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This device is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

The subject device is a polypropylene plastic syringe filled with 0.9% Sodium Chloride for Injection, USP, and capped with a polypropylene plastic cap. The device will be terminally sterilized by gamma radiation sterilization. The device will be marketed as a 12 mL syringe with a 3 mL, 5 mL, or 10 mL fill volume.

This document describes a 510(k) premarket notification for a medical device called "Normal Saline Flush" by Nurse Assist, Inc. The purpose of the submission is to demonstrate substantial equivalence to previously marketed predicate devices. It is not a study proving clinical effectiveness of an AI device.

Therefore, many of the requested categories for describing an AI study are not applicable to this document. I will fill in the relevant information from the provided text.

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

• Seal Testing: no leaks (15 in-Hg for 15 minutes)
• Sterility: confirmation of sterile barrier and product sterility (no growth present) | - Visual Inspection: no major compromise of packaging
• Seal Testing: no leaks
• Sterility: confirmation of sterile barrier and product sterility—no growth present |
  | Shelf Life (Stability) | - Visual: no leaks, holes or cracks
• Seal: no leaks
• Appearance/Color: clear liquid
• Odor: no objectionable or unusual odors
• pH: 4.5 – 7.0
• Sodium Chloride: 0.885 – 0.945%
• Heavy Metals: USP & limits
• Sterility: confirmation of sterile barrier and product sterility (no growth present)
• Particulate: USP limits | - Visual: no leaks, cracks or holes
• Seal: no leaks
• Appearance/Color: no discoloration or cloudiness
• Odor: no objectionable odors
• pH: within upper and lower limits
• Sodium Chloride: within upper and lower limits
• Heavy metals: USP : less than 10 ppm (0.001%), USP : less than 2 ppm
• Sterility: confirmation of sterile barrier and product sterility—no growth present
• Particulate: less than 3,000 for 10 μm and 300 for 25 μm |
  | Biocompatibility (Qualitative) | - Cytotoxicity: Grade 0 (no reactivity)
• Hemocompatibility: Non-hemolytic
• Acute Systemic Toxicity: Non-toxic
• Intracutaneous Irritation: Non-irritant
• Contact Sensitization: Non-sensitizer
• Pyrogenicity: Nonpyrogenic | - Cytotoxicity: Grade 0 (no reactivity)
• Hemocompatibility: Hemolytic index of 0.0% (non-hemolytic)
• Acute Systemic Toxicity: Non-toxic
• Intracutaneous Irritation: Non-irritant
• Contact Sensitization: Non-sensitizer
• Pyrogenicity: Nonpyrogenic |
  | Endotoxin | Less than 0.25 EU/ml | All samples tested at an endpoint of 0.03 EU/ml. Sensitivity of Lysate (AntiLog10 of Mean): 0.03 EU/ml (This implies the results were below or at the detection limit, and below the acceptance criteria.) |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document pertains to the physical and chemical properties, and biocompatibility of a medical device (a saline flush syringe), not an AI algorithm. Therefore, there is no "test set" in the context of an AI study. The data provenance is from non-clinical laboratory testing of the device. The country of origin of the testing is not specified but is implicitly associated with the manufacturer, Nurse Assist, Inc. (Haltom City, TX 76117, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI study. The "ground truth" for these tests are laboratory standards, analytical methods, and biological responses to the device materials.

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

Not applicable. This is not an AI study.

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 is not an AI study.

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

Not applicable. This is not an AI study.

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

The "ground truth" for this device consists of established scientific and regulatory standards for device safety, performance, and sterility. This includes:

• Physical integrity specifications (e.g., no leaks, cracks).
• Chemical composition standards (e.g., pH range, sodium chloride concentration, heavy metals limits).
• Sterility assurance levels (S.A.L. of $10^{-6}$).
• Biocompatibility standards (e.g., ISO, ASTM, USP guidelines for cytotoxicity, hemocompatibility, toxicity, irritation, sensitization, pyrogenicity).
• Endotoxin limits (USP ).

8. The sample size for the training set

Not applicable. This is not an AI study.

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

Not applicable. This is not an AI study.

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