EMBRYOGLUE

• K Number: K031015
• Device Name: EMBRYOGLUE
• Manufacturer: VITROLIFE SWEDEN AB
• Date Cleared: 2003-06-23 ( 84 days)
• Product Code: MQL
• Regulation Number: 884.6180
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: N/A

Intended Use

Medium for In Vitro Fertilization Procedures
Medium for embryo transfer

Device Description

Bicarbonate buffered medium containing Hyaluronan and Recombinant Human Albumin

AI/ML Overview

The provided documents do not contain information regarding acceptance criteria or study data that proves the device meets specific performance metrics. This is a 510(k) premarket notification summary for a medical device (EmbryoGlue™ Assisted Reproduction Media) that has been deemed substantially equivalent to a predicate device.

The review process for a 510(k) emphasizes substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific acceptance criteria and performance data like a PMA (Premarket Approval) application would.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document only states the following:

• Device Name: EmbryoGlue™
• Intended Use/Indications for Use: Medium for embryo transfer in In Vitro Fertilization Procedures.
• Predicate Device: G-2™ version 3, supplemented with G-MM™.
• Technological Characteristics: EmbryoGlue™ is a modification of G-2™ version 3, supplemented with G-MM™. The technological characteristics of EmbryoGlue are essentially similar to those of the predicate device. The EmbryoGlue contains Recombumin and is not intended to be supplemented with albumin prior to use. Other changes are the product packaging and the fact that EmbryoGlue contains a higher concentration of Hyaluronan. None of these differences raise new questions of safety or effectiveness.

The FDA's determination of "substantial equivalence" is based on the comparison of the new device to a legally marketed predicate device, concluding that the new device is as safe and effective as the predicate. This does not typically involve new clinical studies demonstrating specific performance metrics for the new device if suitable predicate data and technological similarities can be established.

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.