(279 days)
Busse Extension Sets are intended to be used with a vascular access device for administrative and withdrawals of fluids.
Busse Extension Set consists of PVC tubing with or without connectors. The tubing accessories include; 3-way connectors, clamps, male and female luer lock, luer slip fitting, and valves. The Extension Set will be provided as sterile, single use only and will be packaged individually and in medical convenience kits. The Extension Sets will be available in a variety of lengths, starting from 6" to 36".
This document describes a 510(k) premarket notification for the "Busse Extension Set," which is an intravascular administration set. The provided text, however, focuses on demonstrating substantial equivalence to a predicate device rather than detailing acceptance criteria and the study proving direct performance against those criteria in the way one might expect for a novel AI/software device.
Instead, the document primarily lists standard tests performed on medical devices of this type to ensure safety and performance compared to existing, legally marketed devices. It does not contain information about an AI/software component, nor does it present the study design typical for evaluating an AI's diagnostic or predictive performance against specific metrics like sensitivity, specificity, or AUC, as would be common in the context of the requested information.
Therefore, many of the requested fields cannot be directly answered because the document describes a physical medical device (an extension set) and not an AI or software-based medical device.
Based on the provided text, here is the information that can be extracted, and where relevant, why other information is not present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in a numerical or statistical format often seen for AI/software performance. Instead, it describes various tests and states that the materials and tests "met the testing requirements and were found to be acceptable for the intended use."
| Test Category | Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | L929 MEM Elution Test | Acceptable for contact with biological systems | Materials met testing requirements, found acceptable. |
| Kligman Maximization Test | Acceptable for contact with biological systems | Materials met testing requirements, found acceptable. | |
| Intracutaneous Injection Test | Acceptable for contact with biological systems | Materials met testing requirements, found acceptable. | |
| Systemic Injection Test | Acceptable for contact with biological systems | Materials met testing requirements, found acceptable. | |
| Rabbit Pyrogen Test | Apyrogenic | Materials met testing requirements, found acceptable. | |
| Hemolysis Test | Non-hemolytic | Materials met testing requirements, found acceptable. | |
| Sterilization | Sterilization (ISO 11135-1) | Sterilized using Ethylene Oxide, SAL 10⁻⁶ | Met ISO 11135-1, SAL 10⁻⁶ |
| Performance Testing | Liquid Leakage | No leakage | Met testing requirements, found acceptable. |
| Pull Test | Adequate tensile strength/connection integrity | Met testing requirements, found acceptable. | |
| Durometer Test | Appropriate material hardness | Met testing requirements, found acceptable. | |
| Conical Fitting | Fittings meet standard specifications for connection integrity | Met testing requirements, found acceptable. | |
| Packaging | Packaging (ISO 11607-2) | Packaging maintains sterility and integrity | Met ISO 11607-2 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing appears to be on physical samples of the device, not a "test set" of data in the AI/software context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. "Ground truth" in the traditional sense, as it relates to expert consensus for diagnostic tasks, is not relevant to the evaluation of a physical medical device like an extension set. The "ground truth" here would be objective physical measurements and chemical/biological assays.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
This information is not applicable and not provided. The device is a physical medical extension set, not an AI or software for diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a physical medical extension set.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the "ground truth" for the device's acceptable performance is based on established industry standards and regulatory requirements (e.g., ISO 10993-1 for biocompatibility, ISO 11135-1 for sterilization, ISO 11607-2 for packaging) as well as established physical and biological testing protocols (e.g., specific liquid leakage, pull tests, durometer tests, and various biocompatibility assays). The success of these tests (e.g., no leakage, non-hemolytic, apyrogenic, meeting specified strength) confirms the "ground truth" of the device's functional and safety characteristics.
8. The sample size for the training set
This information is not applicable and not provided. This document refers to the evaluation of a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
§ 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.