(192 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of cryopreservation media and devices, with no mention of AI or ML.
No.
The device is used for the preparation, storage, and thawing of embryos in Assisted Reproductive Technologies (ART) procedures, not for treating a disease or condition in a patient.
No
This device is used for the preparation and storage/thawing of embryos for Assisted Reproductive Technologies (ART) procedures, which falls under cryopreservation, not diagnosis. The performance data focuses on successful cryopreservation and subsequent pregnancy/birth rates, not on identifying diseases or conditions.
No
The device is a kit containing media solutions and physical devices (Cryotop devices, Repro Plates, dishes) for the vitrification and thawing of embryos. It is not solely software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used in the "preparation, and storage" and "preparation and thawing" of embryos for "Assisted Reproductive Technologies (ART) procedures." While ART procedures themselves are clinical, the preparation and handling of the embryos outside the body using these media and devices falls under the scope of in vitro procedures.
- Device Description: The kits contain "media to vitrify and warm" embryos. These media are solutions that interact with the biological material (embryos) in vitro to preserve and recover them.
- Predicate Device: The predicate device listed (K093273, Vit Kit® - Vitrification Freeze Kit/ Vitrification Thaw Kit) is also a vitrification and thawing kit for embryos, and these types of devices are typically regulated as IVDs.
While the device doesn't directly diagnose a condition, it is used in vitro to prepare and handle biological specimens (embryos) for a medical procedure (ART). This aligns with the definition of an IVD, which includes reagents, instruments, and systems intended for use in the in vitro examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, the information provided is related to the viability and handling of the embryos for successful ART.
The lack of image processing, AI, anatomical site, patient age range, and specific performance metrics like sensitivity and specificity are not necessarily indicators that it's not an IVD. Many IVDs, particularly those involving media and reagents for specimen handling, do not involve these elements.
N/A
Intended Use / Indications for Use
The Cryotop® Vitrification Kit is indicated for use in the preparation, and storage of promuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
The Cryotop® Thawing Kit is indicated for use in the preparation and thawing of vitrified pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Product codes (comma separated list FDA assigned to the subject device)
MOL, MOK
Device Description
The Cryotop® Vitrification and Thawing Kits are composed of a set of five media to vitrify and warm pronuclear (PN) through blastocyst stage embryos for Assisted Reproductive Technologies (ART) procedures.
The Cryotop® Vitrification Kit includes two media components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol and dimethyl sulfoxide. During the vitrification process, embryos are first exposed to ES and then in VS. Using this methodology, the permeating cryoprotectants can replace water in the PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen. The Cryotop® Vitrification Kit comes pre-packaged with one 1.5 ml vial of ES, two 1.5 ml vials of VS, 4 Cryotop devices (Cryotop SC, or Cryotop US), and two Repro Plates.
The Cryotop® Thawing Kit is composed of three media used stepwise for thawing and removing cryoprotectants from vitrified PN through blastocyst stage embryos. The Cryotop® Thawing Kit is composed of TS (Thawing Solution), DS (Dilution Solution) and WS (Wash Solution). The Cryotop 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 of the media in the Cryotop® Vitrification Kit and Cryotop® Thawing Kit contain Gentamicin. The media in these kits undergo aseptic filtration, while storage devices are sterilized by radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
The Cryotop® Vitrification Kit, Cryotop® Thawing Kit, Repro Plate, and 35 mm dish passed all applicable testing in accordance with internal requirements and applicable standards:
- Cleanliness and appearance: Free of turbidity and sedimentation
- pH Testing: Average pH reading is from 7.2 – 7.6 passing
- Endotoxin Testing: Endotoxin values conform to the value
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7, 2016
KITAZATO BioPharma Co., Ltd. % Richard Vincins, CBA, CQA, RAC (US,EU) Vice President, QA/RA Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701
Re: K160864
Trade/Device Name: Cryotop® Vitrification Kit and Cryotop® Thawing Kit Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL. MOK Dated: September 2, 2016 Received: September 7, 2016
Dear Richard Vincins:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
Page 2 - Richard Vincins, CBA, CQA, RAC (US,EU)
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160864
Device Name
Cryotop® Vitrification Kit and Cryotop® Thawing Kit
Indications for Use (Describe)
The Cryotop® Vitrification Kit is indicated for use in the preparation, and storage of promuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
The Cryotop® Thawing Kit is indicated for use in the preparation and thawing of vitrified pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
510(k) Summary
Cryotop Vitrification and Thawing Kit
K160864
1. Submission Sponsor
KITAZATO BioPharma Co., Ltd.
