VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT

K060168 · Irvine Scientific Sales Co., Inc. · MQL · Apr 24, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K060168
• Device Name: VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Apr 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Vit Kit™ - Freeze is intended for ultra-rapid freezing and containment of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures. This kit is designed for use with Irvine Scientific's Blastocyst Vitrification Thaw Kit (Vit Kit" - Thaw, Catalog #90137) for optimal recovery of specimens. Vit Kit™ - Thaw is intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using Irvine Scientific's Blastocyst Vitrification Freeze Kit (Vit Kit™ - Freeze, Catalog #90133) for Assisted Reproductive Technology (A.R.T.) procedures.

Device Story

Vit Kit™ - Freeze and Vit Kit™ - Thaw are media kits for cryopreservation and recovery of human blastocysts. Freeze kit contains two media (ES, VS) used sequentially for preparation and cryostorage; Thaw kit contains three media (TS, DS, WS) used sequentially for thawing and recovery. Media are based on modified Medium 199, HEPES-buffered, containing 20% SSS, gentamicin, and varying concentrations of DMSO, EG, and sucrose. Used in clinical embryology laboratories by trained personnel. Media protect embryos during freezing and thawing processes. Output is recovered blastocysts suitable for implantation. Benefits include preservation of embryos for future implantation attempts in patients with unsuccessful cycles or those desiring multiple children.

Clinical Evidence

No clinical data. Evidence consists of bench testing including endotoxin, mouse embryo freezing/recovery assays, and sterility testing. Performance supported by peer-reviewed literature and field testing results.

Technological Characteristics

Media based on modified Medium 199; HEPES-buffered; contains 20% SSS, 35μg/mL gentamicin, DMSO, EG, and sucrose. Sequential use of specific media formulations for freezing (ES, VS) and thawing (TS, DS, WS). Non-patient contacting. Sterility and endotoxin testing performed as release criteria.

Indications for Use

Indicated for ultra-rapid freezing, containment, and subsequent recovery of human blastocysts in patients undergoing Assisted Reproductive Technology (A.R.T.) procedures.

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

• Notice of Final Rule, 63 FR 48428, Docket number 97N-0335

Submission Summary (Full Text)

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K060168

# 510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)

| Submitted by: | Irvine Scientific Sales Co., Inc.<br>2511 Daimler Street<br>Santa Ana, CA 92705-5588 | APR 24 2006 |
|---------------|--------------------------------------------------------------------------------------|-------------|
| | Telephone: [phone]<br>Facsimile: [phone] | |
| | Contact: Wendell Lee, Pharm.D. | |
| | Date Submitted: December 22, 2005 | |

## Device Identification:

| Trade Name: | Vit Kit™ - Freeze<br>Blastocyst Vitrification Freeze Kit |
|----------------------|--------------------------------------------------------------------------------------------------------|
| | Vit Kit™ - Thaw<br>Blastocyst Vitrification Thaw Kit |
| Common Name: | Blastocyst Vitrification cryopreservation media<br>Blastocyst Vitrification thawing and recovery media |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |

## Predicate Device:

Notice of Final Rule, 63 FR 48428, Docket number 97N-0335

#### Description:

The five (5) media that comprise the two kits, Vit Kit™ - Freeze and Vit Kit™ - Thaw are all based upon the modified formulation of Medium 199. The Medium 199 is HEPES buffered and contains 20% (v/v) SSS, 35μg/mL gentamicin and varying concentrations of DMSO, EG and sucrose. The two (2) freeze, ES and VS, media in the Vit Kit™ - Freeze are intended to be used sequentially, for the preparation for, and cryopreservation of, human blastocysts. ES is used in preparation for freezing and contains 7.5 % (v/v) DMSO and EG. VS is to be used during cryostorage and contains 15% (v/v) DMSO and EG and 0.5M sucrose.

Blastocyst Vitrification Freeze Kit Blastocyst Vitrification Thaw Kit

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The three (3) thaw, TS, DS and WS, media in the Vit Kit™ - Thaw are also intended for sequential use in the thawing and recovery of cryopreserved human embryo. The first medium used in the thawing process, TS, contains 1.0M sucrose. The second medium, DS, contains 0.5M sucrose. The third medium, WS, contains no sucrose.

