(22 days)
For the administration of fluids from a container to the patient through a vascular access device. The Interlink Lever Lock Cannula is indicated to function exclusively with the Interlink Injection Site as a fluid path injection device.
The proposed devices, which are the subject of this Special 510(k) Premarket Notification, consist of the Interlink Lever Lock Cannula, Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink CONTINU-FLO Sets. They are single use disposable devices intended for use with a vascular device for continuous or intermittent fluid administration. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notifications K883638 (cleared on September 23, 1988), K925126 (cleared on June 18, 1993), and K940697 (cleared on August 30, 1994).
The Interlink Lever Lock Cannula is intended to function exclusively with the Interlink Injection Site as a fluid path injection device. It has a female Luer that allows the connection of a svringe or the distal end of an Interlink Secondary Medication Set to an Interlink injection site of an Interlink solution set or an Interlink CONTINU-FLO set.
The Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink CONTINU-FLO Sets are used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They can be used for gravity or pump infusion of I.V. fluids. Interlink CONTINU-FLO Sets contain the Interlink Injection Site that can be used for the administration of secondary medication. They also contain a check valve which prevents blackflow of solution from the secondary medication container into the primary container during the administration of secondary medication. Interlink Secondary Medication Sets are used in conjunction with Interlink CONTINU-FLO sets to administer intermittent fluids to the patient.
The basis for this premarket notification is a modification to the Interlink Lever Lock Cannula, which is an integral part of the Interlink System. The modification consists of replacing the solvent carrier used in the silicone lubrication process of the Interlink Lever Lock Cannula. The product labels are also being updated to add the indications for use statement of the device and clarify their use to comply with Baxter's labeling standards.
Here's an analysis of the provided text regarding the Interlink System, focusing on acceptance criteria and supporting studies:
This 510(k) pertains to a modification of an existing medical device, the Interlink System, specifically replacing the solvent carrier in the silicone lubrication process of the Interlink Lever Lock Cannula. Therefore, the "study" described is a set of non-clinical tests to demonstrate that the modified device remains substantially equivalent to the predicate device and suitable for its intended use. There is no clinical study involving human or AI performance described in this document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" with specific thresholds for each test. Instead, it lists a series of performance assessments conducted to show the device is "suitable for its intended use" and "equivalent to the predicate device." The reported performance is implicitly that the device passed these tests, thus demonstrating suitability and equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Insertion force meets intended performance | Test conducted to show suitability for intended use (passed) |
| Removal force meets intended performance | Test conducted to show suitability for intended use (passed) |
| Tip protector removal force meets intended performance | Test conducted to show suitability for intended use (passed) |
| Lever arm maximum activation integrity meets intended performance | Test conducted to show suitability for intended use (passed) |
| ISO Luer tests on female Luer lock connector meet ISO standards | Tests conducted to show suitability for intended use (passed ISO Luer tests) |
| Lipid resistance meets intended performance | Test conducted to show suitability for intended use (passed) |
| Lever lock flow test meets intended performance | Test conducted to show suitability for intended use (passed) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the non-clinical tests.
The data provenance is within Baxter Healthcare Corporation, as they conducted the risk analyses and design verification tests. These are internal, non-clinical tests, so concepts like "country of origin of the data" or "retrospective/prospective" in the context of patient data do not apply.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document describes non-clinical engineering and performance tests, not clinical performance based on expert review. Therefore, no experts were used to establish ground truth in the traditional clinical sense. The "ground truth" for these tests would be the established engineering specifications and ISO standards that the device is expected to meet.
4. Adjudication Method for the Test Set
Since these are non-clinical engineering tests, no clinical adjudication method (like 2+1 or 3+1) was used. The results of the tests would be objectively measured against predefined engineering specifications and ISO standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done or described in this document. This submission is for a material modification to an existing device and relies on non-clinical performance testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is not an algorithm or AI-driven system. Therefore, the concept of a "standalone" algorithm performance study is not applicable.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests would be:
- Engineering specifications: Internal design requirements for the device's performance (e.g., specific force ranges for insertion/removal, integrity under certain loads).
- Industry standards: Notably, the ISO Luer tests indicate adherence to established international standards for Luer connectors.
8. The Sample Size for the Training Set
This device does not involve a "training set" in the context of machine learning or AI. It is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable. The "ground truth" for the device's design and performance is established through engineering principles, regulatory compliance, and industry standards.
§ 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.