(346 days)
Daylily Single Use Sterile Embryo Transfer Catheters are used to place in vitro fertilized (IVF) embryos into the uterine cavity.
Daylily Single Use Sterile Embryo Transfer Catheters are sterile single use catheters used to deliver in vitro fertilized embryos to the uterine cavity. All models of the Daylily Single Use Sterile Embryo Transfer Catheters consist of a transfer catheter and a guide catheter. Some device models (Type II and Type IV) also include a trial catheter.
The guide catheter is composed of a catheter shaft, connector, and a positioning ring (for certain Type III and IV variants). Guide catheters for some Type III and Type IV variants are also provided pre-curved. Guide catheters have a rounded/blunt tip and marker bands at the distal tip to aid in catheter placement. The guide catheter is delivered through the cervix first and is used to guide the insertion of the transfer catheter holding the embryos into the uterine cavity.
The transfer catheter is composed of a catheter shaft, connector, and a stainless-steel sleeve (for Type III and IV models). Transfer catheters have a rounded/blunt tip and marker bands at the proximal end of the catheter to aid in catheter placement. The transfer catheter is loaded with embryos prior to delivery through the guide catheter and into the uterine cavity. A syringe (not provided with catheters) connected to the connector of the transfer catheter is used to deliver the embryos into the uterine cavity.
The trial catheter is an optional accessory for specific models (Types II and IV), composed of a catheter shaft, connector, and a polymer-coated stainless-steel core. Trial catheters have a rounded/blunt closed tip. The trial catheter is used to provide additional support during guide catheter placement and to assess the placement of the device prior to conducting an actual embryo transfer procedure.
The provided text describes the Daylily Single Use Sterile Embryo Transfer Catheters and reports on the non-clinical performance data to support its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic | Met: Device material found to be non-cytotoxic |
| Non-sensitizing | Met: Device material found to be non-sensitizing | |
| Non-irritating | Met: Device material found to be non-irritating | |
| Endotoxin | and AAMI/ANSI ST72:2019 define acceptable endotoxin levels. |
- Mouse Embryo Assay (MEA): The 2021 FDA guidance "Mouse Embryo Assay for Assisted Reproduction Technology Devices" sets the specification for embryo development.
- Other Bench Tests: Conformity to physical and functional specifications.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. Since there is no training set, this question is not relevant.
§ 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).