(221 days)
Medium for In Vitro Fertilization Procedures
Medium for embryo biopsy
Medium for In Vitro Fertilization Procedures
This document is a 510(k) premarket notification for the G-PGD™ Assisted Reproduction Media. It does not contain information about acceptance criteria, device performance, specific studies with sample sizes, ground truth establishment, or clinical performance metrics.
The document indicates that the device's technological characteristics are "essentially similar to those of the predicate device" (Embryo Biopsy Medium, K021358) and states that "None of these changes raise new questions of safety or effectiveness." This implies that the device achieved substantial equivalence based on its similarity to a previously approved device, rather than through extensive new performance studies detailed in this particular submission.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than presenting detailed study data for the new device.
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X. PREMARKET NOTIFICATION SUMMARY
| Submitted by: | Vitrolife Sweden AB |
|---|---|
| Faktorvägen 13 | |
| SE-434 37 Kungsbacka | |
| SWEDEN |
Contact Person:
Ms. Nina Arvidsson Vitrolife Sweden AB Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN
September 25, 2003
G-PGD™
Mr. Gary L. Yingling Kirkpatrick & Lockhart, LLP 1800 Massachusetts Avenue, NW Washington, DC 20036-1800
Assisted Reproduction Media
(21 CF.R. § 884.6180)
Reproductive Media and Supplements
Embryo Biopsy Medium (K021358)
+37°C and ambient atmosphere.
based on the medium G-MOPS.
safety or effectiveness.
Medium for embryo biopsy
Calcium and Magnesium free MOPS buffered medium. For use after the addition of G-MM™ or HSA-solution™ and temperature equilibration at
Medium for In Vitro Fertilization Procedures
essentially similar to those of the predicate device. Formulation changes where made as G-PGD is
None of these changes raise new questions of
Date Prepared:
Trade Name:
Common Name:
Classification Name:
Predicate Device:
Description of the Device:
Intended Use:
Indications for Use:
Technological Characteristics: The technological characteristics of G-PGD are
15
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head facing left, with three horizontal bars above it, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2004
Vitrolife Sweden AB % Gary L. Yingling, Esq. Consultant Kirkpatrick & Lockhart, L.L.P. 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K033101 Trade/Device Name: G-PGD™ - Assisted Reproductive Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: February 19, 2004 Received: February 23, 2004
Dear Mr. Yingling:
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.
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
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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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancv 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
510(k) Number (if known): K033101
Device Name: G-PGD™ Assisted Reproduction Media
Indications For Use: Medium for embryo biopsy
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
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)
Daniel le Sutyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.