(287 days)
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Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is used for the culture, fertilization, washing, manipulation, and transfer of human oocytes and embryos, which are medical procedures aimed at treating infertility.
No
The device is described for culturing, washing, manipulation, and fertilization of human oocytes and embryos, not for diagnosing a disease or condition.
Unknown
The provided text only describes the intended use of the device, which is a culture medium. It does not contain any information about the device's description, components, or how it functions, making it impossible to determine if it is software-only.
Based on the provided information, these devices are likely IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended uses clearly describe the use of these devices for the culture and manipulation of human gametes (oocytes and sperm) and embryos outside of the human body. This aligns with the definition of in vitro diagnostics, which are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Specimens: The specimens being used are human oocytes, sperm, and embryos, which are derived from the human body.
- Purpose: While not explicitly stated as "diagnostic," the processes described (fertilization, embryo culture, embryo transfer) are integral parts of assisted reproductive technologies (ART), which are used to address infertility. The success of these processes provides information about the viability and development of the embryos, which can be considered a form of diagnostic or monitoring information in the context of ART.
In summary, the devices are used to examine and manipulate human biological specimens outside the body for purposes related to human reproduction, which strongly indicates they fall under the category of In Vitro Diagnostics.
The lack of information in the other sections (Device Description, Performance Studies, etc.) does not negate the strong indication from the Intended Use.
N/A
Intended Use / 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
Product codes
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
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
2
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