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These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body.

Intra-uterine transfer

• 1. Frydman Catheter 4.5, 5.5
• 2. Frydman Catheter 4.5 with 2 lumen and removable mandrel
• 3. Long Frydman Set
• 4. Frydman Set
• 5. Soft Frydman Set
• 6. Soft Frydman Set with madrel
• 7. TDT Set

Intra-fallopian transfer

• 1. Biset for GIFT
• 2. Gift Catheter
• 3. Oliver Set
• 4. Rinsing Valve for Oliver Set

The Assisted Reproduction microtool devices have been down classified FR Vol. 63, No. 175 September 10, 1998. Effective date: October 13, 1998.

As found in the labeling/promotional material:
Frydman™ Catheter: Polyethylene catheter with a flexible end, internal diameter: 1.1mm, outer diameter: 1.6mm, and a distal opening.
Double Lumen Frydman™ Catheter 4.5: Polyethylene catheter, 17.5cm long, consisting of a central tube 2.1mm, stiffened in its proximal part on 13cm by a second polypropylene tube 2.6mm, with two hysterometric markings at 5.5 and 6.5 from the distal opening. The central tube is a double lumen tube: its lateral lumen is provided with a malleable mandrel, and its central lumen 1.1mm, is intended to contain embryo(s).
Soft Frydman™ Set (with or without mandrel): The set includes 2 catheters: Catheter Nº 1: Polypropylene introducer (with a blue adapter), Catheter Nº2 Polyurethane reimplantation catheter, Mandrel, 17.5 cm long, depending on the model.
Short Frydman™ Set (for difficult embryo transfer): The set includes 2 catheters: Catheter No. 1 polypropylene introducer (with an blue adapter), Catheter No. 2 polyethylene reimplantation catheter (with an orange adapter).
Long Frydman™ Set (for difficult embryo transfer): The set includes 2 catheters: Catheter No. 1 polypropylene introducer (with an blue adapter), Catheter No. 2 polyethylene reimplantation catheter (with an orange adapter).
T.D.T.TM Set (for difficult embryo transfer): The set includes 2 catheters: Catheter No. 1 polypropylene introducer, Catheter No. 2 ultra-thin polyethylene reimplantation catheter.
BI SET™ for GIFT: The set includes 2 catheters: Catheter No. 1 introducer (with an blue adapter), Catheter No. 2 polyethylene reimplantation catheter (with an orange adapter), Stainless steel trocar (with green adapter), 20 cm long. Two models are available: 1 transfer catheter, 2 transfer catheters.
Oliver Set MK II ™: The set includes: 1 polyamide, echogenic, introducer, 24 cm long, 1.9mm, 1.1mm, pre-curved at 45°, with an loive-shape tip fitted with a ground stainless steel ring, 1 metal mandrel, 27 cm long, 1mm, 1 polyethylene transfer catheter, 33 cm long, 1mm, 0.6mm.

Function of Device/Significant Physical Characteristics of Device: All devices are malleable, to allow a change in shape for the device; the mandrel is accluded to prevent the in-flow of bodily fluids when inserting into the crevix. All devices contain echolocater ultrasound markers.

This document is a 510(k) summary for the Prodimed Intra-uterine, Intra-fallopian Transfer Assisted Reproduction Catheters. As such, it describes the device and its intended use but does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. These types of details are typically found in more comprehensive study reports or clinical trial summaries, not in a 510(k) summary which focuses on demonstrating substantial equivalence to a predicate device.

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