(274 days)
EmbryoAssist™ is used for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes.
EmbryoAssist™ is a defined sterile medium, used by assisted reproduction professionals and intended for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes. The design of EmbryoAssist™ is based on BlastAssist Medium 1 (MediCult's BlastAssist®System K003156). The EmbryoAssist™ medium is a salt solution added SSR (Synthetic Serum Replacement), HSA, amino acids, a stable form of L-glutamine, vitamins and antibiotics. EmbryoAssist™ is supplied in 10 ml polyethylene plastic vials with screw top closures
Here's an analysis of the provided text regarding the acceptance criteria and study for the EmbryoAssist™ device:
Important Note: The provided document is a 510(k) summary for a medical device (EmbryoAssist™), which is a reproductive medium. The information available in these types of summaries focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results for a diagnostic AI device. Therefore, many of the requested points, especially those related to AI algorithm performance (e.g., sample sizes for training/test sets, expert consensus for ground truth, MRMC studies, standalone performance), are not applicable to this type of device and submission.
This document describes a culture medium and its performance is assessed in terms of its ability to support embryo development, which is a biological outcome.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Safety | No serious adverse events. | "no evidence that the product has been the cause of any serious adverse events." |
| Effectiveness | Supports embryo culture for intended use (up to 4-8 cell stage). | "The results showed that the product is effective and safe for its intended use." |
| Product Controls | Sterility | "Frouner resulting Colliers for sterility..." |
| Osmolarity | "...osmolality..." | |
| pH | "...pH..." | |
| Endotoxin levels | "...endotoxin..." | |
| Mouse Embryo Assay (MEA) | "...Mouse embryo Assay (MEA)." | |
| Stability | Demonstrated stability over time. | "Stability studies have been performed." |
| Substantial Equivalence | Similar intended use and technological characteristics to predicate devices. | Concluded to be substantially equivalent to MediCult's Universal IVF Medium (K991279) and BlastAssist®System (K0013156). |
Explanation of Inferred Criteria: The document directly states the conclusion that the product is "effective and safe for its intended use." The product testing controls listed (sterility, osmolality, pH, endotoxin, MEA, stability) are inherent quality and performance checks for such a biological medium, and the successful completion of these tests implies they met pre-defined acceptance criteria for release. The core acceptance criterion for the 510(k) submission itself is demonstrating substantial equivalence to existing, legally marketed predicate devices.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: The document states, "EmbryoAssist™ has been tested in a human study." It does not specify the sample size of this human study.
- Data Provenance: The study was a "human study," implying prospective collection since it involved testing the new device. The country of origin is not explicitly stated, but the submission came from MediCult a/s in Denmark.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This question is not applicable as the device is a culture medium, not an AI diagnostic tool. "Ground truth" for this product would be the successful development of embryos or lack thereof, observed by embryologists/clinicians, rather than expert interpretation of images or data. No "experts" were used in the sense of adjudicating diagnostic decisions.
4. Adjudication Method for the Test Set
- Not applicable for this type of device (culture medium). Adjudication methods like 2+1 or 3+1 are used in diagnostic studies (e.g., radiology) where multiple readers assess cases and discrepancies are resolved. This is not relevant to a cell culture medium.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- No, an MRMC study was not done. This type of study is specifically for evaluating the performance of human readers, often with and without AI assistance, in interpreting medical images or data. It is not relevant to a cell culture medium.
6. If a Standalone (algorithm only without human-in-the-loop performance) study was done
- No, this is not an AI algorithm. This question is not applicable as EmbryoAssist™ is a physical culture medium, not an algorithm.
7. The Type of Ground Truth Used
- For the human study, the "ground truth" would be the biological outcome of embryo culture, such as:
- Successful fertilization of oocytes.
- Progression of embryos to the 4-8 cell stage (Day 2 or Day 3).
- Absence of adverse effects on embryo morphology or viability.
- Essentially, it's based on observing the biological performance of the medium as intended.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device is not an AI algorithm and does not have a training set or associated ground truth in that context.
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1061309
510(K) SUMMARY Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
FEB 8 2007
| Submitted by: | MediCult a/sMøllehaven 124040 JyllingeDenmarkTelephone: + 45 46 79 02 00Fax: + 45 46 79 03 00 |
|---|---|
| Contact person: | Ronald G. Leonardi, Ph.D. |
Date Submitted: September 8, 2006
Device Identification
Trade name: EmbryoAssist™ Common name: EmbryoAssist™ Classification name: Reproductive media and supplements (21 CFR 884.6180, Product Code MQL)
Predicate device:
Universal IVF Medium (K991279) and BlastAssist®System (K003156) from MediCult.
Description
EmbryoAssist™ is a defined sterile medium, used by assisted reproduction professionals and intended for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes.
The design of EmbryoAssist™ is based on BlastAssist Medium 1 (MediCult's BlastAssist®System K003156). The EmbryoAssist™ medium is a salt solution added SSR (Synthetic Serum Replacement), HSA, amino acids, a stable form of L-glutamine, vitamins and antibiotics. EmbryoAssist™ is supplied in 10 ml polyethylene plastic vials with screw top closures
Intended use
EmbryoAssist™ is used for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes.
Technological Characteristics
The technological characteristics of EmbryoAssist™ are essentially similar to those of the predicate devices they have the same intended use and are based on a physiological salt solution with SSR and amino acids. However, EmbryoAssist™ differs in the composition in containing vitamins. This change does not affect the safety or effectiveness of the device.
Performance data
EmbryoAssist™ has been tested in a human study. The results showed that the product is effective and safe for its intended use. During our studies there have been no registered complaints and no evidence that the product has been the cause of any serious adverse events in connection with the intended use.
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Product Testing Controls
Frouner resulting Colliers for sterility, osmolality, pH, endotoxin and Mouse embryo Assay (MEA). Stability studies have been performed.
Conclusion
It is concluded that the safety and the effectiveness of the product for its intended use is shown in the present submission and that the product is substantial equivalence to the predicated device MediCult's Universal IVF Medium (K991279) and MediCult's BlastAssist®System (K0013156).
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure embracing a three-lined globe.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MediCult a/s % Ronald G. Leonardi, Ph.D. President R & R Registrations 9915 Cam. Chirimolla SAN DIEGO CA 92131
2007 FEB
Re: K061309
Trade/Device Name: EmbryoAssistTM Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: January 19, 2007 Received: January 22, 2007
Dear Dr. Leonardi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "PA" are in the center of the circle in a bold font. The word "Centennial" is below the letters "PA" in a cursive font. There are three stars below the word "Centennial".
Protecting and Promoting Public Health
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Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlvindustry/support/index.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Kob 1309
Device Name:
EmbryoAssist™
Indications For Use:
EmbryoAssist™ is used for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes.
AND/OR Over-The-Counter Use Prescription Use x (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Daniel Ro. Segmann
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
§ 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.