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K Number
K051294
Device Name
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
Manufacturer
FEMSPEC L.L.C.
Date Cleared
2005-12-21

(217 days)

Product Code
HHK
Regulation Number
884.1175
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal and for histological analysis of the uterine mucosal lining. It is indicated for:

  • Cancer screening
  • Endometrial dating
  • Determining response to estrogen replacement therapy
  • Bacterial culturing
  • Detection of pathology resulting in infertility
  • Monitoring patients receiving Tamoxifen therapy
  • Evaluating secondary amenorrhea
Device Description

FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, disposable curette.

AI/ML Overview

The provided text describes the 510(k) clearance for the FemTest™ Endometrial Suction Curette. This document is a regulatory approval, not a scientific study describing performance criteria and results of a device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because the provided text does not contain such details. It is a regulatory letter confirming substantial equivalence to a legally marketed predicate device, not a performance study.

§ 884.1175 Endometrial suction curette and accessories.

(a)
Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.(b)
Classification. Class II (performance standards).