(184 days)
No
The summary describes a set of media and devices for vitrification and thawing of reproductive cells and embryos. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are based on bench testing and literature review of similar chemical formulations and methods.
Yes.
The device is used in Assisted Reproductive Technology (ART) procedures for the preparation, vitrification, storage, and thawing of oocytes and embryos, which is a medical intervention intended to treat infertility.
No
The device is a vitrification and thawing kit used for the preservation of oocytes and embryos, which is a therapeutic rather than a diagnostic purpose.
No
The device is described as a set of six media components and associated physical items (vials, plates, Cryotop devices) used for the physical process of vitrification and thawing of biological samples. It does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the preparation, vitrification, storage, and thawing of oocytes and embryos for Assisted Reproductive Technology (ART) procedures. This is a process performed outside the body to preserve biological material.
- Device Description: The device consists of media and storage devices used for cryopreservation. These are tools and reagents used in a laboratory setting to handle and preserve biological samples.
- Lack of Diagnostic Purpose: An IVD is a device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the safety and compatibility of transfused blood. This device does not perform any diagnostic testing or provide information about a patient's health status. It is a tool used in a therapeutic procedure (ART).
While the device is used with human biological material (oocytes and embryos), its purpose is not to diagnose or provide information about a patient's condition. It is a critical component of the ART process, which is a medical treatment.
N/A
Intended Use / Indications for Use
The Vitrification Kit is indicated for use in the preparation, vitrification and storage of oocytes (MII), 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.
Product codes (comma separated list FDA assigned to the subject device)
MOL, MOK
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. The specifications for the Vitrification Kit and Thawing Kit are listed in Table 1 below.
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)
The subject device is identical to the Kitazato Cryotop Vitrification and Thawing Kit cleared under K160864. Design verification tests were performed on the identical device cleared under K160864. Testing included sterilization validation, packaging validation, and performance (bench) testing. The device passed all the testing. Therefore, the information provided in K160864 was leveraged in this submission to support substantial equivalence of the Vitrification Kit and Thawing Kit.
The clinical information presented provides published papers that specifically identify vitrification/thawing media with HPC that are similar to or identical to the predicate device and the use of the Cryotop as the vitrification method for the cryopreservation of oocytes and blastocyst from human and mouse. A summary of the results are shown below:
- Literature 1: results of the study show comparable oocyte survival rate, implantation rate, clinical pregnancy rate, and live birth rate between a surrogate device (with similar formulation and cryoprotectants to the subject device) and vitrification media containing serum substitute supplement
- Literature 2: results of the study show that human blastocyst survival rate following vitrification was comparable between a surrogate device (with similar formulation to the predicate device) and vitrification media containing serum substitute supplement
- Literature 3: results of the study show comparable oocyte survival rate to other methods of vitrification and a fertilization rate and quality blastocyst rate as comparable to fresh oocytes.
Birth rates following use of vitrified oocytes as compared to the vitrification methods used in the predicate device were shown to be comparable. Each of the studies reported survival rates of oocytes and embryos that are consistent with normal ART procedures using similar IVF treatments and cryopreservation techniques.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
oocyte survival rate, implantation rate, clinical pregnancy rate, live birth rate, human blastocyst survival rate, fertilization rate, quality blastocyst rate, survival rates of oocytes and embryos.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K160864, K112695, K140072, K153027
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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December 14, 2017
Kitazato Corporation % Diane Sudduth Senior Consultant, RA Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746
Re: K171748
Trade/Device Name: Vitrification Kit and Thawing Kit Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL, MOK Dated: November 9, 2017 Received: November 13, 2017
Dear Diane Sudduth:
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
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 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
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Indications for Use
510(k) Number (if known) K171748
Device Name Vitrification Kit and Thawing Kit
Indications for Use (Describe)
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.
