(56 days)
The Extension Set with Anti-Siphon Valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD® pumps.
The Extension Set with microbore tubing attaches to the Micro Medication Reservoir for the administration of fluids or medications with the CADD-Micro® pump.
The purpose of this submission is to offer an alternative, as a matter of customer preference, to the current commercially available SIMS Deltec Extension Sets. The Extension Sets have been modified to include microbore tubing for use in microinfusions and a new compatible female luer on two of the sets. A 0.2 micron filter has been included on two of the sets and is an air eliminating filter similar to the filter on the Baxter Extension Set. An anti-siphon valve is included on one of the sets and is designed to protect against unregulated gravity infusion that can result from an improperly attached reservoir.
The described device is an "Extension Set with Microbore Tubing" and variants. This 510(k) summary does not contain information typically found in an acceptance criteria table or a detailed study report for AI/ML-based medical devices. The submission concerns a standard medical device (tubing) and focuses on functional and biocompatibility testing rather than performance metrics related to AI or a "test set" in the context of an algorithm.
Therefore, I cannot provide the requested information for an AI/ML device. However, I can extract the relevant information about the functional testing performed for this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not detail specific quantitative acceptance criteria or a performance table in the way one would for an AI/ML device. Instead, it states that "Functional testing performed on the sets to establish their operating parameters" and "The results of the testing indicated that the Extension Sets with Microbore Tubing function according to specification." No numerical results or specific pass/fail thresholds are provided in the summary.
2. Sample Size for the Test Set and Data Provenance
This information is not applicable. The submission refers to "functional testing" and "biocompatibility testing" of physical medical devices, not a 'test set' of data for an algorithm. There is no mention of data provenance (e.g., country of origin, retrospective/prospective) because data collection for AI/ML algorithms is not relevant here.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. Ground truth, in the context of an AI/ML algorithm, involves expert labels or pathological findings. For this device, "ground truth" would be the engineering specifications and performance standards against which the functional tests were conducted. The experts would be the engineers and technicians performing the functional and biocompatibility tests, but their number and specific qualifications are not detailed in this summary.
4. Adjudication Method
This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among experts when establishing ground truth for AI/ML training or test sets. This concept does not apply to functional and biocompatibility testing of a physical medical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is used to assess the impact of AI assistance on human reader performance. This device is not an AI/ML algorithm, so such a study was not performed or necessary.
6. Standalone (Algorithm Only) Performance Study
No. This device is a physical medical device (extension set), not an algorithm. Therefore, a standalone performance study for an algorithm was not done.
7. Type of Ground Truth Used
The "ground truth" for this device would be defined by engineering specifications and performance standards. The functional testing verified whether the device performed "according to specification." Biocompatibility testing verified that "the materials used in the sets are biocompatible."
8. Sample Size for the Training Set
This information is not applicable. Training sets are used for machine learning algorithms. The design and testing of this medical device did not involve machine learning, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there was no training set for an algorithm.
§ 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.