(232 days)
Not Found
No
The device description and performance testing focus on the chemical composition of media and the physical properties of the storage device, with no mention of AI or ML.
No.
Explanation: A therapeutic device is used to treat or prevent a disease or condition. This device is used for the vitrification, storage, and warming of human blastocysts for assisted reproduction technologies (ART), which is a procedure rather than a direct treatment or prevention of a disease in an established patient.
No
The device is described as a vitrification kit, warming kit, and straw set intended for the vitrification, storage, and warming of human blastocysts for assisted reproduction technologies (ART). These functions are related to preservation and handling, not to diagnosing a condition or disease.
No
The device description clearly outlines physical components including media solutions and a straw set made of copolyester, indicating it is a hardware device with associated consumables.
Based on the provided information, the VitaVitro Vitrification Kit, VitaVitro Warming Kit, and VitaVitro Straw Set are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use is for the vitrification, storage, and warming of human blastocysts for assisted reproduction technologies (ART). This is a procedure performed on biological material (embryos) outside the body, but it is not for the purpose of diagnosing a disease or condition.
- Device Description: The description details media components for cryopreservation and a storage device. These are tools used in a laboratory procedure, not for analyzing a sample to provide diagnostic information.
- Lack of Diagnostic Purpose: There is no mention of analyzing a sample to detect a substance, measure a parameter, or provide information about a patient's health status or disease.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) to provide diagnostic information. The VitaVitro system facilitates a process (cryopreservation of embryos) within the ART workflow, which is a treatment procedure, not a diagnostic one.
N/A
Intended Use / Indications for Use
VitaVitro Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with VitaVitro Warming Kit.
VitaVitro Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using VitaVitro Vitrification Kit for ART procedures.
VitaVitro Straw Set is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
Product codes (comma separated list FDA assigned to the subject device)
MQL, MQK
Device Description
VitaVitro Vitrification and Warming Kits, and the VitaVitro Straw Set are used for vitrification, storage, and warming of blastocysts as part of human assisted reproduction technology (ART) procedures.
The VitaVitro Vitrification Kit includes three media components, Human Holding Medium (HHM), Human Vitrification Solution 1 (HV1) and Human Vitrification Solution 2 (HV2). All three media have the same base formulation, but HV1 and HV2 contain the cryoprotectants ethylene glycol and dimethyl sulfoxide in increasing concentrations. HV2 also includes sucrose as a non-permeating cryoprotectant. During the vitrification process, blastocysts are first equilibrated in HHM, and then exposed sequentially to HV1 and HV2. Using this methodology, the permeating cryoprotectants replace water in the blastocyst prior to vitrification and storage in liquid nitrogen. The VitaVitro Vitrification Kit includes single 1.0 ml vials of HHM, HV1, and HV2.
The VitaVitro Warming Kit includes three media used stepwise for warming and removing cryoprotectants from vitrified blastocysts. The VitaVitro Warming Kit includes Human Warming Solution 1 (HW1), Human Warming Solution 2 (HW2) and HHM. These media products are the same with the exception that HW1 and HW2 also include sucrose in decreasing concentrations to aid in the rehydration of the blastocysts. The VitaVitro Warming Kit includes two 1.5 ml vials of HW1, one 1.0 ml vial of HW2, and one 1.8 ml vial of HHM.
The VitaVitro Straw Set consists of two components, a straw that holds the blastocysts, and a container that is used to protect the straw. Both components are made from copolyester. The closed end of the container also includes a weight to aid in maintaining the orientation of the device in liquid nitrogen and prevent floating. During use, the container is pre-cooled by placing the closed end in liquid nitrogen with the open end extending above the level of the liquid nitrogen. Straw loading is done by placing the narrow tip of the straw in a 1 µl drop of vitrification media, which draws the media and blastocysts into the storage device. The straw component is then inserted into the pre-cooled container component to effect vitrification. The container component is then sealed to prevent contact between the samples and liquid nitrogen.
All of the products are provided sterile with a six-month shelf-life. The media in the vitrification and warming kits undergo aseptic filtration, while the storage devices are ethylene oxide sterilized.
