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Wound Wash Saline® is intended to be used for cleansing dermal wounds. The label declared indications are: " To cleanse wounds, scrapes and minor burns." The mechanical action of sterile isotonic saline solution irrigating the wound provides for the removal of foreign material such as, but not exclusively, dirt and debris. Wound Wash Saline® can be used to remove tissue debris, wound exudate, and other extraneous matter. Bacteria and tissue metabolic products may also be removed or reduced in level allowing for the natural healing process to take place unimpeded. It may also be used to moisten wound dressings to ease removal from the wound area.

Wound Wash Saline® is indicated for use in cleansing wounds, scrapes, and minor burns

Wound Wash Saline® is a multi-use, isotonic sterile saline solution packaged in a bag-incan aerosol system. Actuation of the device (product can) delivers a consistent flow of sterile isotonic saline solution at published safe and effective wound impact pressures of 4 to15 psi [Clinical Practice Guideline Number 15, AHCPR, U.S. Department of Health and Human Services]. The mechanical action of isotonic saline solution moving across the wound aids in the removal of foreign material, such as dirt and debris, as well as any necrotic tissue, wound exudate and other extraneous matter. No preservatives are added since the finished device is sterilized by gamma irradiation under parameters that have been validated according to ISO/AAMI 11137 requirements [Sterilization of health care products - Requirements for validation and routine control- Radiation sterilization]. Wound Wash Saline® passes the USP Sterility Test. Wound Wash Saline® is an OTC device and will only be labeled for use in cleansing wounds, including the removal of foreign material such as dirt and debris.

The provided document (K083355) is a 510(k) summary for a medical device called "Wound Wash Saline®". It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with detailed acceptance criteria and results in the format you requested.

Therefore, I cannot extract the information required to populate the table of acceptance criteria and device performance, nor can I provide details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document states:

• Acceptance Criteria/Performance: The device "Wound Wash Saline® passes the USP Sterility Test." It also mentions delivering a "consistent flow of sterile isotonic saline solution at published safe and effective wound impact pressures of 4 to 15 psi [Clinical Practice Guideline Number 15, AHCPR, U.S. Department of Health and Human Services]." There is no detailed table of specific acceptance criteria or quantitative performance metrics provided beyond these statements.
• Study Design: The document primarily describes the device's characteristics and compares them to predicate devices to establish substantial equivalence. It does not describe a clinical or performance study with a test set, training set, or expert evaluations in the manner typically seen for complex AI/diagnostic devices. The "study" here is essentially a demonstration of manufacturing control (sterilization validation per ISO/AAMI 11137) and adherence to existing standards (USP Sterility Test, AHCPR guidelines for wound pressure).

Therefore, I cannot fill out the requested table and answer the specific questions because the document does not contain that type of information. It is a regulatory submission focused on demonstrating equivalence for a relatively simple device (saline wound wash).

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