Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)

Q: Who is the manufacturer of Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)?

Guangzhou Hehong Biotech Co., Ltd. filed the 510(k) submission for Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) (K241454).

Q: What is the FDA product code for Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)?

MQK. It is classified under 21 CFR 884.6160 as a Class 2 device in the Obstetrics/Gynecology panel.

Q: What is the regulatory pathway for Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K241454 · Guangzhou Hehong Biotech Co., Ltd. · MQK · Feb 3, 2025 · Obstetrics/Gynecology

Device Facts

Record ID	K241454
Device Name	Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
Applicant	Guangzhou Hehong Biotech Co., Ltd.
Product Code	MQK · Obstetrics/Gynecology
Decision Date	Feb 3, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.6160
Device Class	Class 2

Indications for Use

The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos.

Device Story

Minvitro® Vitrification Straw is a single-use, sterile, disposable cryopreservation storage device used in professional healthcare facilities for vitrification of human oocytes and embryos. The device consists of a handle, a carrier sheet with a flat, triangular-shaped fine tip for sample loading, and a cap with a balancing head. During the procedure, oocytes or embryos are loaded onto the carrier sheet and sealed within the device. The device is designed for closed vitrification systems, achieving cooling rates of -3000°C/min and warming rates of 40000°C/min. By maintaining the integrity of the biological samples during cryostorage, the device facilitates the preservation of reproductive cells for future clinical use. Healthcare providers use the device to securely contain samples during the freezing and thawing process, ensuring sample viability.

Clinical Evidence

Bench testing only. Performance validated via Mouse Embryo Assay (MEA) with ≥80% development to expanded blastocyst at 96 hours. Sterilization validated per ISO 11135. Mechanical performance, seal integrity, and leakage assessment conducted post-cryostorage. Cooling/warming rates verified against predicate. Shelf-life and package integrity confirmed via accelerated aging (ASTM F1980-21) and simulated transportation (ASTM D4169-22). Endotoxin levels verified ≤ 0.5 EU/device.

Technological Characteristics

Materials: ABS handle, PETG carrier sheet/tip/cap, SUS 304 stainless steel balancing head. Dimensions: 131mm total length. Closed vitrification system. Cooling rate: -3000°C/min; Warming rate: 40000°C/min. Sterilization: Ethylene Oxide (SAL 10^-6). Single-use, disposable.

Indications for Use

Indicated for cryopreservation of human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos in professional healthcare facilities.

