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 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.

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.

AI/ML Overview

Acceptance Criteria and Device Performance Study for CaseBioscience Assisted Reproduction Media

This document outlines the acceptance criteria and the study conducted to prove that the CaseBioscience® Assisted Reproduction Media (CaseMONO™ Culture, CaseMONO™ w/HEPES, CaseBioscience® HTF, and CaseBioscience® HTF w/HEPES) meet these criteria, as detailed in the K242107 510(k) Summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each variant of the CaseBioscience Assisted Reproduction Media are based on various non-clinical performance tests. The reported device performance met these acceptance criteria.

Test Category	Acceptance Criteria	Reported Device Performance
Shelf-Life Testing	Product specifications (Appearance, pH, Osmolality, Sterility, Bacterial Endotoxin, MEA) met at time 0 and after aging at 2-8°C for 90 days.	All specified product parameters (Appearance, pH, Osmolality, Sterility, Bacterial Endotoxin, MEA) were met at time 0 and after 90 days of storage at 2-8°C, supporting a 90-day shelf-life.
Appearance	All solutions without precipitates.	Solutions were observed to be clear and free of precipitates.
pH (USP <791>)	CaseMONO™ Culture & CaseBioscience® HTF: 7.2-7.4CaseMONO™ w/HEPES & CaseBioscience® HTF w/HEPES: 7.2-7.6	CaseMONO™ Culture & CaseBioscience® HTF: Measured pH values were within 7.2-7.4.CaseMONO™ w/HEPES & CaseBioscience® HTF w/HEPES: Measured pH values were within 7.2-7.6.
Osmolality (USP <785>)	CaseMONO™ Culture: 260-270 mOsm/kgCaseBioscience® HTF: 285-295 mOsm/kgCaseMONO™ w/HEPES: 260-270 mOsm/kgCaseBioscience® HTF w/HEPES: 285-295 mOsm/kg	CaseMONO™ Culture: Measured osmolality was within 260-270 mOsm/kg.CaseBioscience® HTF: Measured osmolality was within 285-295 mOsm/kg.CaseMONO™ w/HEPES: Measured osmolality was within 260-270 mOsm/kg.CaseBioscience® HTF w/HEPES: Measured osmolality was within 285-295 mOsm/kg.
Sterility (USP <71>)	No microbial growth.	No microbial growth was detected.
Bacterial Endotoxin (USP <85>)	< 0.1 EU/mL	Measured bacterial endotoxin levels were < 0.1 EU/mL.
Mouse Embryo Assay (MEA)	One-Cell MEA:- CaseMONO™ Culture: ≥ 80% embryos developed to expanded blastocyst at 120 hours.- CaseBioscience® HTF: ≥ 80% embryos developed to expanded blastocyst after 96 hours exposure.- CaseMONO™ w/HEPES: ≥ 80% embryos developed to expanded blastocyst at 96 hours after a 1-hour exposure.- CaseBioscience® HTF w/HEPES: ≥ 80% embryos developed to expanded blastocyst at 96 hours after a 1-hour exposure.	One-Cell MEA:- CaseMONO™ Culture: Achieved ≥ 80% expanded blastocyst development at 120 hours.- CaseBioscience® HTF: Achieved ≥ 80% expanded blastocyst development after 96 hours exposure.- CaseMONO™ w/HEPES: Achieved ≥ 80% expanded blastocyst development at 96 hours after a 1-hour exposure.- CaseBioscience® HTF w/HEPES: Achieved ≥ 80% expanded blastocyst development at 96 hours after a 1-hour exposure.
Biocompatibility	Meet criteria for Cytotoxicity, Sensitization, and Irritation per ISO 10993 standards.	The results demonstrated that the patient-contacting subject media (CaseMONO™ Culture and CaseBioscience® HTF) were biocompatible, meeting the requirements of ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), and ISO 10993-23 (Vaginal Irritation).
Aseptic Processing	Validation of aseptic filtration and aseptic filling according to ISO 13408-1:2008 & A1:2013 and ISO 13408-2:2018.	Aseptic filtration and filling were validated according to the specified ISO standards, including a filter challenge test using worst-case production conditions (excluding antimicrobials).
Sterilization	Validation of vial radiation sterilization per ISO 11137-1:2006 (Amd 1 (2013), Amd 2 (2018)) and ISO 11137-2:2013 (Amd 1 (2022)).	Vial radiation sterilization was validated according to the specified ISO standards.
Transportation Testing	Pass per ASTM D4169-22 and cap/seal leak testing using a method equivalent to USP <1207.2>.	The devices passed transportation testing per ASTM D4169-22 and subsequent cap/seal leak testing.

2. Sample Size and Data Provenance

The provided document details non-clinical performance testing for assisted reproduction media. The sample sizes for each specific test (e.g., number of embryos in MEA, number of samples for pH/Osmolality) are not explicitly stated in this summary.

The data provenance is from non-clinical laboratory testing and is retrospective in nature, as it was conducted to support a 510(k) submission for an existing product. The country of origin of the data is not specified, but the testing would have been conducted by or for CaseBioscience, Inc., which is based in Canada.

3. Number of Experts and Qualifications for Ground Truth

This submission pertains to in vitro reproductive media. The ground truth for performance (e.g., embryo development, chemical properties, sterility) is established through standardized laboratory assays and specifications, rather than expert human interpretation of images or patient data. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or clinical diagnosis by multiple medical professionals is not applicable here. The "experts" would be the scientists and quality control personnel in the laboratory performing the assays, adhering to validated methods.

