(268 days)
Not Found
No
The device description focuses on the chemical composition and physical process of vitrification and warming using specific solutions. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI/ML. The performance studies are standard biological and chemical tests.
Yes
This device is used in Assisted Reproductive Technology (ART) procedures for the vitrification and warming of human blastocyst stage embryos, which is a therapeutic intervention aimed at enabling or assisting in conception.
No
This device is used for the vitrification and warming of human blastocyst stage embryos for Assisted Reproductive Technology (ART) procedures, which are therapeutic and storage processes, not diagnostic ones.
No
The device description clearly states that the device consists of physical solutions (Vitsol 1, Vitsol 2, Vitsol 3, Warmsol 1, Warmsol 2, Warmsol 3) which are single-use devices filled into sterilized bottles. This indicates a physical product, not software.
Based on the provided text, the Gems Vitrification Set and Gems Warming Set are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use explicitly states they are used for procedures related to Assisted Reproductive Technology (ART), specifically the vitrification and warming of human blastocyst stage embryos. These are procedures performed in vitro (outside the body) on biological material (embryos).
- Device Description: The description details the composition of the solutions used to interact with the embryos in vitro for the purpose of preservation and recovery.
- Performance Studies: The performance studies include tests like Mouse Embryo Assay (MEA), which assesses the effect of the solutions on biological material in vitro.
While the device itself is a set of solutions and not a diagnostic test in the traditional sense (like a blood test), the definition of an IVD includes reagents, instruments, and systems intended for use in vitro for the examination of specimens, including human embryos in the context of ART. The purpose of these sets is to facilitate a process performed in vitro on human embryos for a medical purpose (ART).
Therefore, based on the intended use and the nature of the device interacting with biological material in vitro, it falls under the category of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Gems Vitrification Set is used for the vitrification of human blastocyst stage embryos for Assisted Reproductive Technology (ART) procedures.
Gems Warming Set is used for the warming of human blastocyst stage embryos that have undergone vitrification.
Product codes
MQL
Device Description
The Gems Vitrification Set and Gems Warming Set are intended for the vitrification and warming of human blastocysts as part of human ART procedures.
The Gems Vitrification Set is designed to facilitate dehydration of blastocysts before vitrification via rapid cooling in liquid nitrogen. Dehydration of the blastocysts is achieved by the step-wise use of increasing concentrations of cryoprotectants in the Gems Vitrification Set, which results in water being withdrawn from the cell. The cryoprotectants also protect the blastocysts by reducing the potential for ice crystal formation during the vitrification process.
The Gems Vitrification Set consists of three solutions (Vitsol 2, and Vitsol 3). The base formulation for Vitsol 1 and Vitsol 2 is a HEPES-buffered medium containing salts, energy substrates, amino acids, and human serum albumin. Vitsol 1 contains the cryoprotectant ethylene qlycol, while Vitsol 2 contains the cryoprotectants ethylene glycol and trehalose. Vitsol 3 consists of dimethyl sulphoxide (DMSO). The Gems Vitrification Set is not provided ready for use as Vitsol 3 must be added to the other vitrification solutions before use. Following DMSO addition to Vitsol 1 and 2, the final vitrification solutions for blastocyst vitrification procedures have the following properties:
- . Vitrification Solution 1 (Vitsol 1 + DMSO) - 8% ethylene glycol and 8% DMSO
- Vitrification Solution 2 (Vitsol 2 + DMSO) 16% ethylene glycol, 16% DMSO, and 0.57M trehalose ●
The Gems Warming Set consists of three warming solutions (Warmsol 2, and Warmsol 3), which are designed to facilitate the re-hydration (warming) of vitrified blastocysts. In the warming process, trehalose in the media manages the inflow of water into blastocysts as concentrations of DMSO and ethylene glycol are reduced during the rehydration process.
All three of the solutions in the Gems Warming Set consist of a HEPES-buffered medium containing salts, energy substrates, amino acids, and human serum albumin, with varying amounts of the cryoprotectant trehalose as described below:
- . Warmsol 1 - 1.0 M trehalose
- Warmsol 2 0.5 M trehalose ●
- Warmsol 3 - No trehalose
These media are single-use devices that are aseptically filled into sterilized bottles and have a sterility assurance level (SAL) of 10 3. The products are tested for pH, osmolality, embryotoxicity, endotoxin, and sterility before lot release.
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
human
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 performed to support substantial equivalence to the predicate devices:
- pH ●
- . Osmolality
- . Aseptic Processing Validation testing that met the requirements in ISO 13408-2:2003
- Sterility testing per USP .
- . Endotoxin testing per USP
- . Mouse embryo assay (MEA)
- One-cell mouse embryos were exposed sequentially to subject devices in the Vitrification and Warming Sets followed by culture at 37°C in an atmosphere containing 5% CO₂. The percent of embryos developed to the expanded blastocyst stage at 96 hours were assessed in comparison with the control group.
