(297 days)
The SmartSite™ Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.
The SmartSite™ Bag is a single-use, empty IV container, which will be available in 100mL, 250mL, and 500mL product sizes. The SmartSite™ Bag is labeled as sterile fluid path, and contains both an add port and a spike port. The add port facilitates aseptic transfer of medication(s) into or out of the bag. The spike port contains a twist-off protective seal. Either the add port or the spike port can be connected to an intravenous (IV) administration set for medication delivery to the patient. The add port may be repeatedly accessed in accordance with the Directions for Use (DFU). The SmartSite™ Bag may be used for up to 24 hours after the initial access of the add port, consistent with prescribing information for the medications used.
The provided text describes the 510(k) submission for the SmartSite Bag, an empty IV container. It outlines the device's indications for use, comparison to a predicate device, and non-clinical tests conducted to demonstrate substantial equivalence. However, the document does NOT contain a formal "study" proving the device meets acceptance criteria in the sense of a clinical trial or a structured performance study with defined acceptance criteria and reported numerical performance measures like sensitivity, specificity, or accuracy for a diagnostic device.
Instead, the document details various engineering and biocompatibility tests designed to ensure the SmartSite Bag functions as intended and is safe for its stated use, thereby demonstrating equivalence to the predicate device. The acceptance criteria are implicitly met by passing these tests and standards.
Here's a breakdown of the information that is present, organized as requested where applicable, and noting where the requested information is not available in the given text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit acceptance criteria in a table format with corresponding numerical performance for the device for a specific clinical outcome. Instead, it lists various non-clinical tests and standards the device was evaluated against, implying that meeting these standards constitutes "acceptance."
| Test Category | Specific Test/Standard | Acceptance Criteria (Implied by standard compliance) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | ISO 10993-1 (Evaluation and testing within a risk management process) | Acceptable biological risk demonstrated by meeting ISO 10993 requirements for contact characterization. | "Acceptable biological risk established by demonstrating that the device meets ISO 10993." |
| - Extractable and Leachables testing and toxicological risk evaluation | Compliance with toxicological risk assessment. | Passed | |
| - Cytotoxicity | Non-cytotoxic. | Passed | |
| - Sensitization | Non-sensitizing. | Passed | |
| - Irritation or Intracutaneous Reactivity | Non-irritating. | Passed | |
| - Acute Systemic Toxicity | No acute systemic toxic effects. | Passed | |
| - Subacute/Subchronic Toxicity | No subacute/subchronic toxic effects. | Passed | |
| - Material-Mediated Pyrogenicity | Non-pyrogenic related to materials. | Passed | |
| - Hemocompatibility | Biocompatible with blood. | Passed | |
| Bacterial Endotoxin | Bacterial Endotoxin testing | Endotoxin requirements of | Meets particulate requirements. |
| Additional Testing | - Maintenance of performance requirements after infusate exposure | Maintained performance after exposure. | Passed |
| - Luer connection performance | Acceptable Luer connection performance. | Passed | |
| - Bag integrity (leakage) | No leakage. | Passed | |
| - Performance after simulated shipping | Maintained performance after simulated shipping. | Passed | |
| - Shelf life | Maintained performance for specified shelf life. | Passed | |
| - SmartSite Microbial Ingress Testing | No microbial ingress. | Passed |
2. Sample size used for the test set and the data provenance
The document does not provide specific sample sizes for each test in a numerical format (e.g., "n=X bags"). It refers to "testing" performed. The data provenance is internal to Gilero, LLC as it refers to non-clinical laboratory testing. There is no mention of country of origin of data or whether it was retrospective or prospective in a clinical sense, as these are non-clinical engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not available in the document. The tests described are non-clinical, laboratory-based evaluations against established standards (e.g., ISO, USP), not assessments requiring expert "ground truth" establishment in a diagnostic context.
4. Adjudication method for the test set
Not applicable. There is no mention of an adjudication method as the tests are objective, laboratory-based measurements against defined standards.
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 a medical device (IV bag), not an AI/diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (IV bag), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on established industry standards and specifications (e.g., ISO 10993, USP , ISO 15747, and internal performance specifications for factors like leakage, Luer connection, and shelf life).
8. The sample size for the training set
Not applicable. This is a traditional medical device, not an AI/machine learning product that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).