(336 days)
ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is a culture medium intended for in vitro fertilization and in vitro culture of human gametes and embryos from fertilization until the blastocyst stage of development (day 5). The medium can also be used for embryo transfer.
ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is a medium for in vitro fertilization and culture of human gametes and embryos from fertilization until the blastocyst stage of development (day 5). The medium can also be used for embryo transfer procedures. The medium is aseptically filtered and provided in in a volume of 10 mL in pre-sterilized 10 mL glass bottles closed with Fluorotec-coated stoppers and aluminum caps. The medium has a shelflife of 10 months when stored at 2-8℃ and is for single-use only.
This document is a 510(k) Summary for a medical device called ARTSMedia In Vitro Culture Medium (AM-IVC Medium). It seeks to demonstrate substantial equivalence to a predicate device. The document is not a study proving an AI device meets acceptance criteria. Therefore, I cannot extract the requested information like expert consensus, MRMC study results, or AI algorithm performance details.
The document discusses non-clinical performance testing for a culture medium, which is a laboratory product used for in vitro fertilization, not an AI device. The tests performed are standard for biological media to ensure aspects like biocompatibility, sterility, pH, osmolality, endotoxin levels, and shelf-life, and include a Mouse Embryo Assay (MEA) to demonstrate functionality.
Therefore, the requested information elements related to AI device performance, such as human reader improvement with AI assistance, standalone algorithm performance, number of experts for ground truth, sample sizes for test and training sets for an AI model, and adjudication methods, are not present in this document.
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February 10, 2023
ARTSMedia Denmark ApS Lotte Stroebech CEO Kongevejen 149 Virum. 2830 Denmark
Re: K220715
Trade/Device Name: ARTSMedia In Vitro Culture Medium (AM-IVC Medium) Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: January 9, 2023 Received: January 11, 2023
Dear Lotte Stroebech:
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/cdrh-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 -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K220715
Device Name ARTSMedia In Vitro Culture Medium (AM-IVC Medium)
Indications for Use (Describe)
ARTSMedia In Vitro Culture Medium) is a culture medium intended for in vitro fertilization and in vitro culture of human gametes and embryos from fertilization until the blastocyst stage of development (day 5). The medium can also be used for embryo transfer.
| Type of Use (Select one or both, as applicable) | X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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510(k) Summary K220715
510(k) Owner
ARTSMedia Denmark ApS Kongevejen 149 2830 Virum Denmark Lotte Stroebech Phone: +45 53504530
Date Prepared
Trade Name Common Name Regulation Name Regulation Number Class Product Code
Predicate Device
February 8, 2023
ARTSMedia In Vitro Culture Medium (AM-IVC Medium) Assisted Reproduction Media Reproductive Media and Supplements 21 CFR 884.6180 Class II MQL (Media, Reproductive)
K133707 ORIGIO als SAGE 1-StepTM supplemented with Human Serum Albumin
The predicate device has not been subject to a designrelated recall.
Device Description
ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is a medium for in vitro fertilization and culture of human gametes and embryos from fertilization until the blastocyst stage of development (day 5). The medium can also be used for embryo transfer procedures.
The medium is aseptically filtered and provided in in a volume of 10 mL in pre-sterilized 10 mL glass bottles closed with Fluorotec-coated stoppers and aluminum caps. The medium has a shelflife of 10 months when stored at 2-8℃ and is for single-use only. Additional information on the formulation and specifications of AM-IVC Medium are provided in the Comparison of the Subject and Predicate Device Intended Use and Technological Characteristics section of this summary.
Indications for Use
ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is a culture medium intended for in vitro fertilization and in vitro culture of human gametes and embryos from fertilization until the blastocyst stage of development (day 5). The medium can also be used for embryo transfer.
