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510(k) Data Aggregation
K Number
K200249Device Name
Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
Manufacturer
Kitazato Corporation
Date Cleared
2020-10-23
(263 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
Kitazato Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sequential Culture Media consists of Fertilization Medium, Cleavage Medium, and Blastocyst Medium that are intended to be used sequentially from fertilization to the blastocyst stage of development. The intended uses of the Fertilization Medium, Cleavage Medium, and Blastocyst Medium are as follows:
Fertilization medium is intended for use during in vitro fertilization (IVF) and intracytoplasmic sperm insertion (ICSI) procedures and culture to the two pronuclei (zygote) stage of development.
Cleavage Medium is intended for culture of embryos from the two pronuclei (zygote) stage to the 8cell stage of development. Cleavage Medium is not intended for transferring embryos to the uterine cavity.
Blastocyst Medium is intended for culture from the 8-cell stage to the blastocyst stage of development. Blastocyst Medium is not intended for transferring embryos to the uterine cavity.
Device Description
Sequential Culture Media are intended for use sequentially from fertilization to late embryonic stages during assisted reproduction technology procedures for insemination and embryo culture.
The Sequential Culture Media is provided in three variants: Fertilization Medium, Cleavage Medium, and Blastocyst Medium. Each variant is provided with or without protein (human serum albumin (HSA) or recombinant HSA (rHA)). All variants contain gentamicin, an antibiotic agent that suppresses bacterial growth. Each Sequential Culture Media solution is offered in three volumes (10mL, 50mL and 100mL).
The Sequential Culture Media solution is a colorless, clear fluid, provided sterile-filtered into a container pre-sterilized by gamma irradiation. The primary container of Sequential Culture Media 10mL is a sterile non-pyrogenic PETG vial, and the primary container of the Sequential Culture Media 50mL and 100mL is a square, non-pyrogenic PETG bottle. The containers are manufactured and provided sterile (with a SAL of 10° ) by ThermoFisher Scientific, Inc. After sterilefilling, the top of the vial and bottle are sealed with tamper-evident shrink-wrap.
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K Number
K193522Device Name
iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
Manufacturer
Kitazato Corporation
Date Cleared
2020-08-25
(250 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
Kitazato Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
iMedium Single Step media are intended to be used as culture media for gametes and embryos from fertilization through day 5/6 of development. iMedium Single Step media are not intended for embryo transfer procedures.
Device Description
The Kitazato iMedium Single Step media are culture media used in assisted reproductive procedures. The iMedium Single Step media are designed for development of the embryo from fertilization through day 5/6 until the embryo transfer, in a continuous and uninterrupted culture system without the need to change media. The iMedium Single Step media are provided in three variants: without protein (Model: IM-S), with human serum albumin (HSA; Model: IM-SS), and with recombinant human albumin (rHA; Model: IM-SC). All variants contain gentamicin, an antibiotic agent that suppresses bacterial growth. Each iMedium Single Step solution is offered in three volumes (10mL, 50mL and 100mL). Each iMedium Single Step solution is a colorless and clear fluid. The product is single-use only, provided aseptically-filtered in a container sterilized by gamma irradiation.
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K Number
K192845Device Name
Sperm Freeze, Sperm Fridge
Manufacturer
Kitazato Corporation
Date Cleared
2020-08-17
(319 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
Kitazato Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sperm Freeze is intended for the cryopreservation of human semen samples prior to use in assisted reproductive technology procedures.
Sperm Fridge is intended to protect human semen samples during refrigerated storage prior to use in assisted reproductive technology procedures.
Device Description
Sperm Freeze and Sperm Fridge are preservation media intended for preserving sperm (short-term and long-term) for in vitro fertilization (IVF) and assisted reproduction technologies (ART). There are two methods for sperm preservation; freezing and refrigeration. Freezing is necessary for long-term sperm preservation, but may have disadvantages such as reduced survival rate and/or sperm motility after thawing. Refrigeration makes it possible to preserve sperm for several days without freezing and may be preferable for short-term preservation. Both products are intended to be used exclusively in a laboratory environment by trained professionals.
Sperm Freeze is a is a Tris-buffered solution containing the cryoprotectants glycerol and trehalose that is used for long-term sperm cryopreservation procedures. Sperm Fridge is a buffered solution (TES and Tris) that includes a nutrient source for sperm (dextrose) that is used for short-term sperm preservation procedures. Sperm Freeze and Sperm Fridge are offered in two volumes (0.5 mL and 10 mL, and 0.5 mL is sold in a pack of 5).
