Vitrification Solution Set and Warming Solution Set

K233846 · Ecmpc, LLC · MQL · Aug 27, 2024 · Obstetrics/Gynecology

Device Facts

• Record ID: K233846
• Device Name: Vitrification Solution Set and Warming Solution Set
• Applicant: Ecmpc, LLC
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Aug 27, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

The Vitrification Solution Set is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. The Warming Solution Set is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.

Device Story

Vitrification and warming media sets for cryopreservation of oocytes and embryos; used in ART laboratories by embryologists. Vitrification set includes Equilibration Solution (ES) and Vitrification Solution (VS); Warming set includes Thawing/Warming Solution (TS), Diluent Solution (DS), and Washing Solution (WS). Media provided in 1.8 ml polypropylene vials. Process involves sequential exposure of oocytes/embryos to solutions to facilitate cryoprotectant uptake/removal, preventing ice crystal formation during freezing and osmotic shock during thawing. Output is cryopreserved or thawed viable gametes/embryos for clinical use. Benefits include preservation of reproductive potential for patients undergoing fertility treatments.

Clinical Evidence

Bench testing only. Performance validated via Mouse Embryo Assay (MEA) per FDA 2021 guidance (≥80% development to expanded blastocyst at 96 hours), sterility testing (USP <71>), endotoxin testing (USP <85>), pH testing (USP <791>), osmolality testing (USP <785>), and transportation/seal integrity testing (ASTM D4169-22, USP <1207.2>). Shelf-life supported by accelerated aging per ASTM F1980:21.

Technological Characteristics

Media components: HEPES, HEPES sodium salt, Ethylene glycol, Dimethyl sulfoxide, Trehalose, Hydroxypropyl cellulose, Gentamicin, Minimum Essential Medium, Polyvinylpyrrolidone, Sodium bicarbonate. Packaging: 1.8 mL polypropylene vials with polyethylene caps and TPE layer. Sterilization: Aseptic filtration. Storage: 2-8°C. Shelf-life: 1 year. Testing standards: ISO 13408-1/2, ASTM F1980:21, ASTM D4169-22, USP <71>, <85>, <791>, <785>, <1207.2>.

Indications for Use

Indicated for vitrification and thawing of human oocytes (MII), pronuclear (PN) zygotes, day 3 cleavage stage embryos, and blastocyst stage embryos in assisted reproductive technology (ART) procedures.

Regulatory Classification

Identification

Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, 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

• Vitrification Kit and Thawing Kit (K171748)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 27, 2024

ECMPC, LLC % Sarah Fitzgerald Senior Consultant Emergo by UL 2500 Bee Cave Road Building 1. Suite 300 Austin, Texas 78746

Re: K233846

Trade/Device Name: Vitrification Solution Set and Warming Solution Set (Models 120, 210, 220) Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL Dated: July 31, 2024 Received: July 31, 2024

Dear Sarah Fitzgerald:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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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,

# Michael T. Bailey -S

For 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) K233846

Device Name

Vitrification Solution Set and Warming Solution Set, Models: 120, 210, 220

Indications for Use (Describe)

The Vitrification Solution Set is intended for use in the virification of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The Warming Solution Set is intended for use in the thawing of vitrified occytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="border: 1px solid black;">  </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary - K233846

### Vitrification Solution Set and Warming Solution Set

#### 1. Submitter

ECMPC, LLC 22751 Professional Drive, Suite 220 Kingwood, TX 77339

Contact: Dr. José Gaytán Melicoff Phone: [phone] Email: [e-mail]

#### 2. Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746

Contact: Sarah Marie Fitzgerald Office Phone: [phone] Email: [e-mail]

#### 3. Date Prepared

August 21, 2024

#### 4. Device Identification

Trade Name: Vitrification Solution Set and Warming Solution Set (Models 120, 210, 220) Common Name: Vitrification Cryopreservation Media Regulatory Class: Class II Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Product Code: MQL

#### 5. Predicate Device

Vitrification Kit and Thawing Kit (K171748) by Kitazato Corporation

The predicate device has not been subject to a design related recall.

