LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA

K142991 · Life Global Group, LLC · MQL · Feb 17, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K142991
• Device Name: LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA
• Applicant: Life Global Group, LLC
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Feb 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended 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

Device Story

LifeGlobal® Global® Total® series are reproductive media and supplements used in assisted reproductive technology (ART) laboratories. These products provide the necessary environment for oocyte and embryo culture, fertilization (including ICSI), washing, manipulation, and embryo transfer. They are intended for professional use by embryologists and clinicians in clinical laboratory settings. The media support the development of embryos from the zygote stage to the blastocyst stage. By providing a controlled chemical environment, these media facilitate successful fertilization and embryo development, ultimately supporting clinical decision-making regarding embryo selection and transfer to improve patient outcomes in fertility treatments.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Reproductive media and supplements containing Human Serum Albumin (HSA). Formulated for specific ART applications including oocyte/embryo culture, fertilization, and manipulation. Class II device under 21 CFR 884.6180 (Product Code: MQL).

Indications for Use

Indicated for use in assisted reproductive technology (ART) procedures, specifically for the culture, fertilization, washing, and manipulation of oocytes and embryos, and for embryo transfer.

Regulatory Classification

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.).

Special Controls

*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.

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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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