(29 days)
The Eeva™ Dish is intended to be used to hold human oocytes and embryos during handling and culture.
The Eeva Dish is a round dish with an outer diameter of 38 mm; the inner diameter of the dish is 35mm. The dish is provided with a lid. The interior of the dish contains a large central ring approximately 10mm in diameter, which contains 12 smaller, round microwells, each intended to hold a single human oocyte or embryo. The device allows for the segregation of embryos while they are immersed in the same drop of culture media The microwells are 350 microns in diameter and 134 microns deep, which creates sufficient room for handling of human oocytes and embryos with a pipette. The center ring has a tapered wall to stabilize and minimize embryo movement in the microwells. The dish also contains three smaller outer rings, approximately 8mm in diameter each, that are intended to hold media drops for rinsing oocytes or embryos. The center and three outer rings can each hold 100ul of media. The dish is constructed of virgin polystyrene and is non-pyrogenic and non-embryotoxic. The dish is single use only and is packaged with 3 units per sterile pouch, 12 pouches per corrugated cardboard shipping carton.
Here's an analysis of the Eeva™ Dish's acceptance criteria and the supporting study, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The device in question (Eeva™ Dish, 12-microwell configuration) is a modification of a previously cleared predicate device (Eeva™ Petri Dish, 16- and 25-microwell configurations). As such, the acceptance criteria are generally aligned with demonstrating "substantial equivalence" to the predicate, particularly in terms of safety and performance for its intended use. The performance criteria largely mirror those established for the original predicate device and testing aims to show the new design doesn't negatively impact these metrics.
| Acceptance Criterion (for Substantial Equivalence to Predicate) | Reported Device Performance (Eeva™ Dish, 12-Microwell) |
|---|---|
| Indications for Use: Intended to hold human oocytes and embryos during handling and culture. | Matches predicate via "Same" (page 1) |
| Principles of Operation / Conditions of Use: Microwell tissue culture dish for use in IVF procedures performed by qualified professionals. | Matches predicate via "Same" (page 2) |
| Dish and Lid Materials: 100% virgin polystyrene. | Matches predicate via "Same" (page 2) |
| Shelf-life: 6-months. | Matches predicate via "Same" (page 2) |
| Sterilization: Gamma irradiation to an SAL of 10-6. | Matches predicate via "Same" (page 2) |
| Packaging: Dish packaged as 3 units in a sterile, nylon, film-to-film pouch. | Matches predicate via "Same" (page 2) |
| Pyrogenicity Testing: Non-pyrogenic (≤ 20 EU/Device) as tested by Limulus Amoebocyte Lysate (LAL) testing. | Non-pyrogenic (page 2) |
| Embryotoxicity Testing: Non-embryotoxic, with ≥ 80% of embryos developing to expanded blastocyst stage within 96 hours (tested by 1-Cell Mouse Embryo Assay (MEA)). | Non-embryotoxic (page 2) |
| Dish Dimensions: Minor differences demonstrated to not raise new safety/effectiveness questions. | Dish Inside Diameter: 35mm (Same as predicate) (page 3) Dish Outside Diameter: 38mm (Predicate: 39mm) (page 3) Dish Height: 11mm (Same as predicate) (page 3) |
| Central Ring Dimensions: Minor differences demonstrated to not raise new safety/effectiveness questions. | Diameter: 10mm (Predicate: 9mm/7mm) (page 3) Height: 2.5mm (Predicate: 0.5mm) (page 3) Walls: Beveled (Predicate: Straight) (page 3) Volume: 100µL (Predicate: 80µL/50µL) (page 3) |
| Outer Rings Dimensions: Minor differences demonstrated to not raise new safety/effectiveness questions. | Diameter: 8mm (Predicate: 7mm) (page 3) Height: 2.5mm (Predicate: 0.5mm) (page 3) Volume: 100µL (Predicate: 50µL) (page 3) |