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#### 6. Device Description

The Vitrification Solution Set and Warming Solution Set are intended for freezing and thawing oocytes and embryos for use in assisted reproductive technology (ART) procedures.

The Vitrification Solution Set consists of two media components, the Equilibration Solution (ES) and the Vitrification Solution (VS). The Warming Solution Set consists of three media components, the Thawing / Warming Solution (TS), Diluent Solution (DS), and Washing Solution (WS). All media are provided in 1.8 ml polypropylene vials with a polyethylene cap. All media in both sets undergo aseptic filtration and are single-use only.

#### 7. Indication for Use

The Vitrification Solution Set is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The Warming Solution Set is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.

#### 8. Substantial Equivalence Discussion

A comparison of the intended use and technological characteristics of the subject device and the predicate device is shown in the table below:

| Attribute | Subject:<br>Vitrification Solution Set and<br>Warming Solution Set<br>(K233846) | Predicate:<br>Vitrification Kit and Thawing<br>Kit (K171748) | Comparison |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Vitrification Solution Set is<br>intended for use in the<br>vitrification of oocytes (MII),<br>pronuclear (PN) zygotes<br>through day 3 cleavage stage<br>embryos, and blastocyst stage<br>embryos.<br><br>The Warming Solution Set is<br>intended for use in the<br>thawing of vitrified oocytes<br>(MII), pronuclear (PN) zygotes<br>through day 3 cleavage stage<br>embryos, and blastocyst stage<br>embryos. | The Vitrification Kit is indicated<br>for use in the preparation,<br>vitrification and storage of<br>oocytes (MII), pronuclear (PN)<br>zygotes through day 3 cleavage<br>stage embryos, and blastocyst<br>stage embryos.<br><br>The Thawing Kit is indicated for<br>use in the preparation and<br>thawing of vitrified oocytes<br>(MII), pronuclear (PN) zygotes<br>through day 3 cleavage stage<br>embryos, and blastocyst stage<br>embryos. | There are differences in<br>the wording of the<br>indications for use<br>statements for the<br>subject and predicate<br>device; however, the<br>intended uses of the<br>subject and predicate<br>devices are the same. |
| Sets /<br>Components | Vitrification Media<br>Warming Media | Vitrification Media<br>Thawing Media<br>Cryotop<br>Repro Plate 35 mm dish | Different: The<br>components of the<br>subject and predicate<br>devices are not the same. |
| Attribute | Subject:<br>Vitrification Solution Set and<br>Warming Solution Set<br>(K233846) | Predicate:<br>Vitrification Kit and Thawing<br>Kit (K171748) | Comparison |
| Embryo Stage | Oocyte, PN through Blastocyst | Oocyte, PN through Blastocyst | Same |
| Vitrification<br>Media<br>Components | 2 – equilibration solution,<br>vitrification solution | 3 – basic solution, equilibration<br>solution, vitrification solution | Different: The number of<br>vitrification media of the<br>subject and predicate<br>devices are not the same.<br>Differences in<br>vitrification solutions do<br>not raise different<br>questions of S&E. |
| Warming<br>Media<br>Components | 3 – thawing solution, diluent<br>solution, washing solution | 3 –thawing solution, diluent<br>solution, washing solution | Same |
| Vitrification<br>Formulation | HEPES<br>HEPES sodium salt<br>Ethylene glycol<br>Dimethyl sulfoxide<br>Trehalose<br>Hydroxypropyl cellulose<br>Gentamicin<br>Minimum Essential Medium<br>Polyvinylpyrrolidone<br>Sodium bicarbonate | Medium 199 HEPES<br>Ethylene glycol<br>Dimethyl sulfoxide<br>Trehalose<br>Hydroxypropyl cellulose<br>Gentamicin | Different: The<br>formulations of the<br>subject and predicate<br>devices are not the same.<br>Differences in device<br>formulations do not raise<br>different questions of<br>S&E. |
| Warming /<br>Thawing<br>Formulation | HEPES<br>HEPES sodium salt<br>Hydroxypropyl cellulose<br>Trehalose<br>Minimum Essential Medium<br>Polyvinylpyrrolidone<br>Sodium bicarbonate<br>Gentamicin | Medium 199 HEPES<br>Hydroxypropyl cellulose<br>Trehalose<br>Gentamicin | |
| Sterilization | Aseptic filtration | Aseptic filtration | Same |
| Sterility | No growth | Passes USP <71> | Same |
| Endotoxins | $≤$ 0.5 EU/ml (LAL) | $<$ 0.25 EU/ml (LAL) | Different: The endotoxin<br>specification of the<br>subject and predicate<br>devices are not the same.<br>Differences in the stated |
| Attribute | Subject:<br>Vitrification Solution Set and<br>Warming Solution Set<br>(K233846) | Predicate:<br>Vitrification Kit and Thawing<br>Kit (K171748) | Comparison |
| | | | endotoxin specifications<br>do not raise different<br>questions of S&E. |
| Mouse Embryo<br>Assay (MEA) | ≥ 80% embryos developed to<br>expanded blastocyst at 96<br>hours | ≥ 80% development to<br>blastocyst at 96 hours | Similar |
| pH | 7.20 - 7.60 | 7.20 - 7.60 | Same |
| Osmolality<br>(mOsm/kg) | ES: 2348-2596<br>VS: 2316-2559 after 1:1<br>dilution<br>TS: 1613-1782<br>DS: 831-928<br>WS: 261-289 | Not available | Different: The osmolality<br>specification of the<br>subject and predicate<br>devices are not the same.<br>Differences in osmolality<br>do not raise different<br>questions of S&E. |
| Storage | 2-8°C | 2-8°C | Same |
| Packaging | Each solution is contained in<br>1.8 mL polypropylene (PP)<br>container and polyethylene<br>(PE) screw caps molded with a<br>thermoplastic elastomer (TPE)<br>layer. | Each solution is contained in<br>1.5 mL or 4 mL plastic vials. | Different: The packaging<br>of the subject and<br>predicate devices are not<br>the same. Differences in<br>packaging do not raise<br>different questions of<br>S&E. |
| Shelf-Life | 1 year | 1 year | Same |

