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510(k) Data Aggregation

    K Number
    K240307
    Device Name
    VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
    Manufacturer
    Shenzhen VitaVitro Biotech Co., Ltd.
    Date Cleared
    2024-08-16

    (196 days)

    Product Code
    MQF
    Regulation Number
    884.6110
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VitaVitro Embryo Transfer Catheter is used to place in vitro fertilized (IVF) embryos into the uterine cavity
    Device Description
    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.
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    K Number
    K232579
    Device Name
    Twoplus Applicator
    Manufacturer
    Hannah Life Technologies Pte Ltd.
    Date Cleared
    2023-12-21

    (118 days)

    Product Code
    QYZ
    Regulation Number
    884.6110
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The twoplus Applicator is indicated for over-the-counter home use by individuals who choose not to conceive through intercourse. The twoplus Applicator kit allows for semen collection and the vaginal canal. The twoplus Applicator should be used during the ovulatory phase of the menstrual cycle.
    Device Description
    Not Found
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    K Number
    K231645
    Device Name
    PherDal® At-Home Insemination Kit
    Manufacturer
    PherDal Fertility Science, Inc.
    Date Cleared
    2023-12-14

    (192 days)

    Product Code
    QYZ
    Regulation Number
    884.6110
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PherDal® At-Home Insemination Kit is indicated for over-the-counter home use, by individuals who have been unable to conceive through intercourse or have chosen not to conceive through intercourse, for semen collection and the delivery of semen to the vaginal canal. The PherDal® At-Home Insemination Kit should be used during the ovulatory phase of the menstrual cycle.
    Device Description
    The PherDal® At-Home Insemination Kit is a sterile, over-the-counter (OTC) medical device intended for intravaginal insemination (IVI) at home. It consists of three sets of sterile, single-use, plastic syringes and semen collection cups, and Instructions for Use. The collection cup is used to hold and contain the sperm and work in conjunction with the syringe when it is time to transfer the syringe. The syringe is used to withdraw the semen from the collection cup and deploy the semen intravaginally.
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    K Number
    K231203
    Device Name
    Mosie Baby Kit
    Manufacturer
    Mosie Baby
    Date Cleared
    2023-11-29

    (216 days)

    Product Code
    QYZ, OYZ
    Regulation Number
    884.6110
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mosie Baby Kit is indicated for over-the-counter home use, by individuals who have been unable to conceive through intercourse or choose not to conceive through intercourse, for semen collection and the delivery of semen or donor sperm to the vaginal canal. The Mosie Baby Kit should be used during the ovulatory phase of the menstrual cycle.
    Device Description
    The Mosie Baby Kit is an over-the-counter (OTC) device intended for intravaginal insemination (IVI) at home. The Mosie Baby Kit includes the following components: - Two Mosie syringes - Two Mosie collection cups - Instructions for Use. Each component is single-use only and supplied non-sterile. The collection cup is used to hold and contain the sperm and work in conjunction with the syringe when it is time to transfer the sperm into the syringe. The syringe is used to withdraw the semen from the collection cup and deploy the semen intravaginally. The syringe features a rounded front end with a slotted tip opening. The syringe has a rounded stopper that fits within the rounded end of the syringe to aid in sperm delivery from the syringe to the vagina. The syringe also contains flanges designed to aid in device handling during use.
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    K Number
    K231730
    Device Name
    FemaSeed Intratubal Insemination
    Manufacturer
    Femasys Inc.
    Date Cleared
    2023-09-22

    (101 days)

    Product Code
    MQF
    Regulation Number
    884.6110
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemaSeed Intratubal Insemination is intended to introduce washed sperm or in vitro fertilized (IVF) embryos into the uterine ostium via ultrasound guidance
    Device Description
    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.
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    K Number
    K220010
    Device Name
    Daylily Single Use Sterile Embryo Transfer Catheter
    Manufacturer
    Shanghai Horizon Medical Technology Co., Ltd.
    Date Cleared
    2022-12-16

    (346 days)

    Product Code
    MQF
    Regulation Number
    884.6110
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Daylily Single Use Sterile Embryo Transfer Catheters are used to place in vitro fertilized (IVF) embryos into the uterine cavity.
    Device Description
    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.
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    K Number
    K200248
    Device Name
    Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
    Manufacturer
    Allwin Medical Devices, Inc.
    Date Cleared
    2020-07-01

    (152 days)

    Product Code
    MQF
    Regulation Number
    884.6110
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K192540
    Device Name
    Kitazato ET Catheters
    Manufacturer
    Kitazato Corporation
    Date Cleared
    2020-05-01

    (228 days)

    Product Code
    MQF
    Regulation Number
    884.6110
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilization.
    Device Description
    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.
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    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
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Allwin Intra Uterine Insemination Catheters are intended for the introduction of washed spermatozoa into the uterine cavity.
    Device Description
    Not Found
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    K Number
    K191015
    Device Name
    Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
    Manufacturer
    Cook Incorporated
    Date Cleared
    2019-05-17

    (30 days)

    Product Code
    MQF
    Regulation Number
    884.6110
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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