FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The product formulation is: Earl's Balanced Salt Solution (EBSS), Sodium Pyruvate, Assisted Reproduction Technology Supplement (ARTS), HEPES, Sodium Bicarbonate, Human Serum Albumin (HSA), Penicillin, Streptomycin, Phenol Red.

AI/ML Overview

The provided text describes specific acceptance criteria for the "Medi-Cult Flushing Medium" products, which are used in In-Vitro Fertilization (IVF) procedures. The study presented aims to demonstrate the safety and effectiveness of these products by comparing their performance to national averages and other clinics.

Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported performance metrics of IVF clinics using Medi-Cult media compared to national averages or other clinics. The primary performance metric is the live birth rate.

Acceptance Criteria	Reported Device Performance
Product Testing Controls (QC-test thresholds)
Bioburden	Production-test
Integrity filter testing	Production-test
Sterility	QC-test
pH	QC-test
Osmolarity	QC-test
Endotoxin	QC-test
Mouse Embryo Assay	>80% hatching
Clinical Performance (Implicit)
Live birth rate per started cycle (Norway)	Clinics using Medi-Cult media generally show live birth rates comparable to or exceeding the national average (e.g., Trondheim: 22.2-25.35% vs. National average: 14.6-17.9%).
Live birth rate per embryo replacement (Sweden)	Carl von Linne Clinic (using Medi-Cult) reported 34%, "best in Sweden" and "well above national average of 25.8%".
Live birth rate per embryo replacement (UK)	Clinics using only Medi-Cult products showed live birth rates ranging from 22.3% to 34.5%, with most exceeding the UK national average of 21.8%.
No registered complaints and no serious adverse events	Confirmed as "no registered complaints" and "no evidence...that the product has been the cause of any serious adverse events."

Study Information

Sample size used for the test set and the data provenance:
- Norway (Live birth rates per started cycle):
  - Dept of Ob & Gyn. Univ of Trondheim: Data from 1992-1996. Number of cycles not specified.
  - The National Hospital, Oslo: Data from 1992-1996. Number of cycles not specified.
  - Provenance: Retrospective clinical data from IVF units in Norway.
- Sweden (Birth rate per embryo replacement):
  - Carl von Linne Clinic: Data for 1997. Number of embryo replacements not specified.
  - Provenance: Retrospective clinical data from a specific IVF clinic in Sweden.
- UK (Live birth rates per embryo replacement):
  - A total of 10 clinics using Medi-Cult products were analyzed. The number of IVF cycles for these clinics ranged from 68 to 1434. The total number of IVF cycles represented by these clinics is 5907.
  - UK national average data covered 33520 IVF cycles.
  - Provenance: Retrospective clinical data from IVF units in the UK for the period April 1, 1996 to March 31, 1997, collected by the Human Fertilization and Embryology Authority (HFEA).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The "ground truth" for clinical performance is real-world live birth rates and national averages, not expert consensus on individual cases. The data collected by national authorities (like HFEA) represent outcomes, not interpretations.
Adjudication method for the test set:
- Not applicable. The data consists of aggregated clinical performance statistics (live birth rates), not individual case assessments 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:
- No. This is not an MRMC study. The product is a culture medium, not an AI-assisted diagnostic device, and therefore does not involve human "readers" or AI assistance in that sense.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a way. The product itself, the culture medium, performs its function (supporting oocytes) without direct human intervention once applied. The clinical data reflects the outcomes achieved when using the product as part of standard IVF protocols. This can be considered a "standalone" performance in the context of the product's function, as it's the medium's intrinsic quality that is being evaluated, albeit within a clinical system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Outcomes data: Specifically, live birth rates per started cycle or per embryo replacement, as reported by clinical centers and national registries. For product testing controls, the ground truth is established by specific QC-test results (e.g., Sterility, pH, Osmolarity, Endotoxin, Mouse Embryo Assay >80% hatching).
The sample size for the training set:
- Not applicable. This is not a machine learning model, so there is no concept of a "training set" for the device itself. The historical extensive use of the culture media since the end of the 1980s by many European IVF units can be seen as long-term observational data that informed the current product and its efficacy, but it's not a formal "training set" for an algorithm.
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of this device.

Summary

Regulation Number and Section

§ 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.