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For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor burns, superficial abrasions and minor irritations of the skin.

For Prescription Use: For moistening absorbent wound dressings and for mostening acute and chronic dernal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

The subject devices are 100 mL, 250 mL or 500 mL sterile normal saline (0.9% Sodium Chloride). The design of these single-use devices incorporates clear, high density polyethylene (HDPE) bottles filled and sealed with a sterile, preservative-free, clear, colorless, aqueous solution, as labeled for device irrigation and wound debridement (not for injection). The subject device will function by means of mechanical action; specifically, by the mechanical mechanism of action associated with applying and moving an aqueous solution across a wound or device surface, which facilitates the moisturizing, debridement and irrigation of these surfaces.

The chemical composition of its aqueous solution is either sterile saline (0.9% Sodium Chloride in sterile water) for irrigation, which have been substantiated to each meet their respective USP monograph criteria, and its formulation contains no additives. The components of the subject device's container and closure system, made from polyethylene (PE) resins and an induction-heat seal and liner, meet the requirements of the Agency's food additive regulations.

The provided text is a 510(k) Premarket Notification for Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP. This document asserts substantial equivalence to a predicate device (Nurse Assist Wound Flush, Sterile Water and Sterile Normal Saline, K083042) rather than proving device performance against specific acceptance criteria through a clinical study.

Therefore, the requested information regarding "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established" is not available in this document.

The document explicitly states: "Summary of Clinical Testing: Not applicable. No clinical testing was done on the proposed device." (Page 9)

Instead, the submission relies on non-clinical testing (bench testing) and a comparison of technological characteristics to demonstrate substantial equivalence to a legally marketed predicate device.

Here's the relevant information provided:

1. A table of acceptance criteria and the reported device performance:

• This document does not present acceptance criteria for a clinical study or a table of reported device performance from such a study. It focuses on demonstrating equivalence through non-clinical means.
• The "Comparison of Proposed and Predicate Devices" (Table 1 on page 6) lists characteristics like product name, K number, product owner, product code, indications for use, regulation number, technological characteristics, chemical composition, design configurations, and performance specifications. The "Comparison Analysis" column for most entries is "Same" or "Similar," indicating that the proposed device matches the predicate in these aspects.

2. Sample sized used for the test set and the data provenance:

• Not applicable, as no clinical test set was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable, as no clinical test set with human ground truth was established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not applicable. The "ground truth" for this 510(k) submission is demonstrated through adherence to USP monographs for sterile water and saline, and safety standards for medical device materials, as assessed through bench testing and comparison to a predicate device.

8. The sample size for the training set:

• Not applicable, as there was no training set for an algorithm.

9. How the ground truth for the training set was established:

• Not applicable.

Summary of Non-Clinical Testing provided:

• Biocompatibility Evaluation: Conducted according to ANSI/AAMI/ISO 10993-1:2009. The device is classified as a surface device with limited contact ( Pyrogen Test Procedure, Material-Mediated Rabbit Pyrogen Testing
• Shelf Life and Sterilization:
  • Sterilized by gamma radiation in accordance with AAMI TIR33 (Sterilization of healthcare products - Radiation - Substantiation of a selected sterilization dose - Method VDmax) to achieve a Sterility Assurance Level (SAL) of 10^-6.
  • Aging studies conducted in accordance with ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems for Medical Devices) to verify shelf life and maintained sterility.
• Performance Testing (Bench): Mentioned generally as being conducted to evaluate safety, performance, and functionality, demonstrating overall safety. Specific details of these bench tests are not provided in this summary.

In conclusion, this 510(k) submission establishes substantial equivalence through non-clinical testing and comparison to a predicate device, as permitted for certain low-to-moderate risk medical devices. It explicitly states that no clinical (human) testing was performed.

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