- Shelf-life studies (real-time and accelerated) were conducted to ensure that the following product ● specifications are met at time zero and the end of shelf-life.
- pH 7.3-7.5 *
-
- Osmolality - See technological comparison table above for specifications
-
- 1-cell MEA – ≥80% developed to the blastocyst stage at 96 hours
-
- Endotoxin -
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 24, 2017
Genea Biomedx Pty Ltd % Roger Gray VP, Ouality Assurance and Regulatory Affairs Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, 00153 Italy
Re: K162409
Trade/Device Name: Gems Vitrification Set and Gems Warming Set Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: April 21, 2017 Received: April 24, 2017
Dear Roger Gray:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply
1
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Charles Viviano -S
For
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162409
Device Name
Gems Vitrification Set and Gems Warming Set
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
Gems Vitrification Set is used for the vitrification of human blastocyst stage embryos for Assisted Reproductive Technology (ART) procedures.
Gems Warming Set is used for the warming of human blastocyst stage embryos that have undergone vitrification.
| | Over-The-Counter Use (21 CFR 801 Subpart C)
X Prescription Use (Part 21 CFR 801 Subpart D) | | | | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| 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 Druq 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."
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Image /page/3/Picture/0 description: The image shows the logo for Genea BIOMEDX. The logo consists of a green square with a white curved line inside, followed by the word "Genea" in gray and "BIOMEDX" in green. The logo is simple and modern, and the colors are eye-catching.
510(k) Summary
l. Submitter Information
| Submitter/Address: | Genea Biomedx Pty Ltd
Level 2, 321 Kent Street
Sydney
NSW 2000
Australia |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Phone: | +61 2 8484 7677 |
| Fax: | +61 2 9229 6478 |
| Correspondent: | Mr. Roger Gray
VP, Quality and Regulatory
Donawa Lifescience Consulting Srl
Piazza Albania 10
00153 Rome
Italy |
| Phone: | +39 06 578 2665 |
| Fax: | +39 06 574 3786 |
| Email: | rgray@donawa.com |
| Date Prepared: | May 22, 2017 |
II. Date Prepared:
III. General Information on Devices
| Device Name: | Gems Vitrification Set and Gems Warming Set |
|---|---|
| Common Name: | Vitrification and Warming Media |
| Classification Name: | Reproductive Media and Supplements (21 CFR 884.6180) |
| Product code: | MQL (Media, Reproductive) |
| Regulatory Class: | II |
IV. Predicate Devices
Cook Sydney IVF Blastocyst Vitrification Kit and Cook Sydney IVF Blastocyst Warming Kit (K143724)
These predicate devices have not been subject to any design-related recalls.
V. Indications for Use
Gems Vitrification Set is used for the vitrification of human blastocyst stage embryos for Assisted Reproductive Technology (ART) procedures.
Gems Warming Set is used for the warming of human blastocyst stage embryos that have undergone vitrification.
VI. Device Description
The Gems Vitrification Set and Gems Warming Set are intended for the vitrification and warming of human blastocysts as part of human ART procedures.
The Gems Vitrification Set is designed to facilitate dehydration of blastocysts before vitrification via rapid cooling in liquid nitrogen. Dehydration of the blastocysts is achieved by the step-wise use of increasing concentrations of cryoprotectants in the Gems Vitrification Set, which results in water being withdrawn from the cell. The cryoprotectants also protect the blastocysts by reducing the potential for ice crystal formation during the vitrification process.
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Image /page/4/Picture/0 description: The image contains the logo for Genea BIOMEDX. The logo consists of a green square with rounded corners and a white curved line inside, resembling a stylized "D". To the right of the square, the word "Genea" is written in gray, and below it, "BIOMEDX" is written in green.
The Gems Vitrification Set consists of three solutions (Vitsol 2, and Vitsol 3). The base formulation for Vitsol 1 and Vitsol 2 is a HEPES-buffered medium containing salts, energy substrates, amino acids, and human serum albumin. Vitsol 1 contains the cryoprotectant ethylene qlycol, while Vitsol 2 contains the cryoprotectants ethylene glycol and trehalose. Vitsol 3 consists of dimethyl sulphoxide (DMSO). The Gems Vitrification Set is not provided ready for use as Vitsol 3 must be added to the other vitrification solutions before use. Following DMSO addition to Vitsol 1 and 2, the final vitrification solutions for blastocyst vitrification procedures have the following properties:
- . Vitrification Solution 1 (Vitsol 1 + DMSO) - 8% ethylene glycol and 8% DMSO
- Vitrification Solution 2 (Vitsol 2 + DMSO) 16% ethylene glycol, 16% DMSO, and 0.57M trehalose ●
The Gems Warming Set consists of three warming solutions (Warmsol 2, and Warmsol 3), which are designed to facilitate the re-hydration (warming) of vitrified blastocysts. In the warming process, trehalose in the media manages the inflow of water into blastocysts as concentrations of DMSO and ethylene glycol are reduced during the rehydration process.
