(15 days)
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.
| Characteristic / Feature | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (FLEBOSET MULTIPLE) |
|---|---|---|
| Intended Use / Claims | Comparable to predicate devices for pharmacy compounding and I.V. administration (excluding lipids). | An ancillary device used as a fluid pathway through which substances from 6 glass source flasks containing the same solution may be continuously delivered for: (a) Pharmacy compounding (with GRI-FILL 2.0) and (b) I.V. administration (with gravity or pump infusion set). Not for use with lipids. |
| Sterilization | One of the methods used by predicate devices (Radiation, Ethylene Oxide). | Ethylene Oxide |
| Contact with Patient | Similar to predicate devices (No direct patient contact, or indirect online use). | NO - Intended for use with the pharmacy compounding device OR INDIRECT - May be used on-line with patient, upstream of the gravity or pump administration sets. |
| Source Solutions | Ability to handle a number of source solutions from predicate devices (1, 2, 3, or 6). | 6 |
| Principle Materials | Similar to materials used in predicate devices (e.g., PVC). | PVC with DEHP plasticizer |
| Sterility | Sterile | Sterile |
| Chemical & Biological Safety | Applicable requirements for intended use met. | All materials used in the construction of FLEBOSET MULTIPLE have been subject to chemical and biological testing in accordance with the applicable requirements taking account of its intended use. |
| Functional Operation | Correct operation in foreseeable operating conditions. | Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use. |
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.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.