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As shown in the table above, there are differences in the indications for use statements and technological characteristics of the subject and predicate devices. However, as stated in the table, the differences in indications for use do not represent a new intended use and the differences in technological characteristics do not raise different questions of safety and effectiveness.

#### 9. Summary of Non-Clinical Performance Testing

To demonstrate safety and effectiveness of the Vitrification Solution Set and Warming Solution Set and to show substantial equivalence to the predicate device, the following non-clinical tests have been performed.

- . Aseptic processing and validation testing that met the requirements of ISO 13408-1:2008/Amd1:2013 and ISO 13408-2:2018. Testing was conducted on the subject device containing no antimicrobials.
- Shelf-life testing was conducted to support a one-year shelf-life for the subject devices through demonstration that the product specifications (shown below) were met at time 0 and after accelerated aging per ASTM F1980:21:
- Sterility per USP <71>: No growth -

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- -Endotoxin per USP <85>: ≤ 0.5 EU/mL
- pH per USP <791>: 7.2-7.6 for all solutions
- -Osmolality per USP <785>: see the table above for acceptance specifications
- -Mouse embryo assay per FDA guidance "Mouse Embryo Assay for Assisted Reproduction Technology Devices" (2021): One-cell system: ≥80% embryos developed to expanded blastocyst at 96 hours
- . Transportation testing per ASTM D4169-22 and cap/seal leak testing using a method equivalent to USP <1207.2> on transportation-conditioned devices.

#### 10. Conclusion

The results of the performance testing described above demonstrate that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.