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K Number
K013501
Device Name
IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B
Manufacturer
GYNETICS MEDICAL PRODUCTS NV
Date Cleared
2001-11-30

(39 days)

Product Code
MQF
Regulation Number
884.6110
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures utilizing washed spermatozoa.
The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures and for transcervical GIFT as an introducer.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for several Intrauterine Insemination (IUI) and GIFT catheters manufactured by Gynétics Medical Products N.V.

Based on the provided text, there is no information about acceptance criteria or a study proving that the device meets those criteria.

The document primarily focuses on:

  • Substantial Equivalence Determination: The FDA has determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This is a regulatory determination, not an assessment of performance against pre-defined acceptance criteria from a study described in this document.
  • Regulatory Information: It details the regulation numbers, product codes, regulatory class, and general controls provisions of the Act that apply to the device.
  • Marketing Authorization: It states that the letter allows the applicant to begin marketing their device.
  • Indications for Use: It lists the intended uses for three specific devices:
    • IUI #4220: For intra uterine artificial insemination procedures utilizing washed spermatozoa.
    • Smooze #4225: For intra uterine artificial insemination procedures utilizing washed spermatozoa.
    • Seminor #4502: For intra uterine artificial insemination procedures and for transcervical GIFT as an introducer.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. This type of information would typically be detailed in the 510(k) submission itself, not in the FDA's decision letter.

§ 884.6110 Assisted reproduction catheters.

(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).