VitaVitro Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with VitaVitro Warming Kit.

VitaVitro Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using VitaVitro Vitrification Kit for ART procedures.

VitaVitro Straw Set is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.

Device Description

VitaVitro Vitrification and Warming Kits, and the VitaVitro Straw Set are used for vitrification, storage, and warming of blastocysts as part of human assisted reproduction technology (ART) procedures.

The VitaVitro Vitrification Kit includes three media components, Human Holding Medium (HHM), Human Vitrification Solution 1 (HV1) and Human Vitrification Solution 2 (HV2). All three media have the same base formulation, but HV1 and HV2 contain the cryoprotectants ethylene glycol and dimethyl sulfoxide in increasing concentrations. HV2 also includes sucrose as a non-permeating cryoprotectant. During the vitrification process, blastocysts are first equilibrated in HHM, and then exposed sequentially to HV1 and HV2. Using this methodology, the permeating cryoprotectants replace water in the blastocyst prior to vitrification and storage in liquid nitrogen. The VitaVitro Vitrification Kit includes single 1.0 ml vials of HHM, HV1, and HV2.

The VitaVitro Warming Kit includes three media used stepwise for warming and removing cryoprotectants from vitrified blastocysts. The VitaVitro Warming Kit includes Human Warming Solution 1 (HW1), Human Warming Solution 2 (HW2) and HHM. These media products are the same with the exception that HW1 and HW2 also include sucrose in decreasing concentrations to aid in the rehydration of the blastocysts. The VitaVitro Warming Kit includes two 1.5 ml vials of HW1, one 1.0 ml vial of HW2, and one 1.8 ml vial of HHM.

The VitaVitro Straw Set consists of two components, a straw that holds the blastocysts, and a container that is used to protect the straw. Both components are made from copolyester. The closed end of the container also includes a weight to aid in maintaining the orientation of the device in liquid nitrogen and prevent floating. During use, the container is pre-cooled by placing the closed end in liquid nitrogen with the open end extending above the level of the liquid nitrogen. Straw loading is done by placing the narrow tip of the straw in a 1 µl drop of vitrification media, which draws the media and blastocysts into the storage device. The straw component is then inserted into the pre-cooled container component to effect vitrification. The container component is then sealed to prevent contact between the samples and liquid nitrogen.

All of the products are provided sterile with a six-month shelf-life. The media in the vitrification and warming kits undergo aseptic filtration, while the storage devices are ethylene oxide sterilized.

AI/ML Overview

This document describes the premarket notification (510(k)) for the VitaVitro Vitrification Kit, VitaVitro Warming Kit, and VitaVitro Straw Set, comparing it to a predicate device (Cryotop® Vitrification Kit and Cryotop® Thawing Kit, K160864).

1. Table of Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria (Subject Device: VitaVitro)	Reported Device Performance (VitaVitro)
Vitrification & Warming Kit Media
pH	7.2 - 7.6	pH: 7.2-7.6 for all solutions (met)
Osmolality (HHM)	295-315	Met (specific value not given, but stated to meet acceptance specifications)
Osmolality (HV1)	N/A (not specified in comparison table)	N/A (not specified in comparison table)
Osmolality (HV2)	N/A (not specified in comparison table)	N/A (not specified in comparison table)
Osmolality (HW1, diluted 1:1)	600-850	Met (specific value not given, but stated to meet acceptance specifications)
Osmolality (HW2)	850-1000	Met (specific value not given, but stated to meet acceptance specifications)
Endotoxin	< 0.25 EU/mL	<0.25 EU/mL (met)
Mouse Embryo Assay (2-Cell MEA, blastocysts 72h)	≥ 80% development to blastocyst at 72h (in comparison to control)	≥80% development to blastocyst at 72h (met)
Sterility	Aseptic processing and sterility	Met ISO 13408-1:2008 and ISO 13408-2:2003, and USP<71> Sterility Testing (met)
Shelf-life	Maintain product specifications for pH, osmolality, MEA, endotoxin, and sterility over six months	Met (product specifications maintained over six-month shelf-life)
Straw Set (Cryopreservation Storage Device)
Cooling Rate	Not an acceptance criteria but a measured characteristic	5,127 °C/min
Warming Rate	Not an acceptance criteria but a measured characteristic	17,899 °C/min
Endotoxin	< 0.5 EU/device	<0.5 EU/device (met)
Mouse Embryo Assay (2-Cell MEA, blastocysts 72h)	≥ 80% development to blastocyst at 72h (in comparison to control)	≥80% development to blastocyst at 72h (met)
Sealed Device Durability	No burst/breakage after 30 second immersion in liquid nitrogen	No burst/breakage after 30 second immersion in liquid nitrogen (met)
Simulated Distribution Testing	Met ASTM D4169-16	Met (testing performed per ASTM D4169-16)
Package Integrity	Met ASTM F1929:2012 (dye penetration) and ASTM F88:2009 (seal strength)	Met (testing performed per specified ASTM standards)
Shelf-life	Maintain product specifications for endotoxin, MEA, cooling/warming rate, and sealed device durability over six months	Met (product specifications maintained over six-month shelf-life)

