What is the FDA product code for Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)?

MQL. It is classified under 21 CFR 884.6180 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)?

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

What are the predicate devices for Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)?

SAGE Vitrification Kit (ART-8025 and ART-8026) and SAGE Vitrification Warming Kit (ART-8030 and ART-8031) (K173731).

Who can help prepare an FDA 510(k) submission like Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)?

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.

Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)

Q: Who is the manufacturer of Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)?

Jiangsu Ruifuda Medical Device Co., Ltd. filed the 510(k) submission for Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) (K242089).

K242089 · Jiangsu Ruifuda Medical Device Co., Ltd. · MQL · Apr 10, 2025 · Obstetrics/Gynecology

Device Facts

Record ID	K242089
Device Name	Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
Applicant	Jiangsu Ruifuda Medical Device Co., Ltd.
Product Code	MQL · Obstetrics/Gynecology
Decision Date	Apr 10, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.6180
Device Class	Class 2

Intended Use

Vitrification Freeze Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. Vitrification Thaw Kit 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 Freeze and Thaw Kits are media solutions for cryopreservation of human embryos and oocytes. Freeze kit contains Equilibration and Vitrification solutions (ethylene glycol, DMSO, human serum albumin, Quinn's Advantage Medium with HEPES, sucrose). Thaw kit contains four thawing solutions (human serum albumin, Quinn's Advantage Medium with HEPES, sucrose in TS1/TS2). Used in clinical embryology laboratories by trained personnel. Solutions facilitate cryoprotection during vitrification and rehydration during thawing. Output is preserved or thawed biological material for subsequent transfer. Benefits include successful storage and recovery of reproductive cells/embryos for assisted reproduction.

Clinical Evidence

Bench testing only. Performance validated via Mouse Embryo Assay (MEA) (≥80% development to expanded blastocyst at 96 hours), sterility testing (USP <71>), endotoxin testing (USP <85> <0.5 EU/mL), and shelf-life stability testing. Aseptic processing validated per ISO 13408-1/2. Transportation testing performed per ASTM D4169-22.

Technological Characteristics

Media solutions containing ethylene glycol, DMSO, sucrose, human serum albumin, and Quinn's Advantage Medium with HEPES. Packaged in polypropylene vials. Sterilization via aseptic filtration. pH 7.30-7.70. Osmolality varies by solution (e.g., ES 700±70 mOsm/kg). Storage 2-8°C. Shelf life 7 weeks.

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 use in in vitro assisted reproduction.

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

SAGE Vitrification Kit (ART-8025 and ART-8026) and SAGE Vitrification Warming Kit (ART-8030 and ART-8031) (K173731)

Related Devices

K223265 — CryoX Vitrification Freeze Kit / Thaw Kit · Zhejiang Horizon Medical Technology Co., Ltd. · May 11, 2023
K171748 — Vitrification Kit and Thawing Kit · Kitazato Corporation · Dec 14, 2017
K242561 — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) · Donnevie Medical Technology (Shanghai) Co. , Ltd. · Apr 10, 2025
K160006 — Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit · Irvine Scientific · May 4, 2016
K233846 — Vitrification Solution Set and Warming Solution Set · Ecmpc, LLC · Aug 27, 2024

