(124 days)
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No
The 510(k) summary describes culture media for embryos and oocytes, with no mention of AI, ML, image processing, or any computational analysis of data.
No
The descriptions indicate the devices are used for culturing, fertilizing, washing, manipulating, and transferring oocytes and embryos, which are in vitro procedures, not therapeutic treatments applied to a patient.
No
The intended use describes the culture and manipulation of oocytes and embryos, which are procedures for fertility treatment, not for diagnosing a condition or disease.
No
The provided 510(k) summary describes culture media for embryos and oocytes, which are biological products, not software. The summary lacks any mention of software components or functionalities.
Based on the provided information, these devices are likely IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended uses clearly describe the devices being used in vitro (outside the body) for the culture, manipulation, and fertilization of human gametes (oocytes and sperm) and embryos. These are all processes performed on biological samples to obtain information or facilitate a medical procedure (assisted reproduction).
- Nature of the Devices: Culture media like these are specifically designed to support the growth and development of biological materials in vitro.
While the "Device Description" is not found, the intended use is the primary indicator for determining if a device is an IVD. The fact that these are used for in vitro procedures involving human biological samples strongly points towards them being IVDs.
The absence of information about image processing, AI/ML, imaging modality, anatomical site, patient age, user, training/test sets, performance studies, metrics, and predicate/reference devices is not surprising for this type of IVD. These details are more commonly found in submissions for imaging devices or devices that perform analysis or diagnosis based on data.
Therefore, based on the provided intended use, these LifeGlobal® Global® Total® products are almost certainly IVDs.
N/A
Intended Use / Indications for Use
LifeGlobal® Global® Total® w/HSA: Culture of embryos from zygote to blastocyst, embryo transfer
LifeGlobal® Global® Total® for Fertilization w/HSA: Oocyte culture and fertilization
LifeGlobal® Global® Total® w/HEPES w/HSA: Oocyte and embryo washing, manipulation, fertilization by intracytoplasmic sperm injection (ICSI), 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
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right, connected by a flowing ribbon-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 17, 2015
Lifeglobal Group, LLC Michael Cecchi President 393 Soundview Road Guilford, CT 06437
Re: K142991 Trade/Device Name: LifeGlobal® Global® Total® w/HSA LifeGlobal® Global® Total® for Fertilization w/HSA LifeGlobal® Global® Total® w/HEPES w/HSA Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: Class II Product Code: MQL Dated: November 17, 2014 Received: November 19, 2014
Dear Michael 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 mav 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Benjamin R. Fisher -S
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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Indications for Use
510(k) Number (if known) K142991
Device Name
LifeGlobal® Global® Total® wHSA; LifeGlobal® Total® for Fertilization wHSA; LifeGlobal® Global® Total® w/HEPES w/HSA
Indications for Use (Describe)
LifeGlobal® Global® Total® w/HSA: Culture of embryos from zygote to blastocyst, embryo transfer
LifeGlobal® Global® Total® for Fertilization w/HSA: Oocyte culture and fertilization
LifeGlobal® Global® Total® w/HEPES w/HSA:
Oocyte and embryo washing, manipulation, fertilization by intracytoplasmic sperm injection (ICSI), embryo transfer
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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