Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)

K233477 · Shandong Wego Ruisheng Medical Device Co., Ltd. · MQL · Jul 1, 2024 · Obstetrics/Gynecology

Device Facts

• Record ID: K233477
• Device Name: Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)
• Applicant: Shandong Wego Ruisheng Medical Device Co., Ltd.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jul 1, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

The Vitrification Kit is indicated for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos. The Warming Kit is indicated for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos. The Cryo-straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.

Device Story

System comprises Vitrification Kit, Warming Kit, and Cryo-straws for assisted reproduction technology (ART). Vitrification Kit uses sequential media (Washing, Equilibrium, Vitrification) containing ethylene glycol, DMSO, and sucrose to replace water in embryos/oocytes. Warming Kit uses sequential media (Thaw, Diluent, Washing) to remove cryoprotectants. Cryo-straws (Type I flat slide, Type III curved slide) serve as storage containers. Used in clinical embryology labs by trained technicians/embryologists. Samples loaded onto straw slide, inserted into pre-cooled sheath, and stored in liquid nitrogen. Output is cryopreserved biological material; clinical benefit is successful long-term storage and subsequent recovery of embryos/oocytes for fertility treatments.

Clinical Evidence

Bench testing only. Includes aseptic processing validation, shelf-life testing (real-time/accelerated), MEA (≥80% blastocyst development), endotoxin (<0.25 EU/mL for media, <0.5 EU/device for straws), sterility (USP <71), transportation testing (ASTM D4169-22), and physical performance (cooling/warming rates, seal strength, dye penetration, liquid nitrogen immersion durability).

Technological Characteristics

Media: Medium 199 HEPES, sodium bicarbonate, sodium pyruvate, gentamicin sulfate, ethylene glycol, DMSO, sucrose. Cryo-straws: PETG construction, rod and sheath design (132.5 mm length). Sterilization: Aseptic filtration (media), Gamma radiation SAL 10^-6 (straws). Standards: ISO 13408, ISO 11737, ISO 11137, USP <791>, <785>, <85>, <71>, <1207.2>, ASTM D4169, F1980, F88, F1929.

Indications for Use

Indicated for vitrification and thawing of human oocytes (MII), pronuclear (PN) zygotes, day 3 cleavage stage embryos, and blastocyst stage embryos for cryopreservation storage.

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 from Kitazato Corporation (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 in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

July 1, 2024

Shandong Wego Ruisheng Medical Device Co., Ltd % Eva Li Consultant Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave. Shanghai. 200122 CHINA

Re: K233477

> Trade/Device Name: Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL, MOK Received: May 28, 2024

Dear Eva Li:

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.

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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" (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 QS 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

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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,

# 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) K233477

Device Name Vitrification Kit (A-3ML, B-6ML) Warming Kit (A-4ML, B-8ML) Cryo-straw (Type I, Type III)

#### Indications for Use (Describe)

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

The Warming Kit is indicated for use in the thawing of vitrified oocvtes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.

The Cryo-straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embrvos.

| 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 K233477

#### 1. Submitter

Shandong Wego Ruisheng Medical Device Co.,Ltd. No. 1 , Weigao Road, Torch High- tech Industrial Development Zone, Weihai, Shandong, China Contact: Yan Tian, R&D Manager Tel: [phone] Email: [e-mail]

#### 2. Date Prepared: July 1, 2024

#### 3. Device

| Trade/Proprietary<br>Name: | Vitrification Kit (A-3ML, B-6mL)<br>Warming Kit (A-4ML, B-8mL)<br>Cryo-straw (Type I, Type III) |
|----------------------------|-------------------------------------------------------------------------------------------------|
| Common Name | Vitrification Cryopreservation Media |
| Regulation | 21 CFR§ 884.6180 |
| Regulation Name | Reproductive Media and Supplements, |
| Product Code | MQL (Media, Reproductive), MQK (Labware, Assisted Reproduction) |
| Classification | Class II |
| Classification panel | Obstetrics/Gynecology |

#### 4. Predicate Device

Vitrification Kit and Thawing Kit from Kitazato Corporation (K171748).

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

#### 5. Device Description

The Vitrification Kit and Warming Kit are assisted reproduction technology (ART) media products for freezing and thawing oocytes (MII), pronuclear (PN) zygotes through Day 3

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Shandong Wego Ruisheng Medical Device Co., LTD. No. 1 , Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China cleavage stage embryos, and blastocyst stage embryos.

