(249 days)
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.
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 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.
The provided document is a 510(k) premarket notification for a medical device: Cryo-straw, Warming Kit, and Vitrification Kit. It details the device's indications for use, comparison to a predicate device, and non-clinical performance data.
However, this document does not describe a study involving an AI/Machine Learning (ML) algorithm or human readers aided by AI. The acceptance criteria and performance data presented are for the physical cryopreservation device and its associated media, focusing on biological and physical properties relevant to in vitro fertilization (IVF) and cryopreservation, such as pH, osmolality, sterility, shelf-life, and mouse embryo assay (MEA) results.
Therefore, I cannot provide the requested information about:
- A table of acceptance criteria and reported device performance related to AI/ML. The acceptance criteria listed are for the physical and chemical properties of the cryopreservation media and device.
- Sample size used for the test set and data provenance: No test set involving AI/ML is described.
- Number of experts used to establish ground truth & qualifications: Not applicable to this device submission.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on laboratory assays (e.g., MEA, sterility, endotoxin) and physical testing.
- Sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Acceptance Criteria and Performance (from document):
The document focuses on demonstrating the substantial equivalence of the "Cryo-straw," "Warming Kit," and "Vitrification Kit" to a legally marketed predicate device (Kitazato Corporation's Vitrification Kit and Thawing Kit, K171748). This is achieved through non-clinical performance data addressing the physical, chemical, and biological properties critical for their intended use in cryopreservation of oocytes and embryos.
Here's the relevant information extracted from the document regarding the device's acceptance criteria and reported performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Parameter | Acceptance Specification (Criteria) | Reported Device Performance (Typically stated as "met the requirements" or similar) |
|---|---|---|---|
| Vitrification/Warming Kit | |||
| Sterility | Aseptic processing validation, Sterility per USP<71> | Met ISO 13408-1:2008/Amd1:2013 & ISO 13408-2:2018 requirements; No microbial growth | Met requirements |
| Shelf-life | Supported shelf-life | 6 months (supported by time 0 and real-time aging data) | Supported a 6-month shelf-life |
| pH | per USP <791> | All solutions: 7.2-7.4 | Met specifications |
| Osmolality | per USP <785> | ES: 1391-1590 (1:1 dilution)VS: 1430-1710 (1:3 dilution)TS: 1,650-2,170DS: 850-925WS: 265-295 | Met specifications |
| Endotoxin | per USP <85> | <0.25 EU/mL | Met specifications |
| Biological Performance | Mouse Embryo Assay (MEA) - One-cell system | ≥80% embryos developed to expanded blastocyst at 96 hours | Met specifications (≥80% embryos developed to expanded blastocyst at 96 hours) |
| Transportation | Transportation testing per ASTM D4169-22 | Met requirements | Met requirements |
| Seal Integrity | Cap/seal leak testing/USP <1207.2> equivalent | Met requirements | Met requirements |
| Cryo-straw | |||
| Sterilization | Process & Validation (ISO 11737-1/2, ISO 11137-3) | Sterilization Assurance Level 10-6 | Met ISO standards, SAL 10-6 |
| Shelf-life | Supported shelf-life | 2 years (supported by time 0, real-time aging, or accelerated aging per ASTM F1980-16) | Supported a two-year shelf-life |
| Cooling Rate | (measured) | Type I: 1,539°C/min; Type III: 1,543°C/min | Achieved specified rates |
| Warming Rate | (measured) | Type I: 21,430°C/min; Type III: 21,385°C/min | Achieved specified rates |
| Dimensional | Dimensional testing | Met specifications | Met specifications |
| Durability | Liquid nitrogen immersion | No damage after 30 second immersion in liquid nitrogen | No damage reported |
| Liquid N2 Penetration | Immersion test | No ingress after 24-hour immersion in liquid nitrogen | No ingress reported |
| Endotoxin | per USP<85> | <0.5 EU/device | Met specifications |
| Package Integrity | Seal strength (F88/F88M-23), dye penetration (ASTM F1929-23) | Met requirements following aging and transportation conditioning | Met requirements |
| Tensile Strength | Rod and sheath | Met specifications | Met specifications |
| Biological Performance | Mouse Embryo Assay (MEA) - One-cell system | ≥80% embryos developed to expanded blastocyst at 96 hours | Met specifications (≥80% embryos developed to expanded blastocyst at 96 hours) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state specific sample sizes for each test. It refers to general testing procedures (e.g., "Shelf-life testing was conducted," "Transportation testing per ASTM D4169-22"). The data provenance is implied to be from internal testing by the manufacturer, Shandong Wego Ruisheng Medical Device Co., Ltd. in China, as part of their 510(k) submission. These are non-clinical (laboratory/bench) tests, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for these tests is established by standardized laboratory methods (USP, ISO, ASTM standards) and measurements, not expert human interpretation in a clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. These are objective laboratory measurements, not subjective human assessments requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was performed as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone algorithm performance was done as this is not an AI/ML device.
