(14 days)
SETS GRI-FILL 3.0 1 WAY and 2 WAY fluid transfer sets are ancillary devices used in the GRI-FILL 3.0 pharmacy compounder in the hospital pharmacy to provide a fluid pathway through which one or two source substances are delivered into a final IV container or syringe.
SETS GRI-FILL 3.0 MULTIPLE fluid transfer sets are ancillary devices used as fluid pathways 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 source containers may be delivered into a final IV container.
This device should not be used with lipids.
This device is intended to be used by trained health-care personnel. It is restricted to sale by or on the order of a physician.
SETS GRI-FILL 3.0 are fluid transfer sets for use with the GRI-FILL 3.0 pharmacy compounding device in order to compound or mix different multi-ingredient solutions and to channel them into a final suitable IV container. The set is a disposable component of the compounding device. The 1WAY / 2WAY models are made up of a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Sets are available for 1 or 2 source substances. Also a Luer female - female adapter is available as an accessory to the 1 or 2 way transfer sets. The MULTIPLE model is also used as an accessory with the 1WAY / 2WAY sets for channeling the same solution from up to six (6) source containers delivering them into a final IV container. It is made up of connectors and tubing to enable interconnection of the different source containers.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SETS GRI-FILL 3.0 device:
Acceptance Criteria and Device Performance Study for SETS GRI-FILL 3.0
The provided text focuses on establishing substantial equivalence for the SETS GRI-FILL 3.0 with predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for a novel medical diagnostic algorithm. The information pertains to fluid transfer sets used in pharmacy compounding.
Based on the document, the "acceptance criteria" can be inferred from the comparison with predicate devices and the functional testing performed. The device's "performance" is reported qualitatively as demonstrating "correct operation" and meeting "applicable requirements."
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (fluid transfer sets) and the documentation provided (510(k) summary for substantial equivalence), the "acceptance criteria" are primarily related to functional and material specifications that ensure safe and effective fluid transfer, consistent with predicate devices.
| Acceptance Criteria (Inferred from comparison & testing) | Reported Device Performance (SETS GRI-FILL 3.0) |
|---|---|
| Sterile / Non-pyrogenic | Sterile / Non-pyrogenic |
| Materials: PVC with DEHP plasticizer | PVC with DEHP plasticizer (matches predicate) |
| Number of Source Containers for 1WAY/2WAY | 1 (1WAY Set), 2 (2WAY Set) |
| Number of Source Containers with MULTIPLE ancillary device | Up to 6 |
| Functionality as a closed system (fluid not in contact with reusable parts) | YES (matches predicate) |
| Prevention of direct patient hook-up | NO (matches predicate) |
| Accurate delivery of specified source solutions | Correct operation demonstrated under normal and stress conditions |
| Fluid / air leakage checking | Correct operation demonstrated (implies passing leakage checks) |
| Chemical and biological compatibility of materials | Materials subjected to chemical and biological testing in accordance with applicable requirements |
| Ethylene Oxide Sterilization | Ethylene Oxide (matches predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a specific "test set" in the context of a typical AI/algorithm study (e.g., patient data). The testing described is functional laboratory testing of the device itself.
- Sample Size: Not specified in terms of number of devices or number of test runs, but it's implied that sufficient testing was done to ensure "correct operation."
- Data Provenance: The "study" (functional laboratory testing) was conducted by Laboratorios Grifols, S.A. (Spain). The data is retrospective in the sense that the results are being presented after the tests were concluded.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. The ground truth for this type of device (fluid transfer set) is established through engineering and functional testing against predefined specifications and industry standards, not expert consensus on diagnostic images or clinical outcomes.
- Qualifications of Experts: N/A. The "experts" would be the engineers and technicians involved in the design, manufacturing, and testing of the device.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the traditional sense of clinical studies requiring expert review. The "adjudication" is inherent in the laboratory testing, where results are compared against pre-defined engineering and performance specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This device is not an AI diagnostic tool that would typically involve human readers.
6. Standalone (i.e. algorithm only without human-in-the loop performance) Study
- Standalone Study Done: Yes, in the sense that the device's functional performance was evaluated independently without human intervention during the fluid transfer process itself (though humans operate the compounding system). The "algorithm" here is the physical design and manufacturing of the transfer set, and its performance was assessed directly.
7. Type of Ground Truth Used
- Type of Ground Truth: Engineering specifications and performance standards. The device's functionality (accurate fluid delivery, no leakage, sterility, material compatibility) serves as its own "ground truth" when tested against these established criteria.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI or machine learning algorithm. There is no "training set" in the context of developing an intelligent system. The design and manufacturing process would involve iterative testing, but not a formal "training set" as understood in AI.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an algorithm. The "ground truth" for the device's design and manufacturing is derived from industry standards, regulatory requirements, and the intended function of a fluid transfer system in pharmacy compounding.
§ 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.