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

Cryotop® US-flash (K181469)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services logo. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font. February 3, 2025 Guangzhou Hehong Biotech Co., Ltd. % Melody Huang Regulatory Consultant Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436 Re: K241454 > Trade/Device Name: Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MQK Received: January 2, 2025 Dear Melody Huang: 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" {1}------------------------------------------------ (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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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 {2}------------------------------------------------ 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 -S 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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K241454 Device Name Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNG, MVT-VSNP) Indications for Use (Describe) The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos. | 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary K241454 #### 1. Submitter Information | Applicant: | Guangzhou Hehong Biotech Co., Ltd. | |------------|-----------------------------------------------------------------------------------------------------| | Address: | A zone, 2/F, Building A, Huazi Industrial Park, Shilou Town, Panyu District, Guangzhou, China | | Contact: | Feng Yu | | Email: | fengyu@minvitro.cn | | Phone: | 020-31135168 | | Fax: | 020-31135028 | #### 2. Submission Correspondent | Contact: | Melody Huang | |----------|---------------------| | Phone: | 86 (138) 236-02134 | | Email: | melody36025@126.com | #### 3. Date prepared: January 31, 2025 #### 4. Device Information | Device Name: | Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNR MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) | |--------------------|----------------------------------------------------------------------------------------------------| | Common Name: | Cryopreservation Storage Device | | Regulation Number: | 21 CFR 884.6160 | | Regulation Name: | Assisted Reproduction Labware | | Product Code: | MQK (Labware, Assisted Reproduction) | | Regulatory Class: | Class II | #### 5. Predicate Device Information | Device Name: | Cryotop® US-flash | |----------------|-----------------------| | 510(k) Number: | K181469 | | Sponsor: | Kitazato Corporation. | The predicate device has not been subject to a design-related recall. #### 6. Device Description The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) are intended for use in closed vitrification procedures to contain and maintain human oocytes (MI), 4-8 cell embryos, and blastocyst stage embryos, and they are intended for use in professional healthcare facilities. The subject devices are for single use, disposable and supplied sterile. The Minvitro® Vitrification Straws (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, {5}------------------------------------------------ MVT-VSNG, MVT-VSNP) are all composed of a cap with a balancing head, a handle, a carrier sheet with a fine tip at the end. The oocytes or embryos are loaded on the carrier sheet, and in which, the fine tip of carrier sheet is flat with a triangular-shaped area for oocyte/embryo loading. The subject devices are sterilized using ethylene oxide (EO) to a sterilization assurance level of 106, are singleuse, and have a 2-year shelf-life. The subject devices are available in five colors: MVT-VSNR. MVT-VSNY. MVT-VSNB. MVT-VSNG, and MVT-VSNP corresponding to Red, Yellow, Blue, Green, and Purple, respectively, all identical in size. ## 7. Indications for Use Statement The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MI), 4-8 cell embryos, and blastocyst stage embryos. #### 8. Comparison of Intended Use and Technological Characteristics with the Predicate Device The table below includes a comparison of the intended use and technological characteristics of the subject and predicate devices. | | K241454 | K181469 | Comparison | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Regulation Number | 21 CFR 884.6160 | 21 CFR 884.6160 | Same | | Product Code | MQK | MQK | Same | | Classification | Class II | Class II | Same | | Indications for Use | The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNR, MVT- VSNY, MVT-VSNB, MVT-VSNG, MVT- VSNP) is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos. | Cryotop® US- flash are cryopreservation storage devices that are intended for use in vitrification procedures to contain and maintain human oocytes (MII) and embryos. | Different | | Design | A handle incorporating a | A handle incorporating a | Same | | | | | | | | sample-loading tip, and a cap to close the device. | sample-loading tip, and a cap to close the device. | | | Film Tip shape | Flat | Flat | Same | | Dimensions | Total length - 131 mm Carrier sheet length - 22 mm Handle length - 84 mm Cap length - 80 mm Cap diameter – 2.9 mm | Total length - 116 mm Film tip/carrier sheet length - 18 mm Handle length - 98 mm Straw/cap length - 90 mm Straw/cap diameter – 3 mm | Different | | Marks/etching | Marks on distal tip end, on body of the stick and at the opening of the cap | Marks on distal tip end, on body of the handle and at the opening of the cap | Same | | Materials | Handle - acrylonitrile butadiene styrene (i.e. ABS) Carrier Sheet and Fine tip – Polyethylene Terephthalate Glycol (i.e. PETG) Cap -Polyethylene Terephthalate Glycol (i.e. PETG) Cap balancing head - SUS 304 stainless steel | Handle - acrylonitrile butadiene styrene Fine tip - polyethylene terephthalate Straw/cap – polypropylene/stai nless steel | Different | | Vitrification system | Closed | Closed | Same | | Cooling rate (closed cap) | -3000 °C/min | -3000°C/min | Same | | Warming rate (closed cap) | 40000 °C/min | 44000 °C/min | Different | | Single use | Yes | Yes | Same | | Sterilization method | Ethylene Oxide | Gamma | Different | | Sterilization assurance level | SAL 10-6 | SAL 10-6 | Same | | Endotoxin tested | Endo LAL, ≤ 0.5 EU/device | Endo LAL, ≤ 0.5 EU/device | Same | | MEA testing | One-Cell System: ≥80% embryos developed to expanded blastocyst | Mouse Embryo Assay (1-Cell to Blastocyst at 96h ≥ 80%) | Different | {6}------------------------------------------------ {7}------------------------------------------------ As shown in the table above, there are differences in the subject and predicate device indications for use statements; however, they have the same intended use (i.e., vitrification and storage of human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos). The subject and predicate devices also have differences in technological characteristics, including different warming rates, material composition, and dimensions. These technological differences do not raise different questions of safety and effectiveness. ## 9. Summary of Non-Clinical Performance Testing #### Sterilization Testing: Sterilization information was provided in accordance with the 2016 FDA guidance "Submission and Review of Sterility Information in Premarket Notification (510(k) Submissions for Devices Labeled as Sterile." The subject devices are subjected to an Ethylene Oxide (EO) process to achieve a Sterility Assurance Level (SAL) of 10-6. The sterilization cycle was validated in accordance with ISO 11135:2014, ISO 11607-1-2006/Amd 1-2014, ISO 11607-2-2006/Amd 1-2014, ISO 11737-1:2018, ISO 11737-2:2009, ISO 11138-2:2017, ISO 10993-7:2008/Cor 1-2009. #### Simulated Transportation and conditioning: Simulated transportation per ASTM D4169-22 and environmental conditioning per ASTM D4332-22 were performed after accelerated aging per ASTM D4169-22. #### Endotoxin Evaluation performed on unaged devices using the Gel-Clot Limulus Amoebocyte Lysate (LAL) method per USP <85>. The acceptance criterion was < 0.5 EU/device. #### Cooling/warming rate A comparative analysis was provided on unaged and accelerated aged subject devices against the predicate device, K181469, to verify cooling/warming rates for closed vitrification storage after immersion and removal from liquid nitrogen. The subject device performed within the specifications noted in the table above. #### Stability and Shelf Life: The following tests were completed to demonstrate that the subject devices maintained their performance in newly manufactured devices and after 2-years of accelerated aging per ASTM F1980-21 and simulated transportation/conditioning: - Mouse embryo assay (MEA) - Testing conducted in accordance with the 2021 FDA guidance "Mouse Embryo Assay for Assisted Reproduction Technology Devices." The acceptance criterion for the 1-Cell MEA was ≥80% embryos expanded to blastocyst at 96 hours. - Package Integrity Testing: - O F1886/F1886M-16 - ASTM F88/F88M-15 O - o ASTM F1929-15 {8}------------------------------------------------ - Mechanical Performance Testing: ● - O Dimensional testing - Examination following cryostorage O - Seal integrity and leakage assessment following cryostorage O - Capping force and torque testing o - Uncapping force and torque testing O #### 10. Conclusion The results of the performance testing described above demonstrate that the subject devices are as safe and effective as the predicate device and support a determination of substantial equivalence.

Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)

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Predicate Devices

Submission Summary (Full Text)

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Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

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