cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrification procedures to contain and maintain human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Device Description

The cryo-GO Vitrification Device is a sterile, single-use, closed assisted reproduction storage device for use in vitrification procedures to contain and maintain oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The cryo-GO Vitrification Device is composed of an injection molded body with an extended loading tip (4.45 inches long with a 0.65 inch loading tip), an injection molded cap (1.76 inches), and a total device combined length of 5.05 inches. Visible marks are on the distal loading tip, body, and at the opening of the cap, to indicate the location of the tip, the upright orientation of the device and the opening of the cap, respectively. The body and cap include a taper design that create a seal when assembled prior to plunging the device in liquid nitrogen for vitrification and for subsequent storage. The device is provided in five different colors: red, yellow, green, blue, and purple. The subject devices are radiation sterilized to a sterilization assurance level of 10-6 and have a one-year shelflife.

AI/ML Overview

A detailed response outlining acceptance criteria and device performance based on the provided text for the cryo-GO Vitrification Device (K241341):

Acceptance Criteria and Device Performance for cryo-GO Vitrification Device (K241341)

The provided documentation, a 510(k) Summary, focuses on demonstrating substantial equivalence to a predicate device (VitriGuard, K200815) rather than explicitly stating pre-defined, quantitative acceptance criteria for all aspects of performance with a dedicated clinical study. However, some functional performance criteria are implicitly accepted through comparison with the predicate device or established standards. The non-clinical performance data section presents the studies undertaken to support the device's safety and effectiveness.

Here’s a breakdown based on the categories requested:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric/Test	Acceptance Criteria (Implicitly Accepted)	Reported Device Performance
Sterility	Sterility Assurance Level (SAL) of 10⁻⁶ (in accordance with ISO 11137-1:2018, 11137-2:2015, and 2024 FDA guidance)	Achieved SAL of 10⁻⁶
Package Integrity (Shipping)	Withstand rigors of shipping and maintain sterile barrier over one-year shelf-life (demonstrated by ASTM D4169-22, visual inspection, ASTM F1929-23, ASTM F88/F88M-21)	Devices withstood simulated transportation and maintained sterile barrier, demonstrating the ability to function within the stated shelf-life.
Shelf Life (General)	Maintained performance for newly manufactured and after one year accelerated aging per ASTM F1980-21	Devices maintained performance after one year of accelerated aging.
Cooling Rate	(Comparison to predicate: -2,271°C/min; subject device found to have a lower rate but deemed not to raise different S&E questions)	-1,650°C/min
Warming Rate	(Comparison to predicate: +36,377°C/min; subject device found to have a lower rate but deemed not to raise different S&E questions)	+16,500°C/min
Dimensional Stability	Maintained dimensions after one year of accelerated aging.	Testing confirmed dimensional stability.
Durability (LN₂ Exposure)	No cracks, deformation, discoloration, or other damage after exposure to liquid nitrogen.	Testing demonstrated device integrity after LN₂ exposure.
Seal Integrity/Leakage (LN₂ )	No leakage after exposure to liquid nitrogen.	Testing confirmed seal integrity and no leakage.
Capping and De-capping Force	Maintained appropriate force for capping and de-capping after one year of accelerated aging.	Testing confirmed acceptable capping and de-capping force.
Ink Marker Resistance	Ink markers remained resistant after one year of accelerated aging.	Testing confirmed ink marker resistance.
Endotoxin Test	≤ 2 EU/device (according to USP<85>, <161>)	≤ 2 EU/device
Mouse Embryo Assay (MEA)	≥ 80% expanded blastocyst within 96 hours (in accordance with 2021 FDA guidance)	≥ 80% expanded blastocyst within 96 hours

Summary of the Study Proving Device Meets Acceptance Criteria:

The "cryo-GO Vitrification Device" underwent non-clinical performance testing to demonstrate its safety and effectiveness, supporting its substantial equivalence to the predicate device. The studies were primarily bench testing and in-vitro biological assays.

2. Sample Size and Data Provenance for Test Set:

The provided document describes non-clinical performance testing rather than a "test set" in the context of AI/machine learning or a clinical trial with patient data. Therefore, the concept of sample size and data provenance as typically applied to such studies does not directly align.

Sample Size: Not explicitly stated as a single "test set" sample size. The testing involved multiple units of the device for various engineering and biological tests (e.g., numerous devices for sterility validation, package integrity, shelf-life testing, and a sufficient number of mouse embryos for the MEA).
Data Provenance: The data comes from laboratory testing performed by the manufacturer, FUJIFILM Irvine Scientific, Inc. The nature of the studies implies that they were prospective bench and in-vitro experiments designed to evaluate the device's physical, chemical, and biological performance. There is no indication of country of origin of "data" in the sense of patient data, as this was a non-clinical submission.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This was a submission for a physical medical device (cryopreservation device), not an AI/software device requiring expert human readers to establish ground truth for image interpretation or diagnosis. The "ground truth" for performance was established through standardized laboratory testing methods (e.g., ISO, ASTM, USP, FDA guidance documents).

