(300 days)
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No
The document describes culture media for assisted reproduction, with no mention of AI or ML technology.
No
The device, a 'Media for Embryo Preparation', is used for in vitro fertilization and culturing of embryos, which supports reproductive procedures. It does not directly treat or cure a disease or condition in a patient.
No
The text describes products related to embryo preparation and culture for assisted reproduction procedures. These are media used for maintaining and manipulating gametes and embryos, not for diagnosing medical conditions.
No
The device description clearly states that the device is "Media for Embryo Preparation products," which are physical substances used in assisted reproduction procedures. This is not a software-only device.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the media are used for "assisted reproduction procedures" and "come in direct physical contact with human gametes or embryos for the purposes of preparation, maintenance, transfer or storage." These procedures are performed in vitro (outside the body) and involve the manipulation and assessment of human biological material (gametes and embryos).
- Device Description: The device description reiterates the use of the media in "assisted reproduction procedures" and their contact with "human gametes or embryos."
While the document doesn't explicitly use the term "diagnostic," the nature of assisted reproduction procedures often involves assessing the viability and development of gametes and embryos. The media are essential components in these in vitro processes that lead to a clinical outcome (pregnancy).
Therefore, the device fits the definition of an IVD as it is used in vitro for purposes related to human health (reproduction) and involves the handling and preparation of human biological specimens.
N/A
Intended Use / Indications for Use
Media for Embryo Preparation products that are used for assisted reproduction procedures. These media come in direct physical contact with human gametes or embryos for the purposes of preparation, maintenance, transfer or storage.
Quinn's® HTF Medium was developed for in vitro fertilization and procedures involving the culture of early cleavage stage mammalian embryos.
Quinn's® HTF Medium with HEPES was developed for in vitro procedures involving manipulations of gametes and embryos not requiring the use of a CO2 incubator. Such procedures include oocyte recovery, gamete washing, micromanipulation, embryo transfer and cryopreservation.
Quinn's® Basal XI HTF Medium was developed for in vitro procedures involving the culture of early cleavage stage mammalian embryos. This is the medium for culture of embryos from Day 1 through to Day 3.
Quinn's® D3+ Medium was developed for in vitro procedures involving the culture of early cleavage stage mammalian embryos. This is the medium for culture of embryos after Day 3 of development.
Product codes
85 MQL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2000
Advanced Reproductive Technologies, Inc. c/o Mr. Greg Holland Holland & Associates 3722 Avenue Sausalito Irvine, CA 92606
Re: K991395
Media for Embryo Preparation Dated: November 30, 1999 Received: December 1, 1999 Requlatory Class: II 21 CFR §884.6180/Procode: 85 MQL
Dear Mr. Holland:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin markeling 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CART David C. Schultz, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Premarket Notification - Advanced Reproductive Technologies, Inc. - Media for Gamete Preparation and Embryo Culture
Page
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Media for Embryo Preparation products that are used for assisted reproduction procedures. These media come in direct physical contact with human gametes or embryos for the purposes of preparation, maintenance, transfer or storage.
Quinn's® HTF Medium was developed for in vitro fertilization and procedures involving the culture of early cleavage stage mammalian embryos.
Quinn's® HTF Medium with HEPES was developed for in vitro procedures involving manipulations of gametes and embryos not requiring the use of a CO2 incubator. Such procedures include oocyte recovery, gamete washing, micromanipulation, embryo transfer and cryopreservation.
Quinn's® Basal XI HTF Medium was developed for in vitro procedures involving the culture of early cleavage stage mammalian embryos. This is the medium for culture of embryos from Day 1 through to Day 3.
Quinn's® D3+ Medium was developed for in vitro procedures involving the culture of early cleavage stage mammalian embryos. This is the medium for culture of embryos after Day 3 of development.
(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 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -------------------------------------------- |
OR
| Over-The-Counter Use
| (Optional Format 1-2-96) | |
|---|---|
| -------------------------------------------------- | -- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K991395 |
|---|---|
| --------------- | --------- |
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