(203 days)
All models of GRI-FLEX are flexible I.V. bags, with incorporated 0.2 um filter for the removal of undesired particulate or microbial matter, for use with the GRI-FILL pharmacy compounding system as a container in the preparation of drug solutions. The drug solution is later administered to the patient by connecting the bag to an I.V. administration set. This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.
GRI-FLEX is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µm filter. It is supplied sterile in sealed peel-pack pouches and is available in volume capacities of 100 ml, 250 ml, 500 ml and 1000 ml.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GRI-FLEX device:
Important Note: The provided document is a 510(k) summary for a medical device. These summaries primarily focus on demonstrating substantial equivalence to existing predicate devices, rather than comprehensive standalone performance studies that would typically be conducted for a novel device or to establish specific performance metrics against clinical endpoints. Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC studies, ground truth for training data) are not typically detailed in these types of submissions because the study design is geared towards showing equivalence based on known performance of the predicate.
Acceptance Criteria and Device Performance for GRI-FLEX
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a device demonstrating substantial equivalence to predicates, the "acceptance criteria" are primarily based on meeting the established performance characteristics and safety profiles of the predicate devices. The study conducted is a non-clinical evaluation to demonstrate these equivalences.
| Characteristic / Feature | Acceptance Criteria (Implied by Predicate Performance) | Reported GRI-FLEX Performance |
|---|---|---|
| Filter membrane | Polyethersulphone (matching predicate filter) | Polyethersulphone |
| Filter pore size | 0.2µm (matching predicate filter) | 0.2µm |
| Filter housing | Polypropylene (matching predicate filter) | Polypropylene |
| Sterility | SAL 10⁻⁶ (matching predicate filter) | SAL 10⁻⁶ ETO (Ethylene Oxide sterilization) |
| Single-use | Yes (matching both predicates) | Yes |
| Intended Use | Comparable to predicate bag + filter | Bag with incorporated 0.2µm filter for removal of particulate/microbial matter in drug solution preparation with GRI-FILL system. |
| Biocompatibility | Fulfillment of ISO 10993 and ISO DIS 15747 (implied) | Fulfills ISO 10993 and ISO DIS 15747 |
| Functional Testing | Correct operation per intended use (implied) | Shows correct operation per intended use based on ISO DIS 15747, USP , ISO 8536-4, ASTM F838-83. |
Study That Proves the Device Meets the Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as a "Summary Discussion of Non-Clinical Data." This involves a series of tests to demonstrate material compatibility, sterility, and functional performance, benchmarking against relevant international standards and the predicate devices.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. For non-clinical functional and biological testing of a device like this, sample sizes would typically be determined by statistical methods or regulatory standards for engineering tests, but are not specified here.
- Data Provenance: The tests were conducted according to international standards (ISO, USP, ASTM), implying that the data was generated specifically for this device submission within a controlled testing environment, likely by the manufacturer (Laboratorios Grifols, S.A.) or a contracted testing laboratory. The country of origin for the data is not explicitly stated, but the manufacturer is based in Spain. The data is prospective in that it was generated for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided in the document. For non-clinical device performance and safety testing, "ground truth" is established by adherence to physical, chemical, and biological testing standards and specifications, not by expert human interpretation in the way it would be for diagnostic imaging or clinical studies.
4. Adjudication Method for the Test Set
Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies for human interpretation of data where there might be disagreement (e.g., radiologists reviewing images). This document describes non-clinical engineering and biological tests which do not involve such adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are typically clinical studies evaluating human reader performance for diagnostic devices, often with and without AI assistance. This submission focuses on the non-clinical performance and safety of a medical container with an integrated filter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical component (an IV bag with a filter), not an algorithm or AI system. Therefore, the concept of "standalone algorithm only performance" does not apply. The functional tests performed (e.g., filter efficacy, material integrity) are analogous to "standalone" performance for a physical device.
7. The Type of Ground Truth Used
The "ground truth" for this device's non-clinical evaluation is based on:
- Reference Standards and Specifications: Adherence to established international standards (ISO 10993 for biocompatibility, ISO DIS 15747, USP , ISO 8536-4, ASTM F838-83 for functional performance).
- Predicate Device Performance: The characteristics and demonstrated safety/efficacy of the legally marketed predicate devices (VIAFLEX PLASTIC CONTAINER and PALL SUPOR AEF filter).
- Material Science and Engineering Principles: Ensuring materials meet appropriate properties and the device design functions as intended.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no "training set" for this type of device submission.
§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).