G-TL

K133568 · Vitrolife, Inc. · MQL · Jul 16, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K133568
• Device Name: G-TL
• Applicant: Vitrolife, Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jul 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Indications for Use

G-TL™ is a medium for culture of embryos from fertilization to blastocyst stage.

Device Story

G-TL™ is an aseptically filtered, bicarbonate-buffered physiological medium used by assisted reproduction professionals. It supports human embryo development from fertilization through the blastocyst stage. The medium is supplied in a 30ml PETG bottle and requires warming to 37°C and equilibration in a CO2 environment prior to use. It contains essential salts, amino acids, vitamins, hyaluronan, and gentamicin. The device provides a controlled environment for embryo culture, facilitating development in vitro. Clinical benefit is derived from its role in maintaining embryo viability during the culture period.

Clinical Evidence

Bench testing only. Performance was validated using the one-cell mouse embryo assay (MEA) comparing G-TL™ to the predicate device (CSC™ Complete). Results showed no differences in embryo development or viability. Shelf life was validated through stability studies up to 21 weeks.

Technological Characteristics

Aseptically filtered, bicarbonate-buffered physiological salt solution. Contains Gentamicin (antibacterial) and therapeutic human serum albumin (HSA). Includes taurine, hyaluronan, and vitamins (calcium pantothenate, pyridoxine, thiamine, riboflavin). pH 7.30 ±0.1; osmolality 270 ±5 mOsm/Kg. Sterility level SAL 10^-3; endotoxin <0.25 EU/ml. Packaged in 30ml PETG bottles with HDPE closures. Storage: dark at +2 to 8°C.

Indications for Use

Indicated for the culture of human embryos from fertilization to the blastocyst stage in an in vitro environment.

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.

Predicate Devices

• CSC™ Complete (K121572)

Reference Devices

• Early Cleavage Medium® (K033462)
• MultiBlast Media™ (K034063)
• G-1™/G-2™ version 3 (K022244)
• G-1™/G-2™ version 3 (K021890)
• G-1™/G-2™ v5 (K081114)
• G-1™/G-2™ v5 (K081117)
• EmbryoAssist (K080473)
• BlastAssist (K080172)

Submission Summary (Full Text)

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Name: G-TL™ K133568

K133568
pg 1 of 5
Vitrolife

## 510(k) Summary

JUL 1 6 2014

Submitted by:

Vitrolife, Inc.

3601 South Inca Street Englewood, CO 80110

USA

Contact Person:

Mark Larman, Ph.D.

Vitrolife, Inc

3601 South Inca Street

Englewood, CO 80110

USA

Phone: [phone]

[phone] Fax:

Email:

#### Date Prepared:

07/14/2014 ·

### Device Identification:

| Trade Name: | G-TL TM |
|-----------------|---------------------------------------------------------------------------------|
| Common Name: | IVF Media |
| Classification: | Class II Reproductive Media and Supplements (CRF 844.6180;<br>Product Code MQL) |

Predicate Device:

CSC™ Complete (K121572)

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#### Description of the device:

G-TL™ is an aseptically filtered and manufactured bicarbonate-buffered physiological medium ready to use after warming to 37°C and equilibration in a CO2 environment. It is designed to be used by professionals within assisted reproduction. G-TL™ is intended for the culture of human embryos from fertilization to the time of embryo transfer. G-TL™ is contained within a 30ml transparent polyethyleneterephthalate glycol (PETG) bottle with high density polyethylene (HDPE) closures. Both the bottle and box are individually labeled and each box contains a package insert.

#### Indication for Use:

G-TL™ is a medium for culture of embryos from fertilization to blastocyst stage.

#### Technical Characteristics:

CSC™ Complete and G-TL™ are aseptically filtered, physiological salt solutions containing pharmaceutical grade Gentamicin as an antibacterial agent and therapeutic human serum albumin (HSA). The predicate and new device are bicarbonate-buffered media for human embryo culture and are ready to use after warming to 37 ℃ and equilibration in a CO2 environment. The predicate and new device have the same sterility level (SAL 10 3), endotoxin level (<0.25 EU/ml), mouse embryo assay (≥80% expanded blastocyst on day 5) and storage conditions (store dark at +2 to 8°C). Physical specifications (pH and osmolality) are in the same physiological range for the predicate and new device (see Table 1). The indications for use are also the same as CSC™ Complete is a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro.

