(56 days)
Administration of Intravenous fluids and drugs.
The Tuta Healthcare Pty. Limited Blood Administration Set is a device used to administer fluids, blood and blood products from a container to a patient's vascular system Through a catheter or venous access system inserted into a vein.
Use of Needle-Free Access site may aide in the prevention of needlestick injury.
The Tuta Healthcare Blood/Solution Administration Set is designed administer fluids from a container to a patient's vascular system through a needle catheter inserted into a vein. The pump helps to control the rate of flow of fluids from the container to the patient.
The provided text describes a 510(k) summary for the Tuta Healthcare Blood/Solution Administration Set, comparing it to the legally marketed Baxter Healthcare's Solution Administration Set (K924721). The submission aims to demonstrate substantial equivalence, focusing on design, materials, intended use, and performance.
However, the document does not contain the kind of detailed information typically found in studies for AI/ML-enabled medical devices or diagnostic devices, especially regarding acceptance criteria, specific performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or adjudication methods for ground truth, as these are not relevant to this type of device (an administration set) or the type of substantial equivalence submission presented.
The study referenced is a laboratory bench testing to assess the new device against the predicate device.
Here's a breakdown of the information that is available in the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Same indication statement as predicate device | Yes, "administration of fluids from a container to a patient's vascular system through a needle catheter inserted into a vein." |
| Same technological characteristics (design, materials, principle of operation) as predicate device | Yes, similar components (PVC tubing, roller regulators, perforators) and same principle of operation. |
| New characteristics do not affect safety or effectiveness | No new characteristics identified that would affect safety or effectiveness. |
| Descriptive characteristics precise enough to ensure equivalence | Yes. |
| Biocompatibility of fluid path materials | Materials suitable for limited contact (tested according to General Program Memorandum #G95). |
| Performance (e.g., Flow rate) compares favorably to predicate device | Flow rate testing of the Blood/Solution Administration Set "compares favourably" to the Baxter Healthcare's Solution Administration Set. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document states "Laboratory beach testing has been performed," but does not provide details on the number of units or test repetitions.
- Data Provenance: The testing was "Laboratory beach testing," implying it was conducted in a controlled environment. The manufacturer is based in Australia, but the testing location is not explicitly stated. It is a prospective study as tests were performed specifically for this submission.
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 device is an administration set, not a diagnostic device requiring expert interpretation of results or establishing ground truth based on clinical expert consensus. The "ground truth" here is the performance of the predicate device and established safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is an administration set. Adjudication methods are typically relevant for diagnostic studies where there's variability in interpretation or a need for consensus on clinical findings.
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-enabled diagnostic tool, and no human reader studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not have an algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the performance of the legally marketed predicate device (Baxter Healthcare's Solution Administration Set K924721) and adherence to recognized safety and performance standards (e.g., biocompatibility testing per General Program Memorandum #G95).
8. The sample size for the training set
Not applicable. There is no "training set" as this is a physical medical device and not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable, as there is no training set. The "ground truth" for comparison is the predicate device's established performance and regulatory compliance.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.