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 (Part 21 CFR 801 Subpart D)
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)
- pH: 7.2-7.6 for all solutions .
- Osmolality: see Table 1 for acceptance specifications .
- Endotoxin (USP): )
- Shelf-life testing to ensure that product specifications for pH, osmolality, MEA, endotoxin, . and sterility, were met over the six-month shelf-life period.
- Cooling Rate Testing: Cooling rate of 5,127℃/min
- Warming Rate Testing: Warming rate of 17,899°C/min .
- . Endotoxin (USP): 80% blastocysts 72h
MEA (Storage Devices): 2-Cell MEA: ≥ 80% blastocysts 72 h
Endotoxin (Media Components):
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
August 29, 2018
Shenzhen Vitavitro Bio-tech Co., Ltd % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou middle road, Nanshan District Shenzhen. Guangdong 518000 CHINA
Re: K180073
Trade/Device Name: VitaVitro Vitrification Kit, VitaVitro Warming Kit, and VitaVitro Straw Set Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL, MQK Dated: July 26, 2018 Received: August 2, 2018
Dear Field Fu:
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 mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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.
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews -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
2
Indications for Use
510(k) Number (if known) K180073
Device Name
VitaVitro Vitrification Kit,VitaVitro Warming Kit, and VitaVitro Straw Set
Indications for Use (Describe)
VitaVitro Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with VitaVitro Warming Kit.
VitaVitto Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using VitaVitro Vitrification Kit for ART procedures.
Vita Vitro Straw Set is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 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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3
510(k) Summary K180073
1. Contact Details
| 1.1 Applicant information | |
|---|---|
| --------------------------- | -- |
| Applicant Name | Shenzhen VitaVitro Bio-tech Co., Ltd |
|---|---|
| Address | R601, Building B, Hai Ke Xing Tech Park, Baoshan Road |
| No.16, Shenzhen, Guangdong, China | |
| Phone No. | +86 755 85235226 |
| Fax No. | +86 755 85235226 |
| Contact person | Jenny Lin |
| Contact person's | |
| jenny@vitavitro.com | |
| Date Prepared | August 25, 2018 |
1.2 Submission Correspondent
| Correspondent Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | Room 1122, International Mayors Communication Centre, No. 55 Shizhou middle road, Nanshan District, Shenzhen |
| Phone No. | +86-755-86069197 |
| Contact person | Field Fu; Christy Young; Jessie You; |
| Contact e-mail | christy@cefda.com; jessie@cefda.com;field@cefda.com |
2. Device information
| Trade name | VitaVitro Vitrification Kit, VitaVitro Warming Kit, and VitaVitro
Straw Set |
|-------------------|--------------------------------------------------------------------------------|
| Common name | Vitrification Cryopreservation Media and storage devices |
| Regulation Name | Reproductive media and supplements |
| Regulation Number | 884.6180 |
| Product Codes | MQL (Media, Reproductive) and MQK (Labware, Assisted
Reproduction) |
| Device Class | II |
3. Legally Marketed Predicate Device
| Trade Name | Cryotop® Vitrification Kit and Cryotop® Thawing Kit |
|---|---|
| 510(k) Number | K160864 |
| Manufacturer | KITAZATO BioPharma Co., Ltd. |
The predicate device has not been subject to a design-related recall.
4. Device Description
VitaVitro Vitrification and Warming Kits, and the VitaVitro Straw Set are used for vitrification, storage, and warming of blastocysts as part of human assisted reproduction technology (ART) procedures.
4
The VitaVitro Vitrification Kit includes three media components, Human Holding Medium (HHM), Human Vitrification Solution 1 (HV1) and Human Vitrification Solution 2 (HV2). All three media have the same base formulation, but HV1 and HV2 contain the cryoprotectants ethylene glycol and dimethyl sulfoxide in increasing concentrations. HV2 also includes sucrose as a non-permeating cryoprotectant. During the vitrification process, blastocysts are first equilibrated in HHM, and then exposed sequentially to HV1 and HV2. Using this methodology, the permeating cryoprotectants replace water in the blastocyst prior to vitrification and storage in liquid nitrogen. The VitaVitro Vitrification Kit includes single 1.0 ml vials of HHM, HV1, and HV2.
