EEVA DISH (WITH 12 MICROWELLS)

K141663 · Auxogyn, Inc. · MQK · Jul 22, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K141663
• Device Name: EEVA DISH (WITH 12 MICROWELLS)
• Applicant: Auxogyn, Inc.
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Jul 22, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Intended Use

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

Device Story

Eeva™ Dish is a sterile, single-use polystyrene culture dish designed for IVF laboratories. It features a central ring with 12 tapered microwells (350 microns diameter, 134 microns deep) to stabilize and segregate individual human oocytes or embryos during culture, plus three outer rings for media rinsing. The device is operated by embryologists or qualified lab professionals. It provides a controlled environment for embryo handling and development. By stabilizing embryos in individual wells, it facilitates observation and management during the culture process, supporting standard IVF workflows.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including pyrogenicity (LAL testing ≤ 20 EU/Device), embryotoxicity (1-Cell Mouse Embryo Assay with ≥ 80% development to blastocyst stage), packaging integrity, shipping validation, sterilization validation, shelf-life verification, and usability testing.

Technological Characteristics

Constructed of 100% virgin polystyrene. Dimensions: 38mm outer diameter, 35mm inner diameter, 11mm height. Features 12 microwells (350 microns diameter, 134 microns deep) with tapered walls. Sterilized via gamma irradiation to an SAL of 10^-6. Single-use, non-pyrogenic, non-embryotoxic. Standalone labware device.

Indications for Use

Indicated for holding human oocytes and embryos during handling and culture in IVF procedures performed by qualified professionals.

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

• Eeva™ Petri Dish (K103028)

Submission Summary (Full Text)

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## Special 510(k) Premarket Notification Eeva™ Dish

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510(k) Summary - K141663 Pg. 1 of 4

JUL 2 2 2 2014

| Applicant: | Auxogyn, Inc.<br>1490 O'Brien Drive, Suite A<br>Menlo Park, CA 94025 |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julia S. Anastas<br>Director, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Summary Prepared: | July 14, 2014 |
| Device Common Name: | IVF Culture Dish |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 884.6160 |
| Classification Name: | Assisted Reproduction Labware |
| Product Code: | MQK |
| Device Proprietary Name | Eeva™ Dish |
| Predicate Device: | Eeva™ Petri Dish |
| Predicate Device<br>Manufacturer: | Auxogyn, Inc.<br>1490 O'Brien Drive<br>Menlo Park, CA 94025 |
| Predicate Device Common<br>Name: | IVF Culture Dish |
| Predicate Device Premarket<br>Notification Number: | K103028 |
| Predicate Device<br>Classification: | Class II |
| Predicate Device Regulation<br>Number: | 21 CFR 884.6160 |
| Classification Name: | Assisted Reproduction Labware |
| Product Code: | MQK |
| Device Description: | The Eeva Dish is a round dish with an outer diameter of 38 mm; the inner diameter<br>of the dish is 35mm. The dish is provided with a lid.<br>The interior of the dish contains a large central ring approximately 10mm in<br>diameter, which contains 12 smaller, round microwells, each intended to hold a<br>single human oocyte or embryo. The device allows for the segregation of embryos<br>while they are immersed in the same drop of culture media The microwells are 350<br>microns in diameter and 134 microns deep, which creates sufficient room for<br>handling of human oocytes and embryos with a pipette. The center ring has a<br>tapered wall to stabilize and minimize embryo movement in the microwells.<br>The dish also contains three smaller outer rings, approximately 8mm in diameter<br>each, that are intended to hold media drops for rinsing oocytes or embryos. The<br>center and three outer rings can each hold 100ul of media. |
| | The dish is constructed of virgin polystyrene and is non-pyrogenic and non-<br>embryotoxic. The dish is single use only and is packaged with 3 units per sterile<br>pouch, 12 pouches per corrugated cardboard shipping carton. |
| Indications for Use: | The Eeva™ Dish is intended to be used to hold human oocytes and embryos during<br>handling and culture. |
| Technological Characteristics<br>and Comparison to Predicate<br>Device: | The dish with 12 microwells is substantially equivalent in indications for use,<br>intended use, and materials and design to the predicate device, the dish with 16 or<br>25 microwells, cleared as the Eeva™ Petri Dish. A comparison of the subject and<br>predicate devices is presented in the table below. |