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Comparison of the Subject and Predicate Device Intended Use and Technological Characteristics
A comparison of the intended use and technological characteristics of the subject and predicate devices are shown in the table below:
| Parameters | K220715 | K133707 | Comparison |
|---|---|---|---|
| AM-IVC Medium | SAGE 1-StepTM | ||
| Subject Device | Predicate Device | ||
| Indicationsfor Use | ARTSMedia In VitroCulture Medium (AM-IVCMedium) is a culturemedium intended for invitro fertilization and invitro culture of humangametes and embryosfrom fertilization until theblastocyst stage ofdevelopment (day 5). Themedium can also be usedfor embryo transfer. | This product is intendedfor the in vitrofertilization and cultureof human gametes andembryos fromfertilization until Day 5/6of development. Themedia can also be usedfor embryo transfer. | The subject deviceindications for usestatement is notidentical to the predicatedevice, as it is only foruse up to day 5 ofdevelopment. However,the overall intended useof the subject andpredicate device is thesame (i.e., forfertilization and cultureof embryos to theblastocyst stage ofdevelopment and foruse in embryo transferprocedures). |
| Conditionsfor Use | Prescription Use Only | Prescription Use Only | Same |
| Formulation | Physiological SaltsAmino AcidsVitaminsCalcium LactateEDTAGentamicin SulphateGlucoseL-glutamineHuman SerumAlbumin (HSA)Sodium BicarbonateSodium HyaluronateSodium PyruvatePhenol RedSeleniteEthanolamineSodium citrateHuman Insulin (fromyeast) | Physiological SaltsAmino AcidsCalcium -L-LactateEDTAGentamicin SulphateGlucoseL-glutamineHuman Serum Albumin(HSA)Sodium BicarbonateSodium HyaluronateSodium PyruvatePhenol Red | Different: Theformulations of thesubject and predicatedevices are not thesame. Differences indevice formulations donot raise differentquestions of safety andeffectiveness (S&E). |
| Sterilization | Aseptic filtration | Aseptic filtration | Same |
| Sterility | No growth | No growth | Same |
| pH | 7.2-7.45 | 7.2-7.4 | Similar |
| Osmolality(mOsm/kg) | 257-275 | 257-273 | Similar |
| MouseEmbryoAssay (MEA) | 1-cell Mouse EmbryoAssay (MEA) ≥ 80%embryos developed toexpanded blastocysts at96 hours. | 1-cell MEA ≥ 80% | Similar |
| Endotoxin(EU/ml) | <0.05 | <0.15 | Different: The subjectdevice has a lowerendotoxin level than thepredicate device. Thisdifference in endotoxinspecification does notraise different questionsof S&E. |
| Shelf life | 10 months | 14 weeks | Different: The subjectdevice has a longershelf-life than thepredicate device.Differences in shelf-lifedo not raise differentquestions of S&E. |
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As shown in the table above, there are differences in the indications for use statements and technological characteristics of the subject and predicate devices. However, as stated in the table, the differences in indications for use do not represent a new intended use and the differences in technological characteristics do not raise different questions of safety and effectiveness.
Summary of Non-Clinical Performance Testing
The following studies have been performed to support substantial equivalence to the predicate device:
- Biocompatibility testing was conducted in support of the subject device that will have direct . contact with the patient during embryo transfer procedures. Testing was conducted in accordance with the 2020 FDA guidance Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process. Testing included:
- Cytotoxicity per ISO 10993-5:2009 -
- Sensitization per ISO 10993-10:2010 -
- -Vaginal Irritation per ISO 10993-10:2010
The testing demonstrated the device formulation to be non-cytotoxic, non-sensitizing, and non-irritating.
- . Aseptic filtration and aseptic filling validation, per ISO 13408-1:2008 & A1:2013 and ISO 13408- 2:2018.
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- Shelf-life testing was conducted to support a 10-month shelf-life for the subject device . through demonstration that the product specifications (shown below) were met at time 0 and after 10 months of real-time aging:
- Appearance: Clear and particulate free -
- pH, per USP <791>: 7.2-7.45
- Osmolality, per USP <785>: 257-275 mOsm/kg -
- Endotoxin, per USP <85>: < 0.05 EU/mL ।
- MEA testing, in accordance with the 2021 FDA guidance Mouse Embryo Assay for । Assisted Reproduction Technology Devices: 1-Cell Mouse Embryo Assay (MEA) ≥80% embryos developed to expanded blastocyst at 96 hours.
- Sterility, per USP <71>: No growth -
- . Transportation testing per ASTM D4169-22 and cap/seal leak testing using a method equivalent to USP <1207.2> on transportation-conditioned devices.
Conclusions
The results of the performance testing described above demonstrate that AM-IVC Medium is as safe and effective as the predicate device 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.