(152 days)
Not Found
No
The summary describes IVF media and its intended use for handling oocytes and embryos. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML.
No
The device is indicated for oocyte collection and handling/manipulating oocytes and embryos, which are laboratory procedures rather than direct therapeutic interventions on a patient.
No
The device is indicated for oocyte collection and handling/manipulating oocytes and embryos, which are procedural and manipulation tasks, not diagnostic ones.
No
The device description explicitly states "IVF Media GIII Series" and "IVF Media G5 Series," which are biological media, not software. The intended use also describes handling and manipulating oocytes and embryos, which would involve physical interaction with these media.
Based on the provided information, G-MOPS™ and G-MOPS™ PLUS are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these products are used for handling/manipulating oocytes and embryos. This involves working with biological samples (oocytes and embryos) outside of the body.
- Device Description: The description confirms their use in the context of IVF (In Vitro Fertilization), which is a process performed outside the body.
- Predicate Device: The predicate device listed (K021893; G-MOPSTM) is also an IVF media, which are typically classified as 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 these specific products aren't directly diagnosing a disease, they are essential components used in the process of IVF, which is a medical procedure involving the manipulation of biological samples for reproductive purposes. Products used in IVF are generally regulated as IVDs.
N/A
Intended Use / Indications for Use
G-MOPSTM is intended for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.
G-MOPS™ PLUS is intended for handling/manipulating oocytes and embryos in ambient atmosphere.
G-MOPS™ is indicated for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.
G-MOPS™ PLUS is indicated for handling/manipulating oocytes and embryos in ambient atmosphere.
Product codes (comma separated list FDA assigned to the subject device)
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-MOPSTM is used for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.
G-MOPSTM PLUS is used for handling/manipulating oocytes and embryos in ambient atmosphere.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
G-MOPSTM (K021893)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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PREMARKET NOTIFICATION SUMMARY x.
SEP 1 7 2008
| 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 |
| Date Prepared: | 3 September 2008 |
| Trade Name: | G-MOPSTM/G-MOPSTM PLUS |
| Common Name: | IVF Media |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Device: | G-MOPSTM (K021893) |
| 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-MOPSTM is used for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.
G-MOPSTM PLUS is used for handling/manipulating oocytes and embryos in ambient atmosphere. |
1
Intended Use:
G-MOPSTM is intended for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.
G-MOPS™ PLUS is intended for handling/manipulating oocytes and embryos in ambient atmosphere.
Technological Characteristics:
G-MOPSTM/G-MOPSTM PLUS is a device used for handling and manipulating oocytes and embryos in ambient atmosphere.
The product G-MOPS™/G-MOPS™ PLUS is a modification of the device G-MOPS™ GIII Series (K021893). The technological characteristics of G-MOPSTM/G-MOPSTM PLUS are essentially similar to those of the predicate device. None of the differences between the predicate device and G-MOPS™ / G-MOPS™ PLUS do raise any new questions of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2008
Mr. Kjell Kjörk Pharmacist, Regulatory Affairs Manager Vitrolife Sweden AB Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN
Re: K081115
Trade Name: G-MOPSTM and G-MOPSTM PLUS Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: September 5, 2008 Received: September 5, 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 yours.
Jose M. Whang
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
4
INDICATIONS FOR USE STATEMENT XI.
510(k) Number (if known): K081115
Device Name:
G-MOPSTM
Indications for Use:
G-MOPS™ is indicated for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_**_
(Per 21 C.F.R. § 801.109)
OR
Over-the Counter Use.
Huld Reume
vision Sign-Off) ivision of Reproductive, Abdomina and Radiological Devices 510(k) Number
5
INDICATIONS FOR USE STATEMENT XI.
510(k) Number (if known): K081115
Device Name:
G-MOPS™ PLUS
Indications for Use:
G-MOPS™ PLUS is indicated for handling/manipulating oocytes and embryos in ambient atmosphere.
(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)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K081115