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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

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.

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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.

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.

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