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.

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.

AI/ML Overview

The provided document describes the iVitri® EZ, a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. The document is a 510(k) summary filed with the FDA, demonstrating substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

Based on the information provided, the "study" is a collection of non-clinical performance tests conducted to demonstrate substantial equivalence to a predicate device. This is not a comparative effectiveness study in the typical sense of comparing human readers with and without AI assistance or a standalone diagnostic performance study with a large test set.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
Cooling Rate	(Implied to be sufficient for vitrification, compared to predicate: -1,494°C/min)	-3,020°C/min
Warming Rate	(Implied to be sufficient for vitrification, compared to predicate: +21,000°C/min)	+40,694°C/min
Sterilization	SAL 10-6	Radiation, SAL 10-6
Endotoxin	≤ 0.5 EU/device	≤ 0.5 EU/device
Mouse Embryo Assay (MEA)	1-Cell MEA ≥ 80% expanded blastocyst formation at 96 hours	1-Cell MEA ≥ 80% expanded blastocyst formation at 96 hours
Durability & Closure Integrity	No leakage, damage (breaks, etc.), deformation, or discoloration after liquid nitrogen exposure and warming	Met acceptance criteria (no failure modes)
Package Integrity	Met ASTM F1980-16, F929-15, F88/F88M-15 standards	Met standards
Shelf-life	MEA, Durability & Closure Integrity, Device appearance, Dimensional assessments are met throughout shelf-life	Met specifications

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of clinical or diagnostic performance. The tests performed are non-clinical, related to the device's physical properties and biological compatibility.

Cooling/Warming Rate Testing: The sample size for devices tested is not explicitly stated.
Durability and Closure Integrity Testing: The sample size for devices tested is not explicitly stated, but it mentions "The samples were assembled..."
Endotoxin Testing: Not explicitly stated, but typically involves a batch or a representative number of devices.
Mouse Embryo Assay (MEA): "1-Cell mouse embryos were incubated in extracts of the subject device." The number of embryos or devices tested is not specified.
Sterilization Validation: Not explicitly stated, typically involves a statistically relevant sample size of devices/batches to confirm SAL.
Package Integrity Testing: Not explicitly stated, involves samples of packaged devices.
Shelf-life Studies: Not explicitly stated, involves samples of the device over time.

Data Provenance: The data is generated from in vitro (MEA) and laboratory/engineering tests conducted by the manufacturer, Reprobitech Corp. The country of origin for the data is not specified, but the applicant (Reprobitech Corp.) is based in Flushing, New York, USA. The studies are prospective in the sense that they were conducted for the purpose of this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for these non-clinical performance tests is based on objective measurements (e.g., temperature, physical integrity, biological response of mouse embryos) against predefined criteria, not expert interpretation of human data.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or adjudication involved in establishing the "ground truth" for the non-clinical tests described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. There is no mention of an MRMC comparative effectiveness study. The device is a labware product, not a diagnostic imaging or AI-assisted diagnostic device, so this type of study is not relevant to its regulatory submission as described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithmic or AI device. The tests performed are for the physical and biological compatibility characteristics of a medical device intended for embryo cryopreservation.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests outlined includes:

Objective Measurements: Temperatures, physical integrity assessments (absence of leakage, damage, deformation, discoloration), and adherence to specified engineering standards (e.g., ASTM standards for package integrity).
Biological Response: Defined as the percentage of 1-cell mouse embryos developing to the expanded blastocyst stage (≥ 80% at 96 hours). This is a biological endpoint widely accepted in the field for assessing embryo toxicity/compatibility.
Chemical Analysis: Endotoxin levels measured against a specified limit (≤ 0.5 EU/device).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The performance tests are for the manufactured physical device itself.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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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.

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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,

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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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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:

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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 – PredicateDevice)	Comments
Indication for Use	The iVitri® EZ is acryopreservation storagedevice that is intended for usein vitrification procedures tocontain and maintain human4-8 cell and blastocyst stageembryos.	The CRYOLOCKTM isa cryopreservation storagedevice that is intended foruse in vitrificationprocedures to contain andmaintain human 1-cellstage embryos	Similar: The predicatedevice is only indicatedfor use for 1-cell stageembryos, the predicateand subject device havethe same intended use– vitrification andstorage of humanembryos.
Design	Consists of a stick (body)component including anembryo loading area and acap. The stick and cap aredesigned to be hermeticallysealed (e.g., twisting cap andbody together) to form aclosed storage device.	Consists of a stick (body)component including anembryo loading area and acap. The stick and cap aredesigned to be hermeticallysealed (e.g., twisting capand body together) to forma closed storage device.	Same
Materials	Polystyrene	Polystyrene	Same
Cooling/WarmingRate	Cooling: -3,020°C/minWarming: +40,694°C/min	Cooling: -1,494°CWarming: +21,000	Different: The coolingand warming rates arehigher in the subjectdevice than in thepredicate device.These differences donot raise differentquestions of S&E asthey are within therange of cooling and

Comparison of Intended Use and Technological Characteristics of Subject and Predicate Devices: 8.

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K162640 Page 3 of 4

			warming rates clearedfor other devices withsimilar uses.
SterilizationMethod/SAL	Radiation, SAL 10-6	Radiation, SAL 10-6	Same
MEA	1-Cell MEA: ≥80% expandedblastocyst formation at 96h	1-Cell MEA: ≥80%blastocyst formation at 96h	Same
Endotoxin	≤ 0.5 EU/device	≤ 2.0 EU/Device	Different - theendotoxin specificationis higher for thepredicate device.However, this does notraise a different S&Equestion

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<85>: ≤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.

Regulation Number and Section

§ 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.