| 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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510(k) Summary
Vitrification Kit and Thawing Kit
K171748
1. Submission Sponsor
Kitazato Corporation
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: (561) 305-5075
Contact: Diane Sudduth, Senior Consultant, RA
Email: project.management@emergogroup.com
3. Date Prepared
14 December 2017
4. Device Identification
| Trade/Proprietary Name: | Vitrification Kit and Thawing Kit |
|---|---|
| Common/Usual Name: | Vitrification Cryopreservation Media |
| Classification Name: | Reproductive Media and Supplements |
| Classification Number: | 884.6180 |
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| Product Code: | MQL - Media, Reproductive |
|---|---|
| MQK – Labware, Assisted Reproduction | |
| Device Class: | Class II |
| Classification Panel: | Obstetrics/Gynecology |
5. Legally Marketed Predicate Devices
K160006, 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.
Device Description 6.
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. The specifications for the Vitrification Kit and Thawing Kit are listed in Table 1 below.
7. Indication for Use Statement
The Vitrification Kit is indicated for use in the preparation, vitrification and storage of oocytes (MII), 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.
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8. Substantial Equivalence Discussion
The following table compares the Vitrification Kit to the predicate devices 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. As noted in the table, there are differences in indications for use and technological characteristics between the subject and predicate devices; however, the differences indications for use do not represent a new intended use, and differences in the technological characteristics do not raise any different questions of safety or effectiveness as compared to the predicate device.
| Manufacturer | Kitazato Corporation | Irvine Scientific Sales Co., Inc. |
|---|---|---|
| Trade Name | Vitrification Kit and Thawing Kit | Vitrification Freeze Kit and |
| Vitrification Thaw Kit (Vit-Kit®-Thaw) | ||
| 510(k) Number | Not assigned | K160006 |
| Product Code | MQL, MQK | MQL |
| Regulation | ||
| Number | 884.6180 | 884.6180 |
| Regulation Name | Reproductive Media and Supplements | Reproductive Media and Supplements |
| Indications for Use | The Vitrification Kit is indicated for use | |
| in the preparation, vitrification and | ||
| storage of oocytes (MII), | ||
| 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. | Vit Kit® - Freeze (Vitrification Freeze | |
| Kit) is intended for use in the | ||
| vitrification of oocytes (MII), | ||
| pronuclear (PN) zygotes through day 3 | ||
| cleavage stage embryos and blastocyst | ||
| stage embryos. | ||
| Vit Kit® - Thaw (Vitrification Thaw Kit) | ||
| is intended for use in the thawing of | ||
| oocytes (MII), pronuclear (PN) zygotes | ||
| through day 3 cleavage stage embryos | ||
| and blastocyst stage embryos. | ||
| Components of Kit | Vitrification Media | |
| Thawing Media | Vitrification Freeze Kit | |
| Vitrification Thaw Kit | ||
| Embryo Stage | Oocyte, PN through Blastocyst | Oocyte, PN through Blastocyst |
| Manufacturer | Kitazato Corporation | Irvine Scientific Sales Co., Inc. |
| Trade Name | Vitrification Kit and Thawing Kit | Vitrification Freeze Kit and |
| Vitrification Thaw Kit (Vit-Kit®-Thaw) | ||
| Principal of | ||
| Operation | Provides users with the ability to | |
| cryopreserve supernumerary oocytes | ||
| or embryos created during the in vitro | ||
| fertilization procedure and then to re- | ||
| warm them for use at a future point in | ||
| time | Provides users with the ability to | |
| cryopreserve supernumerary oocytes | ||
| or embryos created during the in vitro | ||
| fertilization procedure and then to re- | ||
| warm them for use at a future point in | ||
| time | ||
| Vitrification | ||
| Formulation | In a Medium 199 HEPES buffered | |
| Medium | In a Medium 199 HEPES buffered | |
| Medium | ||
| Ethylene glycol | Ethylene glycol | |
| DMSO | DMSO | |
| Trehalose | Sucrose | |
| Hydroxypropyl Cellulose (HPC) | Dextran Serum Supplement (DSS) | |
| Gentamicin | Gentamicin | |
| Vitrification Steps | 2 Step | 2 Step |
| Thawing | ||
