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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, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

The Sterile Water and Sterile Normal Saline devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP <38>. The devices are offered in 100 mL, 250 mL and 500 mL bottles and 120 mL cups

The provided text describes a 510(k) premarket notification for "USP Sterile Water" and "USP Sterile Normal Saline (0.9% Sodium Chloride)." This document is a regulatory submission for medical devices, primarily focusing on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies against specific acceptance criteria.

As such, the document does not contain the detailed information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or its provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm-only) performance.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for the training set was established.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (K083042, Sterile Water and Sterile Normal Saline from Nurse Assist, Inc.) based on:

• Intended Use: The device shares the same intended uses as the predicate, which includes moistening absorbent wound dressings, cleaning minor cuts/burns/abrasions/irritations (OTC use), and moistening/debriding/cleaning acute/chronic dermal lesions and device irrigation (Prescription Use).
• Technological Characteristics: The devices have the same technological characteristics (sterile water or sterile normal saline meeting USP <38> and providing mechanical action for cleaning).
• Mechanism of Action: The mechanism of action is identical – mechanical action of fluid for removing foreign objects.
• Composition: Supplied sterile in containers of identical composition.
• Biocompatibility Testing: The devices were tested according to ISO 10993 standards and found to be non-cytotoxic, non-irritating, and non-sensitizing, with results similar to those reported for the predicate devices.

Conclusion:

The submission concludes that "Based on a comparison of composition, technological characteristics, intended use and biocompatibility test results, we conclude that Sterile Normal Saline perform at least as well as the predicate devices. Sterile Water and Sterile Normal Saline are therefore considered to be substantially equivalent to the above-mentioned predicate devices."

Therefore, for this specific submission, the "acceptance criteria" revolve around demonstrating comparable characteristics and safety to a legally marketed predicate device, rather than quantitative performance metrics against pre-defined clinical thresholds typically seen for more complex diagnostic or therapeutic devices. The "study" that proves the device meets "acceptance criteria" (i.e., substantial equivalence) consists of the comparative analysis described above and the biocompatibility testing.

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