(246 days)
Not Found
No
The document describes culture media for in vitro fertilization and embryo development, focusing on chemical composition, sterilization, shelf-life, and biological performance (MEA). There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes.
The device is intended for the culture and transfer of embryos, which directly impacts a patient's health and reproductive function, classifying it as a therapeutic device.
No
The device description and intended use state that it is for the culture and handling of embryos, and for transfer to the uterus. It does not mention any diagnostic function such as identifying a medical condition or disease. The performance studies also focus on product quality and safety rather than diagnostic accuracy.
No
The device description clearly indicates the device is a physical substance (culture media) provided in bottles, not software. The performance studies also focus on physical and biological properties of the media and its packaging.
Based on the provided information, these devices are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these media are for the culture of embryos from fertilization to various stages (cleavage, blastocyst). This process involves examining and manipulating biological material (embryos) in vitro (outside the body) to assess their development and suitability for transfer.
- Device Description: The description details the composition and purpose of the media for use during in vitro procedures for gamete/embryo culture.
- Performance Studies: The performance studies include tests like the Mouse Embryo Assay (MEA), which is a standard test for assessing the suitability of media for in vitro embryo development.
- Predicate Devices: The predicate devices listed (Giftlife™ Fertilization Medium, Giftlife™ Cleavage Medium, Giftlife™ Blastocyst Medium, Giftlife™ Single Step Medium) are also commonly classified as IVDs used in assisted reproductive technology (ART).
While some of the media are intended for transfer to the uterus, their primary function described is the in vitro culture and manipulation of gametes and embryos. The transfer is a subsequent step after the in vitro assessment and development.
Therefore, the core function of these devices aligns with the definition of an IVD, which is a medical device intended for use in vitro for the examination of specimens derived from the human body. In this case, the specimens are gametes and embryos.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MQL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following studies have been conducted in support of the substantial equivalence of the subject device to the predicate device.
Aseptic filtration and aseptic filling validation, per ISO 13408-1:2008 & A1:2013 and ISO 13408-2:2018. 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
- pH per USP : 7.2-7.4 (CaseMONO Culture & CaseBioscience HTF); 7.2-7.6 (CaseMONO w/HEPES & CaseBioscience HTF w/HEPES)
- Osmolality per USP : 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 : No microbial growth
- Bacterial endotoxin per USP : = 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 1hour exposure to CaseBioscience HTF w/HEPES
- Transportation testing per ASTM D4169-22 and cap/seal leak testing using a method equivalent to USP 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
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) |
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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.
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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:
| 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 | 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 : 7.2-7.4 (CaseMONO Culture & CaseBioscience HTF); 7.2-7.6 (CaseMONO 트 w/HEPES & CaseBioscience HTF w/HEPES)
- . Osmolality per USP : 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 : No microbial growth
- . Bacterial endotoxin per USP : to USP 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.