(121 days)
PBS(-), Phosphate Buffered Saline is intended for use in assisted reproductive procedures that involve the manipulation of gametes and embryos. These procedures include oocyte retrieval from ex vivo ovarian tissues, short term oocyte maintenance, and handling of fertilized embryos prior to embryo transfer.
Phosphate Buffered Saline [PBS(-)] is a colorless isotonic buffered solution with a pH of 7.20-7.60.
PBS(-) composition:
- Sodium Chloride
- · Potassium Chloride
- Monopotassium phosphate
- Di-sodium Hydrogen Phosphate Anhydrous
PBS(-) will be available in volumes of 100mL and 500mL. Packaging for PBS(-) consist of a PETG (Polyethylene Terephtalate Glycol-modified) bottle and HDPE (High Density Polyethylene) cap. PBS(-) has a six-month shelf-life.
This document is a 510(k) premarket notification for a reproductive media called "PBS(-), Phosphate Buffered Saline" by KITAZATO BioPharma Co., Ltd. It outlines the device's description, indications for use, and a comparison to a predicate device, along with performance data to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| ASSAY | SPECIFICATIONS | Reported Device Performance (Implied) |
|---|---|---|
| Color | Clear, Particle Free | Met specifications |
| pH | 7.20-7.60 | Met specifications |
| Osmolality | 279-295mOsm/kg | Met specifications |
| Endotoxin |
§ 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.