical acceptance criteria or used to establish performance metrics in the way clinical studies would.

Missing Information:

• Table of Acceptance Criteria and Reported Device Performance: This information is not present as no clinical studies were performed. The document lists "non-clinical performance testing" with "TEST PERFORMED," "DEVICE DESCRIPTION/SAMPLE SIZE," "TEST METHOD/APPLICABLE STANDARDS," and "SPECIFICATION COMPLIANCE." All results are listed as "Comply," but these are for engineering/performance specifications (e.g., composition, bioburden, antimicrobial efficiency, stability, packaging validation), not clinical performance or acceptance criteria in terms of diagnostic accuracy or clinical outcomes.
• Sample size used for the test set and the data provenance: Not applicable as no clinical studies were conducted.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical studies were conducted.
• Adjudication method: Not applicable as no clinical studies were conducted.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable as no clinical studies were conducted.
• Standalone (algorithm only) performance: Not applicable as this is a medical device (wound cleanser/irrigation solution), not an AI algorithm.
• Type of ground truth used: Not applicable as no clinical studies were conducted.
• Sample size for the training set: Not applicable as no AI algorithm is involved and no clinical training sets are mentioned.
• How the ground truth for the training set was established: Not applicable as no AI algorithm is involved and no clinical training sets are mentioned.

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