(267 days)
Not Found
No
The summary describes chemical solutions for vitrification and warming of oocytes and embryos, with performance testing focused on sterility, endotoxin, pH, osmolality, and mouse embryo assay. There is no mention of AI, ML, image processing, or any computational analysis.
No
The device is used for the vitrification and warming of oocytes and embryos for use in assisted reproductive technology (ART) procedures. It is involved in the preservation and preparation of biological material, not directly in a therapeutic (treatment-oriented) intervention on a patient.
No
Explanation: The device is intended for the vitrification and thawing of oocytes and embryos for use in assisted reproductive technology (ART) procedures. It does not diagnose any condition or disease.
No
The device description clearly states that the device consists of media components provided in polypropylene vials, which are physical, non-software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the vitrification (freezing) and warming (thawing) of oocytes and embryos for use in assisted reproductive technology (ART) procedures. This is a process performed outside the body to preserve biological material, not to diagnose a condition or provide information about a patient's health status.
- Device Description: The device consists of solutions used for the physical process of freezing and thawing cells. It does not involve analyzing biological samples to obtain diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing patient samples, detecting biomarkers, or providing diagnostic results. The performance studies focus on the sterility, chemical properties, and the ability of the solutions to support embryo development in vitro after the process, which are related to the functionality of the freezing/thawing process itself, not a diagnostic test.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or other conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Vitrification Solution Set is intended for use in the virification of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
The Warming Solution Set is intended for use in the thawing of vitrified occytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
Product codes
MOL
Device Description
The Vitrification Solution Set and Warming Solution Set are intended for freezing and thawing oocytes and embryos for use in assisted reproductive technology (ART) procedures.
The Vitrification Solution Set consists of two media components, the Equilibration Solution (ES) and the Vitrification Solution (VS). The Warming Solution Set consists of three media components, the Thawing / Warming Solution (TS), Diluent Solution (DS), and Washing Solution (WS). All media are provided in 1.8 ml polypropylene vials with a polyethylene cap. All media in both sets undergo aseptic filtration and are single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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)
To demonstrate safety and effectiveness of the Vitrification Solution Set and Warming Solution Set and to show substantial equivalence to the predicate device, the following non-clinical tests have been performed.
- Aseptic processing and validation testing that met the requirements of ISO 13408-1:2008/Amd1:2013 and ISO 13408-2:2018. Testing was conducted on the subject device containing no antimicrobials.
- Shelf-life testing was conducted to support a one-year shelf-life for the subject devices through demonstration that the product specifications (shown below) were met at time 0 and after accelerated aging per ASTM F1980:21:
- Sterility per USP : No growth
- Endotoxin per USP : ≤ 0.5 EU/mL
- pH per USP : 7.2-7.6 for all solutions
- Osmolality per USP : see the table above for acceptance specifications
- Mouse embryo assay per FDA guidance "Mouse Embryo Assay for Assisted Reproduction Technology Devices" (2021): One-cell system: ≥80% embryos developed to expanded blastocyst at 96 hours
- Transportation testing per ASTM D4169-22 and cap/seal leak testing using a method equivalent to USP on transportation-conditioned devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Sterility per USP : No growth
- Endotoxin per USP : ≤ 0.5 EU/mL
- pH per USP : 7.2-7.6 for all solutions
- Mouse embryo assay per FDA guidance "Mouse Embryo Assay for Assisted Reproduction Technology Devices" (2021): One-cell system: ≥80% embryos developed to expanded blastocyst at 96 hours
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).
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§ 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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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.
August 27, 2024
ECMPC, LLC % Sarah Fitzgerald Senior Consultant Emergo by UL 2500 Bee Cave Road Building 1. Suite 300 Austin, Texas 78746
Re: K233846
Trade/Device Name: Vitrification Solution Set and Warming Solution Set (Models 120, 210, 220) Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL Dated: July 31, 2024 Received: July 31, 2024
Dear Sarah Fitzgerald:
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.
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"
1
(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 OS 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.
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 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
2
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,
Michael T. Bailey -S
For 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) K233846
Device Name
Vitrification Solution Set and Warming Solution Set, Models: 120, 210, 220
Indications for Use (Describe)
The Vitrification Solution Set is intended for use in the virification of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
The Warming Solution Set is intended for use in the thawing of vitrified occytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K233846
Vitrification Solution Set and Warming Solution Set
1. Submitter
ECMPC, LLC 22751 Professional Drive, Suite 220 Kingwood, TX 77339
Contact: Dr. José Gaytán Melicoff Phone: 281-570-6111 Email: jgaytan@ecmpcservices.com
2. Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746
Contact: Sarah Marie Fitzgerald Office Phone: (512) 327-9997 Email: LST.US.EmergoFDASubmissions@ul.com
3. Date Prepared
August 21, 2024
4. Device Identification
Trade Name: Vitrification Solution Set and Warming Solution Set (Models 120, 210, 220) Common Name: Vitrification Cryopreservation Media Regulatory Class: Class II Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Product Code: MQL
5. Predicate Device
Vitrification Kit and Thawing Kit (K171748) by Kitazato Corporation
The predicate device has not been subject to a design related recall.
