(272 days)
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No
The summary describes a cryopreservation media, a chemical substance used in assisted reproduction. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is used for the preparation and preservation of human embryos for cryopreservation, and for freezing and thawing during assisted reproduction procedures. It is a media, not a device used to treat a disease or condition in a patient.
No
Explanation: This device, Cryopreservation Media, is used for the preservation of human embryos. Its function is to facilitate the freezing and thawing processes for assisted reproduction procedures, not to diagnose a disease, condition, or state of health.
No
The device description clearly states "Cryopreservation Media," which is a physical substance used in a medical procedure, not software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for assisted reproduction procedures, for the purposes of preparation of the human embryos for cryopreservation." This involves handling and processing human biological material (embryos) outside of the body.
- Device Description: "Cryopreservation Media" is a substance used to preserve biological material.
- Assisted Reproduction Procedures: These procedures inherently involve working with human gametes and embryos in a laboratory setting, which falls under the scope of in vitro diagnostics.
While the document doesn't explicitly state "in vitro diagnostic," the nature of the device and its intended use strongly 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 "condition" is related to fertility and the "state of health" is related to the viability of embryos for future implantation.
N/A
Intended Use / Indications for Use
Cryopreservation Media is used for assisted reproduction procedures, for the purposes of preparation of the human embryos for cryopreservation. They are used during the cryopreservation process of preserving embryos, both for freezing and thawing during assisted reproduction procedures.
Product codes
85 MQL
Device Description
Cryopreservation Media
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
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Key Metrics
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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
JAN 1 8 2000
Advanced Reproductive Technologies, Inc. c/o Greg Holland Holland & Associates 3722 Avenue Sausalito Invine, CA 92606
Re: K991390
Quinn's ® Cryopreservation Media, 1.5M Dated: December 6, 1999 Received: December 7, 1999 Requlatory Class: II 21 CFR §884.6180/Procode: 85 MQL
Dear Mr. Holland:
'We have reviewed vour 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 pror 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations. 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 regult 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 submission 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compirance 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,
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. - Cryopreservation Media
Page
510(k) Number (if known):_K991390
Cryopreservation Media Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Cryopreservation Media is used for assisted reproduction procedures, for the purposes of preparation of the human embryos for cryopreservation. They are used during the cryopreservation process of preserving embryos, both for freezing and thawing during assisted reproduction procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive. Abdominal, ENT, and Radiological D 510(k) Number
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use (Optional Format 1-2-96)
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