(252 days)
For the transfer of solutions from one container to another.
The B. Braun Universal Spike is a sterile, single use, disposable fluid transfer device consisting of a closure-piercing component capable of piercing and penetrating the closure of a fluid container, an air-inlet component which allows the dispensing from both rigid and pressure collapsible dispensing containers, and a distal female luer lock adapter which provides access for the attachment of a syringe or fluid transfer set. The closure-piercing component and luer lock adapter are covered by protective caps which prevent contamination of the device until its point of use.
The provided text describes a 510(k) premarket notification for a medical device called the "Universal Spike." The submission focuses on demonstrating substantial equivalence to a predicate device through performance testing. However, the document does not describe an AI/ML-driven device or study. All performance criteria and testing mentioned relate to the physical and functional characteristics of the Universal Spike (a fluid transfer device), not to any algorithmic performance.
Therefore, the requested information specifically related to AI/ML device acceptance criteria, performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document as it is not relevant to the type of device being described.
Summary based on the provided document (not an AI/ML device):
The document details the submission for the Universal Spike, a sterile, single-use, disposable fluid transfer device. The submission aims to demonstrate substantial equivalence to a predicate device, the B. Braun Dispensing Pin with One-Way Valve (K943181), rather than proving the performance of an AI/ML algorithm.
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance tests conducted, implying that successful completion of these tests (meeting referenced standards or specified criteria like "no leakage" or "minimum tensile force") demonstrates the device meets acceptance criteria for substantial equivalence.
| Characteristic / Test | Acceptance Criteria (Implied / Stated) | Reported Device Performance (Implied) |
|---|---|---|
| Chemical Analysis | Meets ISO 8536-4, ISO 10993-18 standards | Successfully met standards |
| Visual Control | Meets ISO 22413, ISO 8536 standards | Successfully met standards |
| Fragmentation Test | Meets ISO 22413 standard | Successfully met standard |
| Penetration Force | Meets ISO 8536-2 standard | Successfully met standard |
| Spike retention / seal ability | Meets ISO 8536-2 standard | Successfully met standard |
| Patency Test | Meets ISO 8536-4 standard | Successfully met standard |
| Pressure Test / Leakage | No leakage detected when subjected to air pressure of 450 mmHg | No leakage detected |
| Pull Test (cap and spike) | Withstands a minimum tensile force of separation between 4.41-44.13 Newtons | Withstood required tensile force |
| Free Flow | Meets ISO 22413 standard | Successfully met standard |
| Particulate Contamination | Meets USP standard | Successfully met standard |
| Luer testing | Meets ISO 594-1 standard | Successfully met standard |
| Biocompatibility (Cytotoxicity, Hypersensitivity, | Meets ISO 10993-5, ISO 10993-10 (x2), ISO 10993-11 (x2), ASTM F756, USP standards | Successfully met standards |
| Intracutaneous Reactivity, Acute Systemic | ||
| Toxicity, Hemocompatibility, Pyrogenicity) | ||
| Overall Conclusion | Demonstrates substantial equivalence to predicate device based on functional and performance testing | Device shown to be substantially equivalent to predicate |
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study, but performance testing of a physical medical device. The document does not specify the number of units tested for each criterion, nor does it refer to "data provenance" in the context of diagnostic data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI/ML, refers to a definitively correct answer for diagnostic tasks. This document describes the physical and functional testing of a device, not a diagnostic algorithm.
4. Adjudication method for the test set: Not applicable. This concept is relevant for expert disagreement resolution in diagnostic studies.
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 document is not about AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used: For the physical and functional tests, the "ground truth" is defined by the technical standards (e.g., ISO, USP, ASTM) and specified criteria (e.g., "no leakage," "minimum tensile force"). There isn't a "ground truth" as understood in diagnostic AI.
8. The sample size for the training set: Not applicable. No training set is involved for this physical device's evaluation.
9. How the ground truth for the training set was established: Not applicable.
§ 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.