(27 days)
Sydney IVF PVP is intended for use as an aid in the immobilization of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.
Sydney IVF PVP is a 10 % polyvinylpyrrolidine solution in a bicarbonate buffered media supplemented with 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. Sydney IVF PVP is ready to use after equilibration to 37℃ and 6% CO2. It is designed to be used by professionals within Assisted Reproduction. This solution is an aseptically filtered sperm medium containing 10% polyvinylpyrrolidone. The PVP increases the viscosity of the solution to facilitate the capture of motile sperm for intracytoplasmic sperm injection (ICSI) procedures during Assisted Reproduction Techniques (ART) procedures. Sydney IVF PVP is provided in glass vials with FluroTec coated rubber stoppers held in place with a tamper evident seal. It is available in a 5 pack carton box with each vial containing 200 µL Sydney IVF PVP.
This document is a 510(k) premarket notification for a medical device called Sydney IVF PVP, which is a sperm immobilization medium. The purpose of the submission is to demonstrate that the new Sydney IVF PVP is substantially equivalent to a previously cleared predicate device (also named Sydney IVF PVP, K031304).
Based on the provided text, a conventional "study" to rigorously prove device performance against acceptance criteria in the manner of a clinical trial or AI model validation has not been performed or described for this specific submission. Instead, the submission relies on demonstrating substantial equivalence by comparing the technological characteristics and performance specifications of the new device to its predicate.
Here's an analysis of the requested information, understanding that "device performance" in this context refers to manufacturing and quality control parameters rather than a clinical outcome measure, and that the "study" is a stability study:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate similarity) | Reported Device Performance (from stability studies) |
|---|---|
| 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.