(147 days)
No
The summary describes a cell culture media and its performance in embryo development, with no mention of AI or ML technologies.
No.
The device is a culture medium used for growing embryos from the 4-8 cell stage to the blastocyst stage and for embryo transfer, which facilitates a physiological process rather than treating a disease or condition.
No
The device is described as a culture medium for embryos and is used for embryo transfer, not for diagnosing a medical condition.
No
The device description clearly states it is a "colorless, non-viscous solution contained in 3mL transparent glass bottles," indicating it is a physical substance (culture media) and not software.
Based on the provided information, BlastGen™ is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the culture of embryos from the 4-8 cell stage through to the blastocyst stage." This process of culturing embryos in vitro (outside the body) is a key component of assisted reproduction, which involves diagnostic and therapeutic procedures performed on biological samples (embryos).
- Device Description: It is a "ready to use by professionals for assisted reproduction." Assisted reproduction procedures often involve in vitro manipulation and assessment of gametes and embryos.
- Quality Control Testing: The extensive quality control testing performed on the product (pH, sterility, Mouse Embryo Assay, endotoxin, osmolality, GM-CSF concentration, GM-CSF potency, and human serum albumin concentration) is typical for products used in in vitro procedures involving human biological material.
- Performance Studies: The performance studies describe the effect of the media on embryo development in vitro (blastocyst rate, developmental competence, apoptotic nuclei, inner cell mass cells). This evaluation of the device's performance in an in vitro setting further supports its classification as an IVD.
- Predicate Device: The predicate device, ORIGIO® Sequential Blast™ (K133387), is also a culture medium used in assisted reproduction, which are generally classified as IVDs.
While the device itself doesn't perform a diagnostic test on a patient sample in the traditional sense (like a blood test), it is a critical reagent used in vitro to support the development and assessment of embryos, which are biological samples. This falls under the scope of in vitro diagnostics as defined by regulatory bodies.
N/A
Intended Use / Indications for Use
BlastGen™ is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage. BlastGen™ can also be used for embryo transfer.
Product codes
MOL
Device Description
BlastGen™ is based on ORIGIO® Sequential Blast™ (K133387) with the supplement of Leukine (Sargramostim) granulocyte macrophage colony-stimulating factor (GM-CSF).
BlastGen™ is a colorless, non-viscous solution contained in 3mL transparent glass bottles with white polypropylene caps, available in a single piece card board box, individually labeled and with instruction for use provided as a package insert. BlastGen™ is a ready to use by professionals for assisted reproduction.
BlastGen™ is quality control tested before release for pH, sterility, Mouse Embryo Assay, endotoxin, osmolality, GM-CSF concentration (by ELISA), GM-CSF potency (TF-1 cell assay) and human serum albumin (HSA) concentration (by ELISA).
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 for 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
Biocompatibility: Cytotoxicity, sensitization, and irritation tests were conducted in accordance with ISO 10993-1:2009.
Sterilization Validation: Aseptically filtration validated in accordance with EN/ISO 13408-2:2011, with a sterility assurance level (SAL) of 103.
Shelf-Life: Evaluated for pH, osmolality, sterility, mouse embryo assay, endotoxin, GM-CSF concentration, GM-CSF potency and HSA concentration. Has 26-week shelf-life in unopened bottle and 7-day stability after opening.
Clinical Evidence:
- A prospective randomized sibling zygote pilot study (n=371 zygotes) showed a trend towards higher blastocyst rate, pregnancy, and ongoing implantation rates for GM-CSF-containing media (EmbryoGen/BlastGen) compared to G1/G2, though not statistically significant (Nakajyo et al., 2016).
- Addition of GM-CSF increased the proportion of embryos developing to the blastocyst stage from 30% to 76%. Also improved developmental competence of blastocysts (hatching and attachment to extracellular matrix-coated culture dishes) (Sjöblom et al., 1999).
- Blastocysts cultured in 2 ng/ml GM-CSF contained 50% fewer apoptotic nuclei and 30% more viable inner cell mass cells compared to control (Sjöblom et al., 2002).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 29, 2016
Origio A/S Tove Kjaer Director Corporate Regulatory Affairs Knardrupvej 2 2760 Måløv Denmark
Re: K152932
Trade/Device Name: BlastGen™ Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: Class II Product Code: MOL Dated: January 29, 2016 Received: February 8, 2016
Dear Tove Kjaer,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/8 description: The image shows the name "Herbert P. Lerner -S" in a large, sans-serif font. The text is black and appears to be the main subject of the image. In the background, there is a faint watermark or logo, possibly indicating the source or context of the image. The overall impression is a clear and simple presentation of the name.