The VitaVitro Warming Kit includes three media used stepwise for warming and removing cryoprotectants from vitrified blastocysts. The VitaVitro Warming Kit includes Human Warming Solution 1 (HW1), Human Warming Solution 2 (HW2) and HHM. These media products are the same with the exception that HW1 and HW2 also include sucrose in decreasing concentrations to aid in the rehydration of the blastocysts. The VitaVitro Warming Kit includes two 1.5 ml vials of HW1, one 1.0 ml vial of HW2, and one 1.8 ml vial of HHM.
The VitaVitro Straw Set consists of two components, a straw that holds the blastocysts, and a container that is used to protect the straw. Both components are made from copolyester. The closed end of the container also includes a weight to aid in maintaining the orientation of the device in liquid nitrogen and prevent floating. During use, the container is pre-cooled by placing the closed end in liquid nitrogen with the open end extending above the level of the liquid nitrogen. Straw loading is done by placing the narrow tip of the straw in a 1 µl drop of vitrification media, which draws the media and blastocysts into the storage device. The straw component is then inserted into the pre-cooled container component to effect vitrification. The container component is then sealed to prevent contact between the samples and liquid nitrogen.
All of the products are provided sterile with a six-month shelf-life. The media in the vitrification and warming kits undergo aseptic filtration, while the storage devices are ethylene oxide sterilized.
5. Indications for Use
VitaVitro Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with VitaVitro Warming Kit.
VitaVitro Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using VitaVitro Vitrification Kit for ART procedures.
VitaVitro Straw Set is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
5
6. Substantial Equivalence Comparison
The following table compares the Vitrification Kit, VitaVitro Warming Kit, and VitaVitro Straw Set to the predicate device:
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| K180073 – VitaVitro | K160864 – Kitazato | ||
| Vitrification Kit, | Cryotop | ||
| VitaVitro Warming Kit, | Vitrification Kit and | ||
| and VitaVitro Straw Set | Cryotop Thawing | ||
| Kit | |||
| Indications | |||
| for Use | VitaVitro Vitrification Kit | ||
| is intended for the | |||
| vitrification of human | |||
| blastocysts for assisted | |||
| reproduction | |||
| technologies (ART). This | |||
| kit is designed for use | |||
| with VitaVitro Warming | |||
| Kit. |
VitaVitro Warming Kit is
intended for the warming
of human blastocysts
that have undergone
vitrification using
VitaVitro Vitrification Kit
for ART procedures.
VitaVitro Straw Set is a
cryopreservation storage
device that is intended
for use in vitrification
procedures to contain
and maintain human
blastocyst stage
embryos. | The Cryotop®
Vitrification Kit –
Vitrification is
indicated
for use in the
preparation,
vitrification
and storage of
pronuclear (PN)
zygotes
through day 3
cleavage
stage embryos and
blastocyst stage
embryos.
The Cryotop®
Thawing
Kit – Thawing is
indicated for use in
the
preparation and
thawing of vitrified
pronuclear (PN)
zygotes
through day 3
cleavage
stage embryos and
blastocyst stage
embryos. | Different: The subject and
predicate devices indications
are not identical. All
components of the subject
device are only for vitrification,
storage and warming of
blastocyst stage embryos,
while the predicate can be
used with pronuclear to
blastocyst stage embryos. The
subject device also includes a
standalone indication for the
VitaVitro Straw Set, which is
sold separately from the media
kits, which is different than the
predicate where storage
devices are included within the
vitrification kit. These
differences do not impact the
overall intended uses of these
devices, which are the same
(vitrification, storage, and
thawing of embryos). |
| Components | Vitrification Media
Thawing Media | Vitrification Media
Thawing Media | Different: Predicate device
includes plates as a |
| | Cryopreservation
storage device | Cryotop
Repro Plate
35 mm dish | convenience to users that
would typically be obtained
separately. The storage device
for the subject device is
provided separately as
compared to the predicate.
