EmbryoSlide+ ic8 dish

K213869 · Vitrolife A/S · MQK · Mar 11, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K213869
• Device Name: EmbryoSlide+ ic8 dish
• Applicant: Vitrolife A/S
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Mar 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Intended 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.

Device Story

EmbryoSlide+ ic8 dish is a single-use, sterile culture dish for human embryos; used in assisted reproduction technology. Device features eight culture wells (20µL each) and four rinsing wells (25-30µL each); requires 1.6mL culture oil overlay. Used in conjunction with EmbryoScope+ incubator. Provides physical containment for embryos during culture; includes barcode area for identification. Clinicians/embryologists use the device to maintain embryo environment; supports embryo development prior to transfer. Benefits include standardized culture environment and traceability.

Clinical Evidence

Bench testing only. Performance validated via Mouse Embryo Assay (MEA) showing ≥80% development to blastocyst at 96 hours. Sterility validated to SAL 10^-6 per ISO 11137. Endotoxin levels ≤20 EU/device per USP <85>. Package integrity and shelf-life validated via accelerated aging (ASTM F1980) and transportation simulation (ASTM D4169).

Technological Characteristics

Polystyrene construction; 8 culture wells, 4 rinsing wells; sterile (SAL 10^-6); non-cytotoxic (ISO 10993-5, USP <87>). Dimensions/form factor: culture dish with lid. No electronic components or software; standalone labware.

Indications for Use

Indicated for culturing, handling, and preparation for transfer of human embryos in assisted reproduction technology procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• EmbryoSlide+ culture dish (K173264)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: | [phone] (main) |
| | [phone] (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 package<br>integrity testing). |
| Endotoxin Testing (USP <85>) | ≤ 20 EU/device |
| Mouse Embryo Assay (MEA) | 1-cell MEA: ≥80% embryos developed to blastocyst at 96<br>hours |
| 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 Device<br>EmbryoSlide+ ic8 dish<br>K213869 | Predicate Device<br>EmbryoSlide Culture Dish<br>173264 | Differences |
|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The EmbryoSlide+ ic8 dish is intended<br>for culturing, handling and preparation<br>for transfer of human embryos. The<br>EmbryoSlide+ ic8 dish must be used<br>together with the EmbryoScope+<br>incubator. | The EmbryoSlide+ culture dish is<br>intended for preparing, storing,<br>and transferring human embryos.<br>The EmbryoSlide+ culture dish<br>must be used together with the<br>EmbryoScope+ incubator. | The indications for the<br>subject and predicate<br>devices are similar. Both the<br>predicate and subject<br>devices are indicated for<br>culturing of embryos for<br>transfer. |
| General design | Optically clear culture dish with a lid | Optically clear culture dish with a<br>lid | Same |
| Material | Polystyrene | Polystyrene | Same |
| Number of culture<br>wells for individual<br>embryo incubation | 8 | 16 | Different: Different number<br>of wells are present in the<br>subject and predicate<br>devices. Differences in well<br>numbers do not raise<br>different questions of safety<br>and effectiveness. |
| Traceability/ID | Individually numbered wells | Individually numbered wells | Same |
| Number of rinsing<br>wells | 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.