(151 days)
Not Found
No
The summary describes an IVF culture media and does not mention any AI or ML components or functionalities.
No
The device is described as a culture medium for embryos, used from day 3 to the blastocyst stage and for embryo transfer. While it supports the development of embryos, it is not directly treating a disease or condition in a patient, which is typically the characteristic of a therapeutic device. It facilitates a biological process outside the body.
No
The device is described as media for the culture of embryos and for embryo transfer, which are procedures for preparing embryos, not for diagnosing a condition.
No
The device description clearly states it is "IVF Media," which are biological/chemical substances used for culturing embryos, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "culture of embryos from day 3 to the blastocyst stage, and for embryo transfer." This process involves handling and manipulating biological material (embryos) outside of the body for diagnostic or therapeutic purposes related to fertility.
- Device Description: The description confirms its use in "culture of embryos," which is a key activity in in vitro fertilization (IVF).
- Predicate Device: The mention of a predicate device, "G-2TM version 3 (K021890)," strongly suggests that this device is also regulated as a medical device, and given its function, it falls under the IVD category. K numbers are associated with FDA clearances for medical devices, including IVDs.
While the document doesn't explicitly use the term "In Vitro Diagnostic," the intended use and the context of IVF procedures clearly place it within the scope of IVD regulation. 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. In this case, the media is used to support the development of embryos, which is a crucial step in addressing infertility.
N/A
Intended Use / Indications for Use
G-2TM v5/G-2TM v5 PLUS is intended for culture of embryos from day 3 to the blastocyst stage, and for embryo transfer.
G-2™ v5 is indicated for culture of embryos from day 3 to the blastocyst stage, and for embryo transfer.
G-2™ v5 PLUS is indicated for culture of embryos from day 3 to the blastocyst stage, and for embryo transfer.
Product codes
MQL
Device Description
The IVF Media GIII Series have been on the market for a number of years and Vitrolife Sweden AB has now made some product changes in order to further improve the robustness of these media. These improved media are called IVF Media G5 Series.
G-2TM v5/G-2TM v5 PLUS is used for culture of embryos from day 3 to the blastocyst stage, and for embryo transfer.
G-2™ v5/G-2™ v5 PLUS is a device used for the culture of embryos from day 3 to the blastocyst stage, and for embryo transfer.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
and the comments of the comments of
:
| Submitted by: | Vitrolife Sweden AB
Faktorvägen 13
SE-434 37 Kungsbacka
SWEDEN |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr Kjell Kjörk
Vitrolife Sweden AB
Faktorvägen 13
SE-434 37 Kungsbacka
SWEDEN
Phone +46 31 721 80 77
Fax +46 31 721 80 90
Mail kkjork@vitrolife.com
SEP 1 6 2008 |
| Date Prepared: | 7 July 2008 |
| Trade Name: | G-2TM v5/G-2TM v5 PLUS |
| Common Name: | IVF Media |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Device: | G-2TM version 3 (K021890) |
| Description of the Device: | The IVF Media GIII Series have been on the market
for a number of years and Vitrolife Sweden AB has
now made some product changes in order to further
improve the robustness of these media. These
improved media are called IVF Media G5 Series.
G-2TM v5/G-2TM v5 PLUS is used for culture of
embryos from day 3 to the blastocyst stage, and for
embryo transfer. |
| Intended Use: | G-2TM v5/G-2TM v5 PLUS is intended for culture of
embryos from day 3 to the blastocyst stage, and for
embryo transfer. |
1
Technological Characteristics:
G-2™ v5/G-2™ v5 PLUS is a device used for the culture of embryos from day 3 to the blastocyst stage, and for embryo transfer.
The product G-2™ v5/G-2™ v5 PLUS is a modification of the device G-2™ version 3 (K021890). The technological characteristics of G-2™ v5/G-2™ v5 PLUS are essentially similar to those of the predicate device. None of the differences between the predicate device and G-2™ v5/G-2™ v5 PLUS do raise any new questions of safety or effectiveness.
2
Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2008
Mr. Kjell Kjörk Pharmacist, Regulatory Affairs Manager Vitrolife Sweden AB Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN
Rc: K081117
Trade Name: G-2TM v5 and G-2TM v5 PLUS Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: August 13, 2008 Received: August 15, 2008
Dear Mr. Kjörk:
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.
3
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 (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.
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 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 240-276-3474. 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 obtain 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) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
hope M.Nhang
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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XI. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K081117
Device Name:
G-2™ v5
Indications for Use:
G-2™ v5 is indicated for culture of embryos from day 3 to the blastocyst stage, and for embryo transfer
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-the Counter Use (Per 21 C.F.R. § 801.109)
Hulut lemm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
Radiological Devices
510(k) Number K081117
5
XI. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K081117
Device Name:
G-2™ v5 PLUS
Indications for Use:
G-2™ v5 PLUS is indicated for culture of embryos from day 3 to the blastocyst stage, and for embryo transfer
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-the Counter Use (Per 21 C.F.R. § 801.109)
Hulun Remen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.