There are two models for each Vitrification Kit and Warming Kit. The difference is the volume of the solutions in the kits. The solutions in the "A" model for each kit are in 1 ml vials, and the solutions in the "B" model are in 2 ml vials. Each model contains two sets of kit media.

The Vitrification Kit includes three sequential media components, Washing solution (WS), Equilibrium solution (ES), and Vitrification solution (VS), containing the cryoprotectants ethylene glycol, dimethyl sulfoxide, and sucrose. Using this methodology, the permeating cryoprotectants can replace water in the oocyte and PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen.

The Warming Kit is composed of three media used sequentially for thawing and removing cryoprotectants from vitrified oocytes and PN through blastocyst stage embryos. The Warming Kit is composed of Thaw solution (TS), Diluent solution (DS), and Washing solution (WS).

All media in the Vitrification Kit and Warming Kit undergo aseptic filtration and are single-use only.

The Cryo-Straw is a single-use, sterile, cryopreservation storage device for holding and maintaining vitrified oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. There are two models for the Cryo-straws: Type I and Type III, and each has 5 colors: brown, orange, blue, red, green. The Cryo-straws are composed of a rod and sheath with a combined length of 132.5 mm. The Type I model has a flat slide and the Type III model has a curved slide for sample loading. The Cryo-straws are sterilized using gamma radiation.

## 6. Indication for Use

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

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

The Cryo-straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.

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#### 7. Substantial Equivalence Discussion

A comparison of the intended use and technological features of the subject and predicate devices are described in the table below:

| Comparison<br>Item | Subject device<br>K233477 | Predicate Device<br>K171748 | Comparison |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K233477 | K171748 | NA |
| Device Name | Vitrification Kit (A-3ML, B-<br>6mL)<br>Warming Kit (A-4ML, B-<br>8mL)<br>Cryo-straw (Type I, Type III) | Vitrification Kit and<br>Thawing Kit | NA |
| Indications<br>for Use | The Vitrification Kit is<br>indicated for use in the<br>vitrification of oocytes<br>(MII), pronuclear (PN)<br>zygotes through day 3<br>cleavage stage embryos,<br>and blastocyst stage<br>embryos.<br>The Warming Kit is<br>indicated for use in the<br>thawing of vitrified oocytes<br>(MII), pronuclear (PN)<br>zygotes through day 3<br>cleavage stage embryos,<br>and blastocyst stage<br>embryos.<br>The Cryo-straw is a<br>cryopreservation storage<br>device that is intended for<br>use in vitrification<br>procedures to contain and<br>maintain vitrified oocytes<br>(MII), pronuclear (PN) | Vit Kit® - Freeze<br>(Vitrification Freeze Kit) is<br>intended for use in the<br>vitrification of oocytes<br>(MII), pronuclear (PN)<br>zygotes through day 3<br>cleavage stage embryos<br>and blastocyst stage<br>embryos.<br>Vit Kit® - Thaw<br>(Vitrification Thaw Kit) is<br>intended for use in the<br>thawing of oocytes (MII),<br>pronuclear (PN) zygotes<br>through day 3 cleavage<br>stage embryos and<br>blastocyst stage<br>embryos. | There are<br>differences in<br>the wording of<br>the indications<br>for use<br>statements for<br>the subject and<br>predicate<br>device; however,<br>the intended<br>uses of the<br>subject and<br>predicate<br>devices are the<br>same. |
| | No. 1, Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China | | |
| | zygotes through day 3<br>cleavage stage embryos,<br>and blastocyst stage<br>embryos. | | |
| Component | Vitrification Media<br>Thawing Media<br>Cryopreservation storage<br>device | Vitrification Media<br>Thawing Media<br>Cryotop<br>Repro Plate 35 mm dish | Different: The<br>components of<br>the subject and<br>predicate<br>devices are not<br>the same.<br>Differences in<br>device<br>components do<br>not raise<br>different<br>questions of<br>safety and<br>effectiveness<br>(S&E). |
| | Media Components | | |
| Vitrification<br>Formulation | Medium 199 HEPES<br>Sodium bicarbonate<br>Sodium pyruvate<br>Gentamicin sulfate Ethylene<br>glycol<br>Dimethyl sulfoxide Sucrose | Medium 199 HEPES<br>Ethylene glycol<br>Dimethyl sulfoxide<br>Trehalose<br>Hydroxypropyl Cellulose<br>Gentamicin | Different: The<br>formulations of<br>the subject and<br>predicate<br>devices are not<br>the same.<br>Differences in<br>device<br>formulations do<br>not raise<br>different<br>questions of<br>S&E. |
| Thawing<br>Formulation | Medium 199 HEPES<br>Sodium bicarbonate<br>Sodium pyruvate<br>Gentamicin sulfate<br>Sucrose | Medium 199 HEPES<br>Hydroxypropyl Cellulose<br>Gentamicin<br>Trehalose | Different: The<br>formulations of<br>the subject and<br>predicate<br>devices are not |

