(88 days)
ASPTM -100, GAMETE -20/ -100
Not Found
No
The summary describes a buffered medium for handling oocytes and embryos, with no mention of AI or ML technology.
No
The device is described as a medium for handling and manipulating oocytes and embryos, which is for laboratory procedures rather than treating a disease or condition in a living organism.
No
The description indicates the device is a medium for handling and manipulating oocytes and embryos, not for diagnosing any condition. Its intended use is for laboratory procedures related to fertility, not for making a diagnosis.
No
The device description clearly states it is a "MOPS buffered medium," which is a chemical substance, not software. The intended use also describes handling and manipulating oocytes and embryos, which is a physical process facilitated by the medium.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Medium for handling and manipulating oocytes and embryos in ambient atmosphere." This directly relates to procedures performed in vitro (outside the living body) involving human reproductive cells.
- Device Description: The description details a "MOPS buffered medium" used for "oocyte collection" and "gamete and embryo manipulation." These are all laboratory procedures performed on biological samples.
- Predicate Devices: The listed predicate devices, ASPTM -100 and GAMETE™ -20/ -100, are known to be media used in assisted reproductive technologies (ART), which are IVD procedures.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use and device description clearly align with the definition of an IVD, which are 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 medium is a critical component used in procedures related to fertility and reproduction, which falls under the scope of IVDs.
N/A
Intended Use / Indications for Use
Medium for handling and manipulating oocytes and embryos in ambient atmosphere.
Product codes
85 MQL
Device Description
MOPS buffered medium. For oocyte collection after temperature equilibration at +37°C and ambient atmosphere. For gamete and embryo manipulation after the addition of G-MM or HSA-solution and temperature equilibration at +37°C and 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)
ASPTM -100, GAMETE -20/ -100
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
6 2002 SEP
PREMARKET NOTIFICATION SUMMARY IX.
| 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-MOPSTM |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Device: | ASPTM -100, GAMETE™ -20/ -100 |
| Description of the Device: | MOPS buffered medium.
For oocyte collection after temperature
equilibration at +37°C and ambient atmosphere.
For gamete and embryo manipulation after the
addition of G-MM or HSA-solution and
temperature equilibration at +37°C and ambient
atmosphere. |
| Intended Use: | Medium for handling and manipulating oocytes
and embryos in ambient atmosphere. |
| Technological Characteristics: | The technological characteristics of G-MOPSTM
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 seal of 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 symbol that resembles an eagle or bird in flight.
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
SEP 6 2002
Vitrolife Sweden AB % Mr. Gary L. Yingling Kirkpatrick & Lockhart 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K021893 Trade/Device Name: G-MOPSTM 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. Snigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
X. - INDICATIONS FOR USE STATEMENT
510(k) Number:
.
KO21893
Device Name:
G-MOPS™ Assisted Reproduction Media
Indications For Use:
Medium for handling and manipulating oocytes and embryos in ambient atmosphere.
Rate Philly f. NCS
(Division Sign Off)
of Reproductive, Abdominal, ological 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__ (Per 21 C.F.R. § 801.109)
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()ver-the Counter Use_________________________________________________________________________________________________________________________________________________________