7. The type of ground truth used:
The ground truth used for these performance tests is based on objective scientific and engineering measurements and standardized biological assays (e.g., MEA, pH, osmolality, endotoxin levels, dimensional measurements, and physical durability tests) performed in a laboratory setting.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML algorithm.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: +860631-5713020 Email: y3tian@163.com
2. Date Prepared: July 1, 2024
3. Device
| Trade/ProprietaryName: | Vitrification Kit (A-3ML, B-6mL)Warming Kit (A-4ML, B-8mL)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:
| ComparisonItem | Subject deviceK233477 | Predicate DeviceK171748 | Comparison |
|---|---|---|---|
| 510(k) Number | K233477 | K171748 | NA |
| Device Name | Vitrification Kit (A-3ML, B-6mL)Warming Kit (A-4ML, B-8mL)Cryo-straw (Type I, Type III) | Vitrification Kit andThawing Kit | NA |
| Indicationsfor Use | The Vitrification Kit isindicated for use in thevitrification of oocytes(MII), pronuclear (PN)zygotes through day 3cleavage stage embryos,and blastocyst stageembryos.The Warming Kit isindicated for use in thethawing of vitrified oocytes(MII), pronuclear (PN)zygotes through day 3cleavage stage embryos,and blastocyst stageembryos.The Cryo-straw is acryopreservation storagedevice that is intended foruse in vitrificationprocedures to contain andmaintain vitrified oocytes(MII), pronuclear (PN) | Vit Kit® - Freeze(Vitrification Freeze Kit) isintended for use in thevitrification of oocytes(MII), pronuclear (PN)zygotes through day 3cleavage stage embryosand blastocyst stageembryos.Vit Kit® - Thaw(Vitrification Thaw Kit) isintended for use in thethawing of oocytes (MII),pronuclear (PN) zygotesthrough day 3 cleavagestage embryos andblastocyst stageembryos. | There aredifferences inthe wording ofthe indicationsfor usestatements forthe subject andpredicatedevice; however,the intendeduses of thesubject andpredicatedevices are thesame. |
| No. 1, Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China | |||
| zygotes through day 3cleavage stage embryos,and blastocyst stageembryos. | |||
| Component | Vitrification MediaThawing MediaCryopreservation storagedevice | Vitrification MediaThawing MediaCryotopRepro Plate 35 mm dish | Different: Thecomponents ofthe subject andpredicatedevices are notthe same.Differences indevicecomponents donot raisedifferentquestions ofsafety andeffectiveness(S&E). |
| Media Components | |||
| VitrificationFormulation | Medium 199 HEPESSodium bicarbonateSodium pyruvateGentamicin sulfate EthyleneglycolDimethyl sulfoxide Sucrose | Medium 199 HEPESEthylene glycolDimethyl sulfoxideTrehaloseHydroxypropyl CelluloseGentamicin | Different: Theformulations ofthe subject andpredicatedevices are notthe same.Differences indeviceformulations donot raisedifferentquestions ofS&E. |
| ThawingFormulation | Medium 199 HEPESSodium bicarbonateSodium pyruvateGentamicin sulfateSucrose | Medium 199 HEPESHydroxypropyl CelluloseGentamicinTrehalose | Different: Theformulations ofthe subject andpredicatedevices 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)VS: 1430-1710 (1:3 dilution)TS: 1,650-2,170DS: 850-925WS: 265-295 | ES: 2,300-2,800VS: 4,900-6,000TS: 1,600-2,000DS: 830-1020WS/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 inshelf-life do notraise differentquestions of S&E | ||
