CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)

Q: Who is the manufacturer of CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)?

Casebioscience, Inc. filed the 510(k) submission for CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) (K242107).

Q: What is the FDA product code for CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)?

MQL. It is classified under 21 CFR 884.6180 as a Class 2 device in the Obstetrics/Gynecology panel.

Q: What is the regulatory pathway for CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K242107 · Casebioscience, Inc. · MQL · Mar 21, 2025 · Obstetrics/Gynecology

Device Facts

Record ID	K242107
Device Name	CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)
Applicant	Casebioscience, Inc.
Product Code	MQL · Obstetrics/Gynecology
Decision Date	Mar 21, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.6180
Device Class	Class 2

Intended Use

CaseMONO™ Culture is intended for use for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus. CaseBioscience® HTF is intended for use for the culture of embryos to the cleavage stage (Day 3). This device can be used for transfer of embryos to the uterus. CaseMONO w/HEPES™ is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transfering to the uterine cavity. CaseBioscience® HTF w/HEPES is intended for use in short-term handling gametes embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavitv.

Device Story

Assisted reproduction media solutions; used for in vitro gamete/embryo culture, handling, washing, and ICSI; includes CaseMONO Culture, CaseMONO w/HEPES, CaseBioscience HTF, and CaseBioscience HTF w/HEPES. Solutions provided in PETG bottles with HDPE caps; aseptically filtered; vials radiation sterilized. Used in clinical embryology laboratories by trained personnel. Supports embryo development from fertilization to blastocyst or cleavage stage; facilitates embryo transfer to uterus (for specific variants). Benefits include maintenance of physiological environment for gametes/embryos during ART procedures.

Clinical Evidence

Bench testing only. Includes aseptic filtration/filling validation (ISO 13408), radiation sterilization validation (ISO 11137), shelf-life stability (90 days), and Mouse Embryo Assay (MEA) showing ≥ 80% development to expanded blastocyst. Biocompatibility testing (ISO 10993) performed for uterine-contacting media, including cytotoxicity, sensitization, and vaginal irritation.

Technological Characteristics

Aqueous media containing salts (NaCl, KCl, MgSO4, KH2PO4, CaCl2), NaHCO3, glucose, pyruvate, lactate, amino acids, gentamicin, phenol red, HEPES, and EDTA. pH 7.2-7.6; osmolality 260-295 mOsm/kg. Provided in PETG bottles with HDPE caps. Sterilized via aseptic filtration and radiation. Shelf-life 90 days at 2-8°C.

Indications for Use

Indicated for use in assisted reproductive technology (ART) procedures including gamete/embryo culture, handling, manipulation, washing, and intracytoplasmic sperm injection (ICSI). Specific media are indicated for embryo culture to blastocyst or cleavage stage and uterine transfer; others are indicated for short-term handling only and are contraindicated for uterine transfer.

Regulatory Classification

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.).

Special Controls

*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.

Predicate Devices

Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium Giftlife™ Single Step Medium (K240149)

