(234 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of media solutions for vitrification and thawing, with no mention of AI or ML technologies.
No.
The device is used for the vitrification and thawing of oocytes and embryos as part of In Vitro Fertilization (IVF) procedures, which are assistive reproductive technologies. It does not directly treat a disease or condition in a living organism.
No
This device is intended for the vitrification and thawing of oocytes and embryos for IVF procedures, which is a process of preservation and revival, not diagnosis. It measures physical and chemical properties of the media, and the success of embryo development after thawing, but these are measures of the product's performance, not diagnostic outputs about a patient's health.
No
The device description clearly states that the device includes a set of five media components provided in polypropylene vials, which are physical substances and containers, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the vitrification and thawing of oocytes and embryos as part of IVF procedures. This is a process performed on biological material outside the body, but it's for the purpose of preserving and preparing those materials for future implantation, not for diagnosing a condition or disease.
- Device Description: The device consists of media solutions containing cryoprotectants. These are used to facilitate the freezing and thawing process, not to analyze a sample for diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic in a sample to provide diagnostic information about a patient's health status.
- Focus on Preservation and Preparation: The entire description revolves around the technical process of preserving and preparing reproductive cells and embryos.
While the process is performed in vitro (in glass/outside the body), the purpose is not diagnostic. It's a tool used in the process of assisted reproduction.
N/A
Intended Use / Indications for Use
V-VITFREEZE is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
V- VITWARM is intended for use in the thawing of vitrified of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Product codes (comma separated list FDA assigned to the subject device)
MQL
Device Description
V-VITFREEZE AND V-VITWARM include a set of five media intended for use in the vitrification and thawing of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos as part of InVitro Fertilization (IVF) procedures.
V-VITFREEZE (2mL vials) includes two media components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol, trehalose (only in VS), and dimethyl sulfoxide. During the vitrification process, embryos are first exposed to ES and then to VS. Using this methodology, the permeating cryoprotectants can replace water in the oocyte or PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen.
V-VITWARM (4mL vials) is composed of three media used stepwise for thawing and removing cryoprotectants from vitrified oocytes and PN through blastocyst stage embryos. It is composed of Thawing Solution (TS), Diluent Solution (DS) and Washing Solution (WS).
The base medium for the vitrification and thawing media includes water, salts, buffering agents, minerals, chelating agents, energy substrates, amino acids, hydroxypropyl cellulose, polymeric substance, gentamicin, and phenol red. Cryoprotectants in the media include ethylene glycol, (7.5% in ES and 15% in VS), DMSO (7.5% in ES and 15% in VS), and trehalose in VS, TS, and DS.
The five solutions in the V-VITFREZE and V-VITWARM kit are aseptically filtered (storage vials sterilized by radiation) and provided in polypropylene vials with high density polyethylene screw caps. They have a shelf-life of 12 months when stored at 2-8℃. 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
Prescription Use Only
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 to the predicate device:
- Aseptic filtration and aseptic filling validation, per ISO 13408-1:2008 & A1:2013 and ISO 13408- 2:2018.
- 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 12-month shelf-life for the subject device through demonstration that the product specifications (shown below) were met at time 0 and after accelerated aging in accordance with ASTM F1980-21:
- Appearance: All of the solutions should be pink to rose color without precipitates A
- pH per USP : WS, DS, TS: 7.20 7.45; VS: 7.50 7.70; ES: 7.30 7.60
- Osmolality per USP : ES 2300-3100 mOsm/kg (1:10 dilution), VS: 4600-6150 mOsm/kg (1:20 dilution), TS: 1250-1600 mOsm/kg (1:4 dilution), DS - 730-930 mOsm/kg (1:2 dilution), WS - 240-300 mOsm/kg (No dilution)
- Sterility per USP : No microbial growth A
- Bacterial endotoxin per USP : on transportation-conditioned 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 13, 2024
VITROMED GmbH c/o Greg Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, California 92606
Re: K240176 Trade/Device Name: V-VITFREEZE and V-VITWARM Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Received: August 8, 2024
Dear Greg Holland:
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" (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).
1
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 Rue"). 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 medical devices and radiation-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) K240176
Device Name V-VITFREEZE and V-VITWARM
Indications for Use (Describe)
V-VITFREEZE is intended for use in the vitrification of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
V- VITWARM is intended for use in the thawing of vitrified of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CER 801 Subpart D) | □ Over-The-Counter Use (21 CER 801 Subpart C) |
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4
510(k) Summary K240176
SUBMITTER I.
| Applicant: | VITROMED GmbH |
|---|---|
| Address: | Raiffeisenstr. 15a, 40764 Langenfeld, Germany |
| Phone: | +49 2173-20041-30 |
| Fax: | +49 2173-20041-58 |
| Contact Person: | Deepesh Changat |
| Email: | qm@vitromed.com |
| Consultant Contact: | Greg Holland, Regulatory Specialists, Inc. |
| Email: | greg@regulatoryspecialists.com |
Date Prepared: September 10, 2024
II. DEVICE
| Trade Name: | V-VITFREEZE; V-VITWARM |
|---|---|
| Common Name: | Assisted Reproduction Media |
| Regulation Name: | Reproductive Media and Supplement |
| Regulation Number: | 884.6180 |
| Product Code: | MQL (Media, Reproductive) |
| Regulatory Class: | II |
III. PREDICATE DEVICE
Vitrification Kit and Thawing Kit (K171748) from Kitazato Corporation. The predicate device has not been subject to a design-related recall.
DEVICE DESCRIPTION IV.
V-VITFREEZE AND V-VITWARM include a set of five media intended for use in the vitrification and thawing of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos as part of InVitro Fertilization (IVF) procedures.