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K Number
K192540Device Name
Kitazato ET Catheters
Manufacturer
Kitazato Corporation
Date Cleared
2020-05-01
(228 days)
Product Code
MQF
Regulation Number
884.6110Why did this record match?
Applicant Name (Manufacturer) :
Kitazato Corporation
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
K190199Device Name
SepaSperm Washing Solution, SepaSperm Solution
Manufacturer
Kitazato Corporation
Date Cleared
2019-09-26
(234 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
Kitazato Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SepaSperm Washing Solution is used for preparation and washing of sperm for use in assisted reprocedures. SepaSperm Washing Solution is not intended for use in intrauterine insemination procedures.
SepaSperm Solution is used for separation of motile sperm from seminal fluid for use in assisted reproduction procedures.
Device Description
SepaSperm is used for preparation and washing of sperm and for separation of motile sperm from semen in assisted reproductive techniques.
The device includes two types of solutions used for density-gradient centrifugation:
- . SepaSperm Solution for sperm preparation and separation from semen, and
- . SepaSperm Washing Solution for sperm washing and preparation
Both solutions are provided in two sizes (100mL and 50mL bottles). This product is single-use only and includes no accessories. The provided sterile-filtered into a container that is sterilized by gamma irradiation.
SepaSperm Solution is offered in four different densities, determined by the amount of silica present:
- SepaSperm Solution 100% -
- -Lower laver solution 80%
- Middle layer solution 60% -
- -Upper layer solution 40%
SepaSperm Solution is composed of silica particles diluted with modified human tubal fluid (m-HTF) medium, with dextran and polyvinylpyrrolidone added. The m-HTF medium is a HEPES-buffered solution which is suitable for use in ambient conditions. All SepaSperm Solutions are provided with and without gentamicin. SepaSperm Solution has a shelf-life of six or 12 months for media without or with gentamicin, respectively.
The SepaSperm Washing Solution consists of m-HTF medium supplemented with dextran and polyvinylpyrrolidone. It contains no silica. SepaSperm Washing Solution is used to wash the prepared sperm and suspend the final pellet. SepaSperm Washing Solutions are provided with and without gentamicin. SepaSperm Washing Solution has a shelf-life of six or 12 months for media without or with gentamicin, respectively.
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K Number
K181469Device Name
Cryotop®US-flash and Cryotop®US-scoop
Manufacturer
Kitazato Corporation
Date Cleared
2018-11-09
(158 days)
Product Code
MQK
Regulation Number
884.6160Why did this record match?
Applicant Name (Manufacturer) :
Kitazato Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cryotop®US-flash and Cryotop®US-scoop are cryopreservation storage devices that are intended for use in vitrification procedures to contain and maintain human oocytes (MII) and embryos.
Device Description
This 510(k) covers two subject devices, the Cryotop®US-flash and Cryotop®US-scoop that are modified versions of the predicate device (Cryotop®US, K153027). Both devices are cryopreservation storage devices intended for embryo/oocyte vitrification. Cryotop®US-flash and Cryotop®US-scoop are provided sterile and are for single-use only.
The Cryotop®US-flash is composed of a polypropylene straw and an acrylonitrile butadiene styrene handle with a polyethylene terephthalate fine tip where oocytes or embryos are loaded. The fine device is flat with a triangular-shaped area for oocyte/embryo loading. The Cryotop®US-scoop is composed of a polypropylene straw and a polystyrene handle and fine tip where oocytes or embryos are loaded. The fine tip of this device is U-shaped. After oocyte or embryo loading, the handle of the subject devices is inserted into the straw enclosure. A hermetic seal is created via a tapered handle with a stop location integrated into the handle. As the handle is placed into the straw enclosure it creates a closed system keeping the fine tip isolated from the liquid nitrogen. The straw component of both devices also includes a weight at its distal end to aid in maintaining correct device position during storage in liquid nitrogen.
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K Number
K182002Device Name
Cumulus Remover
Manufacturer
Kitazato Corporation
Date Cleared
2018-10-23
(89 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
Kitazato Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cumulus Remover is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
Device Description
Cumulus Remover is an enzyme solution containing recombinant human hyaluronidase that digests hyaluronic acid that binds the cumulus and corona cells surrounding oocytes together. This function of hyaluronidase can be used for denuding cumulus and coronal cells from oocytes prior to performing Intracytoplasmic Sperm Injection (ICSI) fertilization procedures. Cumulus Remover is provided in a polypropylene vial (package size 0.5 mL), and five vials are packaged together in a box. This product is aseptically processed and has a shelf-life of six months when stored at 2-8°C. Cumulus Remover is tested for pH, osmolality, endotoxin, sterility, embryotoxicity, and hyaluronidase activity before lot release.
