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• The LiftLoc® Safety Infusion Set device is a safety intravascular administration . set with a non-coring right angle Huber needle, used to access surgically implanted vascular ports.
• The integral LiftLock Safety Infusion Set safety mechanism is manually . activated during the removal of the LiftLoc® Safety Infusion Set needle from a surgically implanted vascular port. The safety mechanism reduces the risk of accidental needlestick injuries by shielding the needle.
• The LiftLoc® Safety Infusion Set is intended for use in the administration of . fluids and drugs, or blood sampling through surgically implanted vascular ports.
• The LiftLoc Safety Infusion Set will be marketed as a sterile, non-pyrogenic, . single use device.
• The LiftLoc® Safety Infusion Set may be used in any appropriate patient ● population.

The LiftLoc® Safety Infusion Set is a non-coring Huber needle and administration set with an integral safety needlestick prevention feature. The LiftLoc® Safety Infusion Set is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling. The LiftLoc® Safety Infusion Set is supplied sterile and non-pyrogenic, for single use only. The product has two configurations: one with an adaptable Y-injection site and one without. A Patient Comfort Pad is also available as an optional accessory.

This 510(k) submission describes a modification to an existing device, the LiftLoc® Safety Infusion Set. The key difference is the presence of lubrication on the needle (medical grade silicone). As such, the submission focuses on demonstrating substantial equivalence to the predicate device rather than conducting a de novo study with extensive clinical trials and establishing new performance criteria.

Therefore, the provided document does not contain specific acceptance criteria, a detailed study proving performance against those criteria, or the other requested information typically associated with a new device's performance evaluation (like sample sizes, expert qualifications, etc.). The FDA's letter explicitly states that the device is deemed "substantially equivalent" to a legally marketed predicate device, meaning it doesn't require new, independent performance validation beyond demonstrating that the minor change doesn't alter its safety or effectiveness.

Here's a breakdown based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in the document. The submission is for a modification to an existing device, and the focus is on maintaining substantial equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

Not provided. Performance data from a specific test set is not detailed in this 510(k) summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not provided. Ground truth establishment is not discussed in the context of this submission.

4. Adjudication Method for the Test Set:

Not applicable/Not provided. There's no test set described for adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable/Not provided. This is a medical device (infusion set), not an AI diagnostic tool, so an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study:

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

7. Type of Ground Truth Used:

Not applicable/Not provided in the context of this submission. The device's performance is assumed to be equivalent to its predicate.

8. Sample Size for the Training Set:

Not applicable/Not provided. This is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable/Not provided.

Summary of Device and 510(k) Process (based on provided text):

• Device Name: LiftLoc® Safety Infusion Set (modified version)
• Predicate Device: LiftLoc® Safety Infusion Set (K013394)
• Modification: Presence of medical grade silicone lubrication on the needle. Enhanced labeling also included.
• Intended Use: As an intravascular administration set with a non-coring Huber needle to access surgically implanted vascular ports for fluid/drug infusion and blood sampling. Features an integral safety mechanism to reduce needlestick injuries.
• 510(k) Outcome: Substantially Equivalent (K042234) to the predicate device, indicating that the FDA determined the modified device is as safe and effective as the existing legally marketed device and does not raise different questions of safety and effectiveness. The marketing authorization is based on this equivalence, not on new, independent performance studies.

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