(88 days)
The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.
The EmbryoSlide+ ic8 dish is single use, sterile for embryo culture, handling, and preparation for transfer during assisted reproduction technology procedures. The EmbryoSlide+ ic8 dish is equipped with barcode label area for unique identification of the culture dish, and a small area which can be used for manual writing. The EmbryoSlide+ ic8 dish has eight culture wells. Each well holds a single embryo in 20µL of culture medium. In addition, four rinsing wells are available, each rinsing well holding 25-30μL medium. The culture area of the dish, comprising both the culture wells, must be covered with 1.6mL culture oil overlay to minimize osmolarity changes during culture in a dry environment.
I am sorry but this document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. This document is an FDA 510(k) premarket notification for a medical device (EmbryoSlide+ ic8 dish) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device.
While it mentions some specifications and testing performed (e.g., sterility, endotoxin testing, mouse embryo assay), it does not detail a formal study designed to prove the device meets specific acceptance criteria in the way you've outlined. The information provided is for regulatory clearance based on substantial equivalence, not a detailed clinical or comparative effectiveness study report.
Therefore, I cannot provide the requested table and detailed study information based on this document.
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March 11, 2022
Vitrolife A/S Belinda Dueholm Regulatory Affairs Specialist Jens Juuls Vei 20 Viby J, 8260 Denmark
K213869 Re: Trade/Device Name: EmbryoSlide+ ic8 dish Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MQK Dated: December 7, 2021 Received: December 13, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213869
Device Name EmbryoSlide+ ic8 dish
Indications for Use (Describe)
The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K213869 EmbryoSlide+ ic8 dish
1. SUBMITTER INFORMATION
| Submitter: | Vitrolife A/S |
|---|---|
| Jens Juuls Vej 20 | |
| 8260 Viby J | |
| Denmark |
| Contact Person: | Ms. Belinda Dueholm |
|---|---|
| Telephone: | +45 7221 7900 (main) |
| +45 2076 3707 (direct) |
2. Date Prepared
March 10, 2021
3. Device Information
| Device Name | EmbryoSlide+ ic8 dish |
|---|---|
| Common Name | Culture dish |
| Regulation Number | 21 CFR 884.6160 |
| Regulation Name | Assisted Reproduction Labware |
| Product Code | MQK (Labware, Assisted Reproduction) |
| Regulatory Class | II |
4. Predicate Device
EmbryoSlide+ culture dish, K173264, (Vitrolife A/S).
The predicate device has not been subject to a design-related recall.
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5. DEVICE DESCRIPTION
The EmbryoSlide+ ic8 dish is single use, sterile for embryo culture, handling, and preparation for transfer during assisted reproduction technology procedures. The EmbryoSlide+ ic8 dish is equipped with barcode label area for unique identification of the culture dish, and a small area which can be used for manual writing.
The EmbryoSlide+ ic8 dish has eight culture wells. Each well holds a single embryo in 20µL of culture medium.
In addition, four rinsing wells are available, each rinsing well holding 25-30μL medium. The culture area of the dish, comprising both the culture wells, must be covered with 1.6mL culture oil overlay to minimize osmolarity changes during culture in a dry environment.
| Parameter | Specification |
|---|---|
| Appearance | Good clarity with no apparent flaw |
| Sterility | SAL 10-6 (based on process validation data and packageintegrity testing). |
| Endotoxin Testing (USP <85>) | ≤ 20 EU/device |
| Mouse Embryo Assay (MEA) | 1-cell MEA: ≥80% embryos developed to blastocyst at 96hours |
| Cytotoxicity (ISO 10993-5, USP <87>) | Non-cytotoxic |
The EmbryoSlide+ ic8 dish has the following device specifications:
6. Indications for Use
The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.
7. Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Device
The table below compares the intended use and technological characteristics of the subject and predicate device.
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| Attribute | Subject DeviceEmbryoSlide+ ic8 dishK213869 | Predicate DeviceEmbryoSlide Culture Dish173264 | Differences |
|---|---|---|---|
| Indications for use | The EmbryoSlide+ ic8 dish is intendedfor culturing, handling and preparationfor transfer of human embryos. TheEmbryoSlide+ ic8 dish must be usedtogether with the EmbryoScope+incubator. | The EmbryoSlide+ culture dish isintended for preparing, storing,and transferring human embryos.The EmbryoSlide+ culture dishmust be used together with theEmbryoScope+ incubator. | The indications for thesubject and predicatedevices are similar. Both thepredicate and subjectdevices are indicated forculturing of embryos fortransfer. |
| General design | Optically clear culture dish with a lid | Optically clear culture dish with alid | Same |
| Material | Polystyrene | Polystyrene | Same |
| Number of culturewells for individualembryo incubation | 8 | 16 | Different: Different numberof wells are present in thesubject and predicatedevices. Differences in wellnumbers do not raisedifferent questions of safetyand effectiveness. |
| Traceability/ID | Individually numbered wells | Individually numbered wells | Same |
| Number of rinsingwells | 4 | 4 | Same |
| Barcode label | Area for label (barcode) | Area for label (barcode) | Same |
As stated in the table, the subject and predicate devices have similar indications for use statements and have the same intended use (i.e., culturing embryos for transfer). The subject and predicate devices have differences in their technological characteristics (i.e., different number of culture wells). The differences in technological characteristics do not raise different questions of safety and effectiveness.
8. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
The following non-clinical performance testing has been conducted on the EmbryoSlide+ ic8 dish to support substantial equivalence to the predicate device:
- . Radiation sterilization and validation testing per ISO 11137-1:2006/A2013, ISO 11137-2:2013, ISO 11737-1:2018, and ISO 11737-2:2019.
- Transportation simulation testing per ASTM D4169-16
- Package integrity testing after accelerated aging per ASTM F1908-16:
- Bubble test per ASTM F2096-11 O
- Peel strength testing ASTM F88/F88M-09 O
- . Endotoxin testing per USP <85>. The testing demonstrated that the device met the specification of ≤20 EU/device.
- Mouse embryo assay (MEA) per the 2021 FDA guidance document "Mouse Embryo
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Assay for Assisted Reproduction Technology Devices:"
One-cell mouse embryos were exposed to subject devices and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage within 96 hours were assessed in comparison with the control group. The testing demonstrated that the device met acceptance criterion of "1-cell MEA ≥80% embryos developed to blastocyst in 96 hours."
- Shelf-life testing (accelerated aging) per ASTM F1980:2016. The following testing was . conducted:
- Endotoxin testing per USP <85> O
- MEA per the 2021 FDA guidance document ""Mouse Embryo Assay for Assisted o Reproduction Technology Devices"
9. Conclusions
The results of the performance testing described above demonstrate that the subject media products are as safe and effective as the predicate devices and support a determination of substantial equivalence.
§ 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.