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION April 10, 2025 Jiangsu Ruifuda Medical Device Co., Ltd % Olivia Meng RA Director Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 14F, Bldg C, Ancillary Project of Phase IV Standard Industrial Park, Guangzhou International Bio-Island Guangdong, 510320 CHINA Re: K242089 Trade/Device Name: Vitrification Freeze Kit (RFD-0101); Vitrification Thaw Kit (RFD-0201, RFD-0202) Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media And Supplements Regulatory Class: II Product Code: MQL Dated: March 4, 2025 Received: March 7, 2025 Dear Olivia Meng: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K242089 - Olivia Meng Page 2 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 (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-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 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 Rule"). 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the {2} K242089 - Olivia Meng 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-devices/device-advice-comprehensive-regulatory-assistance/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} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K242089 Device Name Vitrification Freeze Kit (RFD-0101); Vitrification Thaw Kit (RFD-0201, RFD-0202) Indications for Use (Describe) Vitrification Freeze Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. Vitrification Thaw Kit is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage 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." FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 {4} K242089 Page 1 of 5 # 510(k) Summary K242089 ## 1. Contact Details 510(k) Owner Jiangsu Ruifuda Medical Device Co., LTD Address 1st Floor, No. 567-12, Huaguoshan Avenue, Economic and Technological Development Area, Lianyungang, Jiangsu, China Contact Mr. Wang Jun Phone 008613911776721 Email wang.jun@jsrfd.cn Submission Correspondent Guangzhou Osmunda Medical Device Technical Service Co., Ltd. Address 14F, Building C, Ancillary Project of Phase IV Standard Industrial Park Guangzhou International Bio-Island Guangzhou Guangdong 510320 China Contact Ms. Olivia Meng Phone 008618825133860 Email hui.meng@osmundacn.com Date Prepared April 10, 2025 ## 2. Device Name Trade Name Vitrification Freeze Kit (RFD-0101); Vitrification Thaw Kit (RFD-0201, RFD-0202) Common Name Assisted Reproduction Media Classification Name Reproductive media and supplements Regulation 884.6180 Class Class II Product Code(s) MQL (Media, Reproductive) ## 3. Predicate Device 510(k) # K173731 Sponsor Origio A/S Trade Name SAGE Vitrification Kit (ART-8025 and ART-8026) SAGE Vitrification Warming Kit (ART-8030 and ART-8031) The predicate device has not been subject to a design-related recall. {5} K242089 Page 2 of 5 # 4. Device Description The Vitrification Freeze Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos during the in vitro assisted reproduction. The Vitrification Freeze Kit includes two solutions: Equilibration Solution (ES) and Vitrification Solution (VS). Both solutions contain ethylene glycol, dimethyl sulfoxide (DMSO), human serum albumin, and Quinn's Advantage® Medium with HEPES. The VS also contains additional sucrose to confer intracellular and extracellular cryoprotective effects. The solutions are available in three specifications: 2 mL, 4.5 mL, and 5 mL, all packaged in polypropylene (pp) vials. The kit includes one vial of each solution. The Vitrification Thaw Kit is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos during in vitro assisted reproduction. The Vitrification Thaw Kit includes 4 solutions: Thawing Solution 1 (TS1), Thawing Solution 2 (TS2), Thawing Solution 3 (TS3), and Thawing Solution 4 (TS4). All four solutions contain human serum albumin and Quinn's Advantage® Medium with HEPES. TS1 and TS2 also contain sucrose. The solutions are available in three specifications: 2 mL, 4.5 mL, and 5 mL, all packaged in polypropylene (pp) vials. Model RFD-0201 includes one vial of each solution in the kit, and Model RFD-0202 contains two vials of TS1 and one vial of TS2, TS3, and TS4 each in the kit. # 5. Indications for Use Vitrification Freeze Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. Vitrification Thaw Kit is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos. # 6. Comparison of the Subject and Predicate Device Intended Use and Technological Characteristics A comparison of the intended use and technological features of the subject and predicate devices are described in the table below: | | K242089 Vitrification Freeze Kit (RFD-0101); Vitrification Thaw