Who is the manufacturer of SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS?

Origio A/S filed the 510(k) submission for SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS (K172197).

What is the FDA product code for SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS?

MQL. It is classified under 21 CFR 884.6180 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS

Q: What are the predicate devices for SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS?

SAGE 1-Step™ with HSA and SAGE 1-Step™ with SPS (K133707).

K172197 · Origio A/S · MQL · Oct 13, 2017 · Obstetrics/Gynecology

Device Facts

Record ID	K172197
Device Name	SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS
Applicant	Origio A/S
Product Code	MQL · Obstetrics/Gynecology
Decision Date	Oct 13, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.6180
Device Class	Class 2

Intended 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.

Device Story

SAGE 1-Step™ GM-CSF (with HSA or SPS) is an embryo culture medium used in assisted reproduction. It contains physiological salts, energy substrates, amino acids, antibiotics, protein supplements, and 2 ng/ml of granulocyte-macrophage colony-stimulating factor (GM-CSF). The medium supports embryo development in vitro from fertilization to the blastocyst stage (Day 5/6). It is supplied in 3 ml glass vials, aseptically filtered, and intended for use by embryologists in clinical laboratory settings. The addition of GM-CSF is the primary technological difference from the predicate. The device is used to maintain optimal environmental conditions for embryo growth, potentially improving developmental outcomes. Healthcare providers use the medium to facilitate the culture process prior to embryo transfer.

Clinical Evidence

Bench testing only. Performance validated via pH (7.2-7.4), osmolality (257-273 mOsm/kg), endotoxin (<0.15 EU/ml), and sterility (USP <71>). Mouse embryo assay (MEA) showed ≥80% blastocyst development at 96h. GM-CSF concentration (ELISA) and potency (TF-1 cell assay) met 80-125% recovery/potency specifications. Real-time shelf-life testing confirmed specifications are met throughout the 16-week shelf-life.

Technological Characteristics

Embryo culture medium containing buffering agents, physiological salts, energy substrates, amino acids, antibiotics, protein supplements (HSA or SPS), and 2 ng/ml GM-CSF. Aseptically filtered (SAL 10^-3). Supplied in 3 ml glass vials. Shelf-life 16 weeks. Storage 2-8°C. Testing per USP <71> (sterility), USP <85> (endotoxin), and ISO 13408-2-2003 (aseptic processing).

Indications for Use

Indicated for in vitro culture of human embryos following fertilization until Day 5/6 of development and for embryo transfer procedures.

Regulatory Classification

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.).

Special Controls

*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.

Predicate Devices

SAGE 1-Step™ with HSA and SAGE 1-Step™ with SPS (K133707)

Related Devices

K152932 — BlastGen · Origio A/S · Feb 29, 2016
K133707 — SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS · Origio A/S · Apr 16, 2014
K140317 — EMBRYOGEN · Origio A/S · Jun 16, 2014
K120136 — EMBRYOGEN · Origio A/S · Sep 26, 2012
K170681 — Continuous Single Culture -NX (CSCM-NX) · Irvine Scientific Sales Co., Inc. · Jun 8, 2017

Submission Summary (Full Text)

{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) | <0.15 | <0.15 | Same | | Sterility | Aeptic Filteration SAL 10⁻³, no growth | Aeptic Filteration SAL 10⁻³, no growth | Same | | Shelf-Life | 16 weeks | 26 weeks | Different - The shelf-life of the subject and predicate devices are different. This difference does not raise different questions of safety and effectiveness. | As noted in the table above, the devices have the same intended use and are technologically comparable. Differences in technological characteristics noted above do not raise different questions of safety or effectiveness. # VIII. Summary of Non-Clinical Performance Testing 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 {6}------------------------------------------------ - Sterility testing per USP <71> No microbial growth ● - . Endotoxin testing per USP <85> - <0.15 EU/ml (LAL) - Mouse embryo assay (MEA) 1-Cell MEA: ≥80% blastocysts at 96h ● One-cell mouse embryos were exposed to subject devices and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the blastocyst stage at 96 hours were assessed in comparison with the control group. - GM-CSF concentration (by ELISA) 80-120% recovery . - GM-CSF potency (TF-1 cell assay) - 80-125% potency - Shelf-life testing (real-time) was conducted to ensure that the following product specifications are met at time zero and the end of shelf-life. - pH O - Osmolality O - 1-Cell MEA O - Endotoxin o - Sterility O - GM-CSF concentration O - o GM-CSF potency #### IX. Conclusion The results of the performance testing conducted on the subject devices demonstrates that they are as safe and effective as the predicate devices and support substantial equivalence.