(300 days)
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.
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.
This is a 510(k) premarket notification for a medical device called "Media for Embryo Preparation." The provided documents are NOT a study or a report detailing acceptance criteria and device performance. They are regulatory documents from the FDA, specifically:
- Document 0: An FDA letter granting substantial equivalence (510(k) clearance) for the device. This letter indicates that the FDA has reviewed the submission and determined that the device is as safe and effective as a legally marketed predicate device.
- Document 1: The "Indications For Use" statement from the 510(k) submission, outlining the intended purpose of the embryo preparation media.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth information, MRMC study results, etc.) from these documents because they do not contain that type of technical performance data or study report.
To answer your prompt, I would need a different type of document, such as:
- A clinical study report
- A performance testing report
- A validation study report
- The summary of safety and effectiveness (SSE) part of the 510(k) submission, which often includes details on performance data.
Without such a document, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set and data provenance.
- Number and qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
{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 |
|---|---|
| --------------- | --------- |
Pagee g
§ 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.