#### Table 1 Comparison of Characteristic

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| Shandong Wego Ruisheng Medical Device Co., LTD. |
|---------------------------------------------------------------------------------------|
| No. 1 Weigao Road, Torch High-tech Industrial Development Zone, Weihai Shandong China |

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| No. 1, Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China | | | |
|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | the same. Differences in device formulations do not raise different questions of safety and effectiveness (S&E). |
| Endotoxin | <0.25EU/mL | <0.25 EU/mL | Same |
| MEA | One-cell MEA: ≥80% embryos developed to expanded blastocyst within 96 hours | One-cell MEA: >80% embryos developed to expanded blastocyst within 96 hours | Similar |
| pH | 7.2-7.4 | 7.2-7.6 | Similar |
| Osmolarity (mOsm/kg) | ES: 1391-1590 (1:1 dilution)<br>VS: 1430-1710 (1:3 dilution)<br>TS: 1,650-2,170<br>DS: 850-925<br>WS: 265-295 | ES: 2,300-2,800<br>VS: 4,900-6,000<br>TS: 1,600-2,000<br>DS: 830-1020<br>WS/BS: 240-300 | Different: The subject device and predicate devices have differences in osmolality specifications. These differences in osmolality specifications do not raise different questions of S&E. |
| Sterilization Method | Aseptic Filtration | Aseptic Filtration | Same |
| Shelf-Life | 6 months | 1 year | Different: The subject device has a shorter shelf-life than the predicate device. |

Shandong Wego Ruisheng Medical Device Co., LTD. No. 1 , Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China

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| No. 1, Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China | | | Differences in<br>shelf-life do not<br>raise different<br>questions of S&E |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Storage Device | | | |
| Material<br>Composition | PETG | ABS, polypropylene,<br>stainless steel | Different: The<br>materials of the<br>subject and<br>predicate<br>devices are not<br>the same.<br>Differences in<br>device materials<br>do not raise<br>different<br>questions of<br>S&E. |
| Design/<br>Vitrification<br>Method | Closed vitrification system. | Closed vitrification<br>system. | Similar |
| | The device consists of a rod<br>and a sheath. The rod of<br>Type I Cryo-straw has a flat<br>slide and the Type III Cryo-<br>straw has a curved slide,<br>where the samples are<br>loaded. | The devices are a two<br>piece assembly<br>comprised of a handle<br>shaft attached to a film<br>tip, where the samples<br>are loaded, and a straw<br>enclosure. | |
| | After samples are loaded,<br>the slide is inserted into the<br>pre-cooled sheath to create<br>a sealed closed system. The<br>assembled device is stored<br>in liquid nitrogen (LN). | After samples are loaded,<br>the film tip is inserted<br>into the pre-cooled straw<br>to create a sealed closed<br>system. The sealed<br>device is stored in LN. | |
| Device<br>Dimension | Rod: 118 mm × 2.7 mm<br>Slide:<br>- Type I: 16 mm x 0.2 mm<br>- Type III: 12 mm x 0.24 mm<br>Sheath: 44 mm | Unknown | Different: The<br>device<br>dimension of the<br>predicate<br>devices |
| | No. 1, Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China | | |
| | - OD: 2.9 mm<br>- ID: 1.95 mm | | unknown.<br>Differences in<br>device<br>dimension do<br>not raise<br>different<br>questions of<br>S&E. |
| Media Loading<br>Volume | <0.5 microliter | Unknown | Different: The<br>media loading<br>volume of the<br>predicate<br>devices are<br>unknown.<br>Differences in<br>media loading<br>volume do not<br>raise different<br>questions of<br>S&E. |
| Cooling Rate | Type I: 1,539°C/min<br>Type III: 1,543°C/min | Cryotop CL: -<br>3,000 °C/min<br>Cryotop SC: -<br>2,900 °C/min<br>Cryotop US: -<br>2,900 °C/min | Different: The<br>cooling rates of<br>the subject and<br>predicate<br>devices are not<br>the same.<br>Differences in<br>cooling rates do<br>not raise<br>different<br>questions of<br>S&E. |
| Warming Rate | Type I : 21,430°C/min<br>Type III: 21,385°C/min | Cryotop CL:<br>40,000 °C/min<br>Cryotop SC:<br>42,000 °C/min<br>Cryotop SC:<br>44,000 °C/min | Different: The<br>warming rates of<br>the subject and<br>predicate<br>devices are not<br>the same.<br>Differences in |
| | No. 1, Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China | | |
| | | | warming rates<br>do not raise<br>different<br>questions of<br>S&E. |
| Sterilization | Radiation, SAL 10-6 | Radiation, SAL 10-6 | Same |
| Single-Use | Yes | Yes | Same |
| MEA | One-cell MEA: ≥80%<br>embryos developed to<br>expanded blastocyst within<br>96 hours | One-cell MEA: ≥80%<br>embryos developed to<br>expanded blastocyst within 96 hours | Same |
| Endotoxin | <0.5 EU/device | <0.5 EU/device | Same |
| Shelf-Life | 2 years | 3 years | Different: The<br>subject device<br>has a shorter<br>shelf-life than<br>the predicate<br>device.<br>Differences in<br>shelf-life do not<br>raise different<br>questions of S&E |

