RAPIDVIT BLAST, RAPIDWARM BLAST

K101003 · Vitrolife Sweden AB · MQL · Dec 10, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K101003
• Device Name: RAPIDVIT BLAST, RAPIDWARM BLAST
• Applicant: Vitrolife Sweden AB
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Dec 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

RapidVit™ Blast is intended for vitrification of human blastocyst stage embryos. RapidWarm™ Blast is intended for warming of vitrified human blastocyst stage embryos.

Device Story

RapidVit™ Blast and RapidWarm™ Blast are embryo-physiological solutions for cryopreservation. RapidVit™ Blast uses three solutions with increasing cryoprotectant concentrations (1,2-propanediol, ethylene glycol, sucrose) to dehydrate blastocysts and increase osmolality prior to vitrification. RapidWarm™ Blast uses three solutions with decreasing sucrose concentrations to rehydrate embryos post-thaw. Used in IVF clinics by embryologists; solutions maintain physiological pH via MOPS buffer. Process enables blastocyst survival, development, and hatching post-warming, facilitating embryo transfer. Benefits include successful cryopreservation of blastocysts for future clinical use.

Clinical Evidence

Clinical investigation of vitrified/warmed blastocysts showed high survival rates and successful pregnancy outcomes. Study reported 43 healthy babies born from vitrified/warmed blastocysts. No adverse effects or complications reported. Nonclinical studies included three studies on surplus human blastocysts demonstrating survival, development, and hatching, plus in situ hybridization analysis for chromosomal abnormalities showing results comparable to fresh blastocysts.

Technological Characteristics

Embryo-physiological solutions containing 1,2-propanediol, ethylene glycol, and sucrose. Uses MOPS buffer for pH maintenance. Formulated as multi-step kits for vitrification and warming. Non-automated, manual handling process.

Indications for Use

Indicated for vitrification and warming of human blastocyst stage embryos in IVF clinical settings.

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

• RapidVit™ Cleave and RapidWarm™ Cleave (K080446)
• Vit Kit™ - Freeze and Vit Kit™ - Thaw (K060168)

Submission Summary (Full Text)

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#### X. THE 510(k) SUMMARY

.

ー

| Submitted by: | Vitrolife Sweden AB<br>Box 9080<br>SE-40092 Göteborg<br>SWEDEN | DEC 10 2010 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Mr Kjell Kjörk<br>Vitrolife Sweden AB<br>Box 9080<br>SE-40092 Göteborg<br>SWEDEN<br>Phone [phone]<br>Fax [phone]<br>Mail [e-mail] | |
| Date Prepared: | 3 December 2010 | |
| Trade Name: | RapidVit™ Blast<br>RapidWarm™ Blast | |
| Common Name: | Vitrification freeze kit for blastocysts<br>Vitrification thaw kit for blastocysts | |
| Classification Name: | Reproductive Media and Supplements<br>(21 C.F.R. § 884.6180) | |
| Predicate Devices: | RapidVit™ Cleave and RapidWarm™ Cleave<br>(K080446) from Vitrolife, and<br>Vit Kit™ - Freeze and Vit Kit™ - Thaw from Irvine<br>Scientific Co., Inc. (K060168) | |
| Description of the Device: | RapidVit™ Blast and RapidWarm™ Blast is a<br>device used for vitrification and warming of human<br>blastocysts. The cryoprotectants 1,2-propanediol and<br>ethylene glycol are used together with sucrose for<br>dehydration of the embryo before cryopreservation.<br><br>RapidVit™ Blast consists of three different solutions<br>with increasing concentrations of cryoprotectants<br>intended to prepare the human blastocysts for<br>vitrification by reducing the intracellular water<br>content and increasing the osmolality. Also<br>RapidWarm™ Blast consists of three different<br>solutions with decreasing concentrations of sucrose<br>to restore the water content and osmolality in embryo<br>during warming after vitrification storage. | |

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#### Intended Use:

RapidVit™ Blast is intended for vitrification of human blastocyst stage embryos

RapidWarm™ Blast is intended for warming of vitrified human blastocyst stage embryos

#### Technological Characteristics:

RapidVit™ Blast and RapidWarm™ Blast are devices used for vitrification of blastocysts. The cryoprotectants 1,2-propanediol and ethylene glycol are used together with sucrose for dehydration of the embryo before cryopreservation.

For RapidVit™ Blast and RapidWarm™ Blast two predicate devices have been utilized:

#### Rapid Vit™ Cleave and RapidWarm™ Cleave as predicate device

The Rapid Vit™ Blast and RapidWarm™ Blast device is a modification of the RapidVit™ Cleave and RapidWarm™ Cleave device (K080446) currently marketed by Vitrolife Sweden AB for the vitrification of day 3 cleavage stage embryos.

Rapid Vit™ Blast and RapidWarm™ Blast is similar to the predicate device in most respects. However, the predicate device RapidVit™ Cleave and RapidWarm™ Cleave (K080446) is intended for vitrification of day 3 cleavage stage embryos. RapidVit™ Blast and RapidWarm™ Blast and the predicate device consist of the same components but in somewhat different proportions as they are tailor-made for blastocysts and for cleavage stage embryos respectively.

