Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)

• K Number: K190590
• Device Name: Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
• Manufacturer: Allwin Medical Devices, Inc.
• Date Cleared: 2019-11-25 ( 263 days)
• Product Code: MQE
• Regulation Number: 884.6100
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: N/A

Intended Use

Allwin Ovum Pickup Needles are used for laparoscopic or ultrasound guided transvaginal retrieval of oocytes from ovarian follicles.

Device Description

Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle).

AI/ML Overview

This FDA letter is a notification of substantial equivalence for a medical device (Allwin Ovum Pickup Needles). It does not contain information about acceptance criteria or specific studies that prove the device meets these criteria. The document explicitly states:

"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the FDA has determined the new device is as safe and effective as a legally marketed device already on the market, based on the information provided by the manufacturer in their 510(k) submission. However, the details of the studies and acceptance criteria used by the manufacturer to demonstrate this substantial equivalence are not included in this letter. The letter is the FDA's final decision, not the manufacturer's submission itself.

Regulation Number and Section

§ 884.6100 Assisted reproduction needles.

(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).