All three of the solutions in the Gems Warming Set consist of a HEPES-buffered medium containing salts, energy substrates, amino acids, and human serum albumin, with varying amounts of the cryoprotectant trehalose as described below:
- . Warmsol 1 - 1.0 M trehalose
- Warmsol 2 0.5 M trehalose ●
- Warmsol 3 - No trehalose
These media are single-use devices that are aseptically filled into sterilized bottles and have a sterility assurance level (SAL) of 10 3. The products are tested for pH, osmolality, embryotoxicity, endotoxin, and sterility before lot release.
VII. Comparison of Intended Use and Technological Characteristics of Subject and Predicate Devices
| Parameter | Subject Device - Gems
Vitrification Set and
Gems Warming Set
(K162409) | Predicate Device - COOK
Sydney IVF Blastocyst
Vitrification Kit and COOK
Sydney IVF Blastocyst
Warming Kit (K143724) | Comparison |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Indication
for Use | Gems Vitrification Set is
used for the vitrification of
human blastocyst stage
embryos for Assisted
Reproductive Technology
(ART) procedures.
Gems Warming Set is
used for the warming of
human blastocyst stage
embryos that have
undergone vitrification. | Blastocyst Vitrification Kit is
intended for the vitrification
of human blastocysts for
assisted reproduction
technologies (ART). This kit
is designed for use with
Blastocyst Warming Kit (K-
SIBW-5000).
Blastocyst Warming Kit is
intended for the warming of
human blastocysts that have
undergone vitrification using
COOK
Sydney IVF Vitrification Kit
(K-SIBV-5000) for ART
procedures. | Same Intended Use -
vitrification and warming of
human blastocyst stage
embryos. |
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Image /page/5/Picture/0 description: The image contains the logo for Genea Biomedx. The logo consists of a green square with a white curved line inside, followed by the text "Genea" in gray and "BIOMEDX" in green. The logo is simple and modern, with a focus on the company's name and a clean design.
| Parameter | Subject Device - Gems
Vitrification Set and
Gems Warming Set
(K162409) | Predicate Device - COOK
Sydney IVF Blastocyst
Vitrification Kit and COOK
Sydney IVF Blastocyst
Warming Kit (K143724) | Comparison |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Formulation | HEPES buffered
physiologic
media containing ethylene
glycol, DMSO, trehalose,
and human serum
albumin in addition to
normal physiological
salts.
DMSO provided in a
separate vial and must be
added to vitrification
media before use. | HEPES buffered physiologic
media containing ethylene
glycol, DMSO, trehalose,
human Serum albumin and
gentamicin in addition to
normal physiological
salts.
DMSO provided in a
separate vial and must be
added to vitrification media
before use. | Different - Formulas for the
vitrification and Warming
Vitrification Solutions are similar,
consisting of the same
components with the exception
of gentamicin (not in subject
device). Some differences in
concentrations.
Differences noted above do not
raise different questions of
safety and effectiveness (S&E). |
| pH | 7.3-7.5 | 7.3-7.5 | Same |
| Osmolarity
(mOsm/kg) | Not applicable (N/A) for
vitrification solutions
Warmsol 1 – 1280-1320
Warmsol 2 – 780-820
Warmsol 3 - 295-305 | K-SIBV-SOL1: 285 - 295
K-SIBV-SOL2: N/A
K-SIBV-SOL3: N/A
K-SIBW-SOL1: 657 - 683
K-SIBW-SOL2: 500 - 520
K-SIBW-SOL3: 285 - 295 | Different: Osmolality values are
higher in the subject device than
in the predicate device due to
differences in cryoprotectant
concentrations in the subject
device. Differences in osmolality
do not raise different questions
of S&E. |
| MEA | 1-Cell MEA: ≥80%
developed to blastocysts
at 96h | 2-Cell MEA: ≥80%
blastocyst formation at 72h | Similar |
| Endotoxin | Vitsol 1-2, Warmsol 1-3
.
- . Endotoxin testing per USP
- . Mouse embryo assay (MEA)
- One-cell mouse embryos were exposed sequentially to subject devices in the Vitrification and Warming Sets followed by culture at 37°C in an atmosphere containing 5% CO₂. The percent of embryos developed to the expanded blastocyst stage at 96 hours were assessed in comparison with the control group.
6
Image /page/6/Picture/0 description: The image shows the logo for Genea Biomedx. The logo consists of a green square with a white curved line inside, followed by the text "Genea" in gray and "BIOMEDX" in green. The logo is simple and modern, with a focus on the company's name.
- Shelf-life studies (real-time and accelerated) were conducted to ensure that the following product ● specifications are met at time zero and the end of shelf-life.
- pH 7.3-7.5 *
-
- Osmolality - See technological comparison table above for specifications
-
- 1-cell MEA – ≥80% developed to the blastocyst stage at 96 hours
-
- Endotoxin -