(317 days)
Water for Assisted Reproduction Procedures is to be used for in assisted reproduction procedures. It may be used for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for IVF or other assisted reproduction procedures. It may also be used as the final rinse for labware or other assisted reproduction devices which will contact the gametes or embryos.
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The provided text is a 510(k) clearance letter from the FDA for a device named "Water for Tissue Culture, Model 1500" or "Water for Assisted Reproduction Procedures". This document clears the device for market but does not contain the specific acceptance criteria or details of a study proving the device meets those criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through a detailed clinical study in the way a PMA (Pre-Market Approval) submission would.
Therefore,Based on the provided text, the following information about acceptance criteria and a detailed study is not available:
- A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) clearance letter or the Indications for Use statement.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- 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: This is irrelevant as the device is "Water for Assisted Reproduction Procedures," not an AI diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Irrelevant as the device is "Water for Assisted Reproduction Procedures," not an AI diagnostic device.
- The type of ground truth used: Not provided, as the nature of the device (water) doesn't typically require 'ground truth' in the same way a diagnostic imaging device would. The focus is on purity and sterility.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
Summary of what the document does provide:
- Device Name: Water for Tissue Culture, Model 1500 (also referred to as Water for Assisted Reproduction Procedures)
- Intended Use: For use in assisted reproduction procedures; specifically for reconstitution of media used for aspiration, incubation, transfer, or storage of gametes or embryos in IVF or other assisted reproduction procedures, and as a final rinse for labware or other assisted reproduction devices that will contact gametes or embryos.
- Regulatory Class: Class II
- Procode: 85 MTW
- Regulatory Mechanism: 510(k) clearance, indicating substantial equivalence to a predicate device.
To obtain the detailed acceptance criteria and study data, one would typically need to review the full 510(k) summary and submission documents which are usually publicly available on the FDA website, but are not part of the provided text.
§ 884.6170 Assisted reproduction water and water purification systems.
(a)
Identification. Assisted reproduction water purification systems are devices specifically intended to generate high quality, sterile, pyrogen-free water for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction procedures. These devices may also be intended as the final rinse for labware or other assisted reproduction devices that will contact the gametes or embryos. These devices also include bottled water ready for reconstitution available from a vendor that is specifically intended for reconstitution of media used for aspiration, incubation, transfer, or storage of gametes or embryos for IVF or other assisted reproduction procedures.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, water quality testing, design specifications, labeling requirements, biocompatibility testing, and clinical testing).