Vit Kit- Freeze NX and Vit Kit- Warm NX

K190152 · Fujifilm Irvine Scientific, Inc. · MQL · Jun 21, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K190152
• Device Name: Vit Kit- Freeze NX and Vit Kit- Warm NX
• Applicant: Fujifilm Irvine Scientific, Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jun 21, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended 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 occytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Device Story

Vit Kit-Freeze NX and Vit Kit-Warm NX are sets of cryopreservation media used in assisted reproductive technology (ART) laboratories. The kits consist of basal media (Continuous Single Culture Medium) containing buffers (MOPS, HEPES, sodium bicarbonate), cryoprotectants (DMSO, ethylene glycol), trehalose, DSS, HSA, and gentamicin. The Freeze NX kit is used sequentially to prepare and vitrify oocytes and embryos; the Warm NX kit is used sequentially to thaw and recover them. These media facilitate the cryopreservation process, allowing for the storage and subsequent use of oocytes and embryos in clinical fertility treatments. The device is used by embryologists in a clinical laboratory setting. The output is the successful cryopreservation or recovery of reproductive cells/embryos, which supports clinical decision-making regarding embryo transfer and fertility preservation.

Clinical Evidence

Bench testing only. Performance characteristics evaluated at baseline and after accelerated aging (ASTM F1980-16) included appearance, pH (USP <791>), osmolality (USP <785>), endotoxin (USP <85>), sterility (USP <71>), and Mouse Embryo Assay (MEA). Simulated distribution and handling were tested per ASTM D4169-16. All tests met predefined acceptance criteria.

Technological Characteristics

Media components: Continuous Single Culture Medium (CSCM), MOPS, HEPES, sodium bicarbonate, 20% DSS, 10μg/mL gentamicin, DMSO, trehalose, and ethylene glycol. Sterilization via aseptic filtration. Performance standards: USP <791>, <785>, <85>, <71>; ASTM F1980-16 (accelerated aging), ASTM D4169-16 (distribution).

Indications for Use

Indicated for vitrification and thawing of human oocytes (MII), pronuclear (PN) zygotes, day 3 cleavage stage embryos, and blastocyst stage embryos.

Regulatory Classification

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.).

Special Controls

*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.

Predicate Devices

• Vit Kit - Freeze, Vit Kit - Thaw (K160006)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 100%;"> <span style="text-decoration: underline;"></span> <span style="text-decoration: overline;"></span> <span style="text-decoration: line-through;"></span> </span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size: 100%;"> <span style="text-decoration: underline;"></span> <span style="text-decoration: overline;"></span> <span style="text-decoration: line-through;"></span> </span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## 510(k) SUMMARY

## K190152

#### l. General Information on Submitter

| Submitted/Address | FUJIFILM, Irvine Scientific, Inc.<br>2511 Daimler Street<br>Santa Ana, CA 92705<br>Telephone: [phone]<br>Facsimile: 949-261-6522 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------|
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------|

Contact Person: Jayme Yamaguchi-Owens FUJIFILM Irvine Scientific, Inc. 2511 Daimler Street Santa Ana, CA 92705 Telephone: [phone] Facsimile: Email: see below [e-mail]

| II. | Date Prepared: | June 20, 2019 |
|------|-----------------------------|------------------------------------------|
| III. | General Information | |
| | Device Name: | Vit Kit - Freeze NX<br>Vit Kit - Warm NX |
| | Common Name:<br>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:

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.