These differences do not raise
different questions of safety
and effectiveness (S&E). |
| | Media Components | | |
| Vitrification
Formulation | Medium 199, Ethylene
Glycol (7.5 – 16%),
DMSO (7.5 – 16%),
Sucrose (0.68 M), HSA | Medium 199,
Ethylene Glycol,
DMSO, Trehalose,
Hydroxypropyl
Cellulose (specific
concentrations in
predicate media not
known) | Different: The predicate and
subject device formulas
include many similar
components. However, the
predicate uses trehalose
instead of sucrose and
hydroxypropyl cellulose
instead of serum. However, the
use of a different sugar/serum
replacer do not raise different
questions of S&E. In
addition, the concentrations of
specific components in the
predicate media are not
known; however, differences
would not raise different
questions of S&E. |
| Thawing
Formulation | Medium 199, Sucrose
(0.5 – 1 M), HSA | Medium 199,
Trehalose,
Hydroxypropyl
Cellulose | Different: The predicate and
subject device formulas
include many similar
components. However, the
predicate utilizes trehalose
instead of sucrose and
hydroxypropyl cellulose
instead of serum (see rationale
above). In addition, the
concentrations of specific
components in the predicate
media are not known;
however, differences would not
raise different questions of
S&E. |
| Endotoxin | 80% | 1-Cell MEA: > 80% | Different: Testing using a 1-cell |
| | blastocysts 72h | blastocysts 96 h | or 2-cell method does not raise
different S&E questions. |
| pH | 7.2 - 7.6 | Same | Same |
| Osmolarity | HHM: 295-315
HV1: N/A
HV2: N/A
HW1: 600-850 (diluted
1:1)
HW2: 850-1000 | ES: 2,300 - 2,800
VS: 4,900 - 6,000
TS: 1,600 - 2,000
DS: 830 - 1020
WS: 240 - 300 | Different: The osmolality
specifications are different
between the subject and
predicate devices.
Differences in osmolality do
not raise different questions of
S&E. |
| Sterilization
method | Aseptic filtration | Same | Same |
| | Storage Devices | | |
| Material
composition | Copolyester | Cryotop US,
Cryotop SC, or
Cryotop CL provided
in kits
Cryotop devices
composed of PET,
ABS, and
Polypropylene | Different: The materials in the
subject and predicate device
are different. These
differences do not raise
different questions of S&E. |
| Sealing
mechanism | Heat sealed | Cryotop US - The
shaft handle
contains a taper and
stop. When inserted
into the straw, a
hermetically sealed
closed system is
formed.
Cryotop SC and CL-
the sample holding
stick is heat sealed
within an outer
straw. | Different: The subject device
has a comparable
design/closure system to that
used in the Cryotop SC and CL
devices, but is different than
the Cryotop US. This
difference does not raise
different S&E questions. |
| Cooling Rate | 5,127 °C/min | 3000°C/min for all
versions | Different: The subject device
has a higher cooling rate than
the predicate. A higher
cooling rate does not raise
different questions of S&E. |
| Warming | 17,899 °C/min | 44000°C/min for all | Different: The subject device |
| rate | | versions | has a lower warming rate than
the predicate. A lower
warming rate does not raise
different questions of S&E.
Note: the warming rate for the
subject device is in line with
other cleared devices of this
type. |
| Open/closed
system | Closed | Closed | Same |
| Sterilization
method | EO | Radiation | Different: The subject and
predicate device use different
sterilization methods that are
both common for medical
devices. This difference does
not raise different questions of
S&E. |
| MEA | 2-Cell MEA: ≥ 80%
blastocysts 72 h | 1-Cell MEA: ≥ 80%
blastocysts 96 h | Different: Testing using a 1-cell
or 2-cell method does not raise
different S&E questions. |
| Endotoxin | ): )
- Shelf-life testing to ensure that product specifications for pH, osmolality, MEA, endotoxin, .
9
and sterility, were met over the six-month shelf-life period.
VitaVitro Straw Set
- . Cooling Rate Testing: Cooling rate of 5,127℃/min
- Warming Rate Testing: Warming rate of 17,899°C/min .
- . Endotoxin (USP):