Search Results

for use in transferring contrast, saline, or other diagnostic fluids between bulk containers and a syringe

The Disposable Transfer Sets with and without Swabbable Valves and/or Check Valves are a combination of connectors and accessories, such as clamps, tubing, and spikes, and are used for fluid delivery. The device is designed, like other legally marketed devices, for one end to connect to the syringe to be filled (which is installed on an injector with the plunger forward) and the other end is connected to the bulk container. The plunger is then retracted and contrast, saline, or other diagnostic fluid is drawn into the syringe.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Coeur, Inc. Disposable Transfer Sets:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the bond testing, leak testing, or sterilization product adoption study.
The studies appear to be retrospective in nature, done by Coeur, Inc. to verify the performance of their device prior to seeking regulatory approval.
The data provenance is Coeur, Inc., within the USA (Washington, NC, and Lebanon, TN are listed company addresses).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts or a ground truth established by experts for these non-clinical tests. The tests appear to be objective measurements of physical performance.

4. Adjudication Method for the Test Set

Not applicable as there is no mention of expert-led adjudication for these non-clinical performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This device is a medical accessory (transfer set), and the evaluation focuses on its physical and functional performance, not on clinical diagnostic or treatment efficacy that would involve human readers or AI.

6. If a Standalone Study (i.e. algorithm only without human-in-the-loop performance) was Done

This is not applicable. The device is a physical medical accessory, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests appears to be:

• Engineering specifications/standards for bond and leak testing (implied by "performs acceptably").
• Microbiological standards (Surgical Aseptic Level (SAL) of 10⁻⁶) for sterilization.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm requiring a training set. The "product adoption study" may refer to testing on a set of actual production units, but it's not a "training set" in the context of AI.

9. How the Ground Truth for the Training Set was Established

Not applicable as there is no training set for an AI algorithm.

Ask a specific question about this device

FLEBOSET MULTIPLE is an ancillary device used as fluid pathway through which substances from 6 glass source flasks containing the same solution may be continuously delivered for:

• (a) Pharmacy compounding, when used in conjunction with the GRI-FILL 2.0 pharmacy compounding device and associated transfer sets, and
• (b) I.V. administration, when used in conjunction with a gravity or pump infusion set to channel the solution from the source containers to the infusion set.
  The 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 order of a physician.

FLEBOSET MULTIPLE is a fluid transfer tubing set used to enable continuous (uninterrupted) delivery of drug solutions from 6 glass source containers. It is used in pharmacy compounding or for I.V. fluid transfer to minimize tubing manipulation when working with small volume source containers. The device is made up of 6 spikes connected in series with flexible tubing segments, each segment with an individual clamp. The set terminal, for connection to pharmacy compounding device sets or the administration sets (gravity or pump) consists of a spikeable twist-off valve connector.

This firm did not perform a clinical study to prove substantial equivalence. Instead, they relied on non-clinical data. They compared the technological characteristics of their device (FLEBOSET MULTIPLE) to three predicate devices that are already legally marketed. All materials used in the construction of FLEBOSET MULTIPLE were subject to chemical and biological testing in accordance with applicable requirements, taking into account its intended use, and functional laboratory testing was performed in foreseeable operating conditions that showed correct operation of the device as per its intended use.

Here's the information requested based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state "acceptance criteria" in a quantitative or measurable format typical for device performance metrics. Instead, the demonstration of equivalence is based on the device's characteristics being "very similar" to existing predicate devices and having passed chemical, biological, and functional laboratory testing. The "reported device performance" is described qualitatively.

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not applicable. No clinical test set data is described. The evaluation was based on non-clinical (laboratory and materials) testing and comparison to predicate devices.
• Data provenance: Not applicable for a test set. The non-clinical data would originate from the manufacturer's internal laboratory testing. The document does not specify a country of origin for this testing data, only the submitter's address is Spain.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No ground truth for a clinical test set was established as no clinical study was performed.

4. Adjudication method for the test set

• Not applicable. No clinical test set and thus no adjudication method were used.

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

• Not applicable. This is a medical device for fluid transfer, not an AI-based diagnostic or imaging device. No MRMC study was conducted.

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

• Not applicable. This is a medical device for fluid transfer, not an algorithm.

7. The type of ground truth used

• Not applicable for a clinical ground truth. The "ground truth" equivalent in this submission is the established performance and safety profiles of the predicate devices and the results of laboratory-based chemical, biological, and functional testing.

8. The sample size for the training set

• Not applicable. This is a medical device for fluid transfer, not an AI/algorithm-based device requiring a training set.

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

• Not applicable. This is a medical device for fluid transfer, not an AI/algorithm-based device.

Ask a specific question about this device