| Microwell Dimensions: Minor differences demonstrated to not raise new safety/effectiveness questions. | Number: 12 microwells (Predicate: 16/25) (page 3) Shape & Size: Circle, 350 microns (Predicate: Square, 300x300, 250x250) (page 3) Depth: 134 microns (Predicate: 150/100 microns) (page 3) |
| Packaging Integrity: Validated. | Non-clinical testing indicated (page 4) |
| Shipping Validation: Validated. | Non-clinical testing indicated (page 4) |
| Sterilization Validation: Validated. | Non-clinical testing indicated (page 4) |
| Shelf Life Verification: Verified. | Non-clinical testing indicated (page 4) |
| Lab Equipment Compatibility Verification: Verified. | Non-clinical testing indicated (page 4) |
| Usability Verification: Verified. | Non-clinical testing indicated (page 4) |
Study Details:
The provided document describes a non-clinical testing program conducted on the Eeva™ Dish with 12 microwells to support a determination of substantial equivalence to the predicate devices. The study is a set of tests to ensure the new device functions as intended and safely, similar to the predicate, despite minor design changes.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in terms of specific numbers for each test (e.g., how many dishes were tested for pyrogenicity). The document indicates "Non-clinical testing was conducted on the Eeva Dish with 12 microwells." It implies that sufficient samples were used to meet the requirements of the standards/methods for each test.
- Data Provenance: Not explicitly stated (e.g., country of origin). Given it's a 510(k) submission to the FDA, the testing would generally be expected to follow internationally recognized standards, potentially conducted in the US or by accredited labs elsewhere. The timing (July 2014) is for the summary preparation, the tests themselves would have occurred prior. The study is prospective in nature, as the tests were specifically conducted to evaluate the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable in this context. The Eeva™ Dish is an IVF culture dish, which is a physical labware device. Its performance criteria (e.g., pyrogenicity, embryotoxicity, dimensional accuracy) are assessed through standardized laboratory tests, not through expert interpretation of data or images. "Ground truth" here refers to the quantitative results of these scientific tests against defined criteria.
4. Adjudication method for the test set
- This information is not applicable. As explained above, the tests are objective laboratory assessments with established pass/fail criteria, not subjective interpretations requiring adjudication.
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
- No, an MRMC comparative effectiveness study was not done. This device is a culture dish, not an AI-powered diagnostic tool requiring human reader interaction. Therefore, concepts like "human readers improve with AI" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone AI algorithm study was not done. This device is a physical labware product and does not involve an algorithm.
7. The type of ground truth used
The ground truth used for these tests is based on:
- Standardized assay results: For example, Limulus Amoebocyte Lysate (LAL) testing for pyrogenicity, and 1-Cell Mouse Embryo Assay (MEA) for embryotoxicity (where "non-embryotoxic" is defined by ≥ 80% of embryos developing to the expanded blastocyst stage within 96 hours).
- Engineering specifications and measurements: For dimensional accuracy, packaging integrity, sterilization efficacy, and shelf-life verification.
- Verification of compatibility and usability: Against defined functional requirements.
8. The sample size for the training set
- Not applicable. This device is a physical product, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for this device, there is no ground truth for a training set to be established.