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# 510(k) Summary - K141663 Pg. 2 of 4

| Characteristic | New Device (K141663)<br>Eeva Dish, 12-Microwell<br>configuration | Predicate Device (K103028)<br>Eeva Petri Dish, 16- and 25-Microwell<br>configurations |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Indications for Use | The Eeva™ Dish is intended to hold<br>human oocytes and embryos during<br>handling and culture. | Same |
| Principles of Operation /<br>Conditions of Use | Microwell tissue culture dish for use<br>in IVF procedures performed by<br>qualified professionals. The dish is a<br>restricted device. | Same |
| Dish and Lid Materials | 100% virgin polystyrene | Same |
| Shelf-life | 6-months | Same |
| Sterilization | Gamma irradiation to an SAL of 106 | Same |
| Packaging | Dish is packaged as 3 dish units in a<br>sterile, nylon, film-to-film pouch<br>(single-use only) | Same |
| Pyrogenicity Testing | Non-pyrogenic as tested by Limulus<br>Amoebocyte Lysate (LAL) testing<br>(≤ 20 EU/Device) | Same |
| Embryotoxicity Testing | Non-embryotoxic as tested by 1-Cell<br>Mouse Embryo Assay (MEA), with<br>≥ 80% of embryos developing to<br>expanded blastocyst stage within 96<br>hours. | Same |

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## Special 510(k) Premarket Notification Eeva™ Dish

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510(k) Summary - K141663 Pg. 3 of 4

| Characteristic | New Device (K141663)<br>Eeva Dish, 12-Microwell<br>configuration | Predicate Device (K103028)<br>Eeva Petri Dish, 16- and 25-Microwell<br>configurations | |
|-------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------|
| Dish Dimensions | | | |
| Dish Inside Diameter<br>(mm) | 35 | Same | |
| Dish Outside Diameter<br>(mm) | 38 | 39 | 39 |
| Dish Height (mm) | 11 | Same | |
| Central Ring,<br>Diameter(mm) | 10 | 9 | 7 |
| Central Ring,<br>Height(mm) | 2.5 | 0.5 | 0.5 |
| Central Ring Walls | Beveled walls to stabilize<br>embryos in microwells | Straight walls, no bevel | |
| Central Ring Volume<br>(µL of media) | 100 | 80 | 50 |
| 3 Outer Rings,<br>Diameter (mm) | 8 | 7 | 7 |
| 3 Outer Rings, Height<br>(mm) | 2.5 | 0.5 | 0.5 |
| 3 Outer Rings, Volume<br>(µl of media) | 100 | 50 | 50 |
| Microwell Dimensions | | | |
| Number of Microwells<br>(in central ring) | 12 microwells | 16 microwells | 25 microwells |
| Microwell shape &<br>size (microns) | Circle | Square | Square |
| | 350 | 300 x 300 | 250 x 250 |
| Microwell depth<br>(microns) | 134 | 150 | 100 |

Dish and microwell dimensional differences between the new device and the predicate are minor. The modified dish and microwell dimensions are intended to provide flexibility for the user and aid in device usability. The minor differences in dimensions do not represent a new technology raising new types of safety or effectiveness questions.

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510(k) Summary - K141663 Pg. 4 of 4

| Summary of Non-clinical<br>Supporting Data: | Non-clinical testing was conducted on the Eeva Dish with 12 microwells to support a<br>determination of substantial equivalence to the predicate devices. Testing included: |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Pyrogenicity Testing |
| | Embryotoxicity Testing |
| | Packaging Integrity |
| | Shipping Validation |
| | Sterilization Validation |
| | Shelf Life Verification |
| | Lab Equipment Compatibility Verification |
| | Usability Verification |
| Conclusion: | When compared to the predicate device, the Eeva Dish has the same indication for<br>use and intended use. In addition, the Eeva Dish does not incorporate any<br>significant changes in method of operation, material, or design that would result in a<br>new technology raising new types of safety or effectiveness questions. Therefore,<br>the Eeva Dish, 12-microwell configuration is substantially equivalent to the predicate<br>device. |

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

July 22, 2014

Auxogyn, Inc. Julia Anastas Director, Regulatory Affairs 1409 O'Brien Drive, Suite A Menlo Park, CA 94025

Re: K141663

> Trade/Device Name: Eeva™ Dish Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: Class II Product Code: MQK Dated: June 19, 2014 Received: June 23, 2014

Dear Julia Anastas,

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

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Page 2 - Julia Anastas

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

### Indications for Use

510(k) Number (if known)

#### K141663

Device Name Eeva™ Dish

Indications for Use (Describe)

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

Image /page/6/Picture/7 description: The image contains the name "Benjamin R. Fisher -S" in bold font. Below the name is a timestamp "2014.07.22 16:27:00 -04'00'" which is also in bold font. The timestamp includes the date, time, and timezone offset. The text appears to be extracted from a document or a digital image.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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