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K Number
K171748Device Name
Vitrification Kit and Thawing Kit
Manufacturer
Kitazato Corporation
Date Cleared
2017-12-14
(184 days)
Product Code
MQL, MOK, MOL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
Kitazato Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vitrification Kit is indicated for use in the preparation, vitrification and storage of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
The Thawing Kit is indicated for use in the preparation and thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
Device Description
The Vitrification and Thawing Kits are composed of a set of six media to vitrify and warm MII oocytes, and pronuclear (PN) zygotes through blastocyst stage embryos for Assisted Reproductive Technology (ART) procedures.
The Vitrification Kit includes three media components, Basic Solution (BS), Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol, trehalose, and dimethyl sulfoxide. During the vitrification process, embryos are first exposed to ES and then to VS. In the case of the oocytes, use BS and ES. Using this methodology, the permeating cryoprotectants can replace water in the occyte, PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen. The Vitrification Kit comes prepackaged with one 1.5 ml vial of BS and ES, two 1.5 ml vials of VS, 4 Cryotop devices (Cryotop CL, Cryotop SC, or Cryotop US), and 2 Repro Plates.
The Thawing Kit is composed of three media used stepwise for thawing cryoprotectants from vitrified oocytes, and PN through blastocyst stage embryos. The Thawing Kit is composed of TS (Thawing Solution), DS (Dilution Solution) and WS (Wash Solution). The Thawing Kit comes pre-packaged with two 4.0 ml vials of thawing solution, one 4.0 ml vial of dilution solution, one 4.0 ml vial of washing solution, one Repro Plate, and two 35 mm dishes.
All the media in the Vitrification Kit contain Gentamicin. The media in these kits undergo aseptic filtration, while storage devices and plates are sterilized by radiation.
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K Number
K162878Device Name
Kitazato ET Catheters
Manufacturer
Kitazato Corporation
Date Cleared
2017-07-13
(272 days)
Product Code
MQF
Regulation Number
884.6110Why did this record match?
Applicant Name (Manufacturer) :
Kitazato Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine in vitro fertilisation.
Device Description
Kitazato ET Catheters are sterile, single-use catheters for embryo transfer. The ET Catheters consist of a transfer catheter, guide catheter, and a stylet sheath. The Transfer catheter (hereafter referred to as 'catheter' or 'ET Catheter') is composed of a catheter shaft, a connector and a shaft protective sleeve (protector). The catheter types include a normal catheter (Type1, EC-PRO Normal), a catheter with a stainless outer stiffener (Type2, EC-PRO Supported), a catheter with Echo Line (Type3, EC-PRO Master), and a catheter that has both the stainless outer stiffener and the echo line (Type4, EC-PRO Master Supported), all of which are offered in lengths of 18cm and 23cm, and various versions (v1-v8). A corresponding Trial catheter of the same length is provided for all four Types of the Kitazato ET Catheters. The Guide catheter is offered both with a straight shaft and a 30° pre-curved distal shaft. The Stylet Cannula (Type5) is an optional accessory used when additional rigidity is needed during insertion of the cannula through the cervix, and is offered in two lengths, 13.5 cm and 18.5 cm.
During the implantation procedure of the embryo into the uterus, the catheter is introduced into the uterine cavity through the cervix, then the embryo is delivered into the uterine cavity by plunging the syringe that is coupled at the connector end of the catheter via a 6% taper luer lock. A syringe is not included with the Kitazato ET Catheters.
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K Number
K162881Device Name
Kitazato OPU Needles
Manufacturer
Kitazato Corporation
Date Cleared
2017-07-11
(270 days)
Product Code
MQE, MOE
Regulation Number
884.6100Why did this record match?
Applicant Name (Manufacturer) :
Kitazato Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kitazato OPU Needles consisting of:
- · Kitazato OPU Needle with Connection Tube (model number Type2)
- · Kitazato OPU Reduced Needle (model number Type3)
- · Kitazato OPU Two-Stage Reduced Needle (model number Type4)
are intended to obtain oocytes from ovarian follicles.
Device Description
The Kitazato OPU Needles are single-use sterile devices that are used for ultrasound-guided transvaginal collection of oocytes from ovarian follicles.
All of the Kitazato OPU Needle have a similar general design and device materials. All of the Kitazato OPU Needles are composed of a 304 stainless steel needle, acrylonitrile butadiene styrene (ABS) needle hub, PVC connection tube, and a silicone stopper that is used to connect to a collection tube and vacuum pump.
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