EEVA DISH (WITH 12 MICROWELLS)

{0}------------------------------------------------ ## Special 510(k) Premarket Notification Eeva™ Dish Image /page/0/Picture/1 description: The image shows a logo with the word "auxogyn" written in lowercase letters below a circular graphic. The graphic consists of three curved shapes that appear to be intertwined, creating a stylized and abstract design. The logo has a simple and clean design. 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: 650.763.3875<br>Fax: 650.763.3875<br>E-mail: janastas@auxogyn.com | | 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. | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows a logo with the text "auxogyn" below it. The logo consists of a circular design with interconnected shapes, resembling a stylized flower or a knot. The text is in a simple, sans-serif font and is positioned directly beneath the circular symbol. # 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 | {2}------------------------------------------------ ## Special 510(k) Premarket Notification Eeva™ Dish Image /page/2/Picture/1 description: The image shows a logo with a circular design above the text "auxogvn". The logo consists of a circle with swirling lines around it, enclosed within a semi-circular shape. The text below the logo appears to be a word or abbreviation, presented in a lowercase font. 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. {3}------------------------------------------------ . Image /page/3/Picture/1 description: The image shows a logo with the text "auxogyn" underneath. The logo consists of three overlapping circles, two larger ones on top and a smaller one partially obscured below. The entire design is enclosed within a curved line, resembling a partial circle or arc. 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. | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the text "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall appearance is simple and straightforward, likely part of a document or sign. 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 {5}------------------------------------------------ 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 {6}------------------------------------------------ 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. 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