(257 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, sterilization, and biological compatibility of a cryopreservation storage device. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI/ML.
No.
The device is a cryopreservation storage device for human oocytes and embryos, not a therapeutic device. It is used to contain and maintain these biological materials for vitrification procedures rather than to treat a disease or medical condition.
No
Explanation: The device is a cryopreservation storage device intended for containing and maintaining human oocytes and embryos, not for diagnosing a condition or disease.
No
The device is a physical cryopreservation storage device made of materials like a cap, handle, and carrier sheet, intended for containing and maintaining human oocytes and embryos. It undergoes sterilization and physical performance testing, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos" during vitrification procedures. This is a storage and handling function for biological samples, not a diagnostic test performed on the samples to determine a medical condition or state.
- Device Description: The device is a cryopreservation storage device. It's a physical container designed for holding and preserving biological material.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis, measurement, or interpretation of the biological samples to provide diagnostic information. It doesn't detect markers, analyze genetic material, or perform any other function typically associated with IVDs.
- Performance Studies: The performance studies focus on the device's ability to maintain sterility, withstand transportation and conditioning, have low endotoxin levels, and support embryo development after cryopreservation (MEA testing). These are performance characteristics of a storage device, not a diagnostic device.
IVD devices are designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device facilitates a procedure (vitrification) but doesn't perform a diagnostic test itself.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MQK
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, 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 10-6, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 D4169-21.
Endotoxin:
Evaluation performed on unaged devices using the Gel-Clot Limulus Amoebocyte Lysate (LAL) method per USP . The acceptance criterion was
§ 884.6160 Assisted reproduction labware.
(a)
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.(b)
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.
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) |
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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
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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 . The acceptance criterion was