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Indicated as a single use, sterile device for use in gravity fed I.V. therapy or with a pressure infuser, when an extended fluid path is required for administration.

Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration.

Mobile I.V. Systems device, the Primary I.V. Fluid Administration Set consists of a tubing set with either a 0.2 um or a 1.2um GVS S.p.A filter, universal spike, all position drip chamber, two injection sites and a removable Easydrop flow regulator and is used as a fluid pathway for I.V. administration. Mobile I.V. will offer three models, which will allow the choice of 10drops/ml, 20 drops/ml, or 60 drops/ml. The Primary I.V. Fluid Administration Set was designed for Emergency Medical and Hospital settings and includes an all position drip chamber. The drip chamber allows the flow of liguid regardless of the position of the drip chamber.

The provided text describes a 510(k) premarket notification for an I.V. Administration Set, focusing on its substantial equivalence to a predicate device. It details various bench tests and biocompatibility assessments but does NOT describe an AI-powered device or associated performance studies involving AI. Therefore, I cannot provide details on AI acceptance criteria, specific AI performance metrics, or multi-reader multi-case studies.

However, I can extract the acceptance criteria and the studies that prove the I.V. Administration Set meets these criteria based on the information provided, treating the entire product as the "device" in this context.

Here's an analysis of the provided information, framed to answer the questions about acceptance criteria and study descriptions for the physical medical device:

Acceptance Criteria and Study for MOBILE I.V. SYSTEMS, LLC Primary I.V. Fluid Administration Set

The device in question is a physical medical device, an "I.V. Administration Set," and not an AI-powered diagnostic tool. Therefore, the "acceptance criteria" relate to its functional performance, safety, and substantial equivalence to a predicate device, as demonstrated through bench testing, biocompatibility testing, and sterilization validation.

1. Table of Acceptance Criteria and Reported Device Performance

• ISO 10993-10, Sensitization
• ISO 10993-11, Acute Systemic Injection
• ISO 10993-3, Haemocompatibility
• ISO 10993-5, Cytotoxicity MEM Elution
• ISO 10993-10, Intracutaneous Injection (Note: 10993-10 appears twice for different tests; this is as listed in the document for Sensitization and Intracutaneous Injection) |
  | Infection | Sterility Testing (ISO 11137:2006) | Validation will be done according to ISO 11137:2006, with a sterility assurance level of 10-6. (Note: "Will be done" implies this was a commitment for future validation but accepted for 510(k) submission based on the protocol). |
  | | Sterile Packaging Testing (ISO 11607:2006) | Validation will be done according to ISO 11607:2006. (Same note as above). |
  | | Pyrogen Testing (USP 30:2007, and ) | Sets were validated using the Kinetic Turbidimetric method. Implied successful. |
  | | Bacterial Retention Testing (on predicate device, GVS Speedflow) | Performed on the predicate device (same filter used).
• 0.2 um filter: removed ≥99.9% of Brevundimonas diminuta.
• 1.2 um filter: removed >99.9% of Candida Albicans. (These results were accepted due to the use of the same filter). |
  | Improper Use | Labeling | Mitigation measure is proper labeling. While no "performance" result is given, the implication is that the labeling will be compliant and adequate to mitigate this risk. This is typically reviewed by the FDA as part of the submission process and confirmed by the approval letter. |
  | Overall Equivalence | Substantial Equivalence to Predicate Device (GVS Speedflow I.V. Administration Set with Easydrop Flow Regulator, K061115). The new device has the same materials, solvents, intended use, and similar design elements (e.g., all-position drip chamber). | The FDA determined the device is substantially equivalent to the predicate device, allowing it to be marketed. The summary states that "The materials and solvents... are the same as, GVS Speedflow I.V. Set w/Easydrop Regulatory. K# 061115. The intended use and test results show or will show that the Mobile I.V. Systems Primary I.V. Fluid Administration Set is substantially equivalent to the predicate device." |

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify exact sample sizes (e.g., number of sets tested) for each bench test conducted. It only mentions what tests were performed.

• Test Set: Not explicitly stated as a number of devices, but rather specific tests according to ISO standards.
• Data Provenance: The tests are standard bench tests, not clinical data from patients. They are performed in a laboratory setting. Biocompatibility and Bacterial Retention data were derived from testing performed on the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is a physical device, and its "ground truth" is established through engineering and scientific bench testing against established international standards (ISO, USP) for physical and chemical properties, sterilization, and biocompatibility. There are no "experts" establishing a "ground truth" in the way radiologists establish ground truth for diagnostic images. The test results themselves, when compliant with the specified standards, serve as the "ground truth" for the device's performance.

4. Adjudication Method for the Test Set

Not applicable. This concept ("2+1", "3+1") is typically relevant for expert consensus in clinical data labeling or interpretation, especially with AI. For a physical device, compliance is determined by meeting objective quantitative or qualitative criteria within the specified test methods.

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 an I.V. administration set, not an AI diagnostic tool that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance and safety is based on:

• Compliance with International Standards: ISO 8536-4 (Infusion sets), ISO 10993 (Biocompatibility), ISO 11137 (Sterilization), ISO 11607 (Packaging), and USP 30 (Pyrogen).
• Predicate Device Data: Biocompatibility and bacterial retention were established by tests performed on the predicate device, given the identical materials and components.
• Internal Test Methods: For priming volume testing.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this physical device.

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