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The PhasTIPP System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins. The Illuminator is also indicated for use without the Resector for visualization of varicose veins and infusion of tumescent solution during an ambulatory phlebectomy procedure.

The PhasTIPP System consists of an Illuminator and a Resector. During the surgical procedure, the illuminator shaft is placed through an incision under the skin with its light-emitting end to provide intense light for a better visualization of the varicose veins. A port that runs along the illuminator shaft is used to infuse tumescence solution to cause the contraction of varicosities, which aids vein visualization by creating a subcutaneous fluid pocket through which the illuminator's light can disperse. A powered resector, positioned through a different incision can then be used to morcellate and aspirate the varicosities.

The PhasTIPP Illuminator consists of two devices: a reusable Illuminator Handpiece and a disposable Illuminator.

The Handpiece provides illumination controls and contains an LED to provide intense light. The Handpiece is powered with new batteries for each new surgical procedure (Duracell CR 123a cell). The handpiece is provided non-sterile and must be covered with the microbial barrier sheath attached to the Disposable Illuminator in the sterile field before the procedure begins.

The Disposable Illuminator includes, in addition to the microbial barrier sheath, a distal stainless steel fiber optic light shaft. When connected to a peristaltic pump, the Disposable Illuminator can also infuse tumescence.

The PhasTIPP Resector consists of two devices: a reusable Resector Handpiece and a Resector Disposable (available in two diameters, 4.5mm and 5.5mm). The Disposable Resector also connects to a peristaltic suction pump to remove the resected varicosities.

The Resector Handpiece provides controls for the operation of the rotation blades on the Disposable Resector and is powered with a set of new batteries (TLM-1550 HPM cell), for each surgical procedure. The Resector Handpiece is provided non-sterile and must be covered with the microbial barrier sheath attached to the Disposable Resector in the sterile field.

The Control Unit that was a large equipment in the predicate device is displaced in the subject device. Instead, the Resector Handpiece and the Illuminator Handpiece control the disposable resector and illuminator in the subject device.

This document describes the PhasTIPP System, an external vein stripper. The FDA's 510(k) summary provides details about the device, its intended use, and the testing conducted to establish its substantial equivalence to a predicate device.

1. A table of acceptance criteria and the reported device performance

The provided document doesn't explicitly state "acceptance criteria" in a tabulated format alongside "reported device performance" in the way one might expect for a clinical study with primary endpoints. Instead, it lists various design validation, system validation, and performance tests that were completed to demonstrate the device meets product performance specifications and for substantial equivalence.

For the purpose of this request, I will infer the "acceptance criteria" from the types of tests performed and the "reported device performance" as the overall statement that the device meets these specifications.

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