(122 days)
This product would be used by Nurses and Paramedics in prehospital, emergency room and field situations.
The I.V. Extension Line Assembly with Stopcock is attached to the Primary I.V. to facilitate two advantages. One, is to add extra length between the I.V. Supply and the Patient. A second, is to provide additional supply ports for the administration of alternate solutions and special drugs that are adminstered intraveneously. A four-way stopcock offers selection of the fluid types and sources. Biomedix is offering two models, one with a standard Needle-Type Injection Site at the Outlet and a second with a Blunt Cannula (Needleless) Type Injection Site at the outlet.
The provided document, K961928, is a 510(k) Summary for an "I.V. Extension with Stopcock" device by Biomedix, Inc. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for a diagnostic or AI-powered medical device.
Instead, this document is a submission for substantial equivalence to predicate devices already on the market. It aims to demonstrate that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.
Therefore, many of the requested sections about acceptance criteria, study design, expert ground truth, and human reader performance are not applicable to this type of submission.
Here's how to interpret the available information in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for an IV extension and stopcock, the "acceptance criteria" are implicitly about the physical characteristics and intended use being similar to predicate devices, and the "reported device performance" is a description of the device's features compared to those predicate devices. There are no performance metrics like sensitivity, specificity, or accuracy that would be found in a study for a diagnostic device.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Biomedix) | Predicate Devices (Baxter, Medex, McGaw) |
|---|---|---|
| Stopcock connections (Luer type) | All 3 ports include both threaded and/or slip luer connections. | Baxter: (1) Port has removable needle injection site. (2) remaining ports have slip luer conn. only. Medex: (1) Y-Port for Sharps Devices. McGaw: Not explicitly detailed for stopcock in summary. |
| Capacity (Volume) | 3.75 ml. | Baxter: 2.3 ml. McGaw: 3 mL (G0719), 6 mL (G0726, G0716). Medex: N/A. |
| Tubing dimensions (I.D.) | .114 +/- .002" I.D. | Baxter: .088-.090" I.D. Medex: N/A. McGaw: Not explicitly detailed for tubing I.D. |
| Type of Injection Sites/Connectors | Choice of Needle or Blunt Cannula Y-Site with Male Slip Luer Connector. | Baxter: Male Slip Luer Connector Only. Medex: Male Slip Luer Connector Only. McGaw: Female and Needle Adapter (G0719), (2) Injection Sites (G0726), (2) Injection Sites with check valve and flashtube (G0716). |
| Intended Use (Same as predicate) | Add extra length between I.V. Supply and Patient; provide additional supply ports for administration of alternate solutions/drugs. Use by Nurses and Paramedics in prehospital, emergency room and field situations. | Baxter, Medex, McGaw: Implied similar intended use as "I.V. Extension" or "Intravascular Administration Set". |
| Basic Construction (Similar to predicate) | Basic construction uses commercially available components, similar to existing Biomedix Selec-3 Primary I.V. Set. | Baxter, Medex, McGaw: Implied similar construction from commercially available components. |
| Safety and Effectiveness (Equivalent to predicate) | Design allows direct injection at Patient I.V. Catheter; slip-type clamp prevents backflow/dilution. | Baxter, Medex, McGaw: Assumed to be safe and effective as legally marketed devices. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes a comparison of device specifications, not a clinical trial with a test set of data. The "sample" here refers to the design features of the device and its predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. There is no "ground truth" establishment in the context of a clinical study for this type of 510(k) submission. The "truth" is established by the specifications and existing regulatory clearance of the predicate devices.
4. Adjudication method for the test set
- Not Applicable. No test set or adjudication process as described for a clinical study.
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 not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI or algorithm-driven device.
7. The type of ground truth used
- Not Applicable. For this type of device, "ground truth" is essentially the established performance and safety of legally marketed predicate devices, against which the new device's design and intended use are compared.
8. The sample size for the training set
- Not Applicable. There is no training set for a machine learning model.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set for a machine learning model.
Summary for K961928:
This 510(k) submission is for a medical device (I.V. Extension with Stopcock) that is substantially equivalent to existing devices already on the market. The "study" here is a design comparison and intended use comparison against predicate devices (Baxter PHARMASEAL K52 NOVEX, Medex Extension Set, McGaw I.V. Extension Set series). The acceptance criteria are implicitly that the new device's features, materials, and intended use do not raise new questions of safety or effectiveness compared to the predicates. No clinical trials with patient data, expert reviews, or AI performance metrics are presented as part of this type of submission.
§ 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.