(126 days)
Disposable transfer set through which substances from 2 different vials containing the same solution may be continuously delivered for:
- IV administration when used in conjunction with a gravity or pump infusion set, with a) luer-lock connection to the drip chamber, to channel the solution from the source vials to the infusion set, and
- Pharmacy Compounding when used in conjunction with the Grifill 3.0 pharmacy b) compounding device and associated transfer sets.
Equipped with a spike on each line and a 0.2 um hydrophobic air-filter, it minimizes the formation of aerosols when preparing / dispensing the source substances. Facilitates easy puncture of thick rubber stoppers of small diameter. Provides fast fluid addition and extraction due to the large sufface area of the air-filter.
Set tubing is PVC with DEHP plasticizer. Do not use with lipids, suspensions or solutions that are incompatible with PVC with DEHP plasticizer. Substances that are known to show incompatibility include, but are not limited to, Pacitaxel, Etoposide, Carmustine, Propofol, Nitrogycerin, Isosorbide Dinitrate, Diazepam. For information concerning compatibility of substances, please consult the information provided by the manufacturer.
This device is intended to be used by trained healthcare personnel. It is restricted to sale by or on the order of a physician.
Disposable fluid transfer set for connection to a gravity or pump 1.V. administration set with drip chamber with luer lock connector or for use with the Gri-fill 3.0 pharmacy compounder.
Equipped with a spike on each line and a 0.2 um hydrophobic air-filter, it minimizes the formation of aerosols when preparing / dispensing the source substances. Facilitates easy puncture of thick rubber stoppers of small diameter. Provides fast fluid addition and extraction due to the large surface area of the air-filter.
Set tubing is PVC with DEHP plasticizer. Do not use with lipids, suspensions or solutions that are incompatible with PVC with DEHP plasticizer. Substances that are known to show incompatibility include, but are not limited to, Paclitaxel, Docetaxel, Etoposide, Carmustine, Propofol, Nitroglycerin, Isosorbide Dinitrate, Diazepam, For information concerning compatibility of substances, please consult the information provided by the manufacturer.
The provided document describes the predicate devices comparison for the FLEBOSET DOUBLE and does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria beyond general non-clinical bench testing.
Based on the provided text, I can infer the following:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in quantitative terms (e.g., "flow rate must be X mL/min ± Y%"). Instead, it broadly states that "All tests yielded correct results" for the non-clinical bench testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Leakage Testing | Yielded correct results |
| Infusion Flow-rate Testing | Yielded correct results |
| Functional Checking | Yielded correct results |
| Ethylene Oxide Sterilization Process Residuals | Yielded correct results |
| Manufacturing Process Residuals | Yielded correct results |
| Sterility | Yielded correct results |
| Endotoxins | Yielded correct results |
2. Sample Size for the Test Set and Data Provenance:
The document does not specify the sample size used for the non-clinical bench tests.
The data provenance is not explicitly stated as retrospective or prospective, but it refers to materials, packaging, and manufacturing processes identical to the predicate device, implying that some data might be drawn from previous evaluations of Grifols' existing devices. However, the non-clinical bench testing for FLEBOSET DOUBLE itself would be prospective testing of the new device. The country of origin of the device manufacturer is Spain.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This was a non-clinical bench study, not a clinical study involving expert interpretation of data or images.
4. Adjudication Method:
Not applicable. As this was a non-clinical bench study, there was no need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document explicitly states: "No clinical data presented in this submission." This type of study would fall under clinical data.
6. Standalone Performance Study:
Yes, in the sense that the device itself underwent non-clinical bench testing to demonstrate its performance characteristics. The document mentions "Non-clinical bench testing performed on FLEBOSET DOUBLE included leakage testing, infusion flow-rate testing and functional checking as per its intended use." This represents a standalone evaluation of the device's physical and functional properties.
7. Type of Ground Truth Used:
For the non-clinical bench testing, the ground truth would be based on engineering specifications and established test methods for medical device performance (e.g., standards for leakage, flow rates, sterility, and residual levels).
8. Sample Size for the Training Set:
Not applicable. The description is for a physical medical device (fluid transfer set), not an AI/algorithm-based device that would require a 'training set'.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
§ 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.