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VitaVitro Embryo Transfer Catheter is used to place in vitro fertilized (IVF) embryos into the uterine cavity

The VitaVitro Embryo Transfer Catheters are sterile (ethylene oxide), single use catheters used to deliver in vitro fertilized embryos to the uterine cavity. They have a three-year shelf-life. The device includes five catheter models that are composed of a transfer catheter and a guide catheter (some with obturator). The 172 mm length Guide catheters have OD 2.4 mm for straight (Models ET-SI and ET-S) and OD 2.2 mm for the curved version type (Model ET-A). The curved version type (Model ET-A) has an additional adjustable positioner which aids in positioning the device to the targeted depth within the uterine cavity during a procedure. Both types 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 240 mm transfer catheter with an OD 0.95 mm is loaded with embryos prior to delivery through the guide catheter and into the uterine cavity. A syringe (not provided with catheters) is connected to the connector of the transfer catheter and is used to deliver the embryos into the uterine cavity. The 200 mm obturator with OD 1.3 mm is an optional accessory for the device. It has a rounded/blunt closed tip. The obturator is used to provide additional support (increase rigidity) during guide catheter placement and to assess the placement of the device prior to conducting an actual embryo transfer procedure.

The FemaSeed Intratubal Insemination is intended to introduce washed sperm or in vitro fertilized (IVF) embryos into the uterine ostium via ultrasound guidance

The FemaSeed Intratubal Insemination consists of polymer curved transfer catheter with balloon, polymer guide catheter and separate balloon inflation syringe. The balloon inflation syringe is a 3 mL syringe fitted with clips that allow for the piston to lock in place to maintain balloon inflation. When the clips are pinched, the piston releases, deflating the balloon. The device is intended to deliver washed sperm or in vitro fertilized embryos into the uterine ostium via ultrasound guidance by a licensed healthcare provider specifically trained in women's health. Prior to insertion, the slider is moved back until the curved transfer catheter is fully retracted and contained within guide catheter. The preassembled guide catheter is then passed transvaginally through the cervix to the fundus, under ultrasound guidance. Once in position, the preloaded transfer catheter is advanced approximately 2 cm into the uterine ostium and the balloon is inflated with the provided syringe. The balloon location in the uterine ostium is confirmed using ultrasound. The samples are then instilled into the uterine ostium of the fallopian tube, followed by deflating the balloon and discarding the device. The recommended volume for loading washed sperm should not exceed 1 mL and 50-100 µL when loading embryos.

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.

Allwin Embryo Transfer Catheters are used to introduce in vitro fertilized (IVF) embryos into the uterine cavity. Allwin Embryo Transfer Catheters (Pro Embryo Trans, Pro Echo Trans, Twinkle Pro Embryo Trans, and Bulb Trans Star ETC) include stylets or soft obturators intended to assist in uterine access of the guide catheter during an embryo transfer procedure. Allwin Stylets and Soft Obturators are intended to be used with Allwin Embryo Transfer Catheters to assist in uterine access of the guide catheter during an embryo transfer procedure.

Allwin ETC include the following models: Embryo Trans, Twinkle Embryo Trans, Bulb Trans Ultra, Bulb Trans Star, Pro Embryo Trans, and Twinkle Pro Embryo Trans Embryo Transfer Catheter. Allwin ETC Stylets and Soft Obturators include the following models: Stylet For Embryo Trans / Twinkle Embryo Trans, Stylet For Pro Embryo Trans / Pro Echo Trans / Twinkle Pro Embryo Trans, Stylet for Bulb Trans Ultra / Bulb Trans Star, Soft Obturator For Pro Embryo Trans / Twinkle Pro Embryo Trans Embryo Transfer Catheter.

Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilization.

