VITRIFICATION KIT & VITRIFICATION WARMING KIT

K073522 · Sage In-Vitro Fertilization, Inc. · MQL · Oct 10, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K073522
• Device Name: VITRIFICATION KIT & VITRIFICATION WARMING KIT
• Applicant: Sage In-Vitro Fertilization, Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Oct 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Vitrification Kit: These products are 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 Sage IVF's Vitrification Warming Kit (Ref # ART-8030) for optimal recovery of specimens. Vitrification Warming Kit: These products are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using Sage IVF's Vitrification Kit (Ref # ART-8025) for Assisted Reproductive Technology (A.R.T.) procedures.

Device Story

Vitrification Kit and Vitrification Warming Kit comprise five chemical solutions for cryopreservation of human blastocysts. Vitrification Kit (Equilibration Solution, Vitrification Solution) uses DMSO and ethylene glycol to prepare and freeze specimens. Vitrification Warming Kit (1.0 M Sucrose, 0.5 M Sucrose, MOPS Solution) uses sequential dilution to recover specimens. Used in clinical IVF laboratories by embryologists. Solutions facilitate ultra-rapid freezing and thawing to maintain blastocyst viability for future implantation. Benefit includes preservation of embryos for ART procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including performance testing and sterility verification, comparing the subject device to predicate reproductive media.

Technological Characteristics

Chemical solutions for cryopreservation. Components include dimethyl sulfoxide (DMSO), ethylene glycol, and sucrose. Solutions are intended for sequential use in blastocyst vitrification and warming. Sterility is maintained per standard manufacturing practices for reproductive media. No electronic or software components.

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

• Vit Kit - Freeze and Vit Kit - Thaw (K060168)
• G-FreezeKit Blast (K032154)
• G-ThawKit Blast (K032155)

Submission Summary (Full Text)

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### 5. 510(k) Summary

073522

# OCT 1 0 2008

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Assisted Reproduction Products TM

SAGE In-Vitro Fertilization, Inc. a CooperSurqical Company 95 Corporate Drive Trumbull, CT 06611 [phone] FAX [phone]

Submitter's name: Address:

Phone: Fax number:

Name of contact person:

SAGE In-Vitro Fertilization 95 Corporate Drive Trumbull, CT 09911 203-601-5200 203-601-4737

Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] Fax: [phone] Email: [e-mail]

Date the summary was prepared: December 11, 2007

Name of the device: Trade or proprietary name: Common or usual name: Classification name:

Name of the device: Trade or proprietary name: Common or usual name: Classification name:

Name of the device: Trade or proprietary name: Common or usual name: Classification name:

Name of the device: Trade or proprietary name: Common or usual name: Classification name:

Name of the device: Trade or proprietary name: Equilibration Solution Equilibration Solution Equilibration Solution Reproductive media

Vitrification Solution Vitrification Solution Vitrification Solution Reproductive media

1.0 M Sucrose Warming Solution 1.0 M Sucrose Warming Solution 1.0 M Sucrose Warming Solution Reproductive media

0.5 M Sucrose Warming Solution 0.5 M Sucrose Warming Solution 0.5 M Sucrose Warming Solution Reproductive media

MOPS Solution MOPS Solution

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Common or usual name: Classification name:

MOPS Solution Reproductive media

The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

| Device | Ref# | Decided |
|-------------------------------------|---------|------------|
| Vit Kit - Freeze and Vit Kit - Thaw | K060168 | 04/24/2006 |
| G-FreezeKit Blast | K032154 | 05/07/2004 |
| G-ThawKit Blast | K032155 | 05/07/2004 |

Description of the devices:

There are five (5) solutions that comprise the two kits, Vitrification Kit and Vitrification Warming Kit.

Vitrification Kit: Consists of two solutions, Equilibration Solution (ES) and Vitrification Solution (VS) that are intended to be used sequentially, for the preparation for, and cryopreservation of, human blastocysts.

Equilibration Solution is used in preparation for freezing and contains dimethyl sulfoxide (DMSO) and ethylene glycol (EG).

Vitrification Solution is to be used during cryostorage and contains DMSO and EG and sucrose.

Vitrification Warming Kit: The three (3) warming solutions, 1.0 M Sucrose Warming Solution, 0.5 M Sucrose Warming Solution and MOPS Solution, are also intended for sequential use in the warming and recovery of cryopreserved human blastocysts.

Summary of the technological characteristics of both the Sage products and the Irvine Scientific products:

The technological characteristics of the Sage products as compared to the predicate products are similar in the following areas and do not compromise the safety or efficacy of the device.

- . Indications For Use
- . Formulae
- t Performance testing
- . Sterility

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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OCT 1 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SAGE In-Vitro Fertilization, Inc. c/o Ms. Grace Holland Regulatory Specialist Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606

Re: K073522

> Trade Name: Vitrification Kit & Vitrification Warming Kit Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: September 29, 2008 Received: September 30, 2008

Dear Ms. Holland:

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 (PMA), 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.

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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 (2) CFR Parison 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 tad tion 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 legal]y marketed predicate device results in a classification for your device and thus, permits a 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 mmber at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 24/0276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may potain 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,

Joppu M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 4. Indications for Use Statement Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Vitrification Kit & Vitrification Warming Kit

Indications for Use:

Vitrification Kit: These products are 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 Sage IVF's Vitrification Warming Kit (Ref # ART-8030) for optimal recovery of specimens.

Vitrification Warming Kit:_These products are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using Sage IVF's Vitrification Kit (Ref # ART-8025) for Assisted Reproductive Technology (A.R.T.) procedures.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Torn A. Why

Division of Reproductive, Abdominal, and Radiological Devi

510(k) Number K073522

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