| Formulation | In a Medium 199 HEPES buffered | |
| Medium | In a Medium 199 HEPES buffered | |
| Medium | ||
| Hydroxypropyl Cellulose (HPC) (v/v) | Dextran Serum Supplement (DSS) (v/v) | |
| Gentamicin | Gentamicin | |
| Trehalose | Sucrose | |
| Thawing Steps | 3 Step | 3 Step |
| 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. | ||
| Cryopreservation | ||
| Storage Device | ||
| Used With | Kitazato Corporation | |
| Cryotop®CL-K112695 | ||
| Cryotop®SC - K140072 | ||
| Cryotop®US-K153027 | Irvine Scientific | |
| HSV Straw - K092398 | ||
| CryoTip - K041562 | ||
| Sterile | Solutions sterilized using aseptic | |
| processing techniques through | ||
| filtration | ||
| Vial containers are sterilized via | ||
| radiation | Solutions sterilized using aseptic | |
| processing techniques through | ||
| filtration | ||
| Vial containers are sterilized via | ||
| radiation | ||
| Manufacturer | Kitazato Corporation | Irvine Scientific Sales Co., Inc. |
| Trade Name | Vitrification Kit and Thawing Kit | Vitrification Freeze Kit and |
| Vitrification Thaw Kit (Vit-Kit®-Thaw) | ||
| Endotoxin | Endotoxin by LAL methodology 80% development to blastocyst at 96 | |
| hours | >80% one-cell 96 hours | |
| Sterility Testing | Passes | Passes |
| pH Test | 7.20 - 7.60 | Not available |
| Biocompatibility | Passes | Passes |
| Storage | 2 – 8°C | 2 – 8°C |
| Shelf Life | 1 year | 1 year |
Table 5A - Comparison of Characteristics
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9. Non-Clinical Performance Data
The subject device is identical to the Kitazato Cryotop Vitrification and Thawing Kit cleared under K160864. Design verification tests were performed on the identical device cleared under K160864. Testing included sterilization validation, packaging validation, and performance (bench) testing. The device passed all the testing. Therefore, the information provided in K160864 was leveraged in this submission to support substantial equivalence of the Vitrification Kit and Thawing Kit.
10. Clinical Performance Data
The clinical information presented provides published papers that specifically identify vitrification/thawing media with HPC that are similar to or identical to the predicate device and the use of the Cryotop as the vitrification method for the cryopreservation of oocytes and blastocyst from human and mouse. A summary of the results are shown below:
- Literature 1: results of the study show comparable oocyte survival rate, implantation rate, clinical pregnancy rate, and live birth rate between a surrogate device (with similar formulation and cryoprotectants to the subject device) and vitrification media containing serum substitute supplement1
1 A combination of hydroxypropyl cellulose as supplementation for vitrification of human oocytes: a retrospective cohort study (Coello et al, Journal of Assisted Reproduction Genetics, 2016 March; 33(3): 413-421)
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- Literature 2: results of the study show that human blastocyst survival rate following vitrification was comparable between a surrogate device (with similar formulation to the predicate device) and vitrification media containing serum substitute supplement²
- . Literature 3: results of the study show comparable oocyte survival rate to other methods of vitrification and a fertilization rate and quality blastocyst rate as comparable to fresh oocytes. 3
Birth rates following use of vitrified oocytes as compared to the vitrification methods used in the predicate device were shown to be comparable. Each of the studies reported survival rates of oocytes and embryos that are consistent with normal ART procedures using similar IVF treatments and cryopreservation techniques.
11. Statement of Substantial Equivalence
The results of the performance testing described above demonstrate that the Vitrification Kit and Thawing Kit are as safe and effective as the predicate device and supports a determination of substantial equivalence.
? Hydroxypropyl cellulose as an option for sypprotectant solutions for embryo vitrification in human assisted reproductive technologies (Mori et al, Reproductive BioMedicine Online, 2015 June;30(6):613-21)
3 Efficiency of a Closed Vitrification System with Oocytes and Blastocysts (Inoue et al, Low Temp Med, 2014; 40(3): 53-59)