## Intended Use:

Vit Kit™ - Freeze is intended for ultra-rapid freezing and containment of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures. This kit is designed for use with Irvine Scientific's Blastocyst Vitrification Thaw Kit (Vit Kit" - Thaw, Catalog #90137) for optimal recovery of specimens.

Vit Kit™ - Thaw is intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using Irvine Scientific's Blastocyst Vitrification Freeze Kit (Vit Kit™ - Freeze, Catalog #90133) for Assisted Reproductive Technology (A.R.T.) procedures.

## Technological Characteristics:

Embryos are routinely stored for use in future assisted reproductive procedures. In some instances, excess eggs will be retrieved from the patient, and fertilized. If development of these fertilized eggs indicates a potential for viability during implantation, they may be frozen for future use. In the event that the current transfer is unsuccessful, and does not result in a clinical pregnancy, the patient has embryos in reserve that may be used for implantation in future procedures. Embryos are also routinely frozen when patients have a history of unsuccessful implantation procedures, and also for those patients who desire multiple children. Media to protect the embryos during the preparation for cryopreservation, during storage, and ultimate thawing and recovery are, therefore, different in composition from media used for gamete retrieval, during fertilization and implantation.

Blastocyst Vitrification Freeze Kit Blastocyst Vitrification Thaw Kit

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The media in the Vit Kit™ - Freeze, ES and VS, are designed to be used sequentially for the preparation of vitrified embryos for cryopreservation, as the protective media and containment during cryostorage.

The media in the Vit Kit™ - Thaw, TS, DS and WS, are also designed for sequential use, in the thawing and recovery of cryopreserved vitrified human embryos. None of the media are intended to contact the patient.

#### Additional Information:

Endotoxin, mouse embryo freezing and recovery assay performance and sterility tests will be performed as a condition of release for these products. Results of all release assays performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling. Refer to Appendix B.

# Conclusion:

The results from the field testing (refer to Appendix D) of these products along with the peer reviewed articles (refer to Attachment 1 and Attachment 2) that were presented demonstrates that Vit Kit™ - Freeze and Vit Kit™ - Thaw are suitable for their intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.

Blastocyst Vitrification Freeze Kit Blastocyst Vitrification Thaw Kit

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Wendell Lee, Pharm.D. Vice President Irvine Scientific Sales Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588

APR 2 4 2006

Re: K060168

Trade/Device Name: Vit Kit™ - Freeze

Blastocyst Vitrification Freeze Kit Vit Kit™ - Thaw Blastocyst Vitrification Thaw Kit Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: January 20, 2006 Received: January 24, 2006

## Dear Dr. Lee:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/11 description: The image is a circular logo with the text "1906 - 2006" at the top. Below the text is the acronym "FDA" in large, bold letters. Underneath the acronym is the word "Centennial" in a smaller font. There are three stars arranged in a horizontal line below the word "Centennial". The logo is surrounded by a dotted border.

noting Public J

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(K) Number:_KO60168

Device Name: Vit Kit™ - Freeze Blastocyst Vitrification Freeze Kit

Indications for Use: -

Vit Kit™ - Freeze is intended for ultra-rapid freezing and containment of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures. This kit is designed for use with Irvine Scientific's Blastocyst Vitrification Thaw Kit (Vit Kit™ - Thaw, Catalog #90137) for optimal recovery of specimens.

Prescription Use _ × AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broadon

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devic 510(k) Number

Page 1 of 2

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# INDICATIONS FOR USE STATEMENT

510(K) Number:_K (060168

Device Name: Vit Kit™ - Thaw Blastocyst Vitrification Thaw Kit

Indications for Use:

Vit Kit™ - Thaw is intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using Irvine Scientific's Blastocyst Vitrification Freeze Kit (Vit Kit™ - Freeze, Catalog #90133) for Assisted Reproductive Technology (A.R.T.) procedures.

Prescription Use AND/OR × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 2

Nancy C. Hodgon

(Division Sign-Off) l Division of Reproductive, Abd and Radiological Devices 510(k) Number.