81 Nakajima, Fuji-city
Shizuoka 416-0907
JAPAN
Phone number: +(81) 546-66-2202
Contact: Futoshi Inoue
Title: President
2. Submission Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746
Office Phone: (512) 327.9997
Contact: Richard A. Vincins, Vice President, QA/RA
Email: project.management@emergogroup.com
3. Date Prepared
6 October 2016
4
4. Device Identification
| Trade/Proprietary Name: | Cryotop® Vitrification Kit
Cryotop® Thawing Kit |
|-------------------------|-----------------------------------------------------------------|
| Common/Usual Name: | Vitrification Cryopreservation Media |
| Classification Name: | Reproductive Media and Supplements |
| Regulation Number: | 884.6180 |
| Product Code: | MQL, Media, Reproductive
MQK, Labware, Assisted Reproduction |
| Device Class: | Class II |
| Classification Panel: | Obstetrics/Gynecology |
5. Legally Marketed Predicate Device(s)
K093273, Vit Kit® - Vitrification Freeze Kit/ Vitrification Thaw Kit, Irvine Scientific Sales Co., Inc.
The predicate device has not been subject to a design-related recall.
6. Device Description
The Cryotop® Vitrification and Thawing Kits are composed of a set of five media to vitrify and warm pronuclear (PN) through blastocyst stage embryos for Assisted Reproductive Technologies (ART) procedures.
The Cryotop® Vitrification Kit includes two media components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol and dimethyl sulfoxide. During the vitrification process, embryos are first exposed to ES and then in VS. Using this methodology, the permeating cryoprotectants can replace water in the PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen. The Cryotop® Vitrification Kit comes pre-packaged with one 1.5 ml vial of ES, two 1.5 ml vials of VS, 4 Cryotop devices (Cryotop SC, or Cryotop US), and two Repro Plates.
The Cryotop® Thawing Kit is composed of three media used stepwise for thawing and removing cryoprotectants from vitrified PN through blastocyst stage embryos. The Cryotop® Thawing Kit is composed of TS (Thawing Solution), DS (Dilution Solution) and WS (Wash Solution). The Cryotop 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.
5
All of the media in the Cryotop® Vitrification Kit and Cryotop® Thawing Kit contain Gentamicin. The media in these kits undergo aseptic filtration, while storage devices are sterilized by radiation. The specifications for the Cryotop Vitrification and Thawing Kits are listed in Table 1 below.
7. Indication for Use Statement
The Cryotop® Vitrification Kit is indicated for use in the preparation, vitrification and storage of pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
The Cryotop® Thawing Kit is indicated for use in the preparation and thawing of vitrified pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
8. Substantial Equivalence Discussion
The following table compares the Cryotop® Vitrification and Thawing Kits to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. Based on the information below, the proposed and predicate device have comparable intended uses, and differences in technology noted do not raise different questions of safety or effectiveness as compared to the predicate.
