(281 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological compatibility of a cryopreservation storage device, with no mention of AI or ML technologies.
No.
This device is a cryopreservation storage device for maintaining embryos, not for treating a disease or condition.
No
The device is a cryopreservation storage device intended to contain and maintain embryos, not to diagnose medical conditions or analyze data to inform a diagnosis.
No
The device description clearly states it is a physical cryopreservation storage device made of polystyrene, not software.
Based on the provided information, the iVitri® EZ is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "contain and maintain human 4-8 cell and blastocyst stage embryos" during vitrification procedures. This is a storage and handling function, not a diagnostic test performed in vitro on a specimen to provide information about a patient's health or condition.
- Device Description: The description details a physical device for holding and sealing embryos. It doesn't describe any components or processes related to analyzing biological samples for diagnostic purposes.
- Performance Studies: The performance studies focus on the physical characteristics of the device (cooling/warming rates, durability, sterility, endotoxin levels, embryo viability after storage), which are relevant to its function as a storage container, not a diagnostic test.
- Lack of Diagnostic Metrics: The key metrics provided (cooling/warming rates, sterilization, endotoxin, MEA results) are related to the device's performance in preserving embryos, not diagnostic accuracy (like sensitivity, specificity, etc.).
In summary, the iVitri® EZ is a medical device used in assisted reproductive technology procedures for the cryopreservation of embryos. It facilitates the process but does not perform a diagnostic function.
N/A
Intended Use / Indications for Use
The iVitri® EZ is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
Product codes (comma separated list FDA assigned to the subject device)
MOK, MQK
Device Description
The iVitri®EZ device is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. The iVitri® EZ device is composed of a twopiece polystyrene assembly with a square-shaped stick (body) and cap. As part of the vitrification procedure, the embryos are loaded on the tip, and capped for subsequent storage following vitrification. The tip of the storage device is curved to aid in maintaining and securing the embryos during procedures. The stick and cap include a tapered design that creates a hermetic seal, forming a closed storage system. Markings on the stick and tip of the device are used to aid in the proper orientation during embryo loading procedures. The device is provided sterile and is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Characteristics Performance Data:
- Cooling/warming rate testing: Results showed a cooling rate of -3,020°C/min, and a warming rate of 40,694 °C/min.
- Durability and closure integrity testing: Test samples met the acceptance criteria, showing no leakage, damage, deformation or discoloration after exposure to liquid nitrogen and 37°C temperatures.
- Endotoxin testing per USP: ≤0.5 EU/device
- Mouse Embryo Assay (MEA): 1-Cell mouse embryos were incubated in extracts of the subject device. The acceptance criterion was 1-Cell MEA: ≥80% expanded blastocyst formation at 96 hours.
- Sterilization validation per ISO 11137-1:2006(R)2011 and ISO 11137-2:2013.
- Package integrity testing following accelerated aging per ASTM F1980-16:
- Dye penetration testing per ASTM F929-15
- Seal strength testing per ASTM F88/F88M-15
- Shelf-life studies (real-time and accelerated) were conducted to ensure that the following product specifications were met:
- MEA
- Durability and closure integrity testing
- Device appearance (discoloration, deformation, damage)
- Dimensional assessments
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cooling Rate: -3,020°C/min
Warming Rate: 40,694 °C/min
Sterilization: Radiation, SAL 10-6
Endotoxin: ≤0.5 EU/device
MEA: 1-Cell MEA ≥80% expanded blastocyst formation 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).
Not Found
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, 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 features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2017
Reprobitech Corp. Huai L. Feng, Ph.D. Director 42-31 Colden Street, Suite 202 Flushing, NY 11355
Re: K162640
Trade/Device Name: iVitri® EZ Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MOK Dated: June 2, 2017 Received: June 6, 2017
Dear Huai L. Feng:
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.
1
Page 2 - Huai L. Feng, Ph.D.
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 (reporting of medical device-related 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,
Image /page/1/Picture/8 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the overall impression is clean and professional.
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) K162640
Device Name iVitri® EZ
Indications for Use (Describe)
The iVitri® EZ is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K162640 Page 1 of 4
510(k) Summary K162640 - iVitri® EZ
1. Submission Sponsor:
Reprobitech Corp.
42-31 Colden St., Suite 202 Flushing, New York 11355 Tel: (516) 301-6171 Email: Reprobiotech@gmail.com
2. Contact Person:
Dr. Huai L. Feng Reprobiotech Corp. Director 42-31 Colden Street, Suite 202 Flushing, NY 11355 Doctorf99@gmail.com Tel: (516) 301-6171
Date Prepared: June 30, 2017 3.
4. Device Information:
| Name of Device | iVitri® EZ |
|---|---|
| Common Name | Cryopreservation Storage Device |
| Classification Name | Assisted Reproduction Labware |
| Regulation | 21 CFR 884.6160 |
| Product Code | MQK (Labware, Assisted Reproduction) |
| Device Class | II |
5. Predicate Device Information:
BioTech, Inc. - CRYOLOCK™ (K122982)
The predicate device has not been subject to a design-related recall.
