Vit Kit - Freeze NX (Vitrification Freeze Kit) is intended for use in the vitrification of oocytes (MI) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Vit Kit - Warm NX (Vitrification Warm Kit) is intended for use in the thawing of vitrified occytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Device Description

The five media products that comprise the two kits, Vit Kit - Freeze NX and Vit Kit -Warm NX, consist of a basal media of Continuous Single Culture Medium (CSCM) which utilizes MOPS, HEPES and sodium bicarbonate buffers, 20% (v/v) DSS, 10μg/mL gentamicin and varying levels of cryoprotectants, including dimethyl sulfoxide (DMSO), trehalose, and ethylene glycol (EG).

The two freeze media in the Vit Kit – Freeze NX are intended to be used sequentially for the preparation and cryopreservation of oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The three media in the Vit Kit - Warm NX are intended for sequential use in the thawing and recovery of cryopreserved oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

AI/ML Overview

This document describes a 510(k) premarket notification for Vit Kit - Freeze NX and Vit Kit - Warm NX, which are reproductive media for vitrification (freezing) and thawing of oocytes and embryos.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the non-clinical performance data and the comparison to the predicate device. The document states that "The subject device passed the predefined acceptance criteria for these tests," confirming that the reported device performance met these criteria.

Characteristic	Acceptance Criteria (from Predicate/Similar as per Table 1)	Reported Device Performance (Implicitly Meets Criteria)
Endotoxin	≤ 0.6 EU/mL	Met (Passed predefined acceptance criteria)
MEA (Mouse Embryo Assay)	≥ 80% expanded blastocyst after 96 hours in culture	Met (Passed predefined acceptance criteria)
pH	ES: 7.05 - 7.44 VS: 7.05 - 7.44 TS: 7.05 - 7.45 DS: 7.05-7.45 WS: 7.05 - 7.45	Met (Passed predefined acceptance criteria)
Osmolality (mOsm/KgH2O)	ES: 1,150 - 1,1550 VS: 1,220-1,620 TS: 1,550-1,900 DS: 830-930 WS: 265-300	Met (Passed predefined acceptance criteria)
Appearance	Not explicitly defined, but assumed to be visually acceptable/clear	Met (Passed predefined acceptance criteria)
Sterility	Assumed to meet USP <71> requirements	Met (Passed predefined acceptance criteria)

Note: The document only states "The subject device passed the predefined acceptance criteria for these tests" without providing specific numerical results for each test for the subject device. The table above uses the predicate's specifications or general qualitative criteria as a proxy for the acceptance criteria, which the subject device is stated to have met.

2. Sample Sized Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes used for each non-clinical test (e.g., number of vials tested for pH, number of embryos for MEA).
Data Provenance: The document does not explicitly state the country of origin. The study appears to be a lab-based non-clinical performance evaluation, not involving human subjects or patient data. It is a non-clinical performance data study, retrospectively conducted for the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable to this type of device and study. This 510(k) pertains to reproductive media, not an AI or imaging device requiring expert interpretation of results to establish ground truth. The "ground truth" for media performance is established through standardized laboratory assays (pH, osmolality, endotoxin, sterility, mouse embryo assay).

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective, laboratory-based measurements, not subjective human interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, often with and without AI assistance. This 510(k) is for IVF media, which does not involve human reader interpretation in its intended use or performance evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

No, a standalone algorithm performance study was not done. This concept is specific to AI/machine learning devices where the algorithm's performance is evaluated independently. This product is a biological medium, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance evaluations was established through objective laboratory measurements and standardized biological assays:

Chemical assays (pH, Osmolality)
Microbiological assays (Endotoxin, Sterility)
Biological assays (Mouse Embryo Assay - MEA)

These are empirical measurements against predefined quality control specifications, rather than expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning device that requires a "training set." The device is a manufactured chemical product.

9. How the Ground Truth for the Training Set was Established

This information is not applicable given that the device is not an AI/machine learning product and does not have a "training set."

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 21, 2019

FUJIFILM Irvine Scientific, Inc. Jayme Yamaguchi-Owens Regulatory Affairs Manager 2511 Daimler Street Santa Ana, CA 92705

Re: K190152

Trade/Device Name: Vit Kit- Freeze NX and Vit Kit- Warm NX Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: May 17, 2019 Received: May 20, 2019

Dear Jayme Yamaguchi-Owens:

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. Although this letter refers to your product as a device, please be aware 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. You must comply with all the Act's

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Sharon M. Andrews Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190152

Device Name Vit Kit - Freeze NX Vit Kit - Warm NX

Indications for Use (Describe)

Vit Kit - Freeze NX (Vitrification Freeze Kit) is intended for use in the vitrification of oocytes (MI) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Vit Kit - Warm NX (Vitrification Warm Kit) is intended for use in the thawing of vitrified occytes (MII) and 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

K190152

l. General Information on Submitter

Submitted/Address	FUJIFILM, Irvine Scientific, Inc.2511 Daimler StreetSanta Ana, CA 92705Telephone: 800-437-5706Facsimile: 949-261-6522
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Contact Person: Jayme Yamaguchi-Owens FUJIFILM Irvine Scientific, Inc. 2511 Daimler Street Santa Ana, CA 92705 Telephone: 800-437-5706 949-261-6522 Facsimile: Email: see below Jayme.yamaguchi-owens@fujifilm.com

II.	Date Prepared:	June 20, 2019
III.	General Information
	Device Name:	Vit Kit - Freeze NXVit Kit - Warm NX
	Common Name:Warming Kit	Vitrification Cryopreservation Media and

Regulatory Class: Class II

Regulation Number:

Regulation Name:

MQL (Media, Reproductive) Product Code:

21 CFR 884.6180

Reproductive Media and Supplements

IV. Predicate Device: Vit Kit - Freeze, Vit Kit - Thaw K160006, Irvine Scientific
The predicate device has not been subject to a design related recall.