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Name: G-TL™

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| Table 1. Specifications of predicate and new device | | |
|-----------------------------------------------------------|----------------------|----------------------|
| | CSC™ Complete | G-TL™ |
| | K121572 | K133568 |
| pH | 7.25-7.54 | 7.30 ±0.1 |
| Osmolality (mOsm/Kg) | 265 ±5 | 270 ±5 |
| SAL | 10-3 | 10-3 |
| Bacterial endotoxin<br>(EU/ml) | <0.25 | <0.25 |
| Mouse embryo assay<br>(% expanded blastocyst on<br>Day 5) | ≥80 | ≥80 |
| Storage conditions | Store dark +2 to 8°C | Store dark +2 to 8°C |

The technological characteristics, specifications and indications of use for G-TL™ are comparable to those of the predicate device. Thus, there are no concerns with regards to substantial equivalence or safety and efficacy.

There are six chemical composition differences when comparing CSC™ Complete to G-TL™ (see Table 2).

- Taurine is a derivative of the amino acid cysteine and is present in G-TL™. . Taurine is present in 510(k) cleared devices for embryo culture from day 1-5 (Early Cleavage Medium® K033462 and MultiBlast Media™ K034063: Invine Scientific).
- G-TL™ contains a macromolecule named hyaluronan. Hyaluronan is widely distributed throughout tissues and is the major glycosaminoglycan present in follicular, oviductal and uterine fluid. Hyaluronan has been included in Vitrolife's Sequential Media for in vitro embryo culture G-1™/G-2™ version 3 (K022244 and K021890) since 2005 and continued with G-1™/G-2™ v5 (K081114 and K081117).

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Name: G-TL™ K133568

Image /page/3/Picture/1 description: The image shows the word "Vitrolife" in a large, bold font, with the letters in black. Above the word, there is the text ". K133568 pg. 4 of 5". To the right of the word "Vitrolife", there is a black curved line that resembles a check mark.

- Four vitamins (calcium pantothenate, pyridoxine, thiamine and riboflavin) are . present in G-TL™. Vitamins have been included in Vitrolife's media (K021890 and K081117) and are also found in Origio's EmbryoAssist (K080473) and BlastAssist (K080172) Orgio.
The differences in composition do not affect substantial equivalence and raise no concerns regarding safety and efficacy. Furthermore, animal studies during product development demonstrate that G-TL™ is substantially equivalent to the predicate device.

| Table 2 Chemical composition | | |
|-------------------------------|------------------|---------|
| | CSC™<br>Complete | G-TL™ |
| | K121572 | K133568 |
| Sodium Chloride | X | X |
| Potassium<br>Chloride | X | X |
| Calcium Chloride | X | X |
| Magnesium<br>Sulfate | X | X |
| Sodium/Potassium<br>Phosphate | X | X |
| Sodium<br>Bicarbonate | X | X |
| Sodium pyruvate | X | X |
| Glucose | X | X |
| Sodium L- lactate | X | X |
| EDTA | X | X |
| Sodium Citrate | X | X |

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Name: G-TL™ K133568

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| Taurine | - | X |
|---------------------------------------|---|---|
| Alanyl glutamine | X | X |
| Gentamicin | X | X |
| Hyaluronan<br>(sodium<br>hyaluronate) | - | X |
| Non-essential<br>amino acids | X | X |
| Essential amino<br>acids | X | X |
| Vitamins | - | X |

#### Performance data

The shelf life of G-TL has been validated in stability studies measuring the specifications to 21 weeks.

G-TL™ was compared to CSC™ Complete using the one-cell mouse embryo assay (MEA). There were no differences in embryo development or viability. Therefore, G-TL is considered substantially equivalent to the predicate device CSC™ Complete (K121572).

#### Conclusions:

The data demonstrates that the new device (G-TL™) is as safe and effective as the predicate device. The data also supports the determination of substantial equivalence between the predicate and new device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 16, 2014

Vitrolife, Inc. Mark Larman, Ph.D. Senior Scientist 3601 S. Inca Street · Englewood, CO 80110

K133568 Re:

Trade/Device Name: G-TLTM Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: June 18, 2014 Received: June 19, 2014

Dear Mark Larman.

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.

ff 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 comply with all the Act`s requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mark Larman, Ph.D.

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/Resourcesfor You/Industry/default.htm. 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 (21CFR 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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K133568

Device Name G-TL

Indications for Use (Describe) Medium for culture of embryos from fertilization to blastocyst stage

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 : 1

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Benjamin R. Fisher -S 2014.07.16 18:28:02 -04'00'

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