(302 days)
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No
The summary describes a physical petri dish and its materials, with no mention of software, image processing, or AI/ML terms.
No.
The device is a petri dish used for holding oocytes and embryos during handling and culture. It is a containment device, not a device that provides therapy or treatment.
No
Explanation: The device is a petri dish used for holding oocytes and embryos, which is a containment device for culture, not one that performs diagnostic analysis.
No
The device description clearly states it is a physical petri dish made of polystyrene, which is a hardware component.
Based on the provided information, the Eeva™ Petri Dish is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens obtained from the human body. The Eeva™ Petri Dish is used to hold human oocytes and embryos during handling and culture. While these are human biological materials, the dish itself is a container and tool for manipulating them, not a device that performs a diagnostic test on them.
- The intended use describes a container for biological material. The description focuses on its function as a vessel for holding and culturing oocytes and embryos.
- The performance studies focus on the dish's safety and suitability for culture. The tests mentioned (non-pyrogenic, non-embryotoxic) are related to ensuring the dish doesn't harm the biological material, not to diagnosing a condition or providing information about a patient's health.
- The predicate device is also a petri dish for embryo culture. The predicate device (SunIVF Embryo Corral Dish) is also a container for handling and culturing embryos, further supporting the classification of the Eeva™ Petri Dish as a laboratory tool rather than a diagnostic device.
In summary, the Eeva™ Petri Dish is a laboratory consumable used in assisted reproductive technology (ART) procedures, not a device that performs a diagnostic test on a human specimen.
N/A
Intended Use / Indications for Use
The Eeva™ Petri Dish is intended to be used to hold human oocytes and embryos during handling and culture.
Product codes (comma separated list FDA assigned to the subject device)
MQK
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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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 94025 | |
| Tel: 650-641-2429 | |
| Correspondent Contact | |
| Information: | Robert Newman |
| VP of Regulatory Affairs | |
| Auxogyn, Inc. | |
| 1490 O'Brien Drive, Suite A Menlo Park, CA 94025 | |
| Tel: 650-641-2429 | |
| Device Common Name: | IVF Tissue Culture Dish |
| Device Classification Number: | 21 CFR 884.6160 |
| Assisted Reproduction Labware | |
| Device Classification & | |
| Product Code: | Class II |
| MQK | |
| 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 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.
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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.
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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
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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