(228 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biological performance of culture media, with no mention of AI or ML.
No
The devices are culture and handling media used in assisted reproductive technologies (ART) for gametes and embryos, including in vitro fertilization and embryo transfer. They support the viability and development of cells, but do not actively treat a disease or condition in a patient.
No
Explanation: The device is a culture and handling media used in assisted reproduction technology. Its intended use is for the preparation and handling of gametes and embryos, not for diagnosing a condition or disease.
No
The device description clearly states the devices are "culture and handling media consisting of physiological salts, energy substrates, amino acids, buffering agents, nutrients supplements, antioxidants, gentamicin and human serum albumin," which are physical substances, not software. The performance studies also focus on physical and biological properties of these media.
Based on the provided information, these devices are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that the media are for "preparation and handling of gametes, for in vitro fertilisation and intrauterine insemination" and "culture of embryos from fertilisation to the blastocyst stage and for embryo transfer." These are procedures performed in vitro (outside the body) to aid in diagnosis and treatment related to fertility.
- Device Description: The description details the composition of the media, which are used to support and manipulate biological samples (gametes and embryos) in vitro.
- Intended User: The intended users are "IVF professionals," who are involved in in vitro procedures.
- Performance Studies: The performance studies include tests like the Mouse Embryo Assay (MEA), which assesses the ability of the media to support the development of embryos in vitro.
While the term "diagnostic" might not be explicitly used in the intended use, the procedures described (in vitro fertilization, embryo culture) are inherently linked to the diagnosis and treatment of infertility, which falls under the scope of in vitro diagnostics. The media are essential components used in vitro to facilitate these processes.
N/A
Intended Use / Indications for Use
Gx-IVF™ medium is intended for preparation and handling of gametes, for in vitro fertilisation and intrauterine insemination.
Gx-TL™ medium is intended for culture of embryos from fertilisation to the blastocyst stage and for embryo transfer.
Gx-MOPS™ PLUS medium is intended for handling and manipulating oocytes and embryos in ambient atmosphere.
Product codes (comma separated list FDA assigned to the subject device)
MQL
Device Description
The subject devices are culture and handling media consisting of physiological salts, energy substrates, amino acids, buffering agents, nutrients supplements, antioxidants, gentamicin and human serum albumin. These devices have different applications in Assisted Reproduction Technology (ART) procedures handled by IVF professionals, as follows:
- . Gx-IVF™ medium is intended for preparation and handling of gametes, for in vitro fertilisation and intrauterine insemination.
- . Gx-TL™ medium is intended for culture of embryos from fertilisation to the blastocyst stage and for embryo transfer.
- . Gx-MOPS™ PLUS medium is intended for handling and manipulating oocytes and embryos in ambient atmosphere.
The media are aseptically filtered into gamma sterilised PETG bottles with HDPE closure and a tamper evident seal and tested for pH, osmolality, embryo toxicity, endotoxins, and sterility.
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
IVF professionals
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 device:
- . Aseptic filling validation study per ISO 13408-1:2008 and ISO 13408-2:2018
- Sterility testing per USP (acceptance criterion: no microbial growth) .
- . Bacterial endotoxins testing per USP (acceptance criterion: ●
- Osmolality per USP
- Mouse Embryo Assay (MEA) using established protocol:
One-cell mouse embryos were cultured in test medium droplets. The percentage of embryos developed to the expanded blastocyst stage within 96 hours were assessed in comparison with the control group. The acceptance specification is "I-cell: ≥ 80% embryos developed to expanded blastocyst at 96 hours.
-
. Shelf-life testing was conducted to ensure that the following product specifications are met at time zero and end of shelf-life: pH, osmolality, sterility, endotoxin, and 1-cell MEA.
-
Open/close stability testing was conducted to ensure that the following product specifications are met at two weeks after opening of bottles: pH, osmolality sterility, endotoxin, and 1-cell MEA.
-
Transportation testing was conducted according to ASTM D4169-16 to ensure that ● package integrity and device performance are maintained.