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V. Description of the Device:

VI. Indications for Use:

Vit Kit - Freeze NX (Vitrification Freeze Kit) is intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Vit Kit - Warm NX (Vitrification Warm Kit) is intended for use in the thawing of vitrified oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

VII. Predicate Device Comparison

The table below shows a comparison of the intended use and technological characteristics of the subject device and predicate device.

Table 1: Comparison of Characteristics

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	Subject DeviceK190152	Predicate DeviceK160006
Characteristic	Vit Kit - Freeze NXVit Kit - Warm NX	Vit Kit - FreezeVit Kit - Thaw	Comparison
Indications forUse	Vit Kit - Freeze NX(Vitrification FreezeKit) is intended foruse in thevitrification ofoocytes (MII) andpronuclear (PN)zygotes throughday 3 cleavagestage embryos andblastocyst stageembryos.Vit Kit - Warm NX(Vitrification WarmKit) is intended foruse in the thawingof vitrified oocytes(MII) andpronuclear (PN)zygotes throughday 3 cleavagestage embryos andblastocyst stageembryos.	Vit Kit - Freeze(Vitrification FreezeKit) is intended foruse in thevitrification ofoocytes (MII),pronuclear (PN)zygotes throughday 3 cleavagestage embryos andblastocyst stageembryos.Vit Kit - Thaw(Vitrification ThawKit) is intended foruse in the thawingof vitrified oocytes(MII), pronuclear(PN) zygotesthrough day 3cleavage stageembryos andblastocyst stageembryos.	There are minordifferences inwording, but theintended uses arethe same.
Components	Vitrification Media	Vitrification Media	Identical
	Subject DeviceK190152	Predicate DeviceK160006	Comparison
Characteristic	Vit Kit - Freeze NXVit Kit - Warm NX	Vit Kit - FreezeVit Kit - Thaw
	Thawing Media	Thawing Media
	Media Components
VitrificationMedia	CSCM	Medium 199	The predicate andsubject deviceformulations aresimilar. Thepredicate deviceuses sucrose insteadof trehalose and it
	EG (7.5, 15%)	EG (7.5, 15%)
	DMSO (7.5, 15%)	DMSO (7.5, 15%)
	Trehalose (0.5M)	Sucrose (0.5M)
	DSS	DSS	uses a HEPES buffer
	HSA	HSA
	Gentamicin	Gentamicin	instead of a dualzwitterionic buffer.
	SodiumBicarbonate	SodiumBicarbonate
	HEPES	HEPES
	MOPS
ThawingFormulation	CSCM	Medium 199	The predicate andsubject deviceformulations aresimilar. Thepredicate deviceuses sucrose insteadof trehalose and ituses a HEPES buffer
	Trehalose(0.5M,1.0M)	Sucrose(0.5M,1.0M)
	Dextran	Dextran
	HSA	HSA
	Gentamicin	Gentamicin	instead of a dual
	SodiumBicarbonate	SodiumBicarbonate	zwitterionic buffer.
	HEPES	HEPES
Characteristic	Subject DeviceK190152	Predicate DeviceK160006	Comparison
	Vit Kit - Freeze NXVit Kit - Warm NXMOPS	Vit Kit - FreezeVit Kit - Thaw
Endotoxin	≤ 0.6 EU/mL	≤ 0.6 EU/mL	Identical
MEA	≥ 80% expandedblastocyst after 96hours in culture	≥ 80% expandedblastocyst after 96hours in culture	Identical
pH	ES: 7.05 - 7.44VS: 7.05 - 7.44TS: 7.05 - 7.45DS: 7.05-7.45WS: 7.05 - 7.45	ES: 7.05 – 7.54VS: 7.05 - 7.54TS: 7.05-7.44DS: 7.05-7.44WS: 7.05-7.44	The predicate andsubject devicespecifications aresimilar.

Osmolality(mOsm/KgH2O)	ES: 1,150 - 1,1550VS: 1,220-1,620TS: 1,550-1,900DS: 830-930WS: 265-300	ES: 1,055-1,445VS: 1,100-1,588TS: 1,732-1,912DS: 857-910WS: 268-292	The osmolalityspecifications aresimilar.

SterilizationMethod	Aseptic Filtration	Aseptic Filtration	Identical

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As shown in the table above, the intended use of the subject and predicate device is the same. The technological characteristics of the subject and predicate device are different - the subject device formulation utilizes trehalose instead of sucrose, has a different basal medium formulation, and different osmolality and pH specifications. However, different types of safety and effectiveness questions are not raised by these differences in technological characteristics.

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Non-clinical Performance Data:

Vit Kit - Freeze NX and Vit Kit - Warm NX media were tested for the following performance characteristics at baseline and following accelerated aging (per ASTM F1980-16):

. Appearance
. pH (per USP <791>)
Osmolality (per USP <785>) .
Endotoxin (per USP <85>) .
. Sterility (per USP <71>)
. Mouse Embryo Assay

The following additional assessments were performed on the subject device:

Simulated Distribution and Handling per ASTM D4169-16 .
The subject device passed the predefined acceptance criteria for these tests.

VIII. Conclusion:

The results of the testing described above provide demonstrate that the subject device is as safe and effective as the predicate device and supports and 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.