2. Sample Size and Data Provenance for Test Set

Sample Size for Test Set: The document does not explicitly state the sample size (number of embryos or tests) used for the Mouse Embryo Assay (MEA) or other performance tests. It refers to "Two-cell mouse embryos" without specifying the quantity.
Data Provenance: The document does not specify the country of origin of the data. The manufacturer is Shenzhen VitaVitro Bio-tech Co., Ltd. in China. The study appears to be retrospective, as it involves non-clinical performance testing of the device for submission.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document. The studies described are non-clinical, primarily laboratory-based performance tests (e.g., pH, osmolality, endotoxin, mouse embryo assay, physical durability), rather than clinical studies requiring expert interpretation of results.

4. Adjudication Method for Test Set

This information is not applicable as the studies are non-clinical performance tests, not clinical studies with human subject data requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data with and without AI assistance. The VitaVitro kits are reproductive media and storage devices, not diagnostic software.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. This device is a physical product (media and a straw set), not a software algorithm.

7. Type of Ground Truth Used

For the Vitrification Kit and Warming Kit media, the "ground truth" or reference standard for performance was established through:
- Defined Chemical/Physical Specifications: pH, osmolality, endotoxin levels.
- Biological Assay Performance: Mouse Embryo Assay (MEA) results (percent development to blastocyst) compared against an internal control group.
- Sterility Standards: Adherence to ISO and USP standards.
- Shelf-life stability: Retention of the above characteristics over time.
For the Straw Set, the "ground truth" or reference standard was established through:
- Physical Characteristics: Cooling/warming rates, sealed device durability (no burst/breakage).
- Biological Assay Performance: Mouse Embryo Assay (MEA) results from extracts compared against an internal control group.
- Sterility and Packaging Integrity Standards: Endotoxin levels, simulated distribution testing, and package integrity testing per ASTM standards.
- Shelf-life stability: Retention of the above characteristics over time.

8. Sample Size for Training Set

This information is not applicable as the document describes non-clinical performance testing for a physical medical device, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

This information is not applicable as there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.

August 29, 2018

Shenzhen Vitavitro Bio-tech Co., Ltd % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou middle road, Nanshan District Shenzhen. Guangdong 518000 CHINA

Re: K180073

Trade/Device Name: VitaVitro Vitrification Kit, VitaVitro Warming Kit, and VitaVitro Straw Set Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL, MQK Dated: July 26, 2018 Received: August 2, 2018

Dear Field Fu:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

Sharon M. Andrews -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) K180073

Device Name

VitaVitro Vitrification Kit,VitaVitro Warming Kit, and VitaVitro Straw Set

Indications for Use (Describe)

VitaVitro Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with VitaVitro Warming Kit.

VitaVitto Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using VitaVitro Vitrification Kit for ART procedures.

Vita Vitro Straw Set is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K180073

1. Contact Details

1.1 Applicant information
---------------------------	--

Applicant Name	Shenzhen VitaVitro Bio-tech Co., Ltd
Address	R601, Building B, Hai Ke Xing Tech Park, Baoshan RoadNo.16, Shenzhen, Guangdong, China
Phone No.	+86 755 85235226
Fax No.	+86 755 85235226
Contact person	Jenny Lin
Contact person'se-mail	jenny@vitavitro.com
Date Prepared	August 25, 2018

1.2 Submission Correspondent

Correspondent Name	Shenzhen Joyantech Consulting Co., Ltd
Address	Room 1122, International Mayors Communication Centre, No. 55 Shizhou middle road, Nanshan District, Shenzhen
Phone No.	+86-755-86069197
Contact person	Field Fu; Christy Young; Jessie You;
Contact e-mail	christy@cefda.com; jessie@cefda.com;field@cefda.com

2. Device information

Trade name	VitaVitro Vitrification Kit, VitaVitro Warming Kit, and VitaVitroStraw Set
Common name	Vitrification Cryopreservation Media and storage devices
Regulation Name	Reproductive media and supplements
Regulation Number	884.6180
Product Codes	MQL (Media, Reproductive) and MQK (Labware, AssistedReproduction)
Device Class	II

3. Legally Marketed Predicate Device

Trade Name	Cryotop® Vitrification Kit and Cryotop® Thawing Kit
510(k) Number	K160864
Manufacturer	KITAZATO BioPharma Co., Ltd.