| Manufacturer | Kitazato BioPharma Co,
Ltd. | Irvine Scientific Sales
Co., Inc. | Significant
Differences |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Trade Name | Cryotop® Vitrification
and Thawing Kits | Vit Kit® - Vitrification
Freeze Kit and
Vitrification Thaw Kit | |
| 510(k) Number | K160864 | K093273 | N/A |
| Product Code | MQL, MQK | MQL | Similar |
| Regulation Number | 884.6180 | 884.6180 | Same |
| Regulation Name | Reproductive Media and
Supplements | Reproductive Media and
Supplements | Same |
| Indications for Use | The Cryotop®
Vitrification Kit —
Vitrification is indicated
for use in the
preparation, vitrification
and storage of
pronuclear (PN) zygotes
through day 3 cleavage
stage embryos and | Vit Kit® - Freeze,
Vitrification Freeze Kit for
Embryos (PN through
Blastocyst Stage) is
intended for use in the
vitrification of pronuclear
(PN) zygotes through day
3 cleavage stage embryos
and blastocyst stage | Similar indications –
same intended use |
6
| Manufacturer | Kitazato BioPharma Co,
Ltd. | Irvine Scientific Sales
Co., Inc. | Significant
Differences |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Cryotop® Vitrification
and Thawing Kits | Vit Kit® - Vitrification
Freeze Kit and
Vitrification Thaw Kit | |
| | blastocyst stage
embryos.
The Cryotop® Thawing
Kit – Thawing is
indicated for use in the
preparation and
thawing of vitrified
pronuclear (PN) zygotes
through day 3 cleavage
stage embryos and
blastocyst stage
embryos. | embryos.
Vit Kit® - Thaw,
Vitrification Thaw Kit for
Embryos (PN through
Blastocyst Stage) is
intended for use in the
thawing of pronuclear
(PN) zygotes through day
3 cleavage stage embryos
and blastocyst stage
embryos. | |
| Components of Kit | Vitrification Media
Thawing Media
Cryotop
35 mm dish
Repro Plate | Freeze Kit
Vitrification Thaw Kit | Different. During a
standard procedure,
users would obtain
these components
separately to
complete the
procedure. These
accessories have been
included in this kit as a
convenience to
complete the
procedure. Inclusion
of these components
does not represent a
different question of
safety and
effectiveness. |
| Embryo Stage | PN through Blastocyst | PN through Blastocyst | Same |
| Principal of
Operation | Provides users with the
ability to cryopreserve
supernumerary embryos
created during the in
vitro fertilization | Provides users with the
ability to cryopreserve
supernumerary embryos
created during the in
vitro fertilization | Same |
7
| Manufacturer | Kitazato BioPharma Co,
Ltd. | Irvine Scientific Sales
Co., Inc. | Significant
Differences |
|----------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Cryotop® Vitrification
and Thawing Kits | Vit Kit® - Vitrification
Freeze Kit and
Vitrification Thaw Kit | |
| | procedure and then to
re-warm them for use at
a future point in time | procedure and then to
re-warm them for use at
a future point in time | |
| Vitrification
Formulation | Medium 199 (HEPES
buffered Medium) | Medium 199 (HEPES
buffered Medium) | Similar; the subject
device utilizes
trehalose instead of
sucrose and HPC
instead of DSS in the
formulation.
However, differences
in these components
do not raise different
questions of safety
and effectiveness
(e.g., material safety,
embryotoxicity, post-
thaw survival, etc.). |
| | Ethylene glycol | Ethylene glycol | |
| | DMSO | DMSO | |
| | Trehalose | Sucrose | |
| | Hydroxypropyl Cellulose
(HPC) | Dextran Serum
Supplement (DSS) | |
| | Gentamicin | Gentamicin | |
| Vitrification Steps | 2 Step | 2 Step | Same |
| Vitrification Media
Component | Equilibration Solution
(ES) 1.5mL x 1 Vial | Equilibration Solution
(ES) 1.0mL x 1 Vial | Similar |
| | Vitrification Solution
(VS) 1.5mL x 2 Vials | Vitrification Solution (VS)
1.0mL x 2 Vials | |
| Thawing
Formulation | Medium 199 (HEPES
buffered Medium) | Medium 199 (HEPES
buffered Medium) | Similar; the subject
device utilizes
trehalose instead of
sucrose and HPC
instead of DSS in the
formulation.