Shandong Wego Ruisheng Medical Device Co., LTD.

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Shandong Wego Ruisheng Medical Device Co., LTD. No. 1 . Weigao Road. Torch High-tech Industrial. Development. Zone. Weihai. Shandong. China

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Shandong Wego Ruisheng Medical Device Co., LTD. d. Torch High-tech Industrial Development Zone, Weihai, Shandong, China

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.

## 8. Non-Clinical Performance Data:

Vitrification Kit and Warming Kit:

- Aseptic processing and validation testing that met the requirements of ISO 13408-1:2008/Amd1:2013 and ISO 13408-2:2018.
- Shelf-life testing was conducted to support a 6-month shelf-life for the subject devices through demonstration that the product specifications (shown below) were met at time 0 and after real-time aging:
- pH per USP <791>: 7.2-7.4 for all solutions ।
- -Osmolality per USP <785>: see the table above for acceptance specifications

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Shandong Wego Ruisheng Medical Device Co., LTD.

No.1, Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China

- -Endotoxin per USP <85>: <0.25 EU/mL
- -Mouse Embryo Assay (MEA): One-cell system: ≥80% embryos developed to expanded blastocyst at 96 hours
- Sterility per USP<71>: No microbial growth -
- Transportation testing per ASTM D4169-22 and cap/seal leak testing using a method equivalent to USP <1207.2> on transportation-conditioned devices.

#### Cryo-straw:

- The sterilization process and validation methods in accordance with ISO 11737-1:2018, ISO 11737-2:2019, and ISO 11137-3:2017. The sterilization assurance level of the subject device is 10-6.
- . Shelf-life testing was conducted to support a two-year shelf-life for the subject device through demonstration that the product specifications (shown below) were met at time 0 and after real-time aging or accelerated aging in accordance with ASTM F1980-16:
- -Cooling rate: (Type I:1,539°C/min; Type III:1,543°C/min)
- Warming rate: (Type I :21,430°C/min; Type III:21,385°C/min) -
- -Dimensional testing
- -Durability: No damage after 30 second immersion in liquid nitrogen
- -Liquid nitrogen penetration: No ingress after 24-hour immersion in liguid nitrogen
- -Endotoxin per USP<85: <0.5EU/device
- -Package integrity/Transportation Testing: Seal strength per F88/F88M-23 and dye penetration per ASTM F1929-23 following real-time aging and transportation conditioning device per ASTM D4169-22.
- Tensile strength of rod and sheath -
- -Mouse Embryo Assay (MEA): one-cell system: ≥80% embryos developed to expanded blastocyst at 96 hours

#### 9. Conclusion

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