(287 days)
LifeGlobal Global Total: Culture of human embryos from zygote to blastocyst, and embryo transfer
LifeGlobal Global Total for Fertilization: Human oocyte culture and fertilization
LifeGlobal Global Total w/HEPES: Human oocyte and embryo washing and manipulation, fertilization by intracytoplasmic sperm injection (ICSI), and embryo transfer
Not Found
I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a reproductive media device, not an AI/ML device.
The letter confirms substantial equivalence but does not describe the specific performance studies, acceptance criteria, or ground truth methodologies that would be relevant for an AI/ML product. The document focuses on regulatory compliance and classification of a medical device (reproductive media), not on the evaluation of an AI algorithm's performance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 3 2012
Mr. Michael D. Cecchi President international, Inc. 393 Soundview Road GUILFORD CT 06437
K112083 Re:
Trade/Device Name: LifeGlobal Global Total
LifeGlobal Global Total for Fertilization LifeGlobal Global Total w/HEPES
Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: April 17, 2012 Received: April 18, 2012
Dear Mr. Cecchi:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 or any I vath all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); 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. 1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. Evans
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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international, inc.
INDICATIONS FOR USE
510 (k) Number (if known) K112083
Device Names:
LifeGlobal Global Total LifeGlobal Global Total for Fertilization LifeGlobal Global Total w/HEPES
Indications for Use:
LifeGlobal Global Total:
Culture of human embryos from zygote to blastocyst, and embryo transfer
LifeGlobal Global Total for Fertilization:
Human oocyte culture and fertilization
or
LifeGlobal Global Total w/HEPES
Human oocyte and embryo washing and manipulation, fertilization by intracytoplasmic sperm injection (ICSI), and embryo transfer
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
Over-the Counter Use
Beniamin R. Lope
(Division Sign-Off)
02 May 2012
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112083
B
§ 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.