Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)

• K Number: K190522
• Device Name: Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)
• Manufacturer: Allwin Medical Devices, Inc.
• Date Cleared: 2019-11-14 ( 255 days)
• Product Code: MQF , MOF
• Regulation Number: 884.6110
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: N/A

Intended Use

Allwin Intra Uterine Insemination Catheters are intended for the introduction of washed spermatozoa into the uterine cavity.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for Allwin Intra Uterine Insemination Catheters. It establishes that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The letter focuses on regulatory clearance based on substantial equivalence and general controls, rather than outlining performance metrics or the results of a specific performance study.

Therefore, I cannot provide the requested information.

Regulation Number and Section

§ 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).