-
Biocompatibility studies were performed on the patient-contacting devices as follows:
-
Cytotoxicity testing according to ISO 10993-5:2009 o
-
Tests for Irritation and Skin Sensitization according to ISO 10993- O 10:2010, Guinea Pig Maximization Sensitization Test
-
Tests for Irritation and Skin Sensitization according to ISO 10993o 10:2010, Vaginal Mucosal Irritation Study in Rabbits
The patient-contacting devices were shown to be non-cytotoxic, non-sensitizing, and nonirritating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a bold, sans-serif font and the full name, "U.S. Food & Drug Administration," written below it in a smaller font.
May 14, 2021
Vitrolife Sweden AB Sarah Hood Hagberg Regulatory Affairs Manager Gustaf Werners gata 2 Västra Frölunda. 42132 Sweden
Re: K202862
Trade/Device Name: Gx-IVFTM, Gx-TLTM, Gx-MOPSTM PLUS Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: April 6, 2021 Received: April 8, 2021
Dear Sarah Hood Hagberg:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202862
Device Name Gx-IVF™, Gx-TL™, Gx-MOPSTM PLUS
Indications for Use (Describe)
Gx-IVF™ medium is intended for preparation and handling of gametes, for in vitro fertilisation and intrauterine insemination.
Gx-TL™ medium is intended for culture of embryos from fertilisation to the blastocyst stage and for embryo transfer.
Gx-MOPS™ PLUS medium is intended for handling and manipulating oocytes and embryos in ambient atmosphere.
| 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
510(k) Summary – K202862
1. Submitter Information
| Submitted by: | Vitrolife Sweden AB
Gustaf Werners gata 2
SE - 421 32 Västra Frölunda
Sweden |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sarah Hood Hagberg
Vitrolife Sweden AB
Gustaf Werners gata 2
SE - 421 32 Västra Frölunda
Sweden
Phone: +46 31 721 80 00
Fax: +46 31 721 80 90
Email: shoodhagberg@vitrolife.com |
| 2. Date Prepared: | May 11, 2021 |
| 3. Device Identification | |
| Trade Name: | Gx-IVFTM, Gx-TLTM, Gx-MOPSTM PLUS |
| Common Name: | IVF handling medium, embryo culture medium, IVF transfer medium |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 884.6180 |
| Regulation Name: | Reproductive Media and Supplements |
| Product Code: | MQL (Media, Reproductive) |
| 4. Predicate Device(s): | G-IVFTM PLUS (K081116) manufactured by Vitrolife Sweden AB |
| | G-TLTM (K133568) manufactured by Vitrolife Sweden AB |
| | G-MOPSTM PLUS (K081115) manufactured by Vitrolife
Sweden AB |
The predicate devices have not been subject to a design related recall.
4
5. Device Description
The subject devices are culture and handling media consisting of physiological salts, energy substrates, amino acids, buffering agents, nutrients supplements, antioxidants, gentamicin and human serum albumin. These devices have different applications in Assisted Reproduction Technology (ART) procedures handled by IVF professionals, as follows:
- . Gx-IVF™ medium is intended for preparation and handling of gametes, for in vitro fertilisation and intrauterine insemination.
- . Gx-TL™ medium is intended for culture of embryos from fertilisation to the blastocyst stage and for embryo transfer.
- . Gx-MOPS™ PLUS medium is intended for handling and manipulating oocytes and embryos in ambient atmosphere.
The media are aseptically filtered into gamma sterilised PETG bottles with HDPE closure and a tamper evident seal and tested for pH, osmolality, embryo toxicity, endotoxins, and sterility.
