(82 days)
The MSI transfer devices are decanting devices intended for the asceptic dispensing of solutions from IV containers. Each device is used as follows
VialFlow: used to dispense fluids from glass vials RapidFlow: used to dispense fluids from flexible bags BottleFlow: used to dispense fluids from Large Glass IV Bottles TransFlow: used to dispense fluids from small vial, or to transfer solutions from container to container
The MSI transfer devices are one piece, injection molded transparent hollow tubes with one or more spiked ends. Some models have a splash guard. They are sterile, disposible devices.
This document is a 510(k) premarket notification for "Medical Specialty Innovations, Inc. Transfer Devices". It is a submission to the FDA requesting clearance to market a medical device. These types of documents typically do not contain detailed acceptance criteria, study designs, or performance results in the way machine learning or AI device submissions do.
The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove efficacy or performance in a clinical trial setting. The “study” mentioned is a comparison to predicate devices rather than a standalone clinical performance study involving extensive data and expert reviews.
Therefore, many of the requested fields cannot be directly answered from the provided text. I will address what can be inferred or explicitly stated.
Acceptance Criteria and Study for Medical Specialty Innovations, Inc. Transfer Devices
Based on the provided 510(k) summary, the "study" conducted for these transfer devices focused on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing performance against specific acceptance criteria in a clinical trial.
The acceptance criteria for a 510(k) submission are generally met when the new device is shown to be as safe and effective as a predicate device. This is achieved by comparing materials, dimensions, performance, packaging, sterilization, and intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from 510(k)) | Reported Device Performance (from 510(k)) |
|---|---|---|
| Material Composition | Substantially identical to predicate | "substantially identical in materials" |
| Dimensions | Substantially identical to predicate | "substantially identical in dimensions" |
| Performance (Functionality) | Aseptic dispensing from IV containers; equivalent fluid transfer capabilities | "substantially identical in performance"; decanting from glass vials, flexible bags, bottles. |
| Packaging | Substantially identical to predicate | "substantially identical in packaging" |
| Sterilization Method | Substantially identical to predicate | "substantially identical in sterilization" |
| Intended Use | Aseptic dispensing of solutions from IV containers. | "intended for the asceptic dispensing of solutions from IV containers." |
| Technological Characteristics | No significant differences from predicate | "There are no differences in the characteristics of the subject devices and the predicates." |
2. Sample Size Used for the Test Set and Data Pprovenance
- Sample Size: Not applicable in the context of a 510(k) substantial equivalence claim based on physical/functional comparison. There is no "test set" of patient data or clinical images mentioned. The comparison is between the design and specifications of the new device and the predicate devices.
- Data Provenance: Not applicable. The "data" is the device's design, manufacturing specifications, and intended use, which are compared to existing predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Experts: Not applicable. Ground truth, in the clinical or AI sense, is not established for this type of device submission. The FDA reviews the provided documentation for substantial equivalence, which is a regulatory and engineering assessment rather than a clinical expert consensus on performance.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "test set" requiring adjudication in the context of this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is commonly associated with diagnostic imaging devices or AI-powered solutions, not simple transfer devices.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No, a standalone performance study in the context of AI or algorithm performance was not conducted. The device is a physical, mechanical transfer device, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the sense of clinical "ground truth" (e.g., pathology, outcomes data, expert consensus). The "ground truth" for a 510(k) submission is the existence and legally marketed status of a predicate device, and the demonstration that the new device shares fundamental technological characteristics and intended use with that predicate.
8. Sample Size for the Training Set
- Sample Size: Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. There is no "training set" or need for corresponding ground truth in this submission type.
§ 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.