(257 days)
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.
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 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.
The Minvitro® Vitrification Straw (K241454) is a cryopreservation storage device. It underwent non-clinical performance testing to demonstrate its substantial equivalence to the predicate device, Cryotop® US-flash (K181469).
Here's an overview of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criterion | Reported Device Performance (Minvitro® Vitrification Straw) |
|---|---|---|
| Sterilization | SAL of 10⁻⁶ (EO process) | 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. |
| Endotoxin | ≤ 0.5 EU/device | , and FDA guidance for MEA define the acceptable parameters and outcomes for device performance. |
- Predicate device's specifications: For tests like cooling/warming rates, the predicate device's performance characteristics served as a benchmark for comparison.
- Pre-defined biological endpoints: In the case of the Mouse Embryo Assay, the development of embryos to the blastocyst stage at a certain percentage defines the biological "ground truth" for toxicity and suitability.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set" in the context of algorithm development. The tests described are for a physical medical device.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
§ 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.