RapidVit™ Oocyte, RapidWarm™ Oocyte

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 26, 2019 Vitrolife Sweden AB Nina Arvidsson Regulatory Affairs Manager Gustaf Werners gata 2 SE 421 32 Vastra Frolunda SWEDEN Re: K183486 > Trade/Device Name: RapidVit™ Oocyte, RapidWarm™ Oocyte Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: June 24, 2019 Received: June 26, 2019 Dear Nina Arvidsson: 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 {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183486 Device Name RapidVit "M Oocyte, RapidWarm TM Oocyte #### Indications for Use (Describe) RapidVit™ Oocyte: Media for vitrification of human oocytes (MII). RapidWarm The Oocyte: Media for warming of vitrified human oocytes (MII). | 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the word "Vitrolife" in blue font. The font is a serif font, and the letters are all capitalized except for the "i" in "Vitrolife". To the right of the word "Vitrolife" is a blue swoosh that is also in blue. The swoosh is a stylized wave. ### 510(k) Summary (K183486) ### 1. Submitter Information | Submitted by: | Vitrolife Sweden AB<br>Gustaf Werners gata 2<br>SE - 421 32 Västra Frölunda<br>Sweden | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Nina Arvidsson<br>Vitrolife Sweden AB<br>Gustaf Werners gata 2<br>SE - 421 32 Västra Frölunda<br>Sweden<br>Phone: +46 31 721 80 00<br>Fax: +46 31 721 80 90<br>Email: narvidsson@vitrolife.com | | 2. Date Prepared | July 24, 2019 | | 3. Device Identification | | | Trade Name: | RapidVitTM Oocyte, RapidWarmTM Oocyte | | Common Name: | Oocyte Vitrification/Warming Kit | | Regulatory Class: | Class II | | Regulation Number: | 21 CFR 884.6180 | | Regulation Name: | Reproductive Media and Supplements | | Product Code: | MQL (Media, Reproductive) | - Vit Kit® Freeze (Vitrification Freeze Kit), Vit Kit® Thaw (Vitrification Thaw Kit) - (K160006) manufactured by Irvine Scientific. The predicate device has not been subject to a design related recall. ### 5. Device Description Two sets of media are covered by this 510(k), the RapidVit™ Oocyte for vitrification of oocytes and the RapidWarm™ Oocyte for warming of vitrified oocytes. RapidVit™ Oocyte contains three medium solutions to be used sequentially during oocyte vitrification. RapidWarm™ Oocyte includes four medium solutions to be used sequentially during oocyte warming. The table below outlines the components contained in RapidVit™ Oocyte and RapidWarm™ Oocyte. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Vitrolife. The word "Vitrolife" is written in a blue serif font. To the right of the word is a blue swoosh design. | Component | Formulation characteristics | Utilization | |------------------|----------------------------------------------------------------------------|------------------------------| | Vitri 1TM Oocyte | Contains no cryoprotectants | First step of vitrification | | Vitri 2TM Oocyte | Contains cryoprotectants (ethylene glycol [8%] and propanediol [8%]) | Second step of vitrification | | Vitri 3TM Oocyte | Contains (ethylene glycol [16%], propanediol [16%], and sucrose [0.442 M]) | Third step of vitrification | | Warm 1TM Oocyte | Contains sucrose (1 M) | First step of warming | | Warm 2TM Oocyte | Contains sucrose (0.5 M) | Second step of warming | | Warm 3TM Oocyte | Contains sucrose (0.25 M) | Third step of warming | | Warm 4TM Oocyte | Contains no sucrose | Fourth step of warming | All media are aseptically filtered and filled in 10 ml plastic bottles and have a 25-week shelf-life under recommended storage conditions. They are stable for 2 weeks after opening of the packaging bottle, if stored under recommended conditions. ## 6. Indications for Use RapidVit™ Oocyte: Media for vitrification of human oocytes (MII). RapidWarm™ Oocyte: Media for warming of vitrified human oocytes (MII). # 7. Substantial Equivalence Discussion | Device | K183486 (subject device) | K160006 (predicate device) | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | RapidVitTM Oocyte - Media for<br>vitrification of human oocytes<br>(MII). | Vit Kit® - Freeze (Vitrification Freeze<br>Kit) is intended for use in the vitrification<br>of oocytes (MII), pronuclear (PN) zygotes<br>through day 3 cleavage stage embryos<br>and blastocyst stage embryos. | | | RapidWarmTM Oocyte - Media<br>for warming of vitrified human<br>oocytes (MII). | Vit Kit® - Thaw (Vitrification Thaw Kit)<br>is intended for use in the thawing of<br>vitrified oocytes (MII), pronuclear (PN)<br>zygotes through day 3 cleavage stage<br>embryos and blastocyst stage embryos. | | pH | 7.2-7.4 | Vitrification media – 7.05-7.54<br>Warming media – 7.05-7.44 | | Osmolality<br>(mOsm/kg) | Vitri 1TM Oocyte: 272-288<br>Vitri 2TM Oocyte: 3045-3355<br>Vitri 3TM Oocyte: 6530-7370<br>Warm 1TM Oocyte: 1450-1610<br>Warm 2TM Oocyte: 800-900 | ES Freeze: 1055-1445<br>VS Freeze: 1100-1588<br>TS Thaw: 1732-1912<br>DS Thaw: 857-910<br>WS Thaw: 268-292 | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "Vitrolife" in blue font. To the right of the word is a blue curved line that resembles a check mark. The font is a serif font, and the word is written in all lowercase letters except for the first letter, which is capitalized. The image is simple and clean, with a white background. | | Warm 3TM Oocyte: 560-600<br>Warm 4™ Oocyte: 272-288 | | |---------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | Key components<br>in vitrification<br>media | Amino acids<br>MOPS<br>Human Serum Albumin<br>Ethylene glycol<br>Sucrose<br>Gentamicin<br>Propanediol<br>Hyaluronan | Medium 199<br>Dextran serum supplement<br>Amino acids<br>Ethylene glycol<br>Sucrose<br>Gentamicin<br>DMSO | | Key components<br>in warming<br>media | Amino acids<br>Human Serum Albumin<br>Sucrose<br>Gentamicin<br>Hyaluronan | Medium 199<br>Dextran serum supplement<br>Amino acids<br>Sucrose<br>Gentamicin | Both subject and predicate devices are indicated for vitrification of oocytes and warming of vitrified human MII oocytes, while the predicate device is also indicated for vitrification of embryos (PN-blastocyst stages). Although the subject device has a more limited indication, the intended use (i.e., vitrification and warming of oocytes for use in assisted reproduction procedures) is the same. The subject and predicate devices are different in technological characteristics, including pH. osmolality, and formulation. These differences do not raise different questions of safety and effectiveness, and are common in assisted reproduction technology media devices. ## 8. Summary of Non-Clinical Performance Testing The following studies have been performed to support substantial equivalence to the predicate device: - pH testing per USP <791> ● - . Osmolality testing per USP <785> - Aseptic filling validation study per ISO 11137-1:2006 and ISO 11137-2:2013 ● - Bacterial endotoxins testing per USP <85> (acceptance criterion: < 0.5 EU/ml) . - Sterility testing per USP <71> (acceptance criterion: no microbial growth) ● - Mouse Embryo Assay (MEA) using established protocol: . One-cell mouse embryos were exposed sequentially to each vitrification solution and each warming solution using exposure conditions identical to the maximum exposure durations stated in the Instructions for Use. The embryos were then cultured at 37°C in an atmosphere containing 5% CO2. The percentage of embryos developed to the expanded {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "Vitrolife" in blue font. To the right of the word is a blue swoosh. The font is a serif font. blastocyst stage within 96 hours were assessed in comparison with the control group. The acceptance specification is ">80% of embryos expand to the blastocyst stage by 96h." - Shelf-life testing was conducted to ensure that the following product specifications are . met at time zero and end of shelf-life (25 weeks): pH, osmolality, sterility, 1-cell MEA, and endotoxin. - Stability testing was conducted to ensure that the following product specifications are met . at two weeks after opening of packaging bottles: pH, osmolality, sterility, 1-cell MEA, and endotoxin. # 9. Summary of Clinical Performance Testing A clinical study was conducted to evaluate clinical performance of the subject device using 593 oocytes from 64 donors. The study showed the oocyte survival rate of 94% after vitrification (555/593), fertilization rate of 78% (434/555), Day 5 blastulation rate of 24% (102/434), Day 5/6 utilization rate of 35% (153/434), and clinical pregnancy (confirmed by fetal heartbeat) rate of 50% (27/54 recipients). ## 10. Conclusion The subject and predicate devices have the same intended use and comparable technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.