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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.1490 O'Brien Drive, Suite AMenlo Park, CA 94025 |
|---|---|
| Contact Person: | Julia S. AnastasDirector, Regulatory AffairsPhone: 650.763.3875Fax: 650.763.3875E-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 DeviceManufacturer: | Auxogyn, Inc.1490 O'Brien DriveMenlo Park, CA 94025 |
| Predicate Device CommonName: | IVF Culture Dish |
| Predicate Device PremarketNotification Number: | K103028 |
| Predicate DeviceClassification: | Class II |
| Predicate Device RegulationNumber: | 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 diameterof the dish is 35mm. The dish is provided with a lid.The interior of the dish contains a large central ring approximately 10mm indiameter, which contains 12 smaller, round microwells, each intended to hold asingle human oocyte or embryo. The device allows for the segregation of embryoswhile they are immersed in the same drop of culture media The microwells are 350microns in diameter and 134 microns deep, which creates sufficient room forhandling of human oocytes and embryos with a pipette. The center ring has atapered wall to stabilize and minimize embryo movement in the microwells.The dish also contains three smaller outer rings, approximately 8mm in diametereach, that are intended to hold media drops for rinsing oocytes or embryos. Thecenter and three outer rings can each hold 100ul of media. |
| The dish is constructed of virgin polystyrene and is non-pyrogenic and non-embryotoxic. The dish is single use only and is packaged with 3 units per sterilepouch, 12 pouches per corrugated cardboard shipping carton. | |
| Indications for Use: | The Eeva™ Dish is intended to be used to hold human oocytes and embryos duringhandling and culture. |
| Technological Characteristicsand Comparison to PredicateDevice: | The dish with 12 microwells is substantially equivalent in indications for use,intended use, and materials and design to the predicate device, the dish with 16 or25 microwells, cleared as the Eeva™ Petri Dish. A comparison of the subject andpredicate devices is presented in the table below. |
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510(k) Summary - K141663 Pg. 2 of 4
| Characteristic | New Device (K141663)Eeva Dish, 12-Microwellconfiguration | Predicate Device (K103028)Eeva Petri Dish, 16- and 25-Microwellconfigurations |
|---|---|---|
| Indications for Use | The Eeva™ Dish is intended to holdhuman oocytes and embryos duringhandling and culture. | Same |
| Principles of Operation /Conditions of Use | Microwell tissue culture dish for usein IVF procedures performed byqualified professionals. The dish is arestricted 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 asterile, nylon, film-to-film pouch(single-use only) | Same |
| Pyrogenicity Testing | Non-pyrogenic as tested by LimulusAmoebocyte Lysate (LAL) testing(≤ 20 EU/Device) | Same |
| Embryotoxicity Testing | Non-embryotoxic as tested by 1-CellMouse Embryo Assay (MEA), with≥ 80% of embryos developing toexpanded blastocyst stage within 96hours. | 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)Eeva Dish, 12-Microwellconfiguration | Predicate Device (K103028)Eeva Petri Dish, 16- and 25-Microwellconfigurations | |
|---|---|---|---|
| Dish Dimensions | |||
| Dish Inside Diameter(mm) | 35 | Same | |
| Dish Outside Diameter(mm) | 38 | 39 | 39 |
| Dish Height (mm) | 11 | Same | |
| Central Ring,Diameter(mm) | 10 | 9 | 7 |
| Central Ring,Height(mm) | 2.5 | 0.5 | 0.5 |
| Central Ring Walls | Beveled walls to stabilizeembryos in microwells | Straight walls, no bevel | |
| Central Ring Volume(µL of media) | 100 | 80 | 50 |
| 3 Outer Rings,Diameter (mm) | 8 | 7 | 7 |
| 3 Outer Rings, Height(mm) | 2.5 | 0.5 | 0.5 |
| 3 Outer Rings, Volume(µl of media) | 100 | 50 | 50 |
| Microwell Dimensions | |||
| Number of Microwells(in central ring) | 12 microwells | 16 microwells | 25 microwells |
| Microwell shape &size (microns) | Circle | Square | Square |
| 350 | 300 x 300 | 250 x 250 | |
| Microwell depth(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-clinicalSupporting Data: | Non-clinical testing was conducted on the Eeva Dish with 12 microwells to support adetermination 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 foruse and intended use. In addition, the Eeva Dish does not incorporate anysignificant changes in method of operation, material, or design that would result in anew technology raising new types of safety or effectiveness questions. Therefore,the Eeva Dish, 12-microwell configuration is substantially equivalent to the predicatedevice. |
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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 (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
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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.
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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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§ 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.