(65 days)
For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. For Prescription Use: For moistening absorbent wound dressings and for moistening, . debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.
The Wound Flush, Sterile Water & Sterile Normal Saline device is a wound and device cleansing solution that is intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile saline for irrigation and meets all of the associated requirements defined in the USP . The subject device is offered in various bottle and cup sizes with and without a spray applicator
This 510(k) summary describes a wound and device cleansing solution, but it does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.
The document details:
- Device name: Wound Flush, Sterile Water & Sterile Normal Saline
- Manufacturer: Nurse Assist Incorporated
- Intended Use/Indications for Use: For moistening dressings and cleaning various wound types (minor cuts, burns, abrasions) for both OTC and prescription use, and for device irrigation.
- Technological Characteristics: The mechanical action of fluid aids in the removal of foreign objects.
- Predicate devices: Several legally marketed sterile water/saline and wound care products are listed.
- Regulatory classification: Unclassified, pre-amendment device (Product code FRO).
- FDA determination: Substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information regarding acceptance criteria or a study proving the device meets those criteria, as it is not present in the provided text.
N/A