(88 days)
No
The device description and intended use are for a wound cleansing solution, and there is no mention of AI, ML, image processing, or any data-driven analysis.
No.
The device is described as a "Wound Cleanser" for cleansing and irrigation of dermal wounds, which is typically a cleaning agent rather than a device intended to treat or cure a disease or condition. Its intended use is for cleansing lesions, not for therapeutic intervention.
No
The device is described as a "Wound Cleanser" intended for "cleansing and irrigation of dermal wounds," not for diagnosing conditions.
No
The device description clearly states it is a "colorless, transparent solution supplied nonsterile in 12 fl. oz. plastic bottles equipped with trigger-spray," indicating it is a physical product (liquid and bottle) and not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the cleansing of dermal lesions and wounds. This is a topical application for wound care, not a test performed in vitro (outside the body) on biological specimens to diagnose a condition.
- Device Description: The device is a "Wound Cleanser" solution applied directly to the wound. This aligns with wound care products, not diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This wound cleanser does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.