Search Results

Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration. Environment of use: Hospital, Emergency Medical Services settings, wherever I.V. fluid administration may be indicated.

Device Description

The GVS Speedflow I.V. Administration Set with Easydrop Flow Regulator consists of a tubing set with a 0.2um or a 1.2um filter, various connectors and accessories and an Easydrop flow regulator and is used as a fluid pathway for I.V. administration. A choice can be made on the volume of fluid by easily adjusting the drops/cc setting on the Easydrop Flow Regulator. GVS will offer custom sets to meet customer requirements and specifications.

AI/ML Overview

The provided text describes the acceptance criteria and the studies conducted for the GVS Speedflow I.V. Set with Easydrop Flow Regulator.

Here's the information broken down by your requested categories:

1. Table of Acceptance Criteria and the Reported Device Performance

Identified Risk	Mitigation Measure	Acceptance Criteria / Test Conducted	Reported Device Performance
Device Malfunction	Bench Testing	Leak testing on filter and sets. Joint strength testing. Flowrate testing (drops/minute). Filter Integrity testing.	Implied: The studies were performed to validate critical parameters required to reduce risk. The summary states that "The intended use, materials, and test results show that the GVS Speedflow I.V. Set with Easydrop Flow Regulator is substantially equivalent to predicate devices," implying successful performance in these bench tests. No specific numerical results are provided in this summary document.
Adverse Tissue Reaction	Biocompatibility	Per ISO 10993-10 (Sensitization), ISO 10993-11 (Acute Systemic Injection), ISO 10993-3 (Haemocompatibility), ISO 10993-5 (Cytotoxicity MEM Elution), ISO 10993-10 (Intracutaneous Injection).	Implied: The tests were conducted according to these ISO standards. The summary implies successful performance as part of the overall substantial equivalence claim. No specific numerical results are provided in this summary document.
Infection	Sterilization	Sterility Testing (according to ISO 11137). Shelf Life Testing (according to EN 868-5). Pyrogen Testing (LAL test method). Bacterial Retention Testing.	Sterility: Validated to a maximum dose of 40 kGy's, with a sterility assurance level of 10-6.
Shelf Life: A validation resulted in a 5-year shelf life.
Pyrogen Testing: Sets were tested by the LAL test method and were found to be ≤0.25 EU/ml.
Bacterial Retention (0.2um filter): Found to remove >99.9% of Brevundimonas diminuta.
Bacterial Retention (1.2µm filter): Found to remove ≥99.9% of Candida Albicans.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each individual test. It mentions "Bench Testing" and "Biocompatibility testing" without enumerating the number of units or animals tested.

The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. However, GVS S.p.A. is located in Italy (BOLOGNA), suggesting the testing was likely conducted in Europe or by contractors approved by GVS.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable to this device. The tests performed are primarily laboratory (bench) tests and biological assays, not studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests is established by objective measurements against established international standards (ISO, EN) and industry recommendations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable to this device. Adjudication methods like 2+1 or 3+1 typically refer to consensus-building among multiple human reviewers for subjective assessments (e.g., medical image interpretation). The tests for this I.V. set are objective, laboratory-based measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to this device. This device is an I.V. administration set and does not involve AI or human readers for diagnostic interpretation. Therefore, no MRMC comparative effectiveness study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable to this device. This device is an I.V. administration set, which is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the tests performed on this device is based on:

Established International Standards: ISO 14971 (Risk Analysis), ISO 10993 series (Biocompatibility), ISO 11137 (Sterilization), EN 868-5 (Shelf Life).
Objective Laboratory Measurements: Leakage, joint strength, flowrate (drops/minute), filter integrity, sterility assurance level, pyrogen limits (EU/ml), bacterial removal efficiency (percentage).
Industry Recommendations: For bacterial retention testing.

8. The sample size for the training set

This is not applicable to this device as it is a physical medical device, not an AI or machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable to this device for the same reason as above.

Ask a Question

Ask a specific question about this device

Page 1 of 1