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510(k) Data Aggregation
K Number
K983181Device Name
CYTOPREP
Manufacturer
CYTOPREP INC. EST.
Date Cleared
1998-11-16
(66 days)
Product Code
HHI
Regulation Number
884.5070Why did this record match?
Applicant Name (Manufacturer) :
CYTOPREP INC. EST.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for the use of physicians and other professionals authorized to take sample cells from the cervix of the uterus, transfer them to a fluid suspension (or smear them on a slide, in the case of a traditional PAP test) for further preparation of cytological slides. CYTOPREP® was designed for use in conjunction with Liquid Based Cytology procedures. However, recent tests at the University of Munich. Germany, have proven it equally effective as a sampling device for the traditional PAP smear test.
The device is used to sample the cervix of patients for the purpose of obtaining ecto-cervical, endo-cervical and T-zone sample cells. These sample cells are used for the "PAP" test.
While the product is designed to be used in conjunction with liquid based cytology procedure (monolayer method), it can also be used in conjunction with the traditional "PAP" test procedure.
Device Description
CYTOPRED® consists of two parts, the handle and the head.
The handle is 214mm in length, cylindrical and on one end it carries the name of the product. On the other end , there are two recesses (female) to accommodate the bottom part of the head. These two recesses, along with a special edge (male) on the bottom of the head. secure the head. When the physician has inserted the head in the endocervical canal and is turning the handle to obtain sample cells, the head turns (follows the physician's manipulations) and there is no slippage. Tests made (see XI Performance for attached laboratory report), prove that it will be impossible for a bristle to break and remain in the patient's cervix and almost impossible for the head to accidentally separate from the handle and remain in the cervix.
The head consists of:
The "male" edge on the bottom that is secured in the handle recess (female), stabilizing the head on the handle;
The base, upon which sit lengthy bristles on both sides of the center brush.
The center brush end sits upon the base of the head and its center stem extends beyond the lengthy bristles. On its center stem, perpendicular to the lengthy bristles, sit bristles which extend from the base of the head to the end of the center stem.
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