6. Device Description:
The iVitri®EZ device is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. The iVitri® EZ device is composed of a twopiece polystyrene assembly with a square-shaped stick (body) and cap. As part of the vitrification procedure, the embryos are loaded on the tip, and capped for subsequent storage following vitrification. The tip of the storage device is curved to aid in maintaining and securing the embryos during procedures. The stick and cap include a tapered design that creates a hermetic seal, forming a closed storage system. Markings on the stick and tip of the device are used to aid in the proper orientation during embryo loading procedures. The device is provided sterile and is for single use only.
4
Product specifications are listed in the table below:
| Parameter | Specification |
|---|---|
| Cooling Rate | -3,020°C/min |
| Warming Rate | 40,694 °C/min |
| Sterilization | Radiation, SAL 10-6 |
| Endotoxin | ≤0.5 EU/device |
| MEA | 1-Cell MEA ≥80% expanded blastocyst formation at 96 hours |
7. Indication for Use:
The iVitri® EZ is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
| Parameter | iVitri EZ
(K162640 – Subject Device) | CRYOLOCK
(K122982 – Predicate
Device) | Comments |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The iVitri® EZ is a
cryopreservation storage
device that is intended for use
in vitrification procedures to
contain and maintain human
4-8 cell and blastocyst stage
embryos. | The CRYOLOCKTM is
a cryopreservation storage
device that is intended for
use in vitrification
procedures to contain and
maintain human 1-cell
stage embryos | Similar: The predicate
device is only indicated
for use for 1-cell stage
embryos, the predicate
and subject device have
the same intended use
– vitrification and
storage of human
embryos. |
| Design | Consists of a stick (body)
component including an
embryo loading area and a
cap. The stick and cap are
designed to be hermetically
sealed (e.g., twisting cap and
body together) to form a
closed storage device. | Consists of a stick (body)
component including an
embryo loading area and a
cap. The stick and cap are
designed to be hermetically
sealed (e.g., twisting cap
and body together) to form
a closed storage device. | Same |
| Materials | Polystyrene | Polystyrene | Same |
| Cooling/Warming
Rate | Cooling: -3,020°C/min
Warming: +40,694°C/min | Cooling: -1,494°C
Warming: +21,000 | Different: The cooling
and warming rates are
higher in the subject
device than in the
predicate device.
These differences do
not raise different
questions of S&E as
they are within the
range of cooling and |
Comparison of Intended Use and Technological Characteristics of Subject and Predicate Devices: 8.
5
K162640 Page 3 of 4
| | | | warming rates cleared
for other devices with
similar uses. |
|-----------------------------|----------------------------------------------------------|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization
Method/SAL | Radiation, SAL 10-6 | Radiation, SAL 10-6 | Same |
| MEA | 1-Cell MEA: ≥80% expanded
blastocyst formation at 96h | 1-Cell MEA: ≥80%
blastocyst formation at 96h | Same |
| Endotoxin | ≤ 0.5 EU/device | ≤ 2.0 EU/Device | Different - the
endotoxin specification
is higher for the
predicate device.
However, this does not
raise a different S&E
question |
As noted in the table above, the devices have the same intended use and are technologically comparable. Differences in technological characteristics noted above do not raise different questions of safety or effectiveness.
9. Non-Clinical Characteristics Performance Data:
As part of demonstrating substantial equivalence to the following non-clinical performance tests were conducted. The iVitr® EZ passed all of the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device:
- Cooling/warming rate testing: The purpose of this testing was to evaluate the cooling and warming rates of the subject device. Temperature recording equipment was used to document the temperature profile of devices when used as prescribed in the Instructions for Use throughout the cooling and warming portions of the vitrification process. Results showed a cooling rate of -3,020°C/min, and a warming rate of 40,694 °C/min.
- Durability and closure integrity testing: The purpose of this testing was to assess the integrity of the device following exposure to liquid nitrogen. The samples were assembled as described in the Instructions for Use and submerged in liquid nitrogen. The samples were then exposed to 37°C temperatures. Samples were then assessed for signs of leakage, damage (breaks, etc.), deformation or discoloration. The acceptance criteria were that devices must not exhibit any of the failure modes described above. Test samples met the acceptance criteria.
- Endotoxin testing per USP: ≤0.5 EU/device ●
- Mouse Embryo Assay (MEA): 1-Cell mouse embryos were incubated in extracts of the subject device at ● 37°C in an atmosphere containing 5% CO>. The percent of embryos developed to the expanded blastocyst stage at 96 hours were assessed in comparison with the control group. The acceptance criterion was 1-Cell MEA: ≥80% expanded blastocyst formation at 96 hours.
- Sterilization validation per ISO 11137-1:2006(R)2011 and ISO 11137-2:2013. ●
- Package integrity testing following accelerated aging per ASTM F1980-16:
- o Dye penetration testing per ASTM F929-15
- O Seal strength testing per ASTM F88/F88M-15
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K162640 Page 4 of 4
- Shelf-life studies (real-time and accelerated) were conducted to ensure that the following product ● specifications were met:
- O MEA
- Durability and closure integrity testing o
- Device appearance (discoloration, deformation, damage) O
- Dimensional assessments O
10. Conclusion:
The results of the testing described above demonstrate that the iVitri® EZ device is as safe and effective as the predicate device and supports a determination of substantial equivalence.