(223 days)
Not Found
No
The device description and performance studies focus on the chemical composition, sterility, and biological compatibility of a buffer solution, with no mention of AI or ML technologies.
No.
Explanation: A therapeutic device is used to treat or cure a disease or condition. This device is a buffer used in the removal of oocytes, which is a procedural aid, not a treatment.
No
The device is a medium used for the removal of oocytes, not for diagnosing a condition or disease.
No
The device is a liquid medium composed of various chemical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "used in the removal of oocytes from ovarian follicles." This describes a procedure performed on the patient's body (or directly interacting with cells removed from the body for a procedure), not a test performed in vitro (in a lab) to diagnose a condition or provide information about a patient's health status.
- Device Description: The description details a medium used in an assisted reproduction procedure. While it interacts with biological material (oocytes), its purpose is to facilitate a physical process (retrieval), not to analyze the material for diagnostic purposes.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze the oocytes or surrounding fluid to provide diagnostic information about the patient or the oocytes themselves.
IVD devices are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device is used during a procedure involving the patient's body and the retrieved cells.
N/A
Intended Use / Indications for Use
Gems Oocyte Retrieval Buffer is used in the removal of oocytes from ovarian follicles.
Product codes (comma separated list FDA assigned to the subject device)
MQL
Device Description
The Gems Oocyte Retrieval Buffer is an assisted reproduction medium used for removal of oocytes from ovarian follicles. It consists of salts, energy substrates, amino acids buffering agents, stabilizers and antibiotics. This device has direct contact with the patients and oocytes.
This product is a single-use device that is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10-3. It is tested for pH, osmolality, embryotoxicity, endotoxin and sterility before lot release and has a shelf-life of 30 weeks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ovarian follicles
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
- Osmolality
- Aseptic Processing Validation testing that met the requirements in ISO 13408-2:2003
- Sterility testing per USP
- Endotoxin testing per USP
- Mouse embryo assay (MEA)
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 expanded blastocyst stage within 96 hours were assessed in comparison with the control group. - Biocompatibility studies, as follows:
- Cytotoxicity testing per 10993-5:2009
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010
- Intracutaneous Reactivity testing per ISO 10993-10:2010
- Shelf-life studies (real-time and accelerated) were conducted to ensure that the following product specifications are met at time zero and the end of shelf-life.
- pH - See tables above
- Osmolality - See tables above
- 1-cell MEA - ≥80% developed to the blastocyst stage at 96 hours
- Endotoxin -
§ 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.
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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2017
Genea Biomedx Pty Ltd % Roger Grav VP. Ouality Assurance and Regulatory Donawa Lifescience Consulting Srl Piazza Albania 10 00153 Rome Italy
Re: K170498
Trade/Device Name: Genea Biomedx Gems Oocyte Retrieval Buffer ORB-20, ORB-50 Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: August 28, 2017 Received: August 30, 2017
Dear Roger Gray:
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.
1
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 devicerelated 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 (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,
Charles Viviano -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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Genea Biomedx Gems Oocyte Retrieval Buffer ORB-20, ORB-50
Indications for Use (Describe)
Gems Oocyte Retrieval Buffer is used in the removal of oocytes from ovarian follicles.
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."
Type of Use (Select one or both, as applicable)
3
Image /page/3/Picture/1 description: The image contains the logo for Genea Biomedx. The logo consists of a green square with a white curved line inside, followed by the text "Genea" in gray and "BIOMEDX" in green. The logo is simple and modern, with a focus on the company's name.
510(k) Summary (K170498)
l. General Information on Submitter
| Submitter/Address:
Contact person:
Phone:
Fax: | Genea Biomedx Pty Ltd
Level 2, 321 Kent Street
Sydney
NSW 2000
Australia
Ms. Kea Dent
+61 2 8484 7677
+61 2 9229 6478 |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent:
Phone:
Fax:
Email: | Mr. Roger Gray
VP, Quality and Regulatory
Donawa Lifescience Consulting Srl
Piazza Albania 10
00153 Rome
Italy
+39 06 578 2665
+39 06 574 3786
rgray@donawa.com |
II. Date Prepared: September 28, 2017
III. General Information on Devices
| Device Name: | Gems Oocyte Retrieval Buffer ORB-20, ORB-50 | |
|---|---|---|
| Common Name: | Embryo Culture Media | |
| Classification Name: | Reproductive Media and Supplements (21 CFR 884.6180) | |
| Product code: | MQL (Media, Reproductive) | |
| Regulatory Class: | II |
IV. Predicate Device
Cook Sydney IVF Follicle Flushing Buffer (K002385), manufactured by Cook Ob/Gyn. This predicate device has not been subject to any design related recalls.
V. Device Description
The Gems Oocyte Retrieval Buffer is an assisted reproduction medium used for removal of oocytes from ovarian follicles. It consists of salts, energy substrates, amino acids buffering agents, stabilizers and antibiotics. This device has direct contact with the patients and oocytes.
This product is a single-use device that is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10-3. It is tested for pH, osmolality, embryotoxicity, endotoxin and sterility before lot release and has a shelf-life of 30 weeks.
VI. Indications for Use:
Gems Oocyte Retrieval Buffer is used in the removal of oocytes from ovarian follicles.
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Image /page/4/Picture/1 description: The image shows the logo for Genea Biomedx. The logo consists of a green square with a white curved line inside, followed by the text "Genea" in gray and "BIOMEDX" in green. The logo is clean and modern, with a focus on the company's name and brand.
VII. Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Devices
| Device/Predicate
Devices | Subject device - Gems Oocyte Retrieval
Buffer | Predicate device - Cook IVF Follicle Flushing
Buffer (K002385) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Gems Oocyte Retrieval Buffer is used in
the removal of oocytes from ovarian
follicles. | Cook IVF follicle flushing buffer is intended
for use during in vitro fertilization procedures
for follicle flushing and oocyte collection. |
| pH | 7.3-7.5 | Similar |
| Osmolality | 280-290 mOsm/kg | Similar |
| Formulation | Comparable | |
| The subject and predicate devices have the same intended use – removal of the oocytes from ovarian follicles. The
subject and predicate devices also have comparable pH, osmolality, and formulations. In addition, they have
comparable specifications for MEA, endotoxin, and sterility. There may be minor differences in technological
characteristics between the subject and predicate devices, but these differences do not raise different questions of | | |
safety and effectiveness.
VIII. Summary of Non-clinical Performance Testing
The following studies have been performed to support substantial equivalence to the predicate devices:
- pH
- . Osmolality
- Aseptic Processing Validation testing that met the requirements in ISO 13408-2:2003 ●
- . Sterility testing per USP
- Endotoxin testing per USP
- Mouse embryo assay (MEA)
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 expanded blastocyst stage within 96 hours were assessed in comparison with the control group.
- . Biocompatibility studies, as follows:
-
- Cytotoxicity testing per 10993-5:2009
-
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010
-
- Intracutaneous Reactivity testing per ISO 10993-10:2010
-
- Shelf-life studies (real-time and accelerated) were conducted to ensure that the following product specifications are met at time zero and the end of shelf-life.
-
- pH - See tables above
-
- Osmolality - See tables above
-
- 1-cell MEA - ≥80% developed to the blastocyst stage at 96 hours
-
- Endotoxin -
-