The predicate device has not been subject to a design-related recall.

4. Device Description

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5. Indications for Use

VitaVitro Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with VitaVitro Warming Kit.

VitaVitro Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using VitaVitro Vitrification Kit for ART procedures.

VitaVitro Straw Set is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.

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6. Substantial Equivalence Comparison

The following table compares the Vitrification Kit, VitaVitro Warming Kit, and VitaVitro Straw Set to the predicate device:

	Subject Device	Predicate Device	Comparison
	K180073 – VitaVitro	K160864 – Kitazato
	Vitrification Kit,	Cryotop
	VitaVitro Warming Kit,	Vitrification Kit and
	and VitaVitro Straw Set	Cryotop Thawing
		Kit
Indicationsfor Use	VitaVitro Vitrification Kitis intended for thevitrification of humanblastocysts for assistedreproductiontechnologies (ART). Thiskit is designed for usewith VitaVitro WarmingKit.VitaVitro Warming Kit isintended for the warmingof human blastocyststhat have undergonevitrification usingVitaVitro Vitrification Kitfor ART procedures.VitaVitro Straw Set is acryopreservation storagedevice that is intendedfor use in vitrificationprocedures to containand maintain humanblastocyst stageembryos.	The Cryotop®Vitrification Kit –Vitrification isindicatedfor use in thepreparation,vitrificationand storage ofpronuclear (PN)zygotesthrough day 3cleavagestage embryos andblastocyst stageembryos.The Cryotop®ThawingKit – Thawing isindicated for use inthepreparation andthawing of vitrifiedpronuclear (PN)zygotesthrough day 3cleavagestage embryos andblastocyst stageembryos.	Different: The subject andpredicate devices indicationsare not identical. Allcomponents of the subjectdevice are only for vitrification,storage and warming ofblastocyst stage embryos,while the predicate can beused with pronuclear toblastocyst stage embryos. Thesubject device also includes astandalone indication for theVitaVitro Straw Set, which issold separately from the mediakits, which is different than thepredicate where storagedevices are included within thevitrification kit. Thesedifferences do not impact theoverall intended uses of thesedevices, which are the same(vitrification, storage, andthawing of embryos).
Components	Vitrification MediaThawing Media	Vitrification MediaThawing Media	Different: Predicate deviceincludes plates as a
	Cryopreservationstorage device	CryotopRepro Plate35 mm dish	convenience to users thatwould typically be obtainedseparately. The storage devicefor the subject device isprovided separately ascompared to the predicate.These differences do not raisedifferent questions of safetyand effectiveness (S&E).
	Media Components
VitrificationFormulation	Medium 199, EthyleneGlycol (7.5 – 16%),DMSO (7.5 – 16%),Sucrose (0.68 M), HSA	Medium 199,Ethylene Glycol,DMSO, Trehalose,HydroxypropylCellulose (specificconcentrations inpredicate media notknown)	Different: The predicate andsubject device formulasinclude many similarcomponents. However, thepredicate uses trehaloseinstead of sucrose andhydroxypropyl celluloseinstead of serum. However, theuse of a different sugar/serumreplacer do not raise differentquestions of S&E. Inaddition, the concentrations ofspecific components in thepredicate media are notknown; however, differenceswould not raise differentquestions of S&E.
ThawingFormulation	Medium 199, Sucrose(0.5 – 1 M), HSA	Medium 199,Trehalose,HydroxypropylCellulose	Different: The predicate andsubject device formulasinclude many similarcomponents. However, thepredicate utilizes trehaloseinstead of sucrose andhydroxypropyl celluloseinstead of serum (see rationaleabove). In addition, theconcentrations of specificcomponents in the predicatemedia are not known;however, differences would notraise different questions ofS&E.
Endotoxin	< 0.25 EU/mL	Same	Same
MEA	2-Cell MEA: > 80%	1-Cell MEA: > 80%	Different: Testing using a 1-cell
	blastocysts 72h	blastocysts 96 h	or 2-cell method does not raisedifferent S&E questions.
pH	7.2 - 7.6	Same	Same
Osmolarity	HHM: 295-315HV1: N/AHV2: N/AHW1: 600-850 (diluted1:1)HW2: 850-1000	ES: 2,300 - 2,800VS: 4,900 - 6,000TS: 1,600 - 2,000DS: 830 - 1020WS: 240 - 300	Different: The osmolalityspecifications are differentbetween the subject andpredicate devices.Differences in osmolality donot raise different questions ofS&E.
Sterilizationmethod	Aseptic filtration	Same	Same
	Storage Devices
Materialcomposition	Copolyester	Cryotop US,Cryotop SC, orCryotop CL providedin kitsCryotop devicescomposed of PET,ABS, andPolypropylene	Different: The materials in thesubject and predicate deviceare different. Thesedifferences do not raisedifferent questions of S&E.
Sealingmechanism	Heat sealed	Cryotop US - Theshaft handlecontains a taper andstop. When insertedinto the straw, ahermetically sealedclosed system isformed.Cryotop SC and CL-the sample holdingstick is heat sealedwithin an outerstraw.	Different: The subject devicehas a comparabledesign/closure system to thatused in the Cryotop SC and CLdevices, but is different thanthe Cryotop US. Thisdifference does not raisedifferent S&E questions.
Cooling Rate	5,127 °C/min	3000°C/min for allversions	Different: The subject devicehas a higher cooling rate thanthe predicate. A highercooling rate does not raisedifferent questions of S&E.
Warming	17,899 °C/min	44000°C/min for all	Different: The subject device
rate		versions	has a lower warming rate thanthe predicate. A lowerwarming rate does not raisedifferent questions of S&E.Note: the warming rate for thesubject device is in line withother cleared devices of thistype.
Open/closedsystem	Closed	Closed	Same
Sterilizationmethod	EO	Radiation	Different: The subject andpredicate device use differentsterilization methods that areboth common for medicaldevices. This difference doesnot raise different questions ofS&E.
MEA	2-Cell MEA: ≥ 80%blastocysts 72 h	1-Cell MEA: ≥ 80%blastocysts 96 h	Different: Testing using a 1-cellor 2-cell method does not raisedifferent S&E questions.
Endotoxin	< 0.5 EU/device	Same	Same