## Vit Kit™ - Freeze/Vit Kit™ - Thaw as predicate device

Vit Kit™ - Freeze/Vit Kit™ - Thaw and RapidVit™ Cleave/RapidWarm™ Cleave are embryo-physiological solutions supplemented with permeable and non-permeable cryoprotectants.

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## Main differences between Vit Kit™ - Freeze/Vit Kit™ - Thaw and RapidVit™ Blast/RapidWarm™ Blast

Blast/Rapid Warni--- Diast
The main differences between RapidVit™ Blast and RapidWarm™ Blast and Vit Kit™ - Freeze and Vit Kit™ - Thaw are the following:

- Vit Kit™ Freeze and Vit Kit™ Thaw contain ethylene glycol, DMSO and . Vit Kit ---------------------------------------------------------------------------------------------------------------------------------------------------------------------contain ethylene glycol, 1,2-propanediol and sucrose
- Vit Kit™ Freeze and Vit Kit™ Thaw use an HEPES buffer, while . V It Kit --- Preczed and RapidWarm™ Blast use a MOPS buffer to keep the pH within physiological values during handling outside the incubator

## Justification for use of different media composition

Justification for use of annoverison, in spite of the somewhat different media The Justification for this comparison, in Spice of and Vit Kit™ - Freeze/Vit Kit™ - Thaw, is as follows:

- Most ART centres are now using either 1,2-propanediol or DMSO as the � Most ANT contres are now asing online of embryos. 1,2-propanediol is considered less toxic for embryos and for users
- The MOPS buffer used in RapidVit™ Blast and RapidWarm™ Blast is similar . The MOPS buffer used in Napld vit - Diast and Nit Kit™ - Thaw In addition
to HEPES which is used in Vit Kit™ - Freeze and Vit Kit™ - Thaw of hear lo HEFES winch is used in VR Rt.
the MOPS buffer is used in most of the IVF Media from Vitrolife, and has been used clinically for a very long time with good results

Successful vitrification of animal and human blastocyst stage embryos by use of Successful Vitrification of animal and numan blast of bags
RapidVit™ Blast and RapidWarm™ Blast has been shown in the nonclinical and clinical studies referred to below.

#### Nonclinical studies

Nonclinical studies
Three studies have been performed with vitrified surplus human blastocysts using Three studies have been performed with volues showed good survival,
RapidVit" Blast and RapidWarm" Blast. All studies showed good survival, Rapid Vit Blast and Rapid Warm - Diast. An study also included fluorescence
development and hatching rate of the blastocysts. One study also included ambrios development and hatching fale of the blastery of a comalities and vitrified embryos
in situ hybridisation analysis for chromosomal abnormalities and vitrified embryos in situ hybridisation analysis for onformal cells then non vitrified fresh blastocysts.

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### Clinical studies

Clinical studies
The clinical investigation of RapidVit™ Blast and RapidWarm™ Blast confirmed the The Chillcal findings, showing that the majority of the blastocysts survive vitrification precimical Indulings, snownig that the majority of that vitrification using RapidVit™ Blast and RapidWarm™ Blast can be used with good results in the daily treatment of IVF and Rapid Wallin - "Diast can oc used with good rooms vitrified and warmed blastocysts paticnes. An pations andergoing and included in the data analysis. The reported uuring the Study thire perfou have 0043% per embryo transfer. So far 43 health babies pregilancy falc 13 octiven 2 178 and in from vitrified and warmed blastocysts after the with nothlar outcomes have been obling of the Blast. No adverse effects or complications tise of Rapid Vit - - Diastana Reports are similar to results with other FDA approved devices.

## Conclusions on Nonclinical and Clinical studies

Conclusions on Nonchinear and Chineal clinical investigations, RapidVit™ Bast and RapidWarm™ Blast has showed to be as safe, efficient and performs as well as similar FDA approved devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G605 Silver Spring, MD 20993-0002

Mr. Kjell Kjörk Pharmacist, Regulatory Affairs Manager Vitrolife Sweden AB Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN

DEC 1 0 2010

Re: K101003

Trade Name: RapidVit™ Blast and RapidWarm™ Blast Regulation Number: 21 CER §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: November 23, 2010 Received: November 26, 2010

Dear Mr. Kjörk:

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 indictions 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. The general controls provisions of the Act include requirements for annual registration, Isting 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 onlineer madend

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 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

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1/1 S809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (2) CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli the [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.nrcs.usda.gov/wps/portal/nrcs/detail/national/technical/ecs/resource/?cid=nrcs143_026847

Sincerely yours,

Hubert Humphrey

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K101003

#### INDICATIONS FOR USE STATEMENT XI.

DEC 1 0 2010

510(k) Number (if known):

K101003

Device Name:

RapidVit™ Blast RapidWarm™ Blast

Indications for Use:

RapidVit™ Blast is indicated for vitrification of human blastocyst stage embryos

RapidWarm™ Blast is indicated for warming of vitrified human blastocyst stage embryos

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|---------------------------|---|
| (Per 21 C.F.R. § 801.109) | |

OR

| Over-the Counter Use | |
|----------------------|--|
|----------------------|--|

(Division Sign-Off)

Di sion of Reproductive, Gastro-Renal, and

Urological Devices

510(k) Number