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510(k) Data Aggregation
K Number
K072613Device Name
DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE
Manufacturer
Date Cleared
2008-04-21
(217 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MICRO INVASIVE TECHNOLOGY INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
UROLOGY
DirectView™ Endoscopes may be used by qualified physicians for imaging of a surgical site for diagnostic and surgical urology procedures.
GENERAL SURGERY
DirectView™ endoscopes may be used for general diagnostic and laparoscopic surgical procedures by a qualified physician for visualization of body cavities, organs, and canals to perform various diagnostic and surgical procedures.
Device Description
A laparoscope is a device used for minimally invasive surgery for specific indications of use. The device consists of two separate and distinct optical paths. The illumination usually takes the form of fiber optics connected to a light cable which brings light from an external light source to the instrument.
The second path is an optical telescope that captures an image from inside the body cavity with an optical objective lens system. This image is then transmitted through a series of optical relay lenses and/or rods to convey the image to a eyepiece for viewing by the human eye. Over the years, human viewing using the eyepiece has given way to electronic cameras which projects the image from the telescope on to a video monitor. Recent designs using what is called a chip-ona-stick technology has replaced the optical relay with an electronic camera embedded in the distal end of the device at the expense of bringing wiring into the body cavity.
The basic optical design as well as physical design of the laparoscope has remained constant with the exception of the reduction of its diameter. The device has remained essentially the same since the original Hopkin's design over forty years ago. Major developments have occurred, however, in the application of solid state camera systems and high definition video monitors creating a revolution in minimally invasive surgerv. MITI seeks to make major revisions in the basic design of the device itself to address problems which have largely been unaddressed for decades. MITI defines functionality of its technology in terms of flexibility, sterility, visibility, interchangeability, availability, safety, and affordability.
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