(88 days)
For the cleansing of dermal lesions such as stage I-IV pressure uicers, stasis الداريع s, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritation of the skin.
The Allclenz " Wound Cleanser is a colorless, transparent solution supplied nonsterile in 12 fl. oz. plastic bottles equipped with trigger-spray intended for cleansing and irrigation of dermal wounds.
Biocompatibility of the product has been established by primary dermal irritation (rabbit), ocular irritation (rabbit), sensitization (guinea pig), and in vitro cytotoxicity studies.
The provided text is a 510(k) summary for a medical device (wound cleanser) and does not contain information related to a study that proves the device meets acceptance criteria as typically found for AI/ML-based medical devices or diagnostic tools.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on composition, function, and intended use, along with basic biocompatibility studies. It does not involve performance metrics like sensitivity, specificity, accuracy, or expert adjudication as would be relevant for the questions asked.
Therefore, I cannot provide the requested information, as these details are not present in the provided document.
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510 (k) SUMMARY
K965120
l. ADMINISTRATIVE
Healthpoint Medical Submitter: 307 E. Josephine Street San Antonio, Texas 78215 1-800-441-8227
MAR 2 1 1997
Contact Person: John Maverick
Date of Preparation: March 20, 1997
DEVICE NAME 11.
Proprietary Name: Allclenz " Wound Cleanser Common Name: Wound Cleanser Classification Name: Liquid bandage
III. PREDICATE DEVICE
Dermagran Wound Cleanser with Zinc; Derma Sciences, Inc.; K945802; 2/27/95.
IV. DEVICE DESCRIPTION
The Allclenz " Wound Cleanser is a colorless, transparent solution supplied nonsterile in 12 fl. oz. plastic bottles equipped with trigger-spray intended for cleansing and irrigation of dermal wounds.
Biocompatibility of the product has been established by primary dermal irritation (rabbit), ocular irritation (rabbit), sensitization (guinea pig), and in vitro cytotoxicity studies.
V. INTENDED USE
For the cleansing of dermal lesions such as stage I-IV pressure uicers, stasis الداريع s, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritation of the skin.
VI. COMPARISON TO PREDICATE DEVICES
The Allclenz™ Wound Cleanser is similar in composition, function and Intended use to the Dermagran Wound Cleanser with Zinc (Derma Sciences, Inc.) and other similar wound cleansers.
Accordingly, Healthpoint Medical concluded that the Allclenz " Wound Cleanser is safe and effective for its intended use and performs at least as well as legally marketed predicate devices, such as the Dermagran Wound Cleanser with Zinc.
§ 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.