(29 days)
Not Found
No
The device description and performance studies focus solely on the physical characteristics and biological compatibility of the dish itself, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a dish used to hold oocytes and embryos; it does not provide any therapeutic effect.
No
The device description indicates it is "intended to be used to hold human oocytes and embryos during handling and culture" and describes its physical characteristics for that purpose. There is no mention of it being used to detect, diagnose, or monitor a medical condition.
No
The device description clearly details a physical dish made of polystyrene with specific dimensions and features for holding oocytes and embryos. It is a tangible hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "hold human oocytes and embryos during handling and culture." This describes a container for biological samples, not a device that performs a diagnostic test on those samples.
- Device Description: The description details the physical characteristics of the dish and its compartments for holding and segregating oocytes and embryos. It does not mention any components or processes related to analyzing or testing the samples for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of reagents, assays, measurement of biomarkers, or any other elements typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on the physical and biological compatibility of the dish (pyrogenicity, embryotoxicity, packaging, sterilization, etc.), not on the accuracy or reliability of a diagnostic result.
- Predicate Device: The predicate device is also a "Petri Dish," which is a common laboratory container, not a diagnostic device.
In summary, the Eeva Dish is a laboratory tool designed to facilitate the handling and culture of human oocytes and embryos. It does not perform any diagnostic function on these samples.
N/A
Intended Use / Indications for Use
The Eeva™ Dish is intended to be used to hold human oocytes and embryos during handling and culture.
Product codes
MQK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
IVF procedures performed by qualified professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was conducted on the Eeva Dish with 12 microwells to support a 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.
1490 O'Brien Drive, Suite A
Menlo Park, CA 94025 |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julia S. Anastas
Director, Regulatory Affairs
Phone: 650.763.3875
Fax: 650.763.3875
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
Manufacturer: | Auxogyn, Inc.
1490 O'Brien Drive
Menlo Park, CA 94025 |
| Predicate Device Common
Name: | IVF Culture Dish |
| Predicate Device Premarket
Notification Number: | K103028 |
| Predicate Device
Classification: | Class II |
| Predicate Device Regulation
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
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. |
| Indications for Use: | The Eeva™ Dish is intended to be used to hold human oocytes and embryos during
handling and culture. |
| Technological Characteristics
and Comparison to Predicate
Device: | 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 or
25 microwells, cleared as the Eeva™ Petri Dish. A comparison of the subject and
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)
Eeva Dish, 12-Microwell
configuration | Predicate Device (K103028)
Eeva Petri Dish, 16- and 25-Microwell
configurations |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Indications for Use | The Eeva™ Dish is intended to hold
human oocytes and embryos during
handling and culture. | Same |
| Principles of Operation /
Conditions of Use | Microwell tissue culture dish for use
in IVF procedures performed by
qualified professionals. The dish is a
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
sterile, nylon, film-to-film pouch
(single-use only) | Same |
| Pyrogenicity Testing | Non-pyrogenic as tested by Limulus
Amoebocyte Lysate (LAL) testing
(≤ 20 EU/Device) | Same |
| Embryotoxicity Testing | Non-embryotoxic as tested by 1-Cell
Mouse Embryo Assay (MEA), with
≥ 80% of embryos developing to
expanded blastocyst stage within 96
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)
Eeva Dish, 12-Microwell
configuration | Predicate Device (K103028)
Eeva Petri Dish, 16- and 25-Microwell
configurations | |
|-------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------|
| 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 stabilize
embryos 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.
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
Supporting Data: | Non-clinical testing was conducted on the Eeva Dish with 12 microwells to support a
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
use and intended use. In addition, the Eeva Dish does not incorporate any
significant changes in method of operation, material, or design that would result in a
new technology raising new types of safety or effectiveness questions. Therefore,
the Eeva Dish, 12-microwell configuration is substantially equivalent to the predicate
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.
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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