(301 days)
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.
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.
This document is a 510(k) summary for the SAGE In-Vitro Fertilization Vitrification Kit and Vitrification Warming Kit. It does not contain acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices.
Specifically, the document states:
- "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
- Performance testing
- Sterility"
This indicates that SAGE is relying on the established performance and safety of its predicate devices and making a claim of substantial equivalence based on similar characteristics and the absence of new safety or efficacy concerns. A detailed study with acceptance criteria and device performance metrics would typically be submitted to demonstrate conformity to a specific standard or a novel device's performance, which is not the primary purpose of this 510(k) summary for these "reproductive media" devices.
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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 (203) 601-5200 FAX (203) 601-4737
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: 949-262-0411 Fax: 949-552-2821 Email: grace@regulatoryspecialists.com
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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the eagle. The text is arranged in a circular fashion, following the curve of the border.
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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Page 2
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 (800) 633-2011 or (240) 276-3150 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
Page __ 1_ of __1 __
§ 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.