(238 days)
No
The 510(k) summary describes a physical culture dish and its intended use with a previously cleared device (EmbryoScope). There is no mention of software, algorithms, image processing, AI, or ML in the description or performance studies.
No
The device is a culture dish for preparing, storing, and transferring human embryos; it does not directly treat or diagnose a disease or condition.
No
Explanation: The device is a culture dish intended for preparing, storing, and transferring human embryos. It is used in conjunction with the EmbryoScope device, which is an incubator. Its function is to hold and facilitate the growth of embryos, not to diagnose a condition or disease.
No
The device description clearly describes a physical culture dish with wells for preparing, storing, and transferring human embryos. It is a hardware component intended to be used with a separate device (EmbryoScope).
Based on the provided information, the EmbryoSlide culture dish is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "preparing, storing, and transferring human embryos." This describes a device used in the process of assisted reproductive technology (ART), specifically for handling and incubating embryos. It does not describe a device used to perform a diagnostic test on a sample taken from the human body to provide information about a disease or condition.
- Device Description: The description details a culture dish with wells for holding and incubating embryos. This aligns with its intended use in ART procedures.
- Performance Studies: The performance studies focus on the suitability of the dish for embryo culture (MEA testing), cytotoxicity, endotoxin levels, and sterility. These are tests related to the safety and functionality of the device for its intended purpose of supporting embryo development, not for diagnosing a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample, detecting a marker, or providing diagnostic information about the embryo or the patient.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to detect diseases, conditions, or infections. The EmbryoSlide culture dish is a tool used in a medical procedure (ART) to facilitate the development of embryos, not to diagnose anything.
N/A
Intended Use / Indications for Use
The EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used only with the EmbryoScope device.
Product codes (comma separated list FDA assigned to the subject device)
MOK
Device Description
The Vitrolife A/S EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. The Vitrolife A/S EmbryoSlide culture dish is intended to be used with the EmbryoScope device that was previously cleared via K092183, K111715 and K133712. A previous version of the EmbryoSlide culture dish was cleared via K092183. Minor modifications have been made to the original EmbryoSlide culture dish as described below.
The proposed EmbryoSlide culture dish contains two types of wells which are only used for rinsing and handling the embryos before or after incubation and wells in which the embryos reside during incubation. The original EmbryoSlide culture dish included only wells for which the embryos reside during incubation.
This EmbryoSlide culture dishfits exactly on the culture dish holder in the incubator and holds a maximum of 12 embryos in separate micro wells. As with the original EmbryoSlide culture dish, the proposed EmbryoSlide culture dish contains a large oil reservoir with 12 wells for the incubation of 12 individual embryos. Each well has a volume of 25 ul. Inside each well there is a central depression where the embryo rests. The well has a diameter of approximately 250 um.
As described above, the proposed EmbryoSlide culture dish includes 4 special wells, two at each end of the culture dish that are intended for rinsing and general handling of the embryos either before or after incubation. Like the other wells, these handling/rinsing wells are designed to hold a volume of 25ul.
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
Not Found
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)
The EmbryoSlide® culture dish is tested per LOT for performance by 1-cell Mouse Embryo Assay (MEA) testing, which requires a blastocyst rate of at least 80% at 96 hours for adequate performance.
The EmbryoSlide® culture dish was tested for in vitro cytotoxicity in cultured mammalian cells. The test was performed in accordance with the United States Pharmacopeia (USP) and the ISO 10993-5 guidelines. Based on the results, EmbryoSlide® culture dish passes the requirements of ISO 10993-5 and USP as the cytotoxicity grade was less than or equal to 2.
The EmbryoSlide® culture dish is tested per LOT for bacterial endotoxins using the kinetic chromogenic method. The test of the undiluted extract (the test solution) was performed in accordance with the US Pharmacopeia and . The test solution contained less than 20 EU/device, which is the maximum, as stated in the USP and .
The EmbryoSlide® culture dish devices are sterilized under controlled conditions via electron beam radiation. The minimum dose has been validated according to ISO 11737 to a sterility assurance level of 10-6.
Shelf life was determined through an accelerated aging study evaluating the package integrity and MEA.
