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1. The I-Flow Variable Rate Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intraarterial, subcutaneous, intramuscular and epidural.
2. The I-Flow Variable Rate Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative and postoperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.

The I-Flow Variable Rate Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. This special 510(k) proposes a labeling change to the existing device submitted under K020660 for the variable flow rate component.

The provided document K023883 is a 510(k) summary for a special 510(k) submission. This type of submission is typically used for modifications to a legally marketed device that do not raise new questions of safety and effectiveness.

In this specific case, the submission is for a labeling change to the existing I-Flow Variable Rate Elastomeric Pump (K020660) concerning its variable flow rate component. The document explicitly states: "The Variable Flow Rate Component is identical in design to the one recently cleared under K020660."

Therefore, this submission relies on the substantial equivalence to its predicate device (K020660 and K020251 for the variable flow rate component) rather than presenting new performance data from a dedicated study. As a result, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets them, as it is not a de novo submission or a new device evaluation requiring such extensive testing protocols.

Here's a breakdown of why this information is absent in this particular document:

• No new performance claims: The special 510(k) is for a labeling change and explicitly states the component is identical to a previously cleared one. This means no new performance is being claimed that would require new acceptance criteria or a new study.
• Reliance on predicate device: The basis for clearance is "substantial equivalence" to the existing I-Flow Elastomeric Pump and the variable flow rate component cleared under K020251. The performance characteristics were established and accepted during the clearance of those predicate devices.

Therefore, I cannot populate the table or answer the specific questions because the provided document does not contain a study demonstrating new device performance against new acceptance criteria.

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