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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Vitrolife RapidVit™ Oocyte and RapidWarm™ Oocyte devices, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, it primarily presents data to show that the new device is as safe and effective as the existing one, rather than a full, comprehensive study report with all the details typically found in a clinical trial publication.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are mainly for non-clinical performance and a Mouse Embryo Assay (MEA). The clinical performance is reported as observed rates, not explicitly tied to specific numerical acceptance criteria within the document, although they are presented as evidence of successful function.

Acceptance Criteria Category	Specific Criterion	Reported Device Performance / Result
Non-Clinical Performance
pH Testing	Per USP <791>	N/A (Confirmed compliance, values not provided)
Osmolality Testing	Per USP <785>	N/A (Confirmed compliance, values not provided)
Aseptic Filling Validation	Per ISO 11137-1:2006 and ISO 11137-2:2013	N/A (Confirmed compliance)
Bacterial Endotoxins Testing	< 0.5 EU/ml	N/A (Confirmed compliance, specific value not provided)
Sterility Testing	No microbial growth	N/A (Confirmed compliance)
Mouse Embryo Assay (MEA)	>80% of embryos expand to the blastocyst stage by 96h	N/A (Confirmed compliance, specific percentage not provided in summary)
Stability Testing (Shelf-life & Post-opening)	pH, osmolality, sterility, 1-cell MEA, and endotoxin spec. met at end of shelf-life (25 weeks) and 2 weeks after opening.	N/A (Confirmed compliance)
Clinical Performance
Oocyte Survival Rate	(Not explicitly stated as an acceptance criterion in this format, but the observed rate supports device function)	94% (555/593)
Fertilization Rate	(Not explicitly stated)	78% (434/555)
Day 5 Blastulation Rate	(Not explicitly stated)	24% (102/434)
Day 5/6 Utilization Rate	(Not explicitly stated)	35% (153/434)
Clinical Pregnancy Rate (confirmed by fetal heartbeat)	(Not explicitly stated)	50% (27/54 recipients)

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

Sample Size (Clinical Study): 593 oocytes from 64 donors.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is referred to as "A clinical study was conducted," which typically implies a prospective design, but this is not explicitly stated.

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

This information is not provided in the document. For a medical device like reproductive media, the "ground truth" for clinical performance is generally the observed biological outcomes (survival, fertilization, blastulation, pregnancy), which are objectively measurable laboratory and clinical endpoints rather than subjective expert interpretations of images or data. Therefore, a panel of experts for "ground truth" establishment in the typical sense (e.g., for diagnostic AI) might not be applicable here.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant when human experts are assessing a subjective outcome (e.g., classifying an image, making a diagnosis) and their agreement needs to be established or disagreement resolved. For the clinical outcomes measured in this study (oocyte survival, fertilization, pregnancy rate), the outcomes are objective biological events, not subjective interpretations. Therefore, an adjudication method in this context is not applicable and not mentioned.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., radiologists interpreting images) changes with or without AI assistance. The device in question is a media (liquid solutions) used in an in-vitro fertilization process, not an AI diagnostic tool or system that assists human interpretation.

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

No, a standalone "algorithm only" performance study was not done. This device is a biological media. Its performance is intrinsically tied to its use in a laboratory setting by human embryologists/clinicians performing the vitrification and warming procedures. The concept of an "algorithm only" performance is not applicable to this type of device.

7. The Type of Ground Truth Used

The ground truth used for the clinical study was based on observed biological and clinical outcomes:

Oocyte survival post-warming.
Fertilization rates.
Embryo development (Day 5 blastulation, Day 5/6 utilization).
Clinical pregnancy confirmation by fetal heartbeat.

For the non-clinical tests (pH, osmolality, endotoxins, sterility, MEA), the ground truth was based on established laboratory assay results and conformity to specified criteria.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a biological media, not an algorithm or AI model that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

Summary

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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

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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

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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)

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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 ABGustaf Werners gata 2SE - 421 32 Västra FrölundaSweden
Contact Person:	Nina ArvidssonVitrolife Sweden ABGustaf Werners gata 2SE - 421 32 Västra FrölundaSwedenPhone: +46 31 721 80 00Fax: +46 31 721 80 90Email: 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

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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 forUse	RapidVitTM Oocyte - Media forvitrification of human oocytes(MII).	Vit Kit® - Freeze (Vitrification FreezeKit) is intended for use in the vitrificationof oocytes (MII), pronuclear (PN) zygotesthrough day 3 cleavage stage embryosand blastocyst stage embryos.
	RapidWarmTM Oocyte - Mediafor warming of vitrified humanoocytes (MII).	Vit Kit® - Thaw (Vitrification Thaw Kit)is intended for use in the thawing ofvitrified oocytes (MII), pronuclear (PN)zygotes through day 3 cleavage stageembryos and blastocyst stage embryos.
pH	7.2-7.4	Vitrification media – 7.05-7.54Warming media – 7.05-7.44
Osmolality(mOsm/kg)	Vitri 1TM Oocyte: 272-288Vitri 2TM Oocyte: 3045-3355Vitri 3TM Oocyte: 6530-7370Warm 1TM Oocyte: 1450-1610Warm 2TM Oocyte: 800-900	ES Freeze: 1055-1445VS Freeze: 1100-1588TS Thaw: 1732-1912DS Thaw: 857-910WS Thaw: 268-292

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	Warm 3TM Oocyte: 560-600Warm 4™ Oocyte: 272-288
Key componentsin vitrificationmedia	Amino acidsMOPSHuman Serum AlbuminEthylene glycolSucroseGentamicinPropanediolHyaluronan	Medium 199Dextran serum supplementAmino acidsEthylene glycolSucroseGentamicinDMSO
Key componentsin warmingmedia	Amino acidsHuman Serum AlbuminSucroseGentamicinHyaluronan	Medium 199Dextran serum supplementAmino acidsSucroseGentamicin

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

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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.

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.