Related Devices

K252672 — CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) · Casebioscience, Inc. · Feb 20, 2026
K153290 — Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium · William A. Cook Australia Pty. , Ltd. · Jan 27, 2016
K212426 — Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) · Donnevie Medical Technology (Shanghai) Co. , Ltd. · Jun 16, 2022
K991395 — QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM · Advanced Reproductive Technologies · Feb 15, 2000
K213293 — V-HEPES PLUS · Vitromed Langenfeld · Sep 14, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & 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. March 21, 2025 CaseBioscience, Inc. Monica Mezezi CEO/President 24 Norwich Street East Guelph, Ont N1H 2G6 CANADA Re: K242107 > Trade/Device Name: CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL Dated: July 18, 2024 Received: February 19, 2025 Dear Monica Mezezi: 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 (the 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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ ## Indications for Use ## 510(k) Number (if known) K242107 ### Device Name CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/ HEPES (HHTF) ## Indications for Use (Describe) CaseMONO™ Culture is intended for use for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus. CaseBioscience® HTF is intended for use for the culture of embryos to the cleavage stage (Day 3). This device can be used for transfer of embryos to the uterus. CaseMONO w/HEPES™ is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transfering to the uterine cavity. CaseBioscience® HTF w/HEPES is intended for use in short-term handling gametes embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavitv. 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 ## 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." {4}------------------------------------------------ # 510(k) Summary K242107 #### I. SUBMITTER | Applicant: | CaseBioscience, Inc. | |-----------------|-------------------------------------------------| | Address: | 24 Norwich Street East, Guelph, Ont N1H 2G6 CAN | | Phone: | 1 (226) 243-6483 | | Contact Person: | Monica Mezezi, CEO/President | | Email: | regulatory@casebioscience.com | Date Prepared: March 20, 2025 #### II. DEVICE | Trade Name: | CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) | |--------------------|-----------------------------------------------------------------------------------------------------------------------| | Common Name: | Assisted Reproduction Media | | Regulation Name: | Reproductive Media and Supplements | | Regulation Number: | 884.6180 | | Product Code: | MQL (Media, Reproductive) | | Regulatory Class: | II | #### PREDICATE DEVICE III. Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium Giftlife™ Single Step Medium (K240149) from Gimbo Medical Technology Shenzhen Co., Ltd. The predicate device has not been subject to a design-related recall. #### IV. DEVICE DESCRIPTION CaseMONO Culture, CaseMONO w/HEPES, CaseBioscience HTF, and CaseBioscience HTF w/HEPES are intended for use during in vitro procedures for gamete/embryo culture and one step media. CaseMONO Culture is intended for use for culture of embryos from fertilization to the blastocyst stage. This device is a one-step media and can be used for transfer of embryos to the uterus. {5}------------------------------------------------ CaseMONO w/HEPES is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). CaseBioscience HTF is intended for use for the culture of embryos to the cleavage stage (Day 3). This device is not a one-step medium but can be used for transfer of embryos to the uterus. CaseBioscience HTF w/HEPES is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). CaseMONO Culture and CaseMONO w/HEPES have almost identical composition with differences in amount of NaHCO3 and Phenol red and presence of HEPES in CaseMONO w/HEPES. Similarly, CaseBioscience HTF and CaseBioscience HTF w/HEPES have an almost identical composition with the exception of HEPES present in CaseBioscience HTF w/HEPES and minor difference in composition for NaCl, Sodium L-lactate and Phenol red. CaseMONO Culture and CaseMONO w/HEPES contain EDTA. All media formulations contain antibiotic gentamicin. The four solutions are aseptically filtered (storage vials sterilized by radiation) and provided in PETG square media bottles with HDPE screw-style caps. They have a shelf-life of 90 days when stored at 2-8°C. Media in the vials can be used for up to seven days after vial opening. #### V. INDICATIONS FOR USE CaseMONO™ Culture is intended for use for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus. CaseBioscience® HTF is intended for use for the culture of embryos to the cleavage stage (Day 3). This device can be used for transfer of embryos to the uterus. CaseMONO w/HEPES™ is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavity. CaseBioscience® HTF w/HEPES is intended for use in short-term handling and manipulating gametes embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavity. {6}------------------------------------------------ ## COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS VI. WITH THE PREDICATE DEVICE A comparison of the intended use and technological features of the subject and predicate devices are described in the table below: | Comparison Item | K242107 Subject Device | K240149 Predicate Device | Comparison | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | CaseMONO™ Culture is intended for use for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus. | Giftlife Fertilization Medium is intended for use during in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) procedures and culture to the two pronuclei (zygote) stage of development. | There are differences in the wording of the indications for use statements for the subject and predicate device; however overall, the indications for use statements for the predicate device are similar in intended use for embryo culture, handling, and use during fertilization procedures. | | | CaseBioscience® HTF is intended for use for the culture of embryos to the cleavage stage (Day 3). This device can