ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED
Device Facts
| Record ID | K133387 |
|---|---|
| Device Name | ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED |
| Applicant | Origio A/S |
| Product Code | MQL · Obstetrics/Gynecology |
| Decision Date | Apr 29, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.6180 |
| Device Class | Class 2 |
Indications for Use
ORIGIO® Sequential Blast™ is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage. ORIGIO® Sequential Blast™ can also be used for embryo transfer.
Device Story
ORIGIO® Sequential Blast™ is a non-viscous, aseptically filtered culture medium used in assisted reproduction laboratories. It provides essential nutrients, physiological salts, energy sources (glucose, calcium-L-lactate, sodium pyruvate), and amino acids to support embryo development from the 4-8 cell stage to the blastocyst stage. The medium is also used for embryo transfer into the patient's uterus. It is supplied in PETG bottles and is intended for use by trained professionals in clinical settings. The device functions by maintaining an optimal chemical environment (pH 7.2-7.5, osmolality 272-288 mOsm/kg) for embryo viability. Clinical benefit is derived from supporting embryo development and facilitating successful transfer procedures. The device is a chemical formulation and does not involve automated processing or software.
Clinical Evidence
Bench testing only. Performance was validated through product specifications including sterility, pH (7.2-7.5), osmolality (272-288 mOsm/kg), endotoxin levels (<0.15 EU/mL), and Mouse Embryo Assay (MEA) (≥80% 1-cell MEA). Stability studies validated a 36-week shelf life. Biocompatibility was evaluated per ISO 10993-1, confirming the medium is non-toxic for embryo culture and uterine contact.
Technological Characteristics
Aseptically filtered, non-viscous liquid medium. Components: physiological salts (magnesium sulphate, potassium sulphate, sodium chloride, sodium dihydrogen phosphate), amino acids, N-Alanyl-L-glutamine, energy sources (glucose, calcium-L-lactate, sodium pyruvate), sodium bicarbonate buffer, human serum albumin (5 mg/mL), sodium hyaluronate, and gentamicin sulphate (10 µg/mL). Packaged in 10 mL or 60 mL PETG bottles with HDPE closures. Sterility: No growth.
Indications for Use
Indicated for the culture of human embryos from the 4-8 cell stage through to the blastocyst stage and for embryo transfer in patients undergoing assisted reproduction.
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
- BlastAssist® (K080172)
Reference Devices
Submission Summary (Full Text)
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# a CooperSurgical Company
K133387
# APR 2 9 2014
#### 510(K) SUMMARY
#### Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
| Submitted by: | ORIGIO a/s<br>Knardrupvej 2<br>2760 Måløv<br>Denmark<br>Tel: +45 46790200<br>Fax: +45 46790300 | |
|--------------------------------------|------------------------------------------------------------------------------------------------|--|
| Contact person: | Tove Kjær<br>Director Corporate Regulatory Affairs<br>ORIGIO a/s | |
| | Date Submitted: April 11, 2014 | |
| Device Identification<br>Trade Name: | ORIGIO® Sequential Blast™<br>ORIGIO® Sequential Blast™ with phenol red | |
| Common name: | ORIGIO® Sequential Blast™ | |
| Classification Name: | Reproductive media and supplements (21 CFR 884.6180, Product<br>Code MQL) | |
| Predicate Device<br>ORIGIO a/s | BlastAssist® (K080172) | |
#### Description
ORIGIO® Sequential Blast™ (with and without phenol red) is intended for the culture of human embryos from the 4-8 cell stage through to the blastocyst stage and for embryo transfer.
Two versions of ORIGIO® Sequential Blast™ are available:
- Catalogue no. 8305: ORIGIO® Sequential Blast™ .
- . Catalogue no. 8306: ORIGIO® Sequential Blast™ with phenol red
Both versions of ORIGIO® Sequential Blast™ are aseptically filtered, non viscous solutions, light pink or colorless solutions, which are ready to use by professionals within assisted reproduction.
The ORIGIO® Sequential Blast™ media are contained in 10 mL or 60 mL transparent polyethylene terephthalate glycol (PETG) bottles with high density polyethylene (HDPE) closures, available in card board boxes of 1 x 10 mL and 1 x 60 mL bottles. The bottles and boxes are individually labeled. The boxes also contain instruction for use provided as package insert.
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#### Indication for use
ORIGIO® Sequential Blast™ is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage.
ORIGIO® Sequential Blast™ can also be used for embryo transfer.
#### Technological Characteristics
The design of ORIGIO® Sequential Blast™ as well as the predicate listed in this submission is based on each medium containing the appropriate nutrients for the embryo development stage it is intended for. Table 1 compares the technological characteristics of ORIGIO® Sequential Blast™ to the predicate BlastAssist®. Both similarities and differences are illustrated.