4. Adjudication Method for Test Set:

Not applicable. As noted above, this was non-clinical bench and in-vitro testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations to reconcile discrepancies among human readers or expert panels.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This device is not an AI algorithm or a diagnostic imaging tool that would involve human readers interpreting cases. Therefore, an MRMC study and analysis of AI assistance improving human readers were not performed.

6. Standalone (Algorithm Only) Performance:

Not applicable. The "cryo-GO Vitrification Device" is a physical medical device for cryopreservation, not a software algorithm.

7. Type of Ground Truth Used:

The ground truth for evaluating the device's performance was based on:

Standardized Laboratory Test Results: Measurements and observations against established industry standards (e.g., ISO 11137 for sterility, ASTM standards for package integrity and accelerated aging, USP<85> for endotoxin).
Biological Activity/Functionality: The Mouse Embryo Assay (MEA) provides a biological "ground truth" for the device's non-toxicity and suitability for embryo culture, as defined by the "≥ 80% expanded blastocyst within 96 hours" criterion endorsed by the FDA guidance.

8. Sample Size for Training Set:

Not applicable. This is a physical device, not an AI/machine learning model, so there is no concept of a "training set."

9. How Ground Truth for Training Set Was Established:

Not applicable, for the same reason as point 8.

Summary

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September 26, 2024

FUJIFILM Irvine Scientific Cindy Kha Regulatory Affairs Specialist II 2511 Daimler Street Santa Ana, California 92705

Re: K241341

Trade/Device Name: cryo-GO Vitrification Device Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MQK Received: August 30, 2024

Dear Cindy Kha:

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).

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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 OS 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 Rule"). 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 mediation-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

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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

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Indications for Use

Submission Number (if known)

K241341

Device Name

cryo-GO Vitrification Device

Indications for Use (Describe)

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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510(k) SUMMARY

Submitter/Address	FUJIFILM Irvine Scientific, Inc.2511 Daimler StreetSanta Ana, CA 92705Telephone: (949) 261-7800
Contact Person:	Cindy KhaFUJIFILM Irvine Scientific, Inc.2511 Daimler StreetSanta Ana, CA 92705Telephone: (949) 261-7800Email: cindy.kha@fujifilm.com
Date Prepared:	September 20, 2024
Trade Name:	cryo-GO Vitrification Device
Common Name:	Cryopreservation Storage Device
Regulation Name:	Assisted Reproduction Labware
Regulation Number:	21 CFR 884.6160
Regulatory Class:	Class II
Product Code:	MQK (Labware, Assisted Reproduction)
Legally Marketed Predicate Device:	VitriGuard (K200815)ORIGIO A/S /CooperSurgical, Inc.95 Corporate Drive, Trumbull, CT 06611The predicate device has not been subject to adesign-related recall

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Device Description:

Indication for Use:

Comparison of Intended Use and Technological Characteristics with the Predicate Device:

The table below includes a comparison of the intended use and technological characteristics of the subject and predicate devices.

	Subject Devicecryo-GO VitrificationDeviceK241341	Predicate DeviceVitriGuardK200815	Comparison
Indications for Use	cryo-GO VitrificationDevice is acryopreservation deviceintended for use invitrification procedures tocontain and maintainhuman oocytes (MII),pronuclear (PN) zygotesthrough day 3 cleavagestage embryos and	VitriGuard is intended foruse as a cryopreservationstorage device invitrification procedures andindicated to contain andmaintain human oocytes(MII), 4-8 cell embryos andblastocyst stage embryos.	The subject and predicatedevice have differences intheir indications for usestatements, as the predicatedevice is not intended forvitrification of pronuclear (PN)zygotes. The addition ofzygotes does not represent anew intended use as bothdevices have the same
	blastocyst stageembryos.		intended use (i.e., to serve asa cryopreservation storagedevice for use in vitrificationprocedures).
Design	Stick (injection moldedbody) with cap	Stick with cap	Same
Materials	Methyl MethacrylateButandiene Styrene (MBS)with pad printed ink areas(tip marking and end capmarking)	Polystyrene with blackmarker bands	Different: The subject andpredicate devices are madeof different materials. Thisdifference in device materialsdoes not raise differentquestions of safety andeffectiveness (S&E).
VitrificationSystem	Closed	Closed	Same
Cooling Rate	-1,650°C/ min	-2,271°C/min	Different: The cooling rate ofthe subject device is lowerthan the predicate device.This difference in cooling ratedoes not raise differentquestions of S&E.
Warming Rate	+16,500°C/ min	+36,377°C/min	Different: The warming rateof the subject device is lowerthan the predicate device.This difference in cooling ratedoes not raise differentquestions of S&E.
Endotoxin (EU/mL)	≤ 2 EU/ device	≤ 2 EU/ device	Same
Mouse EmbryoAssay (MEA)	≥ 80% expanded blastocystwithin