#### 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 Device<br>K190152 | Predicate Device<br>K160006 | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Vit Kit - Freeze NX<br>Vit Kit - Warm NX | Vit Kit - Freeze<br>Vit Kit - Thaw | Comparison |
| Indications for<br>Use | Vit Kit - Freeze NX<br>(Vitrification Freeze<br>Kit) is intended for<br>use in the<br>vitrification of<br>oocytes (MII) and<br>pronuclear (PN)<br>zygotes through<br>day 3 cleavage<br>stage embryos and<br>blastocyst stage<br>embryos.<br><br>Vit Kit - Warm NX<br>(Vitrification Warm<br>Kit) is intended for<br>use in the thawing<br>of vitrified oocytes<br>(MII) and<br>pronuclear (PN)<br>zygotes through<br>day 3 cleavage<br>stage embryos and<br>blastocyst stage<br>embryos. | Vit Kit - Freeze<br>(Vitrification Freeze<br>Kit) is intended for<br>use in the<br>vitrification of<br>oocytes (MII),<br>pronuclear (PN)<br>zygotes through<br>day 3 cleavage<br>stage embryos and<br>blastocyst stage<br>embryos.<br><br>Vit Kit - Thaw<br>(Vitrification Thaw<br>Kit) is intended for<br>use in the thawing<br>of vitrified oocytes<br>(MII), pronuclear<br>(PN) zygotes<br>through day 3<br>cleavage stage<br>embryos and<br>blastocyst stage<br>embryos. | There are minor<br>differences in<br>wording, but the<br>intended uses are<br>the same. |
| Components | Vitrification Media | Vitrification Media | Identical |
| | Subject Device<br>K190152 | Predicate Device<br>K160006 | Comparison |
| Characteristic | Vit Kit - Freeze NX<br>Vit Kit - Warm NX | Vit Kit - Freeze<br>Vit Kit - Thaw | |
| | Thawing Media | Thawing Media | |
| | Media Components | | |
| Vitrification<br>Media | CSCM | Medium 199 | The predicate and<br>subject device<br>formulations are<br>similar. The<br>predicate device<br>uses sucrose instead<br>of 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 dual<br>zwitterionic buffer. |
| | Sodium<br>Bicarbonate | Sodium<br>Bicarbonate | |
| | HEPES | HEPES | |
| | MOPS | | |
| Thawing<br>Formulation | CSCM | Medium 199 | The predicate and<br>subject device<br>formulations are<br>similar. The<br>predicate device<br>uses sucrose instead<br>of trehalose and it<br>uses a HEPES buffer |
| | Trehalose<br>(0.5M,<br>1.0M) | Sucrose<br>(0.5M,<br>1.0M) | |
| | Dextran | Dextran | |
| | HSA | HSA | |
| | Gentamicin | Gentamicin | instead of a dual |
| | Sodium<br>Bicarbonate | Sodium<br>Bicarbonate | zwitterionic buffer. |
| | HEPES | HEPES | |
| Characteristic | Subject Device<br>K190152 | Predicate Device<br>K160006 | Comparison |
| | Vit Kit - Freeze NX<br>Vit Kit - Warm NX<br>MOPS | Vit Kit - Freeze<br>Vit Kit - Thaw | |
| Endotoxin | ≤ 0.6 EU/mL | ≤ 0.6 EU/mL | Identical |
| MEA | ≥ 80% expanded<br>blastocyst after 96<br>hours in culture | ≥ 80% expanded<br>blastocyst after 96<br>hours in culture | Identical |
| pH | ES: 7.05 - 7.44<br>VS: 7.05 - 7.44<br>TS: 7.05 - 7.45<br>DS: 7.05-7.45<br>WS: 7.05 - 7.45 | ES: 7.05 – 7.54<br>VS: 7.05 - 7.54<br>TS: 7.05-7.44<br>DS: 7.05-7.44<br>WS: 7.05-7.44 | The predicate and<br>subject device<br>specifications are<br>similar. |
| | | | |
| Osmolality<br>(mOsm/KgH2O) | ES: 1,150 - 1,1550<br>VS: 1,220-1,620<br>TS: 1,550-1,900<br>DS: 830-930<br>WS: 265-300 | ES: 1,055-1,445<br>VS: 1,100-1,588<br>TS: 1,732-1,912<br>DS: 857-910<br>WS: 268-292 | The osmolality<br>specifications are<br>similar. |
| | | | |
| Sterilization<br>Method | 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.