(84 days)
Medium for In Vitro Fertilization Procedures
Medium for embryo transfer
Bicarbonate buffered medium containing Hyaluronan and Recombinant Human Albumin
The provided documents do not contain information regarding acceptance criteria or study data that proves the device meets specific performance metrics. This is a 510(k) premarket notification summary for a medical device (EmbryoGlue™ Assisted Reproduction Media) that has been deemed substantially equivalent to a predicate device.
The review process for a 510(k) emphasizes substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific acceptance criteria and performance data like a PMA (Premarket Approval) application would.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document only states the following:
- Device Name: EmbryoGlue™
- Intended Use/Indications for Use: Medium for embryo transfer in In Vitro Fertilization Procedures.
- Predicate Device: G-2™ version 3, supplemented with G-MM™.
- Technological Characteristics: EmbryoGlue™ is a modification of G-2™ version 3, supplemented with G-MM™. The technological characteristics of EmbryoGlue are essentially similar to those of the predicate device. The EmbryoGlue contains Recombumin and is not intended to be supplemented with albumin prior to use. Other changes are the product packaging and the fact that EmbryoGlue contains a higher concentration of Hyaluronan. None of these differences raise new questions of safety or effectiveness.
The FDA's determination of "substantial equivalence" is based on the comparison of the new device to a legally marketed predicate device, concluding that the new device is as safe and effective as the predicate. This does not typically involve new clinical studies demonstrating specific performance metrics for the new device if suitable predicate data and technological similarities can be established.
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Ko31015
PREMARKET NOTIFICATION SUMMARY X.
| Submitted by: | Vitrolife Sweden ABMölndalsvägen 30SE-412 63 GothenburgSWEDEN |
|---|---|
| Contact Person: | Ms. Nina ArvidssonVitrolife Sweden ABMölndalsvägen 30SE-412 63 GothenburgSWEDEN |
| Mr. Gary L. YinglingMr. Michael H. HinckleKirkpatrick & Lockhart, LLP1800 Massachusetts Avenue, NWWashington, DC 20036-1800 | |
| Date Prepared: | March 27, 2003 |
| Trade Name: | EmbryoGlue™ |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements(21 C.F.R. § 884.6180) |
| Predicate Device: | G-2™ version 3, supplemented with G-MM™ |
| Description of the Device: | Bicarbonate buffered medium containingHyaluronan and Recombinant Human Albumin |
| Intended Use: | Medium for In Vitro Fertilization Procedures |
| Indications for Use: | Medium for embryo transfer |
Technological Characteristics:
The EmbryoGlue™ device is a modification of G-2™ version 3, supplemented with G-MM™. The technological characteristics of EmbryoGlue are essentially similar to those of the predicate device. The EmbryoGlue contains Recombumin and is not intended to be supplemented with albumin prior to use. Other changes are the product packaging and the fact that EmbryoGlue contains a higher concentration of I-Iyaluronan. None of these differences raise new questions of safety or effectiveness.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2003
Ms. Nina Arvidsson Regulatory Affairs Officer Vitrolife Sweden AB Mölndalsvägen 30 SE-412 63 Gothenburg SWEDEN
Re: K031015
Trade/Device Name: EmbryoGlue™ Assisted Reproduction Medium Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: March 27, 2003 Received: March 31, 2003
Dear Ms. Arvidsson:
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. Iisting 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 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
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 XI.
KU31015 510(k) Number:
Device Name:
EmbryoGluc™ Assisted Reproduction Media
Indications For Use:
Medium for embryo transfer
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 C.F.R. § 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
510(k) Number
( )ver-the Counter Use_
18
§ 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.