(12 days)
All models of GRI-BAG are flexible I.V. bags, with incorporated 0.2 urn 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. The device should not be used with lipids.
GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 um 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. The GRI-BAG models have a twist-off valve output connector whereas the GRI-BAG AP models have a conus vial output connector.
The provided text describes a 510(k) summary for the GRI-BAG device, focusing on its substantial equivalence to predicate devices, rather than a study designed to explicitly meet pre-defined acceptance criteria for a new, standalone device performance claim. The key objective of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove a specific performance level against a set of quantitative metrics.
Therefore, several requested sections of your prompt (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are typically not part of a 510(k) submission focused on substantial equivalence. Instead, the submission relies on demonstrating comparable technological characteristics and intended use to predicate devices, supported by non-clinical functional and biocompatibility testing.
Here's an attempt to answer based on the provided text, acknowledging the limitations for a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of explicit "acceptance criteria" for specific performance metrics in the context of a 510(k) for substantial equivalence is different from a performance study for a novel device. For the GRI-BAG, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices and by showing that the device functions correctly as per its intended use during functional testing.
| Characteristic / Feature | Acceptance Criteria (Implicit from Predicate/Standards) | Reported Device Performance (GRI-BAG) |
|---|---|---|
| Filter Membrane Material | Material allowing 0.2µm filtration (e.g., Polyethersulphone for predicate filter) | Cellulose acetate (Different from predicate, but implies acceptable filtration) |
| Filter Pore Size | 0.2µm | 0.2µm |
| Filter Housing Material | Material compatible with intended use (e.g., Polypropylene for predicate filter) | Cyrolite (Different from predicate, but implies compatibility) |
| Bag Material | PVC with DEHP plasticizer | PVC with DEHP plasticizer (Same as predicate bag) |
| Tubing Material | Medical grade PVC | Medical grade PVC (Same as predicate bag) |
| Closure Material | Suitable for sealing and access (e.g., PVC membrane for predicate bag) | PVC membrane with Twist-off valve (GRI-BAG) or Chlorobutyl rubber stopper (GRI-BAG AP) (Different from predicate but comparable functionality) |
| Sterility | SAL 10^-6 | SAL 10^-6 ETO (ETO sterilization method is different from predicate bag but same as predicate filter and achieves same SAL) |
| Single-Use | YES | YES |
| Biocompatibility | Fulfills ISO 10993 and ISO DIS 15747 requirements | Fulfills ISO 10993 and ISO DIS 15747 requirements |
| Functional Operation | Correct operation as per intended use | Correct operation of the device as per its intended use |
| Intended Use | Preparation of drug admixtures, removal of particulates/microbes | Flexible bag with incorporated 0.2 µm filter for removal of undesired particulate or microbial matter, for use with GRI-FILL system in preparation of drug solutions. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the traditional sense of a clinical or performance study with a quantified sample size for statistical analysis of user performance or diagnostic accuracy. Instead, the evaluation focuses on:
- Comparison of Technical Characteristics: This is based on design specifications and material properties, not a "sample size" of devices tested empirically against a specific metric.
- Biocompatibility Testing: According to the text, this was performed on "all materials." No specific sample size for a biological study is provided.
- Functional Testing: Performed "in foreseeable operating conditions" and "in accordance with applicable clauses of [...] standards." No specific sample size for functional tests is provided.
The data provenance is from the manufacturer, Laboratorios Grifols, S.A. (Spain), and the testing appears to be non-clinical (laboratory/bench testing) rather than retrospective or prospective human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for a 510(k) submission like this is primarily based on compliance with established standards (ISO 10993, ISO DIS 15747, ISO 8536-4, ASTM F838-83, AOF-0011) and demonstration of functional equivalence to predicate devices, rather than expert consensus on diagnostic or clinical outcomes from a test set.
4. Adjudication Method for the Test Set
Not applicable, as there is no described test set requiring expert adjudication for clinical or diagnostic performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission is for a device intended for drug solution preparation and filtration, not a diagnostic imaging device typically evaluated with MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable to the GRI-BAG device. It is a physical medical device (I.V. bag with a filter), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is based on:
- Compliance with recognized standards: ISO 10993 (biocompatibility), ISO DIS 15747, ISO 8536-4, ASTM F838-83 (filter pore size rating), AOF-0011 (functional testing).
- Demonstrated functional performance according to the device's intended use and comparison with the established performance of the predicate devices.
- Material specifications against predicate device materials.
8. The Sample Size for the Training Set
Not applicable. This is not a study involving a "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not a study involving a "training set" for an algorithm.
§ 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).