(90 days)
ISOCARE ONE-STEP Sperm Processing Medium is intended for use in assisted reproductive technology procedures that involve the isolation, processing and transfer of sperm. Specifically, ISOCARE ONE-STEP Sperm Processing Medium is intended for use as a sperm isolation and processing medium in the isolation and processing of sperm during intrauterine and other reproductive technology procedures.
ISOCARE ONE-STEP Sperm Processing Medium is a synthetic, defined culture medium composed of a mixture of salts and other physiologically compatible substances supplemented with 5mg/ml human serum albumin. ISOCARE ONE-STEP Sperm Processing Medium is intended for use in sperm processing procedures prior to intrauterine or other assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). ISOCARE ONE-STEP Medium uses a combined sodium bicarbonate/HEPES (J4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid () buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.
The provided text describes the ISOCARE ONE-STEP Sperm Processing Medium, a medical device. Based on the given information, here's an analysis of its acceptance criteria and the study that proves its performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Testing |
|---|---|---|
| Purity/Safety | Absence of toxic components. | Each lot is subjected to cytotoxicity testing and a mouse embryo assay prior to release. The submission states, "These assays assure that the product is both functional for its intended use, and that no toxic components are present in the formulation." Additionally, endotoxin and sterility testing will be performed as a condition of release. |
| Functionality | Support for sperm viability and processing, leading to successful isolation and concentration of viable sperm for assisted reproductive procedures. | Each lot is subjected to sperm motility/hyperactivation analysis. The text mentions, "Sperm isolation and processing media have been used in a variety of clinical settings, for the intended use for a number of years. In that time the product has become the standard media used for sperm isolation, washing and transport." The device is intended to enable concentration of viable sperm and increased availability for fertilization. |
| Regulatory Compliance | Meets the criteria outlined in the Final Rule, 63 FR48428, Docket number 97N-0335. | The conclusion states, "The conclusion from performance testing, as well as a review of published historical information contained in the professional literature shows that ISOCARE ONE-STEP Sperm Processing Medium is suitable for its intended use and meets the criteria outlined in the Final Rule, 63 FR48428, Docket number 97N-0335." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of a clinical study with a defined sample size for the ISOCARE ONE-STEP Sperm Processing Medium. The performance data primarily refers to lot release testing rather than a specific clinical trial.
- Sample Size for Lot Release Testing: Not explicitly stated as a number of samples/patients. It's implied that "each lot" is tested.
- Data Provenance: The document refers to "published historical information contained in the professional literature" and the device becoming "the standard media used for sperm isolation, washing and transport" over "a number of years." This suggests the data provenance is retrospective clinical experience and literature review, coupled with prospective in-vitro lot release testing. There is no specific country of origin mentioned for the historical data, but the submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance data presented is based on objective laboratory assays (cytotoxicity, sperm motility/hyperactivation, mouse embryo assay, endotoxin, sterility) and a general reference to historical clinical usage, rather than expert-adjudicated ground truth from a test set.
4. Adjudication Method for the Test Set
This information is not applicable/provided. As there is no explicitly defined "test set" with expert review for adjudication, no adjudication method is mentioned. The assessment relies on the described laboratory test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study is not applicable to this device. The ISOCARE ONE-STEP Sperm Processing Medium is a culture medium, not an AI-powered diagnostic or assistive technology for human readers. Therefore, there's no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study, as typically understood for an AI algorithm (without human-in-the-loop), is not applicable to this device. The device is a physical medium used in laboratory procedures.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established through:
- In-vitro laboratory assays: Cytotoxicity testing, sperm motility/hyperactivation analysis, mouse embryo assay, endotoxin, and sterility testing. These provide objective measures of the medium's safety and functionality.
- Historical clinical usage/literature: The claim that the product has become "the standard media used for sperm isolation, washing and transport" implies that clinical outcomes and utility have been observed and documented over time, forming a practical "ground truth" of its effectiveness in real-world use.
- Predicate device comparison: The device is deemed substantially equivalent to a predicate device, implying that the established safety and effectiveness of the predicate forms a basis for evaluating the new device.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. It is a physical culture medium, not an algorithm that requires training data. The lot release testing and historical clinical observations serve as validation of the formulation.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" for this type of device.
§ 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.