ORIGIO® Sequential Blast™ is for culture and transfer of embryos as the predicate BlastAssist". Thus, the intended use of ORIGIO® Sequential Blast™ is considered identical to the predicate.
| Product | ORIGIO® Sequential Blast™ | BlastAssist® |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | ORIGIO® Sequential Blast™ is for the<br>culture of embryos from the 4-8 cell<br>stage through to the blastocyst stage.<br>ORIGIO® Sequential Blast™ can also<br>be used for embryo transfer. | BlastAssist® is for culture from the 4-8 cell<br>stage through to blastocyst stage. Can also<br>be used for embryo transfer. |
| Product<br>specification | | |
| pH | 7.2-7.5 | 7.3-7.5 |
| Osmolality<br>(mOsm/kg) | 272-288 | 272-288 |
| Endotoxin (EU/mL) | <0.15 | ≤0.1 |
| Sterility | • No growth | No growth |
| 1-cell MEA | ≥80% | ≥80% |
| Formulation | | |
| Physiological salts | Magnesium sulphate<br>Potassium sulphate<br>Sodium chloride<br>Sodium dihydrogen phosphate | Magnesium sulphate<br>Potassium sulphate<br>Sodium chloride<br>Sodium dihydrogen phosphate |
| Amino acids | X | X |
| Stable form of L-<br>glutamine | N-Alanyl-L-glutamine | N-Acetyl-L-glutamine |
| Energy sources | Glucose<br>Calcium-L-lactate<br>Sodium pyruvate | Glucose<br>Calcium-L-lactate<br>Sodium pyruvate |
| SSR® | X | X |
| Buffer | Sodium Bicarbonate | Sodium Bicarbonate |
#### Table 1. Comparison of ORIGIO® Sequential Blast™ with the predicate.
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| Product | ORIGIO® Sequential Blast™ | BlastAssist® |
|------------------------------------------------|---------------------------|--------------|
| Vitamins | X | X |
| Sodium<br>hyaluronate | X | |
| Protein source | | |
| HSA (Protein<br>composition: > 96%<br>albumin) | 5 mg/mL | 2 mg/mL |
| Antibiotics | | |
| Gentamicin<br>sulphate | 10 µg/mL | 10 µg/mL |
The technological characteristics of ORIGIO® Sequential Blast™ are comparable to those of the predicate device. The main differences are:
- Human Serum Albumin: The majority of commercially available culture media have an HSA . concentration of 5 mg/mL e.g. Universal IVF Medium (K K991279) and G-2™v5 (K081117).
- Sodium hyaluronate: ORIGIO® Sequential Blast™ contains hyaluronate in a concentration . range similar to that added in other ART media products e.g. G-2™v5 (K081117).
- Stable L-glutamine: Both ORIGIO® Sequential Cleav™ and the predicate contain a stable � form of glutamine. Both alanyl-glutamine used in ORIGIO® Sequential Blast™ and acetylglutamine used in the predicate are widely used in ART media and have a history of safe use.
The differences in composition do not impact the substantial equivalence and do not raise any new types of safety or effectiveness concern.
#### Performance data
The product specifications for ORIGIO® Sequential Blast™ and the predicate are similar regarding sterility, osmolality, pH, endotoxin level and Mouse Embryo Assay (MEA) test.
The shelf life of ORIGIO® Sequential Blast™ has been validated in stability studies to 36 weeks. The parameters which have been tested in the stability studies through shelf life includes pH, osmolality, endotoxin, HSA concentration, MEA, and sterility.
In general. ORIGIO® Sequential Blast™ is subject to the same control methods and, to a significant degree, contains the same components as the predicate device. ORIGIO® Sequential Blast™ has similar handling procedures and storage conditions. Therefore, ORIGIO® Sequential Blast™ is considered substantially equivalent to the predicate device BlastAssist® (K080172).
#### Biocompatibility
ORIGIO® Sequential Blast™ is categorized as a medium in direct contact with embryos from the 4-8 cell stage through to the blastocyst stage. Since ORIGIO® Sequential Blast™ can also be used for embryo transfer, it is also in direct contact with the uterus (patient). The biological safety evaluation (ISO 10993-1) demonstrates that ORIGIO® Sequential Blast™ consists of well tested components and is non-toxic in use. ORIGIO® Sequential Blast™ is therefore considered safe for culture of human embryos as well as transfer of embryos into the patient (uterus).
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#### Conclusion
The conclusion from the performance and safety data, intended use comparison, product formulation comparison and test specification comparison, demonstrates that ORIGIO® Sequential Blast™ (with and without phenol red) is suitable for the intended use, and meets the criteria in the comparison to the predicate device (BlastAssist®, K080172) in which substantial equivalence has been demonstrated.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the serpents. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29. 2014
ORIGIO als Tove Kjaer Director Corporate Regulatory Affairs Knardrupvej 2 Måløv 2760 Denmark
Re: K133387
> Trade/Device Name: ORIGIO® Sequential Blast™ and ORIGIO® Sequential Blast™ with phenol red Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: March 14, 2014 Received: March 31, 2014
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 practive, 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.
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Page 2 - Tove Kjaer
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/5/Picture/7 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The letters are black against a white background, making them easily readable. The text appears to be a title or heading, possibly indicating a person's name or a business 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
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
#### 510(k) Number (if known) K133387
#### Device Name
ORIGIO® Sequential Blast™ and ORIGIO® Sequential Blast™ with phenol red
#### Indications for Use (Describe)
ORIGIO® Sequential Blast™ is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage. ORIGIO® Sequential Blast™ 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)
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THE ONLY CONTRACT PERSON FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
# Herbert P. Ler 2014.04.29
