(214 days)
InteGlobal MicroTips TPLG-130 are used for Denuding, handling blastomeres, oocytes and oocyte stripping. LifeGlobal MicroTips TPLG-180, TPLG-225 and TPLG-275 are used for handling embryos and blastocysts.
Not Found
This document does not contain information about acceptance criteria or a study proving that a device meets such criteria.
The provided text is an FDA 510(k) clearance letter for the "LifeGlobal Micro Tips" device. This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It discusses regulatory compliance, labeling requirements, and contact information for further inquiries.
However, it does not include any details on:
- Specific performance acceptance criteria (e.g., accuracy, precision, sensitivity, specificity).
- Any studies (clinical or non-clinical) that were conducted to evaluate the device's performance against such criteria.
- The methodologies for any such studies (sample size, data provenance, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance).
- Any reported device performance metrics.
Therefore, I cannot provide the requested table or answer any of the questions regarding acceptance criteria and studies.
§ 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.