(228 days)
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 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. 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.
This document describes the acceptance criteria and the study that proves the device meets those criteria for the Gx-IVF™, Gx-TL™, and Gx-MOPS™ PLUS media used in Assisted Reproduction Technology (ART).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the subject devices (Gx-IVF™, Gx-TL™, Gx-MOPS™ PLUS) are primarily defined by comparison to their predicate devices and specific performance tests. The tables below summarize the key criteria and reported performance for each device.
Gx-IVF™
| Characteristic | Acceptance Criteria (Predicate: G-IVF™ PLUS K081116) | Reported Device Performance (Gx-IVF™) |
|---|---|---|
| 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 & Performance Specifications | ||
| pH | 7.30 ± 0.10 | 7.30 ± 0.10 |
| Osmolality (mOsm/kg) | 262 ± 5 | 265 ± 5 |
| Bacterial endotoxin | < 0.25 IU or EU/mL | < 0.25 IU or EU/mL |
| Sterility | SAL 10-3 | No evidence of microbial growth |
| Mouse Embryo Assay (MEA) | ≥ 80% expanded blastocyst on day 5 | ≥ 80% embryos developed to expanded blastocyst at 96 hours |
| 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 |
Gx-TL™
| Characteristic | Acceptance Criteria (Predicate: G-TL™ K133568) | Reported Device Performance (Gx-TL™) |
|---|---|---|
| Composition | ||
| Antibiotics | Gentamicin | Gentamicin |
| Protein | Human Serum Albumin | Human Serum Albumin |
| Amino acids | Yes | Yes |
| Glucose | Yes | Yes |
| Hyaluronan | Yes | Yes |
| Physiological salts | Yes | Yes |
| Buffer | Sodium bicarbonate | Sodium bicarbonate |
| Product & Performance Specifications | ||
| pH | 7.30 ± 0.10 | 7.27 ± 0.07 |
| Osmolality (mOsm/kg) | 270 ± 5 | 265 ± 5 |
| Bacterial endotoxin | < 0.25 IU or EU/mL | < 0.25 IU or EU/mL |
| Sterility | SAL 10-3 | No evidence of microbial growth |
| Mouse Embryo Assay (MEA) | > 80% expanded blastocyst within 96 hours | ≥ 80% embryos developed to expanded blastocyst at 96 hours |
| 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 |
Gx-MOPS™ PLUS
| Characteristic | Acceptance Criteria (Predicate: G-MOPS™ PLUS K081115) | Reported Device Performance (Gx-MOPS™ PLUS) |
|---|---|---|
| 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 & Performance Specifications | ||
| pH | 7.27 ± 0.07 | 7.27 ± 0.07 |
| Osmolality (mOsm/kg) | 261 ± 5 | 265 ± 5 |
| Bacterial endotoxin | < 0.25 IU or EU/mL | < 0.25 IU or EU/mL |
| Sterility | SAL 10-3 | No evidence of microbial growth |
| Mouse Embryo Assay (MEA) | ≥ 80% expanded blastocyst on day 5 | ≥ 80% embryos developed to expanded blastocyst at 96 hours |
| 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 |
2. Sample Size Used for the Test Set and Data Provenance
The provided document details non-clinical performance testing. Specific sample sizes for each test are not explicitly given, except for the "1-cell mouse embryos" used in the Mouse Embryo Assay. The data provenance is not stated in terms of country of origin or whether it was retrospective or prospective, as these are in-vitro performance tests rather than clinical trials.
Non-Clinical Performance Testing Performed:
- Aseptic filling validation study
- Sterility testing per USP <71>
- Bacterial endotoxins testing per USP <85>
- pH measurements per USP <791>
- Osmolality per USP <785>
- Mouse Embryo Assay (MEA)
- Shelf-life testing
- Open/close stability testing
- Transportation testing (ASTM D4169-16)
- Biocompatibility studies:
- Cytotoxicity testing (ISO 10993-5:2009)
- Tests for Irritation and Skin Sensitization (ISO 10993-10:2010, Guinea Pig Maximization Sensitization Test)
- Tests for Irritation and Skin Sensitization (ISO 10993-10:2010, Vaginal Mucosal Irritation Study in Rabbits)
3. Number of Experts Used to Establish Ground Truth and Qualifications
This document describes technical performance and biocompatibility studies for medical devices (reproductive media and supplements). It does not involve human subject data or image analysis that would typically require expert consensus for ground truth establishment. Therefore, information regarding "number of experts" or their qualifications is not applicable in this context. The "ground truth" here is defined by established scientific and regulatory standards (e.g., USP <71> for sterility, ISO 10993 for biocompatibility).
4. Adjudication Method for the Test Set
Not applicable for this type of non-clinical, in-vitro performance testing where results are based on objective laboratory measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes the testing of in-vitro fertilization media, not an AI-assisted diagnostic device. Therefore, an MRMC comparative effectiveness study to assess human reader improvement with AI assistance is not relevant or applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The devices are media for ART, not algorithms requiring standalone performance analysis.
