(86 days)
PVP (polyvinylpyrrolidone) is intended for use in assisted reproductive technology procedures involving the manipulation of gametes. Specifically, PVP is intended for use as a medium for the immobilization of sperm during intracytoplasmic sperm injection (ICSI) procedures.
PVP consists of polyvinylpyrrolidone that has been dissolved in ultra-pure water and Ivophilized.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Irvine Scientific PVP-Polyvinylpyrrolidone device.
Acceptance Criteria and Device Performance
The provided document describes the device, its intended use, and its technological characteristics. However, it does not explicitly list specific numerical acceptance criteria for performance. Instead, it relies on a historical review and the established use of the product.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicit) | Reported Device Performance |
|---|---|
| N/A (See note below) | Has been used in a variety of clinical settings for its intended use for a number of years. |
| N/A (See note below) | Has become one of the standard media used for the immobilization and isolation of human sperm cells for use in ICSI procedures. |
| N/A (See note below) | Suitable for its intended use. |
| N/A (See note below) | Meets criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335. |
Note on Acceptance Criteria: The document references a "Notice of Final Rule" and "criteria outlined" within it, but these specific criteria are not detailed in the provided text. The submission primarily argues substantial equivalence based on the device's history of use and the fact it is considered a "standard" in the field.
Study Information:
The submission does not describe a specific clinical study with a test set, ground truth, or statistical analysis in the way a typical medical device study would. Instead, it relies on historical and widespread clinical adoption.
1. Sample sizes used for the test set and data provenance:
* Test Set Sample Size: Not applicable. No dedicated "test set" in the conventional sense is described.
* Data Provenance: The device's performance is supported by its "use in a variety of clinical settings" and its status as "one of the standard media" in the field over "a number of years." This implies broad, retrospective, and multi-country provenance, though specific countries or retrospective/prospective distinctions are not provided.
2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
* Not applicable. No explicit "ground truth" establishment process for a test set is described. The "ground truth" seems to be established by consensus in the professional literature over time, reflecting widespread clinical acceptance and efficacy.
3. Adjudication method for the test set:
* Not applicable. No formal adjudication method is mentioned as there's no specific test set undergoing expert review.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
* Not applicable. This is not an AI-assisted device, and no MRMC study or comparison of human reader performance with/without AI is mentioned.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is not an algorithm. Its performance is inherent in its chemical properties and how it aids human procedures (ICSI).
6. The type of ground truth used:
* The primary "ground truth" appears to be expert consensus and widespread clinical use/outcomes over time, as evidenced by the statement: "The conclusion from a review of the historical information contained in professional literature shows that PVP is suitable for its intended use..." and that it "has become one of standard media used for the immobilization and isolation of human sperm cells for use in ICSI procedures." This implies that successful clinical outcomes historically have validated its efficacy.
7. The sample size for the training set:
* Not applicable. This device is a chemical medium, not a machine learning algorithm requiring a training set.
8. How the ground truth for the training set was established:
* Not applicable. There is no training set mentioned.
Summary of Approach:
Irvine Scientific's 510(k) submission for PVP-Polyvinylpyrrolidone relies heavily on its historical use and established position as a standard product in the field of intracytoplasmic sperm injection (ICSI). The regulatory filing is for a device that has already gained significant clinical acceptance and is presenting this historical performance as evidence of its safety and effectiveness, rather than reporting on a new, specific clinical trial. This approach is common for devices seeking substantial equivalence where a strong predicate device or an extensive history of safe and effective use already exists. The "study" proving it meets acceptance criteria is effectively the accumulated body of professional literature and clinical experience over "a number of years."
§ 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.