(195 days)
No
The document describes a sterile culture medium for assisted reproduction and does not mention any AI or ML components.
No
This device is a culture medium used for fertilization and culture of embryos, as well as embryo transfer. It is not a therapeutic device that treats or diagnoses a condition.
No.
This device is a culture medium used for fertilization, embryo culture, and embryo transfer in assisted reproduction, not for diagnosing a condition or disease.
No
The device description clearly states that EmbryoAssist™ and EmbryoAssist™ with Phenol Red are "defined sterile media" supplied in "polyethylene plastic vials." This indicates a physical, chemical product, not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the media are for "fertilization and culture until the 2-8 cell stage" and "embryo transfer at day 2 or 3." These are procedures performed in vitro (outside the living body) to assist in reproduction.
- Device Description: The description states it is a "defined sterile media used by professionals within assisted reproduction." Media used for culturing and manipulating biological samples in vitro are characteristic of IVDs.
- Context of Use: The device is used by "professionals within assisted reproduction," which aligns with the typical users of IVD products in a clinical or laboratory setting.
While the document doesn't explicitly use the term "In Vitro Diagnostic," the intended use and nature of the device (a culture medium for in vitro fertilization and embryo development) firmly place it within the definition of an IVD.
N/A
Intended Use / Indications for 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.
Product codes
MQL
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professionals within assisted reproduction
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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).
2
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
3
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
4
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
5
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