7. The Type of Ground Truth Used
The ground truth for these devices is based on established scientific and regulatory standards and objective laboratory methods for determining chemical, physical, and biological properties. This includes:
- Regulatory Standards: USP <71>, USP <85>, USP <791>, USP <785>, ISO 13408-1:2008, ISO 13408-2:2018, ISO 10993-5:2009, ISO 10993-10:2010.
- Defined Acceptance Specifications: pH ranges, osmolality ranges, endotoxin limits, percentage of embryo development in MEA, absence of microbial growth, non-cytotoxic, non-sensitizing, non-irritating outcomes.
- Comparison to Predicate Devices: The performance of the subject devices is demonstrated to be substantially equivalent to that of the legally marketed predicate devices, implying the predicate devices' established safety and effectiveness serve as a benchmark.
8. The Sample Size for the Training Set
Not applicable. There is no machine learning or AI algorithm involved that would require a training set. The "training" in this context refers to manufacturing validation and quality control processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an algorithm is involved.
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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.
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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
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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) |
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510(k) Summary – K202862
1. Submitter Information
| Submitted by: | Vitrolife Sweden ABGustaf Werners gata 2SE - 421 32 Västra FrölundaSweden |
|---|---|
| Contact Person: | Sarah Hood HagbergVitrolife Sweden ABGustaf Werners gata 2SE - 421 32 Västra FrölundaSwedenPhone: +46 31 721 80 00Fax: +46 31 721 80 90Email: 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 VitrolifeSweden AB |
The predicate devices have not been subject to a design related recall.
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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 ofgametes, for in vitro fertilisation and intrauterine insemination. |
| Gx-TLTM | Gx-TLTM medium is intended for culture of embryos fromfertilisation to the blastocyst stage and for embryo transfer. |
| Gx-MOPSTM PLUS | Gx-MOPSTM PLUS medium is intended for handling andmanipulating oocytes and embryos in ambient atmosphere. |
6. Indications for Use
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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 intendedfor preparation and handling ofgametes, for in vitrofertilisation and intrauterineinsemination. | Medium for preparation andhandling of gametes, for invitro fertilization. |
| Composition | ||
| Antibiotics | Gentamicin | Gentamicin |
| Protein | Human Serum Albumin | Human Serum Albumin |
| Amino acids | YES | YES |
| Glucose | YES | YES |
| Physiologicalsalts | 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 orEU/mL] | < 0.25 | < 0.25 |
| Sterility | No evidence of microbialgrowth | SAL 10-3 |
| Mouse Embryo Assay(MEA) | 1-cell: ≥ 80% embryosdeveloped to expandedblastocyst at 96 hours | 1-cell MEA % Expandedblastocyst on day 5:≥ 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 withHDPE closure and tamperevident seal | Nalgene PETG bottle withHDPE closure and tamperevident seal |
The subject and predicate devices have similar Indications for Use and have 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 |
|---|---|---|
| (K133568) | ||
| Trade name | Gx-TLTM | G-TLTM |
| Indications for Use | Gx-TLTM medium is intendedfor culture of embryos fromfertilisation to the blastocyst | Medium for culture ofembryos from fertilisation tothe blastocyst stage |
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| stage and for embryo transfer. | ||
|---|---|---|
| Composition | ||
| Antibiotics | Gentamicin | Gentamicin |
| Protein | Human Serum Albumin | Human Serum Albumin |
| Amino acids | Yes | Yes |
| Glucose | Yes | Yes |
| Hyaluronan | Yes | Yes |
| Physiological salts | Yes | Yes |
| Buffer | Sodium bicarbonate | Sodium bicarbonate |
| Product and performance specification | ||
| pH | $7.27 \pm 0.07$ | $7.30 \pm 0.10$ |
| Osmolality (mOsm/kg) | $265 \pm 5$ | $270 \pm 5$ |
| Bacterial endotoxin (LAL assay) [IU or EU/mL] | < 0.25 | < 0.25 |
| Sterility | No evidence of microbial growth | SAL 10-3 |
| Mouse Embryo Assay (MEA) | 1-cell: ≥ 80% embryos developed to expanded blastocyst at 96 hours | 1-cell MEA % Expanded blastocyst within 96 hours: > 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 isintended for handling andmanipulating oocytes andembryos in ambientatmosphere | Medium for handling andmanipulating oocytes andembryos 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 |
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| Bacterial endotoxin(LAL assay) [IU orEU/mL] | < 0.25 | < 0.25 |
|---|---|---|
| Sterility | No evidence of microbialgrowth | SAL 10-3 |
| Mouse Embryo Assay(MEA) | 1-cell: ≥ 80% embryosdeveloped to expandedblastocyst at 96 hours | 1-cell MEA % Expandedblastocyst on day 5:≥ 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 withHDPE closure and tamperevident seal | Nalgene PETG bottle withHDPE closure and tamperevident seal |
intended use.
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.
8. Summary of Non-Clinical Performance Testing
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 <71> (acceptance criterion: no microbial growth) .
- . Bacterial endotoxins testing per USP <85> (acceptance criterion: <0.25 EU/ml)
- pH measurements per USP <791> ●
- Osmolality per USP <785>
- 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:
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- 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.
§ 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.