(136 days)
Not Found
No
The device description and performance studies focus on the chemical composition and mechanical cleansing properties of the solution, with no mention of AI or ML.
Yes
The device is described as a 'Wound Cleanser' intended for 'mechanical cleansing and debriding acute and chronic wounds', which is a therapeutic function aimed at treating or alleviating a condition.
No
The device is described as a wound cleanser intended for mechanical cleansing and debriding of wounds, which is a therapeutic function, not a diagnostic one. It does not mention detection, diagnosis, or assessment of a medical condition.
No
The device description clearly states it is an "aqueous solution" and describes its chemical composition (sodium hypochlorite, sodium bicarbonate). This indicates a physical substance, not software.
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 mechanical cleansing and debriding of wounds. This is a direct application to the body surface for therapeutic or cleansing purposes.
- Device Description: The device is an aqueous solution applied externally.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. IVDs are typically used to test blood, urine, tissue, or other bodily fluids or samples.
The device is clearly intended for external wound care, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
OTC: Wound Cleanser is intended for mechanical cleansing of dirt and debris from skin, abrasions, cuts, and minor irritations.
Professional Use: Wound Cleanser for mechanical cleansing and debriding acute and chronic wounds; such as stage I-IV pressure ulcers, diabetic foot ulcers, pre and post surgical wounds, first and second degree burns, grafted and donor sites.
Product codes
FRO
Device Description
The Wound Cleanser is an aqueous solution of sodium hypochlorite, modified with sodium bicarbonate, used as a solution to mechanically cleanse and debride open wounds. The sodium hypochlorite concentration 0.0125% weight / volume.
Sodium hypochlorite is a solution preservative.
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
Environment of Use: Hospitals, nursing homes, wound clinics and pre and post hospitals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Oculus - Dermacyn - K042729, Anacapa - Anasept Skin and Wound Cleanser -K073547
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) Summary Page 1 of 4 5-Aug-09
AUG
07 2009
Century Pharmaceuticals, Inc. Tel (317) 849-4210 10377 Hague Road Fax (317) 849-4263 Indianapolis, IN 46256 Ross Deardorff - President Official Contact: Wound Cleanser Proprietary or Trade Name: Wound cleanser Common/Usual Name: FRO - Dressing, wound, drug Classification Name/Code: CFR - unclassified - pre-amendment Wound Cleanser Device: Oculus - Dermacyn - K042729 Predicate Devices: Anacapa - Anasept Skin and Wound Cleanser -K073547
Device Description:
The Wound Cleanser is an aqueous solution of sodium hypochlorite, modified with sodium bicarbonate, used as a solution to mechanically cleanse and debride open wounds. The sodium hypochlorite concentration 0.0125% weight / volume.
Sodium hypochlorite is a solution preservative.
Indications for Use:
OTC: Wound Cleanser is intended for mechanical cleansing of dirt and debris from skin, abrasions, cuts, and minor irritations.
Professional Use: Wound Cleanser for mechanical cleansing and debriding acute and chronic wounds; such as stage I-IV pressure ulcers, diabetic foot ulcers, pre and post surgical wounds, first and second degree burns, grafted and donor sites.
Patient Population: Patients with acute or chronic wounds.
Environment of Use: Hospitals, nursing homes, wound clinics and pre and post hospitals
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510(k) Summary
Summary of substantial equivalenc
| | Predicate | Predicate | Proposed
Wound Cleanser | Features and Performance Characteristics | Predicate
Oculus - Dermacyn
K042729 | Predicate
Anacapa - Anasept
K073547 | Proposed
Wound Cleanser |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Oculus – Dermacyn
K042729 | Anacapa - Anasept
K073547 | | Ingredients | Purified Water 99.97%,
chloride