Conclusion: The performance testing demonstrates that the subject device is substantially equivalent to the proposed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 04, 2015
Vitrolife A/S Belinda Dueholm Regulatory Affairs Specialist Jens Juuls Vej 20 DK-8260 Viby J Denmark
Re: K150961
Trade/Device Name: Embryoslide Culture Dish Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: Class II Product Code: MOK Dated: October 2, 2015 Received: October 7, 2015
Dear Belinda Dueholm,
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 (reporting of medical device
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/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) K150961
Device Name
EmbryoSlide culture dish
Indications for Use (Describe)
The EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used only with the EmbryoScope device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary for the Vitrolife A/S EmbryoSlide Culture Dish
(per 21CFR 807.92(c))
1. SUBMITTER/510(K) HOLDER
Vitrolife A/S Jens Juuls Vej 20 DK-8260 Viby J Denmark
Contact Person: Ms. Belinda Dueholm Telephone: +45 7221 7900 (main) +45 2076 3707 (direct)
Date Prepared: April 1, 2015
2. DEVICE NAME
EmbryoSlide culture dish Proprietary Name: Common/Usual Name: IVF Incubator and Accessories Classification Name: Assisted Reproduction Labware (21 CFR 884.6160)
3. PREDICATE AND REFERENCE DEVICES
- K092183. Vitrolife A/S EmbryoSlide culture dish (Predicate device) ●
- K070047, Nunc IVF 4-Well Dish (Reference device) ●
4. DEVICE DESCRIPTION
The Vitrolife A/S EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. The Vitrolife A/S EmbryoSlide culture dish is intended to be used with the EmbryoScope device that was previously cleared via K092183, K111715 and K133712. A previous version of the EmbryoSlide culture dish was cleared via K092183. Minor modifications have been made to the original EmbryoSlide culture dish as described below.
The proposed EmbryoSlide culture dish contains two types of wells which are only used
4
for rinsing and handling the embryos before or after incubation and wells in which the embryos reside during incubation. The original EmbryoSlide culture dish included only wells for which the embryos reside during incubation.
This EmbryoSlide culture dishfits exactly on the culture dish holder in the incubator and holds a maximum of 12 embryos in separate micro wells. As with the original EmbryoSlide culture dish, the proposed EmbryoSlide culture dish contains a large oil reservoir with 12 wells for the incubation of 12 individual embryos. Each well has a volume of 25 ul. Inside each well there is a central depression where the embryo rests. The well has a diameter of approximately 250 um.
As described above, the proposed EmbryoSlide culture dish includes 4 special wells, two at each end of the culture dish that are intended for rinsing and general handling of the embryos either before or after incubation. Like the other wells, these handling/rinsing wells are designed to hold a volume of 25ul.
ട. INTENDED USE
The EmbryoSlide culture dish is intended for preparing, and transferring human embryos. It is intended to be used only with the EmbryoScope device.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The subject and predicate device have the following differences in technological characteristics: addition of rinsing wells to the culture dish, changes to the dimensions of the dish, the use of a different polystyrene formulation, and modifications to the device packaging. The differences in technological characteristics do not raise different questions of safety and effectiveness.
PERFORMANCE TESTING 7.
The EmbryoSlide® culture dish is tested per LOT for performance by 1-cell Mouse Embryo Assay (MEA) testing, which requires a blastocyst rate of at least 80% at 96 hours for adequate performance.
The EmbryoSlide® culture dish was tested for in vitro cytotoxicity in cultured mammalian cells. The test was performed in accordance with the United States Pharmacopeia (USP) and the ISO 10993-5 guidelines. Based on the results, EmbryoSlide® culture dish passes the requirements of ISO 10993-5 and USP as the cytotoxicity grade was ≤ 2.
The EmbryoSlide® culture dish is tested per LOT for bacterial endotoxins using the kinetic chromogenic method. The test of the undiluted extract (the test solution) was performed in
5
accordance with the US Pharmacopeia and . The test solution contained less than 20 EU/device, which is the maximum, as stated in the USP and .
The EmbryoSlide® culture dish devices are sterilized under controlled conditions via electron beam radiation. The minimum dose has been validated according to ISO 11737 to a sterility assurance level of 10-6.
Shelf life was determined through an accelerated aging study evaluating the package integrity and MEA.
Conclusion
The performance testing demonstrates that the subject device is substantially equivalent to the proposed predicate device.