(56 days)
Medium for culture of embryos from the pronucleate stage to day 2 or day 3.
Bicarbonate buffered medium containing Hyaluronan. For use after the addition of G-MMTM or HSA-solution™ and pre-equilibration at +37°C and 6% CO2.
The provided text is a 510(k) premarket notification summary and a letter from the FDA regarding the G-1TM version 3 Assisted Reproduction Media. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a medical device utilizing AI/machine learning would.
This device is a culture medium, not an AI-powered diagnostic tool. Therefore, the requested information about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size, and ground truth establishment for training sets, is not applicable and cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence to a predicate device (G1.2TM) based on technological characteristics and intended use. The "improvement in performance" mentioned refers to the chemical formulation of the culture medium itself, not the performance of an algorithm or diagnostic accuracy.
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SEP 6 2002
IX. PREMARKET NOTIFICATION SUMMARY
| Submitted by: | Vitrolife Sweden ABMölndalsvägen 30SE-412 63 GothenburgSWEDEN |
|---|---|
| Contact Person: | Mr. Eiler AndersonVitrolife Sweden ABMölndalsvägen 30SE-412 63 GothenburgSWEDEN |
| Date Prepared: | July 10, 2002 |
| Trade Name: | G-1TM version 3 |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements(21 C.F.R. § 884.6180) |
| Predicate Device: | G1.2TM |
| Description of the Device: | Bicarbonate buffered medium containingHyaluronan. For use after the addition of G-MMTM or HSA-solution™ and pre-equilibration at+37°C and 6% CO2. |
| Intended Use: | Medium for In Vitro Fertilization Procedures |
| Technological Characteristics: | The technological characteristics of G-1TM areessentially similar to those of the predicate device.The G-1 is a modification of the predicate deviceand is intended to be supplemented with albuminprior to use. Other formulation changes weremade to improve the performance of the G-1device. None of these differences raise newquestions of safety or effectiveness. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
6 2002
Vitrolife Sweden AB % Mr. Gary L. Yingling Kirkpatrick & Lockhart 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K022244
Trade/Device Name: G-1TM version 3 Assisted Reproduction Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MOL Dated: July 10, 2002 Received: July 12, 2002
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 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 (OS) 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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Page 2
This letter will allow you to begin marketing your device as described in your 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.
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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:
| 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" (21 CFR Part 807.97). 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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X. - INDICATIONS FOR USE STATEMENT
510(k) Number:
022244
Device Name:
11:00:00 :
G-1TM version 3 Assisted Reproduction Media
Indications For Use:
Medium for culture of embryos from the pronucleate stage to day 2 or day 3.
Rate Phillips f NCS
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use_ (Per 21 C.F.R. § 801.109)
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()ver-the Counter Use_________________________________________________________________________________________________________________________________________________________
§ 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.