Continuous Single Culture-NX Complete (CSCM-NXC)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 13, 2022 Irvine Scientific Sales Co., Inc. Jayme Yamaguchi-Owens Regulatory Affairs Manager 2511 Daimler Street Santa Ana, CA 92705 Re: K170602 Trade/Device Name: Continuous Single Culture®-NX Complete (CSCM-NXC) Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dear Jayme Yamaguchi-Owens: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 7, 2017. Specifically, FDA is updating this SE Letter to include the correct version of the 510(k) Summary. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Monica Garcia, Ph.D., OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, (240) 402-2791, monica.garcia@fda.hhs.gov. 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 {1}------------------------------------------------ Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with a focus on the shape of the face and neck. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 7, 2017 Irvine Scientific Sales Co., Inc. Jayme Yamaguchi-Owens Regulatory Affairs Manager 2511 Daimler Street Santa Ana, CA 92705 Re: K170602 Trade/Device Name: Continuous Single Culture®-NX Complete (CSCM-NXC) Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: May 18, 2017 Received: May 19, 2017 Dear Jayme Yamaguchi-Owens: 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. 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. {2}------------------------------------------------ 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 contact the Division of Industry and Consumer Education 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 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, # Benjamin R. Fisher -S 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 {3}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K170602 Device Name Continuous Single Culture®-NX Complete (CSCM-NXC) Indications for Use (Describe) The Continuous Single Culture®-NX Complete (CSCM-NXC) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro. This device can be used for transfer of embryos to the uterus. 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {4}------------------------------------------------ # 510(k) Summary #### -General Information on Submitter | Submitter/Address: | Irvine Scientific Sales Co., Inc.<br>2511 Daimler Street<br>Santa Ana, CA 92705<br>Telephone: 800-437-5706<br>Facsimile: 949-261-6522 | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jayme Yamaguchi-Owens<br>Regulatory Affairs Manager<br>Irvine Scientific<br>2511 Daimler Street<br>Santa Ana, CA 92705<br>Tel: 949-261-7800 ext 254<br>Fax: 949-261-6522<br>Email: jfy@irvinesci.com | | II. Date Prepared: | June 6, 2017 | recalls. #### III. General Information on Device | Device Name: | Continuous Single Culture®-NX Complete (CSCM-NXC) | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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: | Continuous Single Culture Complete (K121572),<br>manufactured by Irvine Scientific Sales Co., Inc. This<br>predicate device has not been subject to any design related | #### V. Description of the Device: The Continuous Single Culture®-NX Complete (CSCM-NXC) is a culture medium using a formulation modified from the predicate device. It is intended for culture of embryos from fertilization to balstulation and transfer of embryos to the uterus. This medium consists of salts, energy substrates, amino acids, buffering agents, nutrients supplements, antibiotics, and human serum albumin. This product is a single-use device supplied in a fill volume of 20 mL. It is aseptically filled into the sterilized bottle and has a sterility assurance level (SAL) of 10-3. The product is tested for pH, osmolality, embryotoxicity, spermtoxicity, endotoxin, and sterility before lot release. The product has a four-month shelf-life and remains stable for four weeks after open/close of bottle, when it is stored at 2-8°C. {5}------------------------------------------------ ## VI. Indication for Use: The Continuous Single Culture®-NX Complete (CSCM-NXC) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro. This device can be used for transfer of embryos to the uterus. ## VII. Comparison of Intended Use and Technological Characteristics of Subject and Predicate Devices | Device & Predicate | K170602 | K121572 | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device(s): | (subject device) | (predicate device) | | Indications for Use | The Continuous Single Culture®-<br>NX Complete (CSCM-NXC) is<br>intended for use as a culture<br>medium for human gametes and<br>embryos from fertilization through<br>day 5/6 of development in vitro.<br>This device can be used for<br>transfer of embryos to the uterus. | Continuous Single Culture<br>complete is intended for use<br>as a culture medium for<br>human gametes and<br>embryos from fertilization<br>through day 5/6 of<br>development in vitro. | | pH (under 5% CO2) | Same as predicate | 7.25-7.54 | | Osmolality | Same as predicate | 260-270 mOsm/kg | | Formulation | Same ingredients as in predicate | 36 ingredients | The subject and predicate devices have the same indication - culture of embryos from fertilization to blastulation. The subject device is also indicated for embryo transfer, while predicate device does not have this indication. This difference does not represent a new intended use as both devices are intended for in vitro fertilization (IVF) procedures that require transfer of embryos into the uterus, and is in-line with other devices cleared under the same regulation/product code that are used for both culture and embryo transfer. The subject and predicate devices are composed of the same ingredients and have the same pH and osmolality specifications. The only difference is that the concentrations of certain ingredients are modified in the subject device. The difference noted is minor and does not raise different questions of safety and effectiveness. In addition to pH and osmolality, the acceptance criteria for mouse embryo assay (MEA), human sperm survival assay (HSSA), endotoxin testing, and sterility testing for the subject device are same to those of the predicate device. #### VIII. Summary of Non-clinical Performance Testing The following studies have been performed to support substantial equivalence to the predicate device: - pH ● - Osmolality ● - o Aseptic Processing Validation testing per ISO 13408-1:2008 and ISO 13408-2:2003 - Sterility testing per USP <71> ● Continuous Single Culture®-NX Complete (CSCM-NXC) {6}------------------------------------------------ - o Endotoxin testing per USP <85> - Mouse embryo assay (MEA) o 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 at 96 hours were assessed in comparison with the control group. - Biocompatibility studies, as follows: o - ★ 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 acceptance criteria for product characteristics are met at time zero and the end of shelf-life: - ★ pH - See table above - ★ Osmolality - See table above - 1-cell MEA ≥80% developed to the blastocyst stage at 96 hours ★ - ★ HSSA – ≥70% of original motility at 24 hours - * Endotoxin - ≤0.25 EU/ml (LAL) - Sterility No microbiological growth ★ - Stability testing was conducted to ensure that acceptance criteria for the product characteristics are met after repeated opening/closing of bottles for four weeks if handled appropriately. #### XI. Conclusion: The subject and predicate devices have the same intended use. Although there is a difference in formulation between the subject and predicate devices, this difference does not raise different questions of safety or effectiveness. The performance data also demonstrate that the subject device is substantially equivalent to the predicate device.