(23 days)
All models of SETS GRI-FILL 2.0 fluid transfer sets are ancillary devices used in conjunction with the GRI-FILL 2.0 pharmacy compounding device in hospites in hospites for a macy to provide a fluid pathway through which one or more source solutions are delivered into a single Gri-bag or Gri-flex container or into a standard syringe or pump. The device should not be used with lipids. It is restricted to sale by or on order of a physician.
SETS GRI-FILL 2.0 are fluid transfer sets for use with the GRI-FILL 2.0 pharmacy compounding device in order tc compound or mix different multi-ingredient solutions and to channel them into a final suitable container. The set is a disposable component of the compounding device made up of a syringe, a distributor and tubing to channel the fluid. Sets are available for 1 or 2 source solutions. Also a Luer female - female adapter is available as an accessory to the 1 or 2 way transfer sets. The model Luer Connection Tube can be joined to the 1 way or 2 ways sets as prolongation for connection to source solution containers with luer terminals.
Here's a breakdown of the acceptance criteria and the study information for the SETS GRI-FILL 2.0 based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance |
|---|---|
| Intended Use | Disposable component of the GRI-FILL 2.0 pharmacy compounding system to provide a fluid pathway for 1+ source solutions into a single final solution. Not for direct patient connection. |
| Technological Features: | |
| - Sterilization Method | Ethylene Oxide |
| - Direct Patient Hook-up | NO |
| - Number of Source Solutions | 2 (Sets available for 1 or 2 source solutions) |
| Main Transfer Materials | PVC with DEHP plasticizer |
| Physical, Mechanical, Biological Specs | Sterile / Non-pyrogenic |
| Closed System | YES (fluid not in contact with any reusable part of the compounding device) |
| Chemical and Biological Testing | All materials used were subject to chemical and biological testing in accordance with applicable requirements for a parenteral drug solution transfer set. |
| Functional Laboratory Testing | Showed correct operation of the device as per its intended use: |
| - Accurate Delivery | Accurate delivery of specified source solutions under normal and stress conditions. |
| - Fluid / Air Leakage | Fluid / air leakage checking performed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "sample size" for the test set in terms of number of devices or number of tests conducted for each functional parameter. It broadly mentions "Functional laboratory testing performed in foreseeable operating conditions." The data provenance is not explicitly mentioned as country of origin, but the submission is from Laboratorios Grifols, S.A. in Spain. The study appears to be prospective as it's a submission for premarket notification, indicating the tests were conducted for the purpose of demonstrating substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for a "test set" in the context of clinical or diagnostic performance. The evaluation is focused on the device's functional integrity and material compatibility, which would typically be assessed through engineering and laboratory testing rather than expert-derived ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert opinions or interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is an I.V. fluid transfer set, and its evaluation focuses on functional and material equivalence, not diagnostic or clinical accuracy requiring human interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the evaluation described is essentially a standalone (algorithm only, if "algorithm" refers to the device's inherent design and function) performance assessment. The device itself performs the function of fluid transfer, and its performance was evaluated in this standalone capacity through laboratory functional testing. There is no human-in-the-loop component in the performance of the device itself (though human operators operate the compounding device with which it is used).
7. The type of ground truth used
The "ground truth" for this device's evaluation is based on engineering specifications, material compatibility standards (chemical and biological testing), and functional performance criteria (e.g., accurate fluid delivery, no leakage). It is not based on expert consensus, pathology, or outcomes data in the clinical sense, as the device's function is mechanical fluid transfer.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-driven device with a "training set." The evaluation is based on the physical and functional properties of the manufactured device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this 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.