be used for transfer of embryos to the uterus. | Giftlife Cleavage Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from pronucleate stage to day 2 or day 3. This medium is not intended for transferring embryos to the uterine cavity. | | | | CaseMONO w/HEPES™ is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavity. | Giftlife Blastocyst Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from day 3 to the blastocyst stage. This medium is not intended for transferring embryos to the uterine cavity. | | | | CaseBioscience® HTF w/HEPES is intended for use in short-term handling and manipulating gametes embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavity. | Giftlife Single Step Medium is used for culture of embryos from fertilization to the blastocyst stage. | | | | | | | | Comparison Item | K242107 Subject Device | K240149 Predicate Device | Comparison | | Conditions for Use | Prescription Use Only | Prescription Use Only | Same | | Composition | NaCl, KCl, $MgSO4·7H2O$ , KH2PO4, CaCl2·2H2O, NaHCO3, Glucose, Sodium pyruvate, Sodium L-lactate, GlyGln Essential and Non-Essential Amino Acids, Gentamicin, Phenol Red, HEPES, EDTA, Water | Not available publicly | Different: The subject device and predicate devices have differences in media formulation. These differences in composition do not raise different questions of safety and effectiveness (S&E). | | pH | 7.2-7.4 (CaseMONO Culture & CaseBioscience HTF) 7.2-7.6 (CaseMONO w/HEPES & CaseBioscience HTF w/HEPES) | Not available publicly | Different: The differences in pH specifications do not raise different questions of S&E. | | Osmolality (mOsm/kg) | 260-270 mOsm/kg (CaseMONO Culture) 285-295 mOsm/kg (CaseBioscience HTF) 260-270 mOsm/kg (CaseMONO w/HEPES) 285-295 mOsm/kg (CaseBioscience HTF w/HEPES) | Not available publicly | Different: The differences in osmolality specifications do not raise different questions of S&E. | | Comparison Item | K242107 Subject Device | K240149 Predicate Device | Comparison | | Bacterial Endotoxin | <0.1 EU/mL | Not available publicly | Different: The differences in endotoxin specifications do not raise different questions of S&E. | | Mouse Embryo Assay | One-Cell MEA: ≥ 80% embryos developed to expanded blastocyst at 120 hours for CaseMONO One-Cell MEA: ≥ 80% embryos developed to expanded blastocyst after 96 hours exposure to CaseBioscience HTF One-Cell MEA: ≥ 80% embryos developed to expanded blastocyst at 96 hours after a 1-hour exposure to CaseMONO w/HEPES One-Cell MEA: ≥ 80% embryos developed to expanded blastocyst at 96 hours after a 1-hour exposure to CaseBioscience HTF w/HEPES | Not available publicly | Different: The differences in MEA specifications do not raise different questions of S&E. | | Sterilization Method | Aseptic Filtration Vials are sterilized via radiation | Not available publicly | Similar | | Shelf-Life | 90 days | Not available publicly | Different: The differences in | | Comparison Item | K242107 Subject Device | K240149 Predicate Device | Comparison | | | | | shelf-life specifications do not raise different questions of S&E. | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ 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. #### VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING The following studies have been conducted in support of the substantial equivalence of the subject device to the predicate device. - A Aseptic filtration and aseptic filling validation, per ISO 13408-1:2008 & A1:2013 and ISO 13408-2:2018. - 트 For filter challenge test per ISO 13408-2, the solutions used for testing did not contain antimicrobials (gentamicin was excluded from subject media formulation) and were representative of worst-case production conditions. - > Vial radiation sterilization, per ISO 11137-1:2006 (including: Amendment 1 (2013) and Amendment 2 (2018)) Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2:2013 -Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)]. - Shelf-life testing was conducted to support a 90-days shelf-life for the subject device through > demonstration that the product specifications (shown below) were met at time 0 and after aging at 2-8°C: - Appearance: All of the solutions should be without precipitates {10}------------------------------------------------ - pH per USP <791>: 7.2-7.4 (CaseMONO Culture & CaseBioscience HTF); 7.2-7.6 (CaseMONO 트 w/HEPES & CaseBioscience HTF w/HEPES) - . Osmolality per USP <785>: 260-270 mOsm/kg (CaseMONO Culture); 285-295 mOsm/kg (CaseBioscience HTF); 260-270 mOsm/kg (CaseMONO w/HEPES); 285-295 mOsm/kg (CaseBioscience HTF w/HEPES) - . Sterility per USP <71>: No microbial growth - . Bacterial endotoxin per USP <85>: < 0.1 EU/mL - . MEA per the 2021 FDA guidance Mouse Embryo Assay for Assisted Reproduction Technology Devices: - One-Cell MEA: ≥ 80% embryos developed to expanded blastocyst at 120 hours for o CaseMONO - One-Cell MEA: ≥ 80% embryos developed to expanded blastocyst after 96 hours O exposure to CaseBioscience HTF - One-Cell MEA: ≥ 80% embryos developed to expanded blastocyst at 96 hours after a 1- O hour exposure to CaseMONO w/HEPES - O One-Cell MEA: ≥ 80% embryos developed to expanded blastocyst at 96 hours after a 1hour exposure to CaseBioscience HTF w/HEPES - Transportation testing per ASTM D4169-22 and cap/seal leak testing using a method equivalent > to USP <1207.2> on transportation-conditioned devices. - Biocompatibility testing was conducted on the patient contacting subject media (CaseMONO > Culture and CaseBioscience HTF) intended for transfer of embryos to uterine cavity in accordance with the 2023 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows: - . Cytotoxicity (ISO 10993-5:2009/(R)2014) - . Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2021) - . Vaginal Irritation (ISO 10993-23: 2021) The results of the testing conducted support the biocompatibility of the patient contacting subject devices. {11}------------------------------------------------ #### CONCLUSION VIII. The results of the performance testing described above demonstrate that CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) is as safe and effective as the predicate device and supports a determination of substantial equivalence.