(60 days)
The CryoTip is a cryopreservation device that is intended to be used to contain, freeze and maintain oocytes and/or embryos.
The CryoTip is a medical grade plastic drawn device designed to contain, freeze and maintain oocytes and/or embryos. It has a fine tip at one end (drawn to an inner diameter of ~200 micrometers), along with a stainless steel cover sleeve which can slide along the length of the CryoTip to expose or cover and protect the fine drawn tip. This device is designed to be heat sealed on each end of the plastic straw to create a closed system for long-term frozen storage of oocytes and/or embryos. The CryoTip has four (4) identifiable marks at specified locations to aid the Embryologist in loading the specimens into the optimal reqions of the device during Cryo Preservation procedures. The device is designed to be heat sealed using an impulse heat sealer after the oocytes and/or embryos have been drawn into the fine tip.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: CryoTip (Cryopreservation container and microtool)
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Suitability for intended use (contain, freeze, and maintain oocytes and/or embryos) | "The results from the field testing of these products demonstrates that CryoTips are suitable for their intended use." |
| Meets "criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335." | "The results from the field testing of these products demonstrates that CryoTips are suitable for their intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335." |
| Application, ease of use, and effectiveness in cryopreservation procedures. | "The response and feedback from the laboratories that evaluated the device indicates it was well received in terms of its application, ease of use, and effectiveness in the cryopreservation procedures." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The study used "one-cell mouse embryos." The exact number of mouse embryos used is not specified, only the type of biological sample.
- Data Provenance: The study was conducted by "five (5) independent field laboratories." This suggests the data is prospective, generated specifically for evaluating the CryoTip, and comes from multiple institutional settings. The country of origin is not specified but is implicitly in the US, given the FDA submission.
3. Number of Experts and Qualifications for Ground Truth
- The study involved feedback from "five (5) independent field laboratories."
- The individuals providing feedback were "Embryologist[s]" as implied by the description of the device's use and its target users in "cryopreservation procedures."
- Their specific qualifications or years of experience are not detailed in the provided text.
4. Adjudication Method for the Test Set
The text does not mention an explicit adjudication method (e.g., 2+1, 3+1). The feedback was gathered from "five (5) independent field laboratories," suggesting a consensus or collective feedback approach rather than a formal adjudication process between individual experts on specific cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done to assess how much human readers (Embryologists) improve with AI vs. without AI assistance. The CryoTip is a physical medical device, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable, as the CryoTip is a physical medical device and does not involve an algorithm.
7. Type of Ground Truth Used
The ground truth used was based on:
- Expert Feedback/Opinion: The "response and feedback from the laboratories" who evaluated the device.
- Biological Outcome: The "effectiveness in the cryopreservation procedures" using "one-cell mouse embryos," implying observations of successful cryopreservation (though the specific metrics of effectiveness are not detailed beyond "well received").
- Compliance with Regulatory Standard: Meeting the "criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335."
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
§ 884.6130 Assisted reproduction microtools.
(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.