|---|---|---|---|
| Storage Device | |||
| MaterialComposition | PETG | ABS, polypropylene,stainless steel | Different: Thematerials of thesubject andpredicatedevices are notthe same.Differences indevice materialsdo not raisedifferentquestions ofS&E. |
| Design/VitrificationMethod | Closed vitrification system. | Closed vitrificationsystem. | Similar |
| The device consists of a rodand a sheath. The rod ofType I Cryo-straw has a flatslide and the Type III Cryo-straw has a curved slide,where the samples areloaded. | The devices are a twopiece assemblycomprised of a handleshaft attached to a filmtip, where the samplesare loaded, and a strawenclosure. | ||
| After samples are loaded,the slide is inserted into thepre-cooled sheath to createa sealed closed system. Theassembled device is storedin liquid nitrogen (LN). | After samples are loaded,the film tip is insertedinto the pre-cooled strawto create a sealed closedsystem. The sealeddevice is stored in LN. | ||
| DeviceDimension | Rod: 118 mm × 2.7 mmSlide:- Type I: 16 mm x 0.2 mm- Type III: 12 mm x 0.24 mmSheath: 44 mm | Unknown | Different: Thedevicedimension of thepredicatedevices |
| No. 1, Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China | |||
| - OD: 2.9 mm- ID: 1.95 mm | unknown.Differences indevicedimension donot raisedifferentquestions ofS&E. | ||
| Media LoadingVolume | <0.5 microliter | Unknown | Different: Themedia loadingvolume of thepredicatedevices areunknown.Differences inmedia loadingvolume do notraise differentquestions ofS&E. |
| Cooling Rate | Type I: 1,539°C/minType III: 1,543°C/min | Cryotop CL: -3,000 °C/minCryotop SC: -2,900 °C/minCryotop US: -2,900 °C/min | Different: Thecooling rates ofthe subject andpredicatedevices are notthe same.Differences incooling rates donot raisedifferentquestions ofS&E. |
| Warming Rate | Type I : 21,430°C/minType III: 21,385°C/min | Cryotop CL:40,000 °C/minCryotop SC:42,000 °C/minCryotop SC:44,000 °C/min | Different: Thewarming rates ofthe subject andpredicatedevices are notthe same.Differences in |
| No. 1, Weigao Road, Torch High-tech Industrial Development Zone, Weihai, Shandong, China | |||
| warming ratesdo not raisedifferentquestions ofS&E. | |||
| Sterilization | Radiation, SAL 10-6 | Radiation, SAL 10-6 | Same |
| Single-Use | Yes | Yes | Same |
| MEA | One-cell MEA: ≥80%embryos developed toexpanded blastocyst within96 hours | One-cell MEA: ≥80%embryos developed toexpanded blastocyst within 96 hours | Same |
| Endotoxin | <0.5 EU/device | <0.5 EU/device | Same |
| Shelf-Life | 2 years | 3 years | Different: Thesubject devicehas a shortershelf-life thanthe predicatedevice.Differences inshelf-life do notraise differentquestions 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.
§ 884.6180 Reproductive media and supplements.
(a)
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.).(b)
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.