(195 days)
EmbryoAssist™ and EmbryoAssist™ with Phenol Red are for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ and EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3.
EmbryoAssist™ and EmbryoAssist™ with Phenol Red are each a defined sterile media used by professionals within assisted reproduction and intended for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ and EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3. The composition of EmbryoAssist™ and EmbryoAssist™ with Phenol Red are almost identical to The predicate device Embryo Assist™ (K061309), but with an extension of the intended use including a transfer indication. The EmbryoAssist" medium is a salt solution containing SSR (Synthetic Serum Replacement), HSA, amino acids, a stable form of L-glutamine, vitamins and antibiotics. EmbryoAssist™ is supplied in 10 ml and 60 ml polyethylene plastic vials with screw top closures.
The provided 510(k) summary for EmbryoAssist™ and EmbryoAssist™ with Phenol Red describes a medical device, a cell culture medium, rather than a diagnostic AI device. Therefore, many of the requested categories related to AI specific performance, such as sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable to this submission.
However, I can extract the information that is present and relevant to the "acceptance criteria" (implied functional and safety requirements) and the "study that proves the device meets the acceptance criteria" from the provided text.
Acceptance Criteria and Device Performance
The core acceptance criteria for this type of device (reproductive media) revolve around its safety and effectiveness for its intended use, which is fertilization, culture until the 2-8 cell stage, and embryo transfer. The primary way this is demonstrated for a 510(k) submission is through substantial equivalence to a legally marketed predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: No serious adverse events | "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." |
| Effectiveness: Capable of supporting fertilization, culture (2-8 cell stage), and embryo transfer successfully. | "The results showed that the product is effective and safe for its intended use." (This is a general statement, relying on comparison to predicate and the human study data.) |
| Quality Control: Meets established physical and biological parameters. | "Each batch is tested according to Ph. Eur. and USP for sterility, osmolality, pH, endotoxin and Mouse Embryo Assay (MEA). Stability studies have been performed." |
| Substantial Equivalence: Similar technological characteristics and intended use to predicate devices. | The device's composition is "almost identical" to a predicate, with an extended intended use (transfer indication). It is concluded to be "substantially equivalent." |
Study Information
As this is a 510(k) for an in vitro diagnostic/culture medium, the "study" is a human clinical study aimed at demonstrating safety and effectiveness, leveraging the concept of substantial equivalence.
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. It mentions "a human study" but does not give the number of participants or embryos.
- Data Provenance: The study was "a human study." The sponsoring company, MediCult a/s, is located in Denmark, suggesting the study may have been conducted there or in a similar regulatory environment, but this is not explicitly stated. It is a prospective study as it states "During our studies there have been no registered complaints," implying current data collection.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a cell culture medium, not an AI diagnostic device where expert ground truth is typically assigned to images or patient data. The "ground truth" here is the biological outcome of the cultures and transfers.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
-
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 AI device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this type of device, the "ground truth" would be the observed biological outcomes (e.g., successful fertilization, embryo development to the 2-8 cell stage, successful transfer leading to pregnancy/live birth outcomes – although the latter is often not required for 510(k) for culture media, usually focusing on early embryological development and safety). The text specifically states: "The results showed that the product is effective and safe for its intended use." This efficacy is based on the biological performance observed in the human study.
-
The sample size for the training set:
- Not Applicable. This is not an AI device, so there is no training set in the AI sense.
-
How the ground truth for the training set was established:
- Not Applicable. See point 7.
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SEP - 3 2008
510(K) SUMMARY Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
| Submitted by: | MediCult a/s |
|---|---|
| Møllehaven 12 | |
| 4040 Jyllinge | |
| Denmark | |
| Telephone: + 45 46 79 02 00 | |
| Fax: + 45 46 79 03 00 | |
| Contact person: | Ronald G. Leonardi, Ph.D. |
| R&R Registrations | |
| 9919 Cam. Chirimolla | |
| San Diego CA 92131 | |
| Date Submitted: 2008, August |
Device Identification
Trade name: EmbryoAssist™ and EmbryoAssist™ with Phenol Red
Common name: EmbryoAssist™ and EmbryoAssist™ with Phenol Red Classification name: Reproductive media and supplements (21 CFR 884.6180, Product Code MQL)
Predicate device:
Universal IVF Medium (K991279), EmbryoAssist™ (K061309) and ISM1™ (K030490) from MediCult.
Description
EmbryoAssist™ and EmbryoAssist™ with Phenol Red are each a defined sterile media used by professionals within assisted reproduction and intended for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ and EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3.
The composition of EmbryoAssist™ and EmbryoAssist™ with Phenol Red are almost identical to The predicate device Embryo Assist™ (K061309), but with an extension of the intended use including a transfer indication.
The EmbryoAssist" medium is a salt solution containing SSR (Synthetic Serum Replacement), HSA, amino acids, a stable form of L-glutamine, vitamins and antibiotics. EmbryoAssist™ is supplied in 10 ml and 60 ml polyethylene plastic vials with screw top closures.
Intended use
EmbryoAssist™ and EmbryoAssist™ with Phenol Red are for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ and EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3.
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.
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Performance data
EmbryoAssist™ has been tested as both culture and transfer medium 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.
Product Testing Controls
Each batch is tested according to Ph. Eur. and USP 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 products are substantial equivalent to the predicate device MediCult's Universal IVF Medium (K991279), MediCult's EmbryoAssist™ (K061309)and MediCult's ISM1™ (K030490).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP - 8 2008
MediCult A/S c/o Ronald G. Leonardi, Ph.D. R&R Registrations 9915 Cam. Chirimolla SAN DIEGO CA 92131
Re: K080473
Trade/Device Name: EmbryoAssist™ and EmbryoAssist™ with Phenol Red Regulation Number: 21 CFR §884.6180 Regulation Name: Reproduction Media and Supplements Regulatory Class: II Product Code: MQL Dated: July 29, 2008 Received: July 30, 2008
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 logo. Below that is the acronym "FDA" in large, bold letters. Underneath the acronym, the word "Centennial" is written in a cursive font. There are three stars below the word "Centennial."
Protecting and Promoting Public Health
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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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely vours.
Nancy 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): K080473
Device Name:
EmbryoAssist™ with Phenol Red
Indications for Use:
EmbryoAssist™ with Phenol Red is for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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
Julius Helmer
livision S Division of Reproductive, Abdomin and Radiological De 510(k) Number
010
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Indications for Use
510(k) Number (if known): K080473
Device Name:
EmbryoAssist™
Indications for Use:
EmbryoAssist™ is for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ can also be used for embryo transfer at day 2 or 3.
Prescription Use __________ AND/OR Over-The-Counter Use ______________________________________________________________________________________________________________________ (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
eproductive, Abdominal, Radiological Device
510(k) Number K080477
011
§ 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.