(44 days)
ENHANCE HTF with HEPES is a medium that is used for in vitro procedures involving the manipulation of gametes and embryos not requiring the use of a CO2 incubator.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called "ENHANCE HTF with HEPES," which is a reproductive media and supplement. This document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the way typically associated with an AI/ML medical device.
The letter pertains to a traditional medical device and primarily confirms its substantial equivalence to previously marketed predicate devices under the 510(k) pathway. This pathway does not involve the elaborate performance studies common for AI/ML devices, nor does it typically detail acceptance criteria in the manner requested.
Therefore, most of the requested information cannot be extracted from this document as it is not relevant to the type of device and regulatory pathway described.
Information that CANNOT be extracted from the provided document:
- A table of acceptance criteria and the reported device performance: This document does not specify performance acceptance criteria or report device performance data.
- Sample size used for the test set and the data provenance: Not applicable; this is not a study assessing performance against a test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable; this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is not an AI/ML device.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable; this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
What the document does indicate about the device:
- Device Name: ENHANCE HTF with HEPES
- Regulation Number: 21 CFR 884.6180
- Regulation Name: Reproductive media and supplements
- Regulatory Class: II
- Product Code: 85 MQL
- Indications For Use: ENHANCE HTF with HEPES is a medium that is used for in vitro procedures involving the manipulation of gametes and embryos not requiring the use of a CO2 incubator.
- Regulatory Pathway: 510(k) Premarket Notification, cleared based on substantial equivalence to predicate devices.
§ 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.