(202 days)
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.
| Acceptance Criteria (Inferred from Tests) | Reported Device Performance (Summary) |
|---|---|
| Illuminator Design Validation: | The Illuminator's design, including shaft dimensions, flow rate, light output, leak testing, sheath integrity and usability, and tensile/torque strengths of components, met specifications. |
| Shaft diameter, length, IV spike to pump, pump tube, pump to hub lengths | Met specifications |
| Flow Rate (ml/min) | Met specifications |
| Light Output (lumens) | Met specifications |
| Leak Testing | Passed |
| Sheath Length (in) | Met specifications |
| Usability Through Sheath | Confirmed |
| Sheath Maintains Microbial Barrier | Confirmed |
| Tensile Strength: Hub to Shaft (lbf), Disposable (lbf), Pump tube to Connectors, IV Spike to Tubing (lbf) | Met specifications |
| Torque Strength: Disposable (in-lb) | Met specifications |
| Kink Test: Infusion Tubing | Passed |
| Illuminator System Validation: | The Illuminator's system functions, including basic operation and low battery performance, were verified. |
| Basic Function | Verified |
| Low Battery Functionality | Verified |
| Fault Insertion and Power Supply Fuse testing | Verified |
| Resector System Validation: | The Resector's system functions, including voltage regulation, motor RPM, home position, communications, diagnostics, embedded processor, and battery critical function, were verified. |
| Voltage Regulation | Verified |
| Motor RPM | Verified |
| Home Position and Home Position Drift | Verified |
| Communications and Diagnostic Logging | Verified |
| Embedded Processor Hardware Basic Function | Verified |
| Jam Clear | Verified |
| Battery Critical Function | Verified |
| Embedded processor/Software load | Verified |
| Resector Software Integration Validation: | The Resector's software integration for timer, low battery, hardware configuration, motor state machine, oscillation, anti-stall, high current fault, motor time save/retrieve, and RTC were validated. |
| Timer functionality | Validated |
| Low battery functionality | Validated |
| Low level hardware configuration of the micro-controller hardware | Validated |
| Motor state machine running | Validated |
| Functionality of the oscillation feature and software | Validated |
| Fault states related to the "anti-stall routine | Validated |
| High motor current fault by simulating excessive motor current | Validated |
| Motor time save and retrieve function | Validated |
| Real Time Clock (RTC) against the system clock | Validated |
| Battery critical lockout feature | Validated |
| Resector Design Validation: | The Resector's design, including shaft diameters and lengths, aspiration tube characteristics, sterile sheath integrity, and tensile/torque strengths of components, met specifications. |
| Shaft Diameter (4.5mm & 5.5mm) | Met specifications |
| Shaft Length (4.5mm & 5.5mm) | Met specifications |
| Aspiration Tube Length | Met specifications |
| Aspiration Tube tensile strength to Connector | Met specifications |
| Kink Testing & Leak Testing | Passed |
| Bond Tubing to Back Lid | Met specifications |
| Aspiration Flow Rate Comparison (4.5 & 5.5) | Met specifications |
| Motor Functionality Data | Met specifications |
| Sterile Sheath: Adequate length, Microbial Barrier Testing, Maintains Contamination Barrier | Confirmed |
| Tensile Strength: Disposable Hub to Main Shaft (4.5mm & 5.5mm), Driven Gear to the resector inner shaft (4.5mm & 5.5mm), Disposable Assembly to Handpiece | Met specifications |
| Torque Strength: Disposable Hub to Shaft assembly, Driven Gear to the resector inner shaft | Met specifications |
| Bonded joint between proximal hub and the backlid | Met specifications |
| Distal Hub Pinned to proximal resector | Met specifications |
| Microbial Sheath Barrier Design Validation: | The sheath's bubble leak test confirmed its barrier integrity. |
| Sheath Bubble Leak Test | Passed |
| PhasTIPP Illuminator Injection Line Design Validation: | The injection line's pressurized leak testing met specifications. |
| Pressurized Leak Testing | Passed |
| PhasTIPP Illuminator Injection Line Shelf Life Validation (2 years Accelerated aging): | The injection line maintained performance after accelerated aging. |
| Pressurized Leak Testing | Passed |
| Flow Rate Measurement | Met specifications |
| Luer Fitting Tensile Strength test | Met specifications |
| Overall Length | Met specifications |
| PhasTIPP Performance Testing: | System performance was confirmed in a 3D in-vitro bench test. |
| System performance in 3D in-vitro bench test | Confirmed |
| PhasTIPP Illuminator Heat Evaluation: | The heat produced by the Illuminator was evaluated. |
| Evaluation of heat produced by PhasTIPP Illuminator | Evaluated (implies within acceptable limits for a medical device) |
| PhasTIPP Testing to IEC 60601 Medical Electrical Equipment: | The device met relevant IEC 60601 standards for electromagnetic compatibility. |
| Radiated Emissions | Compliant |
| Electro-Static Discharge | Compliant |
| Radiated Field Immunity | Compliant |
| Power Frequency Magnetic Field | Compliant |
| Biocompatibility (ISO 10993-1:2018): | The device was found to be biocompatible for its intended use. |
| External Communicating Device, Contact Circulating Blood, limited use ( |
§ 870.4885 External vein stripper.
(a)
Identification. An external vein stripper is an extravascular device used to remove a section of a vein.(b)
Classification. Class II (performance standards).