(111 days)
SET GRI-FILL 3.0 6 to 1 is a fluid transfer set to be used in conjunction with SETS GRI-FILL 3.0 1 WAY or 2 WAY through which the same substance from up to 6 rubberstoppered glass vials may be delivered into a final IV container.
SET GRI-FILL 3.0 6 TO 1 is an ancillary device used as a fluid pathway in conjunction with the Gri-fill 3.0 Pharmacy Compounder and associated 1 way or 2 way transfer sets through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. Equipped with a spike on each line and a 0.2 µm 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.
This device should not be used 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 and Diazepam. For information concerning compatibility of substances, please consult the information provided with the substance.
Fluid transfer set consisting of PVC tubing linking 6 minispikes to be used in conjunction with SETS GRI-FILL 3.0 1 Way or 2 Way transfer sets through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the source substances. The spike on each line facilitates easy puncture of thick rubber stoppers of small diameter. The device provides fast fluid addition and extraction due to the large surface area of the air-filter that quickly equalizes pressures.
This document, K093182, describes the SET GRI-FILL 3.0 6 to 1, a fluid transfer set. The information provided outlines the device's technical specifications and a summary of non-clinical data used to establish substantial equivalence to predicate devices, rather than a detailed study demonstrating quantitative performance against specific acceptance criteria. This submission focuses on comparing the new device against existing, legally marketed predicate devices (QUICKPIN and FLEBOSET MULTIPLE).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device facilitates fluid transfer of same substance from up to 6 rubber-stoppered glass vials into a final IV container. | "Functional laboratory bench testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use." (Page 3) |
| Aerosol Minimization: Equipped with a 0.2 µm hydrophobic air-filter to minimize aerosol formation. | "Equipped with a spike on each line and a 0.2 µm hydrophobic air-filter, it minimizes the formation of aerosols when preparing / dispensing the source substances." (Page 2) |
| Puncture Ease: Spikes facilitate easy puncture of thick rubber stoppers of small diameter. | "The spike on each line facilitates easy puncture of thick rubber stoppers of small diameter." (Page 1) |
| Fast Fluid Addition/Extraction: Due to large surface area of air-filter. | "The device provides fast fluid addition and extraction due to the large surface area of the air-filter that quickly equalizes pressures." (Page 1) |
| Material Compatibility: Materials must be compatible with its intended use and substances it contacts (except specified incompatibilities with PVC with DEHP plasticizer). | "All materials used in the construction of SET GRI-FILL 3.0 6 to 1 have been subject to chemical and biological testing in accordance with the applicable requirements taking account of its intended use." (Page 3) |
| Safety: No adverse influence on safety by new technological characteristics. | "Technological differences including the different output connector configuration on the transfer set have been addressed and verified by bench-testing to have no adverse influence on the safety and performance of the proposed device." (Page 3) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document refers generally to "bench testing" and "functional laboratory bench testing" (Page 3). It does not provide specific numerical sample sizes for these tests.
- Data Provenance: The studies were non-clinical, functional laboratory bench tests. The submitter is Laboratorios Grifols, S.A. in Barcelona, Spain. The data is thus likely from retrospective internal testing performed by the manufacturer in Spain.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided. The evaluation relies on "functional laboratory bench testing" and "chemical and biological testing" rather than human expert interpretation of results. The ground truth for device performance would be established by the physical and chemical properties of the device itself and its interaction with fluids, as measured in a lab setting, not by human experts.
4. Adjudication Method for the Test Set
- An adjudication method is not applicable here as the "ground truth" is determined by objective physical and chemical testing, not by expert consensus on subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a medical device (fluid transfer set), not an imaging or diagnostic AI tool that would typically involve human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- This is not applicable as the device is a physical medical device, not a software algorithm. The "performance" refers to the device's physical function and material compatibility, which is inherently "standalone" in its operation.
7. The Type of Ground Truth Used
- The ground truth used primarily involves the physical and chemical performance measurements of the device components and the assembled system in a laboratory setting. This includes:
- Verification of fluid transfer functionality.
- Measurement of aerosol minimization (implied by the 0.2 µm hydrophobic filter).
- Assessment of spike puncturing capability.
- Evaluation of fluid addition/extraction speed.
- Chemical and biological compatibility testing of materials.
8. The Sample Size for the Training Set
- This concept is not applicable here. This is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for a physical medical 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.