(88 days)
G2.2TM
Not Found
No
The summary describes a culture medium, not a device with computational capabilities. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is a culture medium for in vitro embryo development, not a therapeutic device applied to a patient.
No
The device is described as a "medium for culture of embryos," which is a laboratory tool for maintaining biological samples, not for diagnosing medical conditions.
No
The device description clearly states it is a "Bicarbonate-buffered medium," which is a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Medium for culture of embryos from day 3 to the blastocyst stage." This clearly indicates that the device is used in vitro (outside the body) to support the growth and development of biological material (embryos).
- Device Description: The description of a "Bicarbonate-buffered medium" further supports its use as a laboratory reagent or culture medium, which are common types of IVDs.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this specific device isn't directly diagnosing a disease, it's used in a process (embryo culture) that is part of assisted reproductive technology, which falls under the broader scope of IVD regulation as it involves the manipulation and assessment of biological material in vitro for clinical purposes.
The presence of a predicate device (G2.2TM) also strongly suggests that this device is being regulated as an IVD, as predicate devices are used in the regulatory submission process for new IVDs.
N/A
Intended Use / Indications for Use
Medium for culture of embryos from day 3 to the blastocyst stage.
Product codes
85 MQL
Device Description
Bicarbonate-buffered medium. For use after the addition of HSA-solution™ or G-MM™ and equilibration at +37°C and 6% CO2
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
G2.2TM
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
SEP 6 2002
IX. PREMARKET NOTIFICATION SUMMARY
| Submitted by: | Vitrolife Sweden AB
Mölndalsvägen 30
SE-412 63 Gothenburg
SWEDEN |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Eiler Anderson
Vitrolife Sweden AB
Mölndalsvägen 30
SE-412 63 Gothenburg
SWEDEN |
| Date Prepared: | June 7, 2002 |
| Trade Name: | G-2TM version 3 |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Device: | G2.2TM |
| Description of the Device: | Bicarbonate-buffered medium. For use after the
addition of HSA-solution™ or G-MM™ and
equilibration at +37°C and 6% CO2 |
| Intended Use: | Medium for culture of embryos from day 3 to the
blastocyst stage. |
| Technological Characteristics: | The technological characteristics of G-2TM version
3 are identical to other legally marketed culture
media classified under 21 C.F.R. § 884.6180,
Reproductive Media and Supplements. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The caduceus is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2002 SEP
Vitrolife Sweden AB % Mr. Gary L. Yingling Kirkpatrick & Lockhart 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K021890 Trade/Device Name: G-2TM version 3 Assisted Reproduction Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: June 7, 2002 Received: June 10, 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 (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.
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.
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
3
INDICATIONS FOR USE STATEMENT X.
510(k) Number:
K02/890
Device Name:
G-2TM version 3 Assisted Reproduction Media
Indications For Use:
Medium for culture of embryos from day 3 to the blastocyst stage.
Rale Palle NGB
(Division Sign-Off) (Division Sign-City)
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)
Prescription Use_ 1 (Per 21 C.F.R. § 801.109)
OR
Over-the Counter Use_