Kitazato ET Catheters are sterile, single-use catheters for use in embryo transfer procedures. The catheter is used to hold and deliver embryos to the uterine cavity during a procedure. Catheters are available in 3Fr and 4Fr sizes, both of which are provided in lengths of 220 mm and 250 mm, as well as one version that is 3Fr and 400 mm length that has the same uterine insertion depth as the other device versions, but allows the user to be positioned further from the patient during a procedure. Devices also include versions with and without an echo reflective chip in the tip of the catheter. The echo reflective chip aids in visualization of the catheter during a transfer procedure; all transfer procedures are to be done under ultrasound guidance. Both the Type 2 devices also include a stainless steel or polyimide core to provide additional rigidity to the catheter. The guide is used to navigate the pathway through the cervical canal to allow for easier catheter insertion Guides are provided with a 30° pre-curved distal shaft and are available in lengths of 170 mm and 200 mm. Guides also include a styrene elastomer stopper to aid in positioning the targeted uterine insertion depth. The guides are also available with a straight or bulb tip design, and with and without an echo reflective chip in the tip of the guide. An obturator with a length of 170 mm or 200 mm is provided with the Type 2 versions of the device to prevent ingress of fluid into the guide lumen during guide insertion. The Stylet is an optional accessory used when additional rigidity is needed during insertion of the guide through the cervix, and is provided in two lengths, 170 mm and 200 mm. The stainless steel core of the Stylet can be shaped to aid in guide delivery through the cervix.

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

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The Soft-Pass™ Embryo Mock Transfer Catheter Sets are used for mock (simulated) embryo transfer procedures to and in verifying catheter access and positioning in advance of an embryo transfer procedure.

The Soft-Pass Embryo Mock Transfer Catheter Sets are used to aid in verifying access and positioning of embryo transfer catheters prior to placing transfer catheters containing embryos into the uterine cavity. These devices consist of a polyethylene guide catheter that is 6.8 Fr in diameter and either 12 or 17.3 cm long, and a polyethylene mock transfer catheter that is 4.4 Fr in diameter and 19.7 or 24.7 cm long. The tip of the mock transfer catheter is closed. The echogenic tip versions of the device also include an echogenic stainless steel band on the distal tip of the mock transfer catheter to aid in tip visualization when using ultrasound. The echogenic tip versions also include a supporting stainless steel cannula in the proximal portion of the mock transfer catheter. Depth markers are also included on both the guide and mock transfer catheters to aid in placement of the device during a mock procedure. These devices are sterilized by ethylene oxide, single-use only, and have a three-year shelf-life.

Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, and Soft -Trans Malleable Obturator: Used to supplement and assist uterine access of a cleared, dimensionally compatible embryo transfer device for placement of in vitro fertilized (IVF) embryos into the uterine cavity. GuardiaTM ETS Embryo-Tested Syringe: For use with catheters indicated for intrauterine insemination and embryo transfer. Flushing Catheter: The Flushing Catheter is intended for instillation of sterile medium into the cervical canal prior to embryo transfer.

This 510(k) covers eight devices from five of COOK's device families. These devices, as outlined in the table below, are sold separately. The polyurethane obturators are designed to fit dimensionally compatible embryo transfer guide catheters. Some of these devices are designed to be adjustable in length. The flushing catheter is a 20 cm tube measuring 14.9 Fr at the proximal end and tapering to 3.5 Fr at the distal end. It features a depth indicator and directional side port with an ink mark aligned with the position of the side port. This device is identical to the Insemi-Cath IUI catheter cleared under K172321. The Guardia Embryo-Tested Syringe is two-part syringe with a polypropylene barrel and a highdensity polyethylene plunger. This device undergoes Mouse Embryo Assay (MEA) and endotoxin testing (LAL) before lot release. All subject devices are supplied sterile and intended for one-time use. The Guardia Embryo-Tested Syringe has a shelf-life of five years, whereas the remaining subject devices have a shelflife of three years.

The Towako Transmyometrial Embryo Transfer Set is indicated for transfering IVF embryo(s) into the endometrial cavity through the myometrium for patients undergoing Assisted Reproductive Procedures.

The Towako Transmyometrial Embryo Transfer Set is comprised of an echo tipped stainless steel 19 Gauge needle, matching stainless steel stylet and a 2 Fr polyethylene transfer catheter. The stylet fits into the needle with both bevels flush, and is inserted with the stylet in-situ to prevent blockage of the needle lumen and provide stiffness to the needle during insertion. When the needle is positioned correctly, the stylet is removed and the transfer catheter with the embryos loaded is inserted to allow embryo transfer. The device is used when difficulty is experienced in transferring embryos into the uterine cavity using a standard trans-cervical route. The Towako Transmyometrial Embryo Transfer Set is a sterile and single-use device.