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6. Device Description
The Vitrification Solution Set and Warming Solution Set are intended for freezing and thawing oocytes and embryos for use in assisted reproductive technology (ART) procedures.
The Vitrification Solution Set consists of two media components, the Equilibration Solution (ES) and the Vitrification Solution (VS). The Warming Solution Set consists of three media components, the Thawing / Warming Solution (TS), Diluent Solution (DS), and Washing Solution (WS). All media are provided in 1.8 ml polypropylene vials with a polyethylene cap. All media in both sets undergo aseptic filtration and are single-use only.
7. Indication for Use
The Vitrification Solution Set is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
The Warming Solution Set is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
8. Substantial Equivalence Discussion
A comparison of the intended use and technological characteristics of the subject device and the predicate device is shown in the table below:
| Attribute | Subject:
Vitrification Solution Set and
Warming Solution Set
(K233846) | Predicate:
Vitrification Kit and Thawing
Kit (K171748) | Comparison |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Vitrification Solution Set is
intended for use in the
vitrification of oocytes (MII),
pronuclear (PN) zygotes
through day 3 cleavage stage
embryos, and blastocyst stage
embryos.
The Warming Solution Set is
intended for use in the
thawing of vitrified oocytes
(MII), pronuclear (PN) zygotes
through day 3 cleavage stage
embryos, and blastocyst stage
embryos. | The Vitrification Kit is indicated
for use in the preparation,
vitrification and storage of
oocytes (MII), pronuclear (PN)
zygotes through day 3 cleavage
stage embryos, and blastocyst
stage embryos.
The Thawing Kit is indicated for
use in the preparation and
thawing of vitrified oocytes
(MII), pronuclear (PN) zygotes
through day 3 cleavage stage
embryos, and blastocyst stage
embryos. | There are differences in
the wording of the
indications for use
statements for the
subject and predicate
device; however, the
intended uses of the
subject and predicate
devices are the same. |
| Sets /
Components | Vitrification Media
Warming Media | Vitrification Media
Thawing Media
Cryotop
Repro Plate 35 mm dish | Different: The
components of the
subject and predicate
devices are not the same. |
| Attribute | Subject:
Vitrification Solution Set and
Warming Solution Set
(K233846) | Predicate:
Vitrification Kit and Thawing
Kit (K171748) | Comparison |
| Embryo Stage | Oocyte, PN through Blastocyst | Oocyte, PN through Blastocyst | Same |
| Vitrification
Media
Components | 2 – equilibration solution,
vitrification solution | 3 – basic solution, equilibration
solution, vitrification solution | Different: The number of
vitrification media of the
subject and predicate
devices are not the same.
Differences in
vitrification solutions do
not raise different
questions of S&E. |
| Warming
Media
Components | 3 – thawing solution, diluent
solution, washing solution | 3 –thawing solution, diluent
solution, washing solution | Same |
| Vitrification
Formulation | HEPES
HEPES sodium salt
Ethylene glycol
Dimethyl sulfoxide
Trehalose
Hydroxypropyl cellulose
Gentamicin
Minimum Essential Medium
Polyvinylpyrrolidone
Sodium bicarbonate | Medium 199 HEPES
Ethylene glycol
Dimethyl sulfoxide
Trehalose
Hydroxypropyl cellulose
Gentamicin | Different: The
formulations of the
subject and predicate
devices are not the same.
Differences in device
formulations do not raise
different questions of
S&E. |
| Warming /
Thawing
Formulation | HEPES
HEPES sodium salt
Hydroxypropyl cellulose
Trehalose
Minimum Essential Medium
Polyvinylpyrrolidone
Sodium bicarbonate
Gentamicin | Medium 199 HEPES
Hydroxypropyl cellulose
Trehalose
Gentamicin | |
| Sterilization | Aseptic filtration | Aseptic filtration | Same |
| Sterility | No growth | Passes USP | Same |
| Endotoxins | $≤$ 0.5 EU/ml (LAL) | $: No growth -
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- -Endotoxin per USP : ≤ 0.5 EU/mL
- pH per USP : 7.2-7.6 for all solutions
- -Osmolality per USP : see the table above for acceptance specifications
- -Mouse embryo assay per FDA guidance "Mouse Embryo Assay for Assisted Reproduction Technology Devices" (2021): One-cell system: ≥80% embryos developed to expanded blastocyst at 96 hours
- . Transportation testing per ASTM D4169-22 and cap/seal leak testing using a method equivalent to USP on transportation-conditioned devices.
10. Conclusion
The results of the performance testing described above demonstrate that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.