Table 1 – Comparison of Characteristics

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As shown in the table above, the intended uses of the subject and predicate devices are the same. In addition, the table shows many similarities between the subject and predicate devices; however, there are also differences (e.g., formulation, specifications, etc.). The differences noted between the subject and predicate device do not raise different questions of safety and effectiveness for the reasons stated in the table.

7. Non-clinical Performance Testing

VitaVitro Vitrification Kit and VitaVitro Warming Kit

pH: 7.2-7.6 for all solutions .
Osmolality: see Table 1 for acceptance specifications .
Endotoxin (USP<85>): <0.25 EU/mL .
Mouse Embryo Assay (MEA): .
- Two-cell mouse embryos were exposed sequentially to subject devices in the Vitrification and Warming Kits followed by culture at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage at 72 hours were assessed in comparison with the control group. The acceptance specification was ≥80% development to blastocyst at 72h.
Aseptic processing and validation testing that met the requirements of ISO 13408-1:2008 . and ISO 13408-2:2003.
. Sterility Testing (USP<71>)
Shelf-life testing to ensure that product specifications for pH, osmolality, MEA, endotoxin, .

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and sterility, were met over the six-month shelf-life period.

VitaVitro Straw Set

. Cooling Rate Testing: Cooling rate of 5,127℃/min
Warming Rate Testing: Warming rate of 17,899°C/min .
. Endotoxin (USP<85>): <0.5 EU/device
. Mouse Embryo Assay (MEA):

Two-cell mouse embryos were exposed to test article extracts (media incubated with the test article for 30 min at 37°C) followed by culture at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage at 72 hours were assessed in comparison with the control group. The acceptance specification was ≥80% development to blastocyst at 72h.

Sealed Device Durability: No burst/breakage after 30 second immersion in liquid nitrogen .
Simulated distribution testing per ASTM D4169-16 .
Package integrity testing per ASTM F1929:2012 (dye penetration) and ASTM F88:2009 ● (seal strength) to support sterile barrier maintenance over the shelf-life of the device.
. Shelf-life testing to ensure that product specifications for endotoxin, MEA, cooling/warming rate, and sealed device durability were met over the six-month shelf-life period.

8. Conclusion

The results of the performance testing described above demonstrates that the VitaVitro Vitrification Kit, VitaVitro Warming Kit, and VitaVitro Straw Set are as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 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.