Kit (RFD-0201, RFD-0202) | K173731 SAGE Vitrification Kit (ART-8025 and ART-8026); SAGE Vitrification Warming Kit (ART-8030 and ART-8031) | Comparison | | --- | --- | --- | --- | {6} K242089 Page 3 of 5 | Indications for Use | Vitrification Freeze Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. Vitrification Thaw Kit is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos. | SAGE Vitrification Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. SAGE Vitrification Warming Kit is intended for use in the thawing of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. | Same | | --- | --- | --- | --- | | Conditions for Use | Prescription Use Only | Prescription Use Only | Same | | Solutions | Vitrification Freeze Kit: Equilibration Solution; Vitrification Solution Vitrification Thaw Kit: Thawing Solution 1; Thawing Solution 2; Thawing Solution 3; Thawing Solution 4 | SAGE Vitrification Kit: Equilibration Solution; Vitrification Solution SAGE Vitrification Warming Kit: 1.0 M Sucrose Warming Solution; 0.5 M Sucrose Warming Solution; MOPS Solution | Different: There are differences in the medium solutions for the subject and predicate devices; however, these differences do not raise different questions of S&E. | | Formulation | Ethylene glycol; DMSO; Sucrose; Gentamicin; Human Serum Albumin; Quinn’s Advantage® Medium with HEPES | Ethylene glycol; DMSO; Sucrose; Gentamicin; Human Serum Albumin; Modified Human Tubal Fluid (MOPS-Buffered); Amino Acids | Different: The formulation of the predicate device is not known; however, the differences in media product formulations do not raise different questions of S&E. | | Sterilization | Aseptic filtration | Aseptic filtration | Same | | Sterility | No growth | No growth | Same | {7} K242089 Page 4 of 5 | pH | 7.30-7.70 | 7.20-7.40 | Different: The subject device has a higher pH range than the predicate device. This difference in pH range does not raise different questions of S&E. | | --- | --- | --- | --- | | Endotoxin (EU/ml) | <0.5 | <0.5 | Same | | Osmolality (mOsm/kg) | ES: 700±70 (1:3 dilution) VS: 1,000±80 (1:5 dilution) TS1: 1500-1900 TS2: 840-920 TS3: 240-300 TS4: 240-300 | ES: 2331-2,849 VS: 5,603-6,849 1.0 M WS: 1,255-1,535 0.5 M WS: 745-911 MS: 257-273 | Different: The subject device has a lower osmolality level than the predicate device. This difference in osmolality specifications does not raise different questions of S&E. | | MEA | One-cell system: ≥ 80% embryos developed to expanded blastocyst at 96 hours | One-cell system: ≥ 80% blastocyst at 96 hours | Same | | Storage | 2-8°C | 2-8°C | Same | | Shelf Life | 7 weeks | 52 weeks | Different: The subject device has a shorter shelf life than the predicate device. Difference does not raise different questions of S&E. | As shown in the table above, there are differences in the indications for use statements and technological features of the subject and predicate devices. However, the subject and predicate devices have the same intended use and the differences in technological features do not raise different questions of safety and effectiveness. {8} K242089 Page 5 of 5 # 7. Summary of Non-Clinical Performance Testing The following studies have been performed to support substantial equivalence to the predicate devices: - Aseptic filtration and aseptic filling validation, per ISO 13408-1:2008 – Aseptic Processing of Health Care Products – Part 1 General Requirements (including Amendment 1 (2013)) and ISO 13408-2:2018 – Aseptic Processing of Health Care Products – Part 2 Sterilizing Filtration. - Shelf-life testing was conducted to support the 7-week shelf-life for the subject device through demonstration that the product specifications (shown below) were met at time 0 and after real-time aging. Testing conducted is shown below: Appearance: pH (USP <791>): 7.30-7.70 Osmolality (USP <785>) (mOsm/kg): Equilibration Solution (ES): 700±70 (ES:purified water=1:3) Vitrification Solution (VS): 1000±80 (VS:purified water=1:5) Thawing Solution 1 (TS1): 1500-1900 Thawing Solution 2(TS2): 840-920 Thawing Solution 3 (TS3): 240-300 Thawing Solution 4 (TS4): 240-300 Endotoxin testing (USP <85>): <0.5 EU/mL Mouse Embryo Assay (MEA): One-Cell System: ≥80% embryos developed to expanded blastocyst at 96 hours Sterility testing (USP <71>): No microbial growth - Transportation testing per ASTM D4169-22 and USP <1207.2>. # 8. Conclusions The results of the performance testing described above demonstrated that the Vitrification Freeze Kit and Vitrification Thaw Kit are as safe and effective as the predicate devices and support a determination of substantial equivalence.