(148 days)
Single Step Medium is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of Single Step Medium as a culture medium from fertilization through day 5/6 of embryo development in vitro.
Single Step Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances designed to be used during fertilization and culture of zygote/embryo through the desired development stage (up to 5/6 days) in vitro.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Irvine Scientific Single Step Medium (K072609):
Overall Assessment:
The provided document is a 510(k) summary for a reproductive media device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a comprehensive clinical study with detailed acceptance criteria and performance metrics typically seen for high-risk devices or AI/software. The "performance data" section primarily describes a quality control assay and makes a general statement about the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated/Inferred) | Reported Device Performance |
|---|---|
| Functional for intended use: Support of embryonic growth | Assayed by mouse embryo assay prior to release to market. This assay assures that the product is both functional for its intended use, the support of embryonic growth. (No specific quantitative metric or pass/fail threshold is provided in this document). |
| Absence of toxic components: Assured by assay | Assayed by mouse embryo assay prior to release to market. This assay assures...that no toxic components are present in the formulation. (No specific quantitative metric or pass/fail threshold is provided in this document). |
| Meets criteria outlined in Notice of Final Rule, 63 FR 48428 | "The conclusion from performance testing, as well as a review of the historical information contained in professional literature in addition to the comparison to the predicate devices show that Single Step Medium is suitable for its intended use, and meets the criteria outlined in the Notice of Final Rule..." (This is a general statement of compliance, not a specific performance metric.) |
| Substantial Equivalence to Predicate Devices (K034063, K053552) | Demonstrated through comparison of intended use and technological characteristics. The FDA's 510(k) clearance implies that this criterion was met. |
| Mouse embryo testing (as condition of release) | "Mouse embryo testing will be performed as a condition of release for this product." (This is a future quality control action, not a performance result from a specific study for this submission). |
| Endotoxin testing (as condition of release) | "Endotoxin...testing will be performed as a condition of release." |
| Sterility testing (as condition of release) | "Sterility testing will be performed as a condition of release." |
Note: For this type of device (in vitro embryo culture medium), the "acceptance criteria" are predominantly related to manufacturing quality control (sterility, endotoxin), general functionality as demonstrated by a biological assay (mouse embryo assay), and comparison to legally marketed predicate devices for substantial equivalence. The document does not provide specific numerical performance targets (e.g., embryo blastocyst rates, live birth rates) from a clinical study for K072609, but rather references a quality control test and general concordance with regulatory requirements.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified for a discrete "test set" in the context of a clinical study. The performance data section refers to a "mouse embryo assay," which is a quality control test. The number of mouse embryos used in this assay is not provided.
- Data Provenance: The mouse embryo assay is an internal quality control measure. No information is given about the country of origin for any human clinical data because clinical studies, in the typical sense for a new device's primary efficacy, are not presented for K072609. The document mentions that the predicate device (MultiBlast Medium) "has been used in a variety of clinical settings." This implies real-world usage, but no specific study details are provided for K072609 itself.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. The document does not describe a study involving expert review for establishing ground truth, as it is not a diagnostic device or an AI/software product requiring human interpretation. The "ground truth" for this product is its biological efficacy in supporting embryo development, which is assessed via an in vitro mouse embryo assay, not expert consensus.
4. Adjudication Method
- Not Applicable. As no expert review or human interpretation study is described, there is no need for an adjudication method like 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not mentioned. This type of study is typically relevant for diagnostic imaging devices or AI systems that assist human readers in making diagnoses. This device is a culture medium.
6. Standalone Performance Study (Algorithm Only)
- Not Applicable. This is a physical biological medium, not an algorithm or AI product.
7. Type of Ground Truth Used
- The primary "ground truth" or performance assessment method described is the mouse embryo assay. This is an in vitro biological assay designed to assess the product's ability to support embryonic growth and its lack of toxicity. It's a form of biological assay outcome data.
- The overall "ground truth" for K072609's market clearance is substantial equivalence to legally marketed predicate devices, meaning it performs as expected for its intended use based on comparison rather than entirely novel clinical trial data.
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/ML product, so there is no concept of a "training set" in the conventional sense for algorithm development.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (See point 8).
§ 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.