Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K042274
    Device Name
    PSD-60/ENDOPLASMA
    Date Cleared
    2005-02-22

    (183 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    OLYMPUS SHIRAKAWA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PSD-60 has been designed to be used with OLYMPUS endoscope (fiberscope, videoscope and rigid scope) compatible with electrosurgical accessories and other ancillary equipment for general, laparoscopic and endoscopic electrosurgery ( cutting, coagulation, including soft tissue coagulation). The argon plasma coagulation unit has been designed to be used with the electrosurgical unit, OLYMPUS PSD-60 for argon plasma coagulation (APC) of living tissues in treatment using OLYMPUS endoscope compatible with electrosurgery, argon plasma coagulation accessories and other ancillary equipment for endoscopic electrosurgery (coagulation).
    Device Description
    The PSD-60 is an Electrosurgery unit and is used in conjunction with a OLYMPUS ENDO-PLASMA, or can be used alone. The PSD-60 has a 7-segment LCD (Liquid Crystal Display) that provides the user with an on-screen setting and operational information. The unit has various cutting and coagulation modes with defined effect levels to provide the physician flexibility in applications (i.e. Its ability is to generate the HF current.). The system has automatic start and stop features. When activated, the device has an alarm as well as a visual error system (i.e. malfunctions or user errors are detected with medical personnel being alerted visually and/or by sound with, in some cases, no energy being delivered.). Upon activation, energy delivered from the PSD-60 to the tissue is displayed in watts on the 7-segment display. Also, the unit can be used in association with an OLYMPUS compatible ENDOPLASMA Argon plasma coagulator. The unit is non-sterile and is reusable. The OLYMPUS ENDOPLASMA is an Argon plasma coagulation system and is used in conjunction with an OLYMPUS PSD-60. The PSD-60 provides high frequency (HF) voltage to electrically charge Argon gas from the ENDOPLASMA to form plasma in the gas stream when in close proximity to tissue. Current density concentrates at the tissue surface from ENDOPLASMA (probe) causes coagulation. The ENDOPLASMA with the PSD-60 has a 7-segment LCD (Liquid Crystal Display) that provides the user with an on-screen setting operational information. Software in the PSD-60 controls the microprocessor chip in an ENDOPLASMA. The PSD-60/ENDOPLASMA are programmable and have error monitoring features. There is a communications bus cable for the PSD-60 to communicate with an ENDOPLASMA. A pressure reducer with sensor is provided to regulate the Argon gas going into the ENDOPLASMA. The ENDOPLASMA and its accessory are supplied non-sterile and are reusable. Cleaning/ disinfection, and sterilization (as applicable) are provided in the respective user manual. The ENDOPLASMA membrane filter is also a part of the system. The filter is disposable single-use. The filter is connected between the ENDOPLASMA (at the Argon gas port) and connector hose. The filter creates a barrier to protect the ENDOPLASMA from potential contamination. Filters are supplied sterile by means of ethylene oxide and are disposable (single use). They are sterilized by the manufacturer and the sterilization cycle has been validated. Accessories include: Footswitch, P-cord, APC-cable, APC-probe, Irrigation adapter, Pressure reducer, S-cord.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1