(84 days)
No
The device description and performance studies focus on the chemical composition and biological effects of embryo culture media, with no mention of AI or ML technologies.
No
The device is an embryo culture media product used for in vitro culture of human embryos, which does not directly treat a disease or condition in a patient.
No
This device is an embryo culture medium, used for the in vitro culture of human embryos. It is a therapy support device, not a diagnostic one.
No
The device description clearly states it is an embryo culture media product consisting of various chemical agents, salts, and proteins, supplied in glass vials. This is a physical product, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in vitro culture of human embryos following fertilization." This means the device is used outside of the body to support a biological process (embryo development).
- Device Description: The description details the components of the culture media, which are used to create the environment for the in vitro culture.
- Performance Studies: The performance studies include tests like pH, osmolality, embryotoxicity, endotoxin, and sterility, which are all relevant to ensuring the quality and safety of a product used for in vitro biological processes.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this device isn't directly diagnosing a disease, it is used in the process of assisted reproduction, which is a medical intervention performed in vitro to address infertility. The culture media is a critical component of this in vitro process.
Therefore, the intended use and nature of the device align with the characteristics of an In Vitro Diagnostic product.
N/A
Intended Use / Indications for Use
The product is intended for in vitro culture of human embryos following fertilization until Day 5/6 of development. The media can also be used for embryo transfer.
Product codes
MOL
Device Description
SAGE 1-Step™ GM-CSF with HSA and SAGE 1-Step™ GM-CSF with SPS are assisted reproduction embryo culture media products consisting agents, physiological salts, energy substrates, amino acids, antibiotics, protein supplements (HSA or SPS), and granulocyte-macrophage colony-stimulating factor (GM-CSF, 2 ng/ml).
These devices are aseptically filtered (sterility assurance level of 10 %), and supplied in 3 ml glass vials. They are tested for pH, osmolality, embryotoxicity, endotoxin, sterility, and GM-CSF concentration and potency before lot release. These devices have a shelf-life of 16 weeks, and can be used for up to seven days after vial opening when stored at 2-8°C.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following studies have been performed to support substantial equivalence to the predicate devices:
- pH 7.2-7.4
- Osmolality - 257-273 mOsm/kg
- Aseptic processing validation testing that meet the requirements in ISO 13408-2-2003
- Sterility testing per USP No microbial growth
- Endotoxin testing per USP -
§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 13, 2017
ORIGIO a/s Tove Kjaer Director, Corporate Regulatory Affairs Knardrupvej 2 Malov, 2760 Denmark
Re: K172197 Trade/Device Name: SAGE 1-Step™ GM-CSF with HSA, SAGE 1-Step™ GM-CSF with SPS Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: Class II Product Code: MOL Dated: July 24, 2017 Received: July 26, 2017
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 (DICE) 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 (DICE) 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.
Joyce M. Whang -S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172197
Device Name
SAGE 1-Step™ GM-CSF with HSA SAGE 1-Step™ GM-CSF with SPS
Indications for Use (Describe)
The product is intended for in vitro culture of human embryos following fertilization until Day 5/6 of development. The media 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 Druq 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/0 description: The image shows the word "origio" in a stylized, lowercase font. The letters are a deep purple color. The 'g' is designed with a unique, almost circular shape, and the overall design has a modern and minimalist aesthetic.
a CooperSurgical Company
K172197 Page 1 of 4
510(k) SUMMARY K172197
- Submitter Information L
Submitter:
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 Email: tkjaer@origio.com
- II. Date prepared: Oct. 13 2017
III. Device Information
| Device Name: | SAGE 1-Step™ GM-CSF with HSA
SAGE 1-Step™ GM-CSF with SPS |
|------------------------|--------------------------------------------------------------|
| Common name: | Embryo Culture Media |
| Classification name: | Reproductive media and supplements |
| Classification Number: | 21 CFR 884.6180 |
| Product Code: | MQL (Media, Reproductive) |
| Regulatory Class: | II |
IV. Predicate Device
ORIGIO a/s - SAGE 1-Step™ with HSA and SAGE 1-Step™ with SPS (K133707)
These predicate devices have not been subject to any design-related recalls.
V. Indication for use
The product is intended for in vitro culture of human embryos following fertilization until Day 5/6 of development. The media can also be used for embryo transfer.
4
VI. Device Description
SAGE 1-Step™ GM-CSF with HSA and SAGE 1-Step™ GM-CSF with SPS are assisted reproduction embryo culture media products consisting agents, physiological salts, energy substrates, amino acids, antibiotics, protein supplements (HSA or SPS), and granulocyte-macrophage colony-stimulating factor (GM-CSF, 2 ng/ml).
These devices are aseptically filtered (sterility assurance level of 10 %), and supplied in 3 ml glass vials. They are tested for pH, osmolality, embryotoxicity, endotoxin, sterility, and GM-CSF concentration and potency before lot release. These devices have a shelf-life of 16 weeks, and can be used for up to seven days after vial opening when stored at 2-8°C.
VII. Comparison of Intended Use and Technological Characteristics of Subject and Predicate Devices
| Parameter | Subject device-
SAGE 1-StepTM
GM-CSF (with HAS
or SPS) (K172197) | Predicate Device-
SAGE 1-StepTM (with
HAS or SPS)
(K133707) | Comparison |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The product is
intended for in vitro
culture of human
embryos following
fertilization until Day
5/6 of development.
The media can also
be used for embryo
transfer. | This product is
intended for in vitro
fertilization and
culture of human
gametes and
embryos from
fertilization until Day
5/6 of development.
The medium can
also be used for
embryo transfer. | Different- The
subject and
predicate devices
are both indicated
for culturing embryos
following fertilization
until the blastocyst
stage (Day 5/6) of
development, and
for use in embryo
transfer procedures.
The predicate is also
indicated for use
during fertilization,
which is different
than the subject
device. This
difference does not
represent a new
intended use, but
rather a more limited
use of the subject
device. |
| Formulation | Buffering agents,
physiological salts | Buffering agents,
physiological salts | Different -Base
formulations of the |
5
| | energy substrates,
amino acids,
antibiotics, protein
supplements (HSA
or SPS), and GM-
CSF | energy substrates,
amino acids,
antibiotics, and
proteins
supplements (HSA
or SPS) | subject and
predicate devices
are similar; however,
the subject device
also includes GM-
CSF. This
difference does not
raise different
questions of safety
and effectiveness
(e.g.,
biocompatibility,
embryotoxicity, etc.). |
|-------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| pH | 7.2-7.4 | 7.2-7.4 | Same |
| Osmolality | 257-273 | 257-273 | Same |
| MEA | 1-Cell MEA: ≥80%
blastocysts at 96h | 1-Cell MEA: ≥80%
blastocysts at 96h | Same |
| Endotoxin (EU/ml) | No microbial growth ●
- . Endotoxin testing per USP -