(103 days)
HTF Media is used as a general purpose media. May be used in procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), invitro fertilization (IVF), intrauterine insemination (IUI).
It may also be used as a holding media at the time of retrieval of the gametes and for the holding of the oocytes in day 1 and 2, prior to transfer.
The indications for use of this media is based on the general procedures for preparation of semen for Intrauterine Insemination described by Paul S. Weatherbee, Ph.D. and Lawrence B. Werlin, M.D., Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of California, Invine Medical Center.
Not Found
The provided text describes a 510(k) submission for a medical device: " Fertilization Media - HTF". This is a regulatory document seeking marketing clearance for a fertilization media, not an AI medical device. Therefore, the questions related to AI device performance metrics, such as acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth types, are not applicable to this document.
The document focuses on demonstrating substantial equivalence of the " Fertilization Media - HTF" to legally marketed predicate devices.
Here's the relevant information that can be extracted:
Acceptance Criteria and Device Performance (based on Substantial Equivalence):
The acceptance criteria for a 510(k) submission like this are generally that the new device is substantially equivalent to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
| Acceptance Criterion | Reported Device Performance (Claim of Substantial Equivalence) |
|---|---|
| Same Intended Use | HTF Media is used as a general-purpose media for in vitro washing and incubation of sperm, and as a holding media for gametes/oocytes, similar to predicate devices. |
| Similar Technological Characteristics | The HTF Media uses the "same original formula" first described by Patrick Quinn (Fertility and Sterility 41:202, 1984; 44:493, 1985). This formula is also referenced by the predicate devices (Irvine Scientific products). |
| Safety and Effectiveness | Implied through the "same original formula" and "same intended use" as legally marketed predicate devices (Sperm Capacitation Media K962816, Irvine Sperm Washing Media K872102, Irvine Capacitation Media K861166/A). The FDA's clearance (JUL 19 1999 letter) confirms that the device is deemed substantially equivalent for the stated indications for use. |
Irrelevant Information for this document (due to it being a fertilization media, not an AI device):
- Sample size used for the test set and the data provenance: Not applicable. This is a chemical formulation, not an algorithm tested on a dataset.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here. The "ground truth" in this context would be the established effectiveness and safety of the predicate devices.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No image-based or diagnostic test set requiring adjudication.
- 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. There is no AI involved.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices based on their historical marketing and scientific literature.
- The sample size for the training set: Not applicable. No AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable. No AI model.
§ 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.