However, differences
in these components
do not raise different
questions of safety
and effectiveness |
| | Hydroxypropyl Cellulose
(HPC) (v/v) | Dextran Serum
Supplement (DSS) (v/v) | |
| | Gentamicin | Gentamicin | |
| | Trehalose | Sucrose | |
8
| Manufacturer | Kitazato BioPharma Co,
Ltd. | Irvine Scientific Sales
Co., Inc. | Significant
Differences |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Cryotop® Vitrification
and Thawing Kits | Vit Kit® - Vitrification
Freeze Kit and
Vitrification Thaw Kit | |
| | | | (e.g., material safety,
embryotoxicity, post-
thaw survival, etc.). |
| Thawing Steps | 3 Step | 3 Step | Same |
| Thawing Media
Component | Thawing Solution (TS)
4.0mL x 2 Vials | Thawing Solution (TS)
1.0mL x 4 Vials | Similar |
| | Diluent Solution (DS)
4.0mL x 1 Vial | Diluent Solution (DS)
1.0mL x 1 Vial | |
| | Washing Solution (WS)
4.0mL x 1 Vial | Washing Solution (WS)
2.0mL x 1 Vial | |
| Carton Packaging | Each solution is
contained in plastic
vials. Vials are packed in
a card board outer box
with partition. | Each solution is
contained in plastic vials.
Vials are packed in a card
board outer box with
partition. | Same |
| Cryopreservation
Storage Device Used
With | Kitazato BioPharma,
Cryotop®CL - K112695
Cryotop®SC - K140072
Cryotop®US - K153027 | None are provided with
the kit | Different. During a
standard procedure,
users would obtain
cleared storage
devices separately to
complete the
procedure. Storage
devices have been
included in this kit as a
convenience to
complete the
procedure. Inclusion
of storage devices
does not represent a
different question of
safety and
effectiveness. |
| Sterile | Solutions sterilized using
aseptic processing | Solutions sterilized using
aseptic processing | Same |
9
| Manufacturer | Kitazato BioPharma Co,
Ltd. | Irvine Scientific Sales
Co., Inc. | Significant
Differences |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Cryotop® Vitrification
and Thawing Kits | Vit Kit® - Vitrification
Freeze Kit and
Vitrification Thaw Kit | |
| | techniques through
filtration.
Vials, vitrification
storage device, 35 mm
dish, and Repro Plate
are sterilized via
radiation. | techniques through
filtration.
Vial containers are
sterilized via radiation. | |
| Endotoxin | Passes | Passes | Same |
| Mouse Embryo
Assay | >80% blastocyst at 96
hours (one-cell MEA) | >80% blastocyst at 96
hours (one-cell MEA) | Same |
| Sterility Testing | Passes | Passes | Same |
| pH Test | 7.20 - 7.60 | Not available | n/a |
| Osmolarity | ES: 2,300 - 2,800
VS: 4,900 - 6,000
TS: 1,600 - 2,000
DS: 830 - 1020
WS: 240 - 300 | Not available | n/a |
| Storage | 2 – 8°C | 2 – 8°C | Same |
| Shelf Life | 6 months | 1 year | Different; the subject
device has a shorter
shelf life period. The
shorter shelf-life does
not raise different
questions of safety or
effectiveness. |
9. Non-Clinical Performance Data
The Cryotop® Vitrification Kit, Cryotop® Thawing Kit, Repro Plate, and 35 mm dish passed all applicable testing in accordance with internal requirements and applicable standards that are shown below to support substantial equivalence of the subject device:
10
- Cleanliness and appearance: Free of turbidity and sedimentation ●
- pH Testing: Average pH reading is from 7.2 – 7.6 passing
- . Endotoxin Testing: Endotoxin values conform to the value ´ Ku, P. Lee, R.K. Lin, S. Lin, M. Hwu, Y. "Comparison of the clinical outcomes between fresh blastocyst and vitrified-thawed blastocyst transfer." J Assist Reprod Genet 2012. 29:1353-56
3 Inoue, F., Yelian, F.. "Efficiency of a Closed Vitrification System with Oocytes and Blastocysts." Low Temperature Medicine 2014. 40/3:53-59