(28 days)
The product is intended for use as an oil overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulations outside the incubator.
NidOil™ is a light, highly purified, paraffin oil product to be used as an overlay for gamete and embryo culture in the incubator, and for manipulations outside the incubator. Shelf life of two years from production date in unopened bottle Spec. density of 0.82 - 0.87 glcm; Dynamic viscosity (20 ℃) 25.0 - 80.0 mPas Cinematic viscosity (40 ℃)
This document describes a 510(k) submission for a medical device called NidOil™. It's a reproductive media product. Crucially, this document is a 510(k) summary, not a detailed study report. Therefore, much of the information you've requested regarding specific study details, sample sizes, expert qualifications, and detailed performance metrics is not present in the provided text.
The primary method for demonstrating safety and effectiveness in a 510(k) submission is to show substantial equivalence to a predicate device, not necessarily to perform extensive de novo clinical trials with detailed performance acceptance criteria as might be expected for novel AI/diagnostic devices.
Here's an analysis based on the provided text, highlighting what is and isn't available:
Acceptance Criteria and Device Performance
The concept of "acceptance criteria" in a typical quantitative sense (e.g., sensitivity, specificity thresholds) is not explicitly detailed in the provided K012123 document. The acceptance criteria for a 510(k) submission like this, seeking substantial equivalence, generally revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from 510(k) Submission) | Reported Device Performance (NidOil™) |
|---|---|
| I. Intended Use and Indications are the Same | Met: "The intended use of the product is the same." (Section 5) The stated Indications for Use for NidOil™ are "as an oil overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulations outside the incubator." (Section 3 and Indications for Use statement) |
| II. Composition and Physical Properties Similar to Predicate | Met (by comparison): "NidOil™ is a light, highly purified, paraffin oil product..." (Section 4) Specific properties provided: |
- Shelf life: two years from production date in unopened bottle
- Spec. density: 0.82 - 0.87 g/cm³
- Dynamic viscosity (20 ℃): 25.0 - 80.0 mPas
- Cinematic viscosity (40 ℃):
§ 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.