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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.

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.

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intended for the administration of solutions and drugs into vascular implant ports. The proposed Huber Needle Extension Sets with InterLink® Y-Site or InterLink® T-Site. like other products containing the InterLink® injection site are designed to reduce the risk of accidental needle sticks when used in conjunction with the InterLink® cannula, as part of a "needleless" IV access system.

The proposed products consist of a line of Huber Needle Extension Sets which may be manufactured in four basic types: Huber Needle Extension Set without an injection site Huber Needle Extension Set with a standard injection site Huber Needle Extension Set with an InterLink® Y-injection site (Y-Site) Huber Needle Extension Set with an InterLink® T-injection site (T-Site)

This 510(k) summary describes a Huber Needle Extension Set. The information provided heavily emphasizes device description, comparative technological characteristics to predicate devices, and an overall statement about nonclinical testing. However, it lacks the specific details requested regarding acceptance criteria and a study proving those criteria are met.

Therefore, I cannot populate the requested table or answer most of your detailed questions. The document states:

"Testing included flow rate, total volume, pressure testing of set bonds and tensile strength testing. Performance testing indicates that the proposed sets meet or exceed all functional requirements and support their suitability for use."

This is a general statement, not a detailed report of acceptance criteria or study results.

Here's what I can extract based on the provided text, and what I cannot:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. This is a medical device, not an AI or diagnostic imaging study where experts typically establish ground truth. The "ground truth" here would be the physical properties and performance characteristics of the device.

4. Adjudication method for the test set:

• Not applicable/Not specified.

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:

• No, an MRMC study was not done. This is a medical device, not an AI or diagnostic imaging study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this type of device would be the defined engineering specifications and physical performance standards (e.g., specific tensile strength in Newtons, specific flow rate in mL/hr under certain pressure). The document states "functional requirements," implying these standards exist, but doesn't detail them.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI algorithm requiring a "training set."

9. How the ground truth for the training set was established:

• Not applicable.

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