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152932
Device Name BlastGen™
Indications for Use (Describe)
BlastGen™ is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage. BlastGen™ can also be used for embryo transfer.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the word "origio" in a stylized, sans-serif font. The color of the text is a deep purple. The letters are rounded and have a modern, minimalist design. The letter "g" is particularly unique, with a curved shape that resembles a number 8.
K152932 - BlastGen™
510(k) SUMMARY
| Submitted by: | ORIGIO a/s
Knardrupvej 2,
2760 Måløv,
Denmark |
|-----------------|------------------------------------------------------------------|
| Contact Person: | Tove Kjær
Director Corporate Regulatory Affairs
ORIGIO a/s |
| | Phone: +45 4679 0220
Fax: +45 4679 0300 |
| | Date Prepared: |
Device Identification
| Trade name: | BlastGen™ (Cat. No. 1205) |
|---|---|
| Common name: | BlastGen™ (Cat. No. 1205) |
| Classification name: | Reproductive media and supplements (21 CFR 884.6180, Product |
| Code MQL) |
Predicate Devices: ORIGIO® Sequential Blast™ (Cat. No. 8305) (K133387)
Device Description:
BlastGen™ is based on ORIGIO® Sequential Blast™ (K133387) with the supplement of Leukine (Sargramostim) granulocyte macrophage colony-stimulating factor (GM-CSF).
BlastGen™ is a colorless, non-viscous solution contained in 3mL transparent glass bottles with white polypropylene caps, available in a single piece card board box, individually labeled and with instruction for use provided as a package insert. BlastGen™ is a ready to use by professionals for assisted reproduction.
BlastGen™ is quality control tested before release for pH, sterility, Mouse Embryo Assay, endotoxin, osmolality, GM-CSF concentration (by ELISA), GM-CSF potency (TF-1 cell assay) and human serum albumin (HSA) concentration (by ELISA).
Indication for Use:
BlastGen™ is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage. BlastGen™ can also be used for embryo transfer.
Performance and Safety Data:
Biocompatibility
BlastGen™ is categorized as a medium in direct contact with embryos from the 4-8 cell stage to blastocyst stage. Since BlastGen™ can also be used for embryo transfer, it is also in contact with the uterus (patient). In accordance with ISO 10993-1:2009, the
4
cytotoxicity, sensitization and irritation tests have been conducted and the results demonstrated that BlastGen™ was safe.
Sterilization Validation
BlastGen™ is manufactured by aseptically filtration that was validated in accordance with EN/ISO 13408-2:2011. This product has a sterility assurance level (SAL) of 103.
Shelf-Life
The BlastGen™ has been evaluated for pH, osmolality, sterility, mouse embryo assay, endotoxin, GM-CSF concentration, GM-CSF potency and HSA concentration in shelf-life testing. Under recommended storage conditions. BlastGen™ has 26-week shelf-life in unopened bottle and 7-day stability after the bottle has been opened.
Clinical Evidence
A prospective randomized sibling zygote pilot study (n=371 zygotes) of GM-CSFcontaining media (EmbryoGen/BlastGen) for culturing embryos to the blastocyst stage showed a trend towards higher blastocyst rate in the EmbryoGen/BlastGen group compared to G1/G2 although these differences did not reach statistical significance. A trend towards higher pregnancy and ongoing implantation rates were also observed for EmbryoGen/BlastGen (Nakajyo et al., 2016).
The addition of GM-CSF increased the proportion of embryos that developed to the blastocyst stage from 30 to 76%. The developmental competence of these blastocysts (hatching and attachment to extracellular matrix-coated culture dishes), was also improved by GM-CSF (Sjöblom et al., 1999).
Blastocysts cultured in 2 ng/ml GM-CSF contained 50% fewer apoptotic nuclei and 30% more viable inner cell mass cells, compared to the control (Sjöblom et al., 2002)
Conclusion:
BlastGen™ and predicate device have the same indications and comparable technological characteristics. Based on non-clinical and clinical performance data, BlastGen™ is substantially equivalent to the predicate device in terms of safety and effectiveness.