| Device | Indications for Use |
|---|---|
| Gx-IVFTM | Gx-IVFTM medium is intended for preparation and handling of |
| gametes, for in vitro fertilisation and intrauterine insemination. | |
| Gx-TLTM | Gx-TLTM medium is intended for culture of embryos from |
| fertilisation to the blastocyst stage and for embryo transfer. | |
| Gx-MOPSTM PLUS | Gx-MOPSTM PLUS medium is intended for handling and |
| manipulating oocytes and embryos in ambient atmosphere. |
6. Indications for Use
5
7. Comparison of intended use and technological characteristics of subject and predicate devices
| Device | Subject Device | Predicate Device (K081116) |
|---|---|---|
| Trade name | Gx-IVFTM | G-IVFTM PLUS |
| Indications for Use | Gx-IVFTM medium is intended | |
| for preparation and handling of | ||
| gametes, for in vitro | ||
| fertilisation and intrauterine | ||
| insemination. | Medium for preparation and | |
| handling of gametes, for in | ||
| vitro fertilization. | ||
| Composition | ||
| Antibiotics | Gentamicin | Gentamicin |
| Protein | Human Serum Albumin | Human Serum Albumin |
| Amino acids | YES | YES |
| Glucose | YES | YES |
| Physiological | ||
| salts | YES | YES |
| Buffer | Sodium bicarbonate | Sodium bicarbonate |
| Product and performance specification | ||
| pH | 7.30 ± 0.10 | 7.30 ± 0.10 |
| Osmolality (mOsm/kg) | 265 ± 5 | 262 ± 5 |
| Bacterial endotoxin | ||
| (LAL assay) [IU or | ||
| EU/mL] | 80 | |
| Sterilization method | Aseptic filtration | Aseptic filtration |
| Storage conditions | Store dark at +2 to +8°C | Store dark at +2 to +8°C |
| Bottle | Nalgene PETG bottle with HDPE closure and tamper evident seal | Nalgene PETG bottle with HDPE closure and tamper evident seal |
| The subject and predicate device have similar Indications for Use and the same intended use, as both the subject device and the predicate device are intended for use in ART procedures | ||
| The subject and predicate device have different technological features, including different ingredients and specifications. The different technological characteristics, including composition and specifications, do not raise different questions of safety and effectiveness. |
| Device | Subject Device | Predicate device |
|---|---|---|
| (K081115) | ||
| Trade name | Gx-MOPS™ PLUS | G-MOPS™ PLUS |
| Indications for Use | Gx-MOPS™ PLUS medium is | |
| intended for handling and | ||
| manipulating oocytes and | ||
| embryos in ambient | ||
| atmosphere | Medium for handling and | |
| manipulating oocytes and | ||
| embryos in ambient atmosphere | ||
| Composition | ||
| Antibiotics | Gentamicin | Gentamicin |
| Protein | Human Serum Albumin | Human Serum Albumin |
| Amino acids | Yes | Yes |
| Glucose | Yes | Yes |
| Physiological salts | Yes | Yes |
| Buffer | MOPS | MOPS |
| Product and performance specification | ||
| pH | 7.27 ± 0.07 | 7.27 ± 0.07 |
| Osmolality (mOsm/kg) | 265 ± 5 | 261 ± 5 |
7
| Bacterial endotoxin
(LAL assay) [IU or
EU/mL] | (acceptance criterion: no microbial growth) .
- . Bacterial endotoxins testing per USP (acceptance criterion: ●
- Osmolality per USP
- Mouse Embryo Assay (MEA) using established protocol:
One-cell mouse embryos were cultured in test medium droplets. The percentage of embryos developed to the expanded blastocyst stage within 96 hours were assessed in comparison with the control group. The acceptance specification is "I-cell: ≥ 80% embryos developed to expanded blastocyst at 96 hours.
- . Shelf-life testing was conducted to ensure that the following product specifications are met at time zero and end of shelf-life: pH, osmolality, sterility, endotoxin, and 1-cell MEA.
- Open/close stability testing was conducted to ensure that the following product specifications are met at two weeks after opening of bottles: pH, osmolality sterility, endotoxin, and 1-cell MEA.
- Transportation testing was conducted according to ASTM D4169-16 to ensure that ● package integrity and device performance are maintained.
- Biocompatibility studies were performed on the patient-contacting devices as follows:
8
- Cytotoxicity testing according to ISO 10993-5:2009 o
- Tests for Irritation and Skin Sensitization according to ISO 10993- O 10:2010, Guinea Pig Maximization Sensitization Test
- Tests for Irritation and Skin Sensitization according to ISO 10993o 10:2010, Vaginal Mucosal Irritation Study in Rabbits
The patient-contacting devices were shown to be non-cytotoxic, non-sensitizing, and nonirritating.
9. Conclusion
The nonclinical performance testing described above demonstrate that Gx-IVF™, Gx-TLTM, and Gx-MOPS™ PLUS are as safe and effective as the predicate devices and supports a determination of substantial equivalence.