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.

AI/ML Overview

The provided text describes the "Eeva™ Petri Dish," which is an IVF tissue culture dish. The document is primarily a 510(k) summary for FDA clearance, focusing on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in the context of demonstrating safety and effectiveness as an IVF tissue culture dish, rather than a diagnostic AI device with performance metrics like sensitivity/specificity.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Proxy for Performance Goal)	Reported Device Performance
Non-pyrogenic	Tested by LAL; found to be non-pyrogenic
Non-embryotoxic	Tested by 1-Cell Mouse Embryo Assay (MEA); results showed ≥ 80% of embryos developed to expanded blastocyst stage within 96 hours
Intended Use Equivalence	Substantially equivalent in intended use, Indications for Use, materials and design to the predicate device (SunIVF Embryo Corral Dish). Both devices are used to culture embryos during IVF procedures.
Material Equivalence	Constructed of 100% virgin polystyrene, same as predicate.
Functionality Equivalence	Both devices allow for the segregation of embryos while immersed in the same drop of culture media.
Sterilization Equivalence	Both are single-use only and gamma irradiation sterilized.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Non-pyrogenic (LAL test): The sample size for the LAL test is not specified. The data provenance is not mentioned (e.g., country of origin, retrospective/prospective).
Non-embryotoxic (MEA test): The sample size (number of embryos or tests) for the 1-Cell Mouse Embryo Assay is not specified. The data provenance is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the studies performed (LAL and MEA) are laboratory-based tests for material properties and biological compatibility, not expert-opinion-based evaluations of a ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the tests described. The LAL and MEA tests have specific, objective measurement endpoints.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study and no AI component mentioned in the provided text. This device is a petri dish, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

There was no standalone algorithm performance study as this is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Non-pyrogenic: Ground truth is established by the LAL (Limulus Amebocyte Lysate) assay, which detects bacterial endotoxins. This is an objective, standardized laboratory test.
Non-embryotoxic: Ground truth is established by the 1-Cell Mouse Embryo Assay (MEA), which assesses the device's impact on embryo development. The criterion for success is a predefined percentage (e.g., ≥ 80%) of embryos developing to a specific stage (expanded blastocyst). This is an objective, standardized biological assay.
Substantial Equivalence: The ground truth for this aspect is the comparison of device characteristics (intended use, materials, design) to a legally marketed predicate device, as determined by regulatory review.

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as this is not an AI/machine learning device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a logo with the word "auxogyn" written below it. The logo consists of three overlapping circles, with the top two circles partially obscuring the bottom circle. The word "auxogyn" is written in lowercase letters and appears to be a company or brand name.

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

Device Information:
Category	Comments
Sponsor:	Auxogyn, Inc.1490 O'Brien Drive, Suite A Menlo Park, CA 94025Tel: 650-641-2429
Correspondent ContactInformation:	Robert NewmanVP of Regulatory AffairsAuxogyn, Inc.1490 O'Brien Drive, Suite A Menlo Park, CA 94025Tel: 650-641-2429
Device Common Name:	IVF Tissue Culture Dish
Device Classification Number:	21 CFR 884.6160Assisted Reproduction Labware
Device Classification &Product Code:	Class IIMQK
Device Proprietary Name:	EevaTM Petri Dish

Predicate Device Information:

Predicate Device:	SunIVF Embryo Corral Dish
Predicate Device Manufacturer:	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 constructed of polystyrene and is non-pyrogenic and non-embryotoxic.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows a logo with a stylized design above the word "auxogyn". The logo consists of three interconnected shapes resembling stylized letters or symbols, enclosed within a circle. The word "auxogyn" is written in a simple, sans-serif font, positioned directly below the circular logo.

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 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (DHHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

{3}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows a logo with the word "auxogyn" written below it. The logo consists of a circular design with three smaller circles inside. The circles are arranged in a cluster, with one large circle and two smaller circles overlapping each other.

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)

Page 1 of __ 1________________________________________________________________________________________________________________________________________________________________

form R. Whay

astro-Renal, and

Regulation Number and Section

§ 884.6160 Assisted reproduction labware.

(a)
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.(b)
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.