EEVATM PETRI DISH

K103028 · Auxogyn, Inc. · MQK · Aug 11, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K103028
• Device Name: EEVATM PETRI DISH
• Applicant: Auxogyn, Inc.
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Aug 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Intended Use

The Eeva™ Petri Dish is intended to be used to hold human oocytes and embryos during handling and culture.

Device Story

The Eeva™ Petri Dish is a 39mm diameter polystyrene culture dish designed for IVF procedures. It features a large center well with 16 or 25 micro-wells for embryo segregation and three outer 7mm rings for media drops used in rinsing oocytes or embryos. The device is used by embryologists in clinical laboratory settings to facilitate the handling and culture of embryos while they remain immersed in the same culture media. It is a single-use, gamma-sterilized labware product.

Clinical Evidence

Bench testing only. The device was tested for non-pyrogenicity using LAL testing and non-embryotoxicity using the 1-Cell Mouse Embryo Assay (MEA). Results demonstrated ≥ 80% of embryos developed to the expanded blastocyst stage within 96 hours.

Technological Characteristics

Constructed of 100% virgin polystyrene. Dimensions: 39mm diameter. Features a center well with 16 or 25 micro-wells and three 7mm outer rings. Sterilization: Gamma irradiation. Single-use.

Indications for Use

Indicated for holding human oocytes and embryos during handling and culture in an IVF laboratory setting.

Regulatory Classification

Identification

Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, 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

• SunIVF Embryo Corral Dish (K993881)

Submission Summary (Full Text)

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Section 5: 510(k) Summary AUG 1 1 2011

| Device Information: | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Category | Comments |
| Sponsor: | Auxogyn, Inc.<br>1490 O'Brien Drive, Suite A Menlo Park, CA 94025<br>Tel: [phone] |
| Correspondent Contact<br>Information: | Robert Newman<br>VP of Regulatory Affairs<br>Auxogyn, Inc.<br>1490 O'Brien Drive, Suite A Menlo Park, CA 94025<br>Tel: [phone] |
| Device Common Name: | IVF Tissue Culture Dish |
| Device Classification Number: | 21 CFR 884.6160<br>Assisted Reproduction Labware |
| Device Classification &<br>Product Code: | Class II<br>MQK |
| Device Proprietary Name: | EevaTM Petri Dish |

# Predicate Device Information:

| Predicate Device: | SunIVF Embryo Corral Dish |
|-------------------------------------------|-------------------------------|
| Predicate Device Manufacturer: | <GenX> International, Inc. |
| Predicate Device Common Name: | IVF Tissue Culture Dish |
| Predicate Device Premarket Notification # | K993881 |
| Predicate Device Classification: | 21 CFR 884.6160 |
| | Assisted Reproduction Labware |
| Predicate Device Classification & | Class II |
| Product Code: | MQK |

### b. Date Summary Prepared

August 3rd, 2011

## c. Description of Device

The Eeva™ Petri Dish is 39mm in diameter with a lid and consists of a large center well containing 16 or 25 micro-wells. The Eeva Petri dish also contains three smaller outer rings, approximately 7mm in diameter each, which are intended to hold media drops for rinsing the oocytes or embryos.

The Eeva™ Petri Dish is constructed of polystyrene and is non-pyrogenic and non-embryotoxic.

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#### d. Indication for Use

The Eeva™ Petri Dish is intended to be used to hold human oocytes and embryos during handling and culture.

### e. Comparison to Predicate Device

The Eeva™ Petri Dish is substantially equivalent in intended use, Indication for Use, materials and design to the predicate device, the SunIVF Embryo Corral Dish, originally cleared as the <genX> dish (K993881).

Both devices are used to culture embryos during IVF procedures. Both devices are constructed of 100% virgin polystyrene. Both devices allow for the segregation of embryos while immersed in the same drop of culture media. Both devices are non-pyrogenic and non-embryotoxic.

Both devices are single use only and are gamma irradiation sterilized.

Auxogyn, Inc. concludes that the devices are substantially equivalent.

### f. Summary of Supporting Data

The Eeva™ Petri Dishes are non-pyrogenic as tested by LAL and non-embryotoxic as tested by 1-Cell Mouse Embryo Assay (MEA), with ≥ 80% of embryos developed to expanded blastocyst stage within 96 hours.

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

Mr. Robert Newman Vice-President, Regulatory Affairs Auxogyn, Inc. 1490 O'Brien Drive, Suite A MENLO PARK CA 94025

AUG 1 1 2011

K103028 Trade Name: Eeva™ Petri Dish Regulation Number: 21 CFR §884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MQK Dated: August 3, 2011 Received: August 5, 2011

Dear Mr. Newman:

Re:

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 comply with 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 of medical device-related

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Section 4: Indications for Use Statement

510(k) Number (if known): K | 03 02 3

Eeva™ Petri Dish Device Name:

Indications For Use:

The Eeva™ Petri Dish is intended to be used to hold human oocytes and embryos during handling and culture.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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form R. Whay

astro-Renal, and