4. Adjudication Method for the Test Set

As the evaluation is based on objective laboratory measurements and standardized assays (e.g., pH meters, osmometers, bacterial growth cultures, embryo development rates), an "adjudication method" in the sense of a consensus process among human readers (e.g., 2+1, 3+1) is not applicable. The results are quantitative and binary (pass/fail against a threshold).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study is typically performed for AI/CADe systems where human readers interpret medical images. Since this submission is for in vitro assisted reproduction media, which do not involve human interpretation of images or AI assistance in the diagnostic process, an MRMC comparative effectiveness study was not performed. Therefore, effect size of human improvement with AI assistance is not relevant or measurable in this context.

6. Standalone (Algorithm Only) Performance Study

This submission is for a medical device that is a consumable media, not a software algorithm. Therefore, a "standalone algorithm only" performance study is not applicable. The performance is assessed based on the physical, chemical, and biological properties of the media itself.

7. Type of Ground Truth Used

The ground truth used for proving the device meets the acceptance criteria is based on:

Laboratory-established specifications and thresholds: For parameters like pH, osmolality, bacterial endotoxin, and appearance.
Standardized biological assays: Specifically, the Mouse Embryo Assay (MEA), where the "ground truth" for success is a predefined percentage of embryos reaching a certain developmental stage (expanded blastocyst) within a specified timeframe.
Compliance with international standards: For sterilization, aseptic processing, and biocompatibility testing (e.g., ISO, USP, ASTM).

8. Sample Size for the Training Set

This product is an in vitro medical device, not an AI/ML software. Therefore, there is no "training set" in the context of machine learning model development. The product is manufactured and tested according to established quality control procedures and specifications.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set for an AI/ML model, this question is not applicable. The "ground truth" for the performance of the media is established by validated laboratory methods and industry/regulatory standards.

Summary

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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.

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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

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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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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.

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 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.

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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).

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.

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.

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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:

ComparisonItem	K242107Subject Device	K240149Predicate Device	Comparison
Indications forUse	CaseMONO™ Culture is intended foruse for culture of embryos fromfertilization to the blastocyst stage. Thisdevice can be used for transfer ofembryos to the uterus.	Giftlife Fertilization Medium isintended for use during in vitrofertilization (IVF) andintracytoplasmic sperm injection(ICSI) procedures and culture to thetwo pronuclei (zygote) stage ofdevelopment.	There aredifferences in thewording of theindications foruse statementsfor the subjectand predicatedevice; howeveroverall, theindications foruse statementsfor the predicatedevice aresimilar inintended use forembryo culture,handling, and useduringfertilizationprocedures.
	CaseBioscience® HTF is intended foruse for the culture of embryos to thecleavage stage (Day 3). This device canbe used for transfer of embryos to theuterus.	Giftlife Cleavage Medium isintended for use during in vitrofertilization (IVF) for culture ofembryos from pronucleate stage today 2 or day 3. This medium is notintended for transferring embryos tothe uterine cavity.
	CaseMONO w/HEPES™ is intendedfor use in short-term handling andmanipulating gametes and embryos,including washing and intracytoplasmicsperm injection (ICSI). This medium isnot intended for transferring embryosto the uterine cavity.	Giftlife Blastocyst Medium isintended for use during in vitrofertilization (IVF) for culture ofembryos from day 3 to theblastocyst stage. This medium is notintended for transferring embryos tothe uterine cavity.
	CaseBioscience® HTF w/HEPES isintended for use in short-term handlingand manipulating gametes embryos,including washing and intracytoplasmicsperm injection (ICSI). This medium isnot intended for transferring embryosto the uterine cavity.	Giftlife Single Step Medium is usedfor culture of embryos fromfertilization to the blastocyst stage.

ComparisonItem	K242107Subject Device	K240149Predicate Device	Comparison
Conditions forUse	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-EssentialAmino Acids, Gentamicin, Phenol Red,HEPES, EDTA, Water	Not available publicly	Different: Thesubject deviceand predicatedevices havedifferences inmediaformulation.These differencesin compositiondo not raisedifferentquestions ofsafety andeffectiveness(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: Thedifferences in pHspecifications donot raisedifferentquestions ofS&E.
Osmolality(mOsm/kg)	260-270 mOsm/kg (CaseMONOCulture)285-295 mOsm/kg (CaseBioscienceHTF)260-270 mOsm/kg (CaseMONOw/HEPES)285-295 mOsm/kg (CaseBioscienceHTF w/HEPES)	Not available publicly	Different: Thedifferences inosmolalityspecifications donot raisedifferentquestions ofS&E.
ComparisonItem	K242107Subject Device	K240149Predicate Device	Comparison
BacterialEndotoxin	<0.1 EU/mL	Not available publicly	Different: Thedifferences inendotoxinspecifications donot raisedifferentquestions ofS&E.
MouseEmbryo 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: Thedifferences inMEAspecifications donot raisedifferentquestions ofS&E.
SterilizationMethod	Aseptic FiltrationVials are sterilized viaradiation	Not available publicly	Similar
Shelf-Life	90 days	Not available publicly	Different: Thedifferences in
ComparisonItem	K242107Subject Device	K240149Predicate Device	Comparison
			shelf-lifespecifications donot raisedifferentquestions ofS&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.

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

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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.

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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.

Regulation Number and Section

§ 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.