V-VITFREEZE (2mL vials) includes two media components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol, trehalose (only in VS), and dimethyl sulfoxide. During the vitrification process, embryos are first exposed to ES and then to VS.
5
Using this methodology, the permeating cryoprotectants can replace water in the oocyte or PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen.
V-VITWARM (4mL vials) is composed of three media used stepwise for thawing and removing cryoprotectants from vitrified oocytes and PN through blastocyst stage embryos. It is composed of Thawing Solution (TS), Diluent Solution (DS) and Washing Solution (WS).
The base medium for the vitrification and thawing media includes water, salts, buffering agents, minerals, chelating agents, energy substrates, amino acids, hydroxypropyl cellulose, polymeric substance, gentamicin, and phenol red. Cryoprotectants in the media include ethylene glycol, (7.5% in ES and 15% in VS), DMSO (7.5% in ES and 15% in VS), and trehalose in VS, TS, and DS.
The five solutions in the V-VITFREZE and V-VITWARM kit are aseptically filtered (storage vials sterilized by radiation) and provided in polypropylene vials with high density polyethylene screw caps. They have a shelf-life of 12 months when stored at 2-8℃. Media in the vials can be used for up to seven days after vial opening.
V. INDICATIONS for USE
V-VITFREEZE is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
V-VITWARM is intended for use in the thawing of vitrified of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
VI. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS 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 | K240176
Subject Device | K171748
Predicate Device | Comparison |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | V-VITFREEZE is intended
for use in the vitrification of
oocytes (MII), pronuclear
(PN) zygotes through day 3 | The Vitrification Kit is
indicated for use in the
preparation, vitrification,
and storage of oocytes
(MII), pronuclear (PN) | There are differences in
the wording of the
indications for use
statements for the subject
and predicate device; |
| Comparison Item | K240176
Subject Device | K171748
Predicate Device | Comparison |
| | cleavage stage embryos and
blastocyst stage embryos.
V-VITWARM is intended for
use in the thawing of vitrified
of oocytes (MII), pronuclear
(PN) zygotes through day 3
cleavage stage embryos and
blastocyst stage embryos. | 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. | however, the intended
uses of the subject and
predicate device media
are the same (i.e.,
vitrification and warming
of oocytes and embryos). |
| Conditions for Use | Prescription Use Only | Prescription Use Only | Same |
| Kit components | V-VITFREEZE consists of
Equilibration Solution (ES)
and Vitrification Solution
(VS). V-VITWARM includes
TS (Thawing Solution), DS
(Dilution Solution) and WS
(Washing Solution). | The Vitrification Kit
includes three media
components, Basic
Solution (BS),
Equilibration Solution (ES)
and Vitrification Solution
(VS). The Vitrification Kit
comes prepackaged with 4
Cryotop devices (Cryotop
CL, Cryotop SC, or
Cryotop US), and 2 Repro
Plates.
The Thawing Kit is
composed of TS
(Thawing Solution), DS
(Dilution Solution) and
WS (Wash Solution). The
Thawing Kit comes pre-
packaged with one Repro | The predicate device
includes an additional
basic solution component,
equipment to conduct the
procedure (plates), and a
closed cryopreservation
storage device that are
different than the subject
device. These differences
do not raise different
questions of S&E. |
| Comparison Item | K240176
Subject Device | K171748
Predicate Device | Comparison |
| | | Plate, and two 35 mm
dishes. | |
| Freeze Kit Formulation | Base medium (see Device
Description section of
summary) with
cryoprotectants Ethylene
Glycol, DMSO, and
Trehalose | Medium 199, Ethylene
Glycol, DMSO, Sucrose,
Dextran Serum
Supplement, Gentamicin | Different: The
formulations of the
subject and predicate
devices are not the same.
Differences in device
formulations do not raise
different questions of
safety and effectiveness
(S&E). |
| Thaw Kit Formulation | Base medium (see Device
Description section of
summary) with
cryoprotectant Trehalose | Medium 199; Sucrose,
Dextran Serum
Supplement, 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. |
| pH | WS; DS; TS: 7.20 - 7.45
VS: 7.50 - 7.70
ES: 7.30 - 7.60 | 7.2-7.6 | Different: The subject
device has a higher pH
range than the predicate
device. These differences
in pH specifications do
not raise different
questions of S&E. |
| Osmolality (mOsm/kg) | ES - 2300-3100 (1:10
dilution)
VS: 4600-6150 (1:20
dilution)
TS: 1250-1600 (1:4 dilution)
DS - 730-930 (1:2 dilution)
WS - 240-300 (No dilution) | Not available publicly | Different: The subject
device and predicate
devices have differences
in osmolality
specifications. These
differences in osmolality
specifications do not raise |
| Comparison Item | K240176
Subject Device | K171748
Predicate Device | Comparison |
| Bacterial Endotoxin | pH per USP : WS, DS, TS: 7.20 7.45; VS: 7.50 7.70; ES: 7.30 7.60
9
- ≫ Osmolality per USP : ES 2300-3100 mOsm/kg (1:10 dilution), VS: 4600-6150 mOsm/kg (1:20 dilution), TS: 1250-1600 mOsm/kg (1:4 dilution), DS - 730-930 mOsm/kg (1:2 dilution), WS - 240-300 mOsm/kg (No dilution)
- Sterility per USP : No microbial growth A
-
Bacterial endotoxin per USP : on transportation-conditioned devices.
VIII. CONCLUSION
The results of the performance testing described above demonstrate that V-VITFREEZE and V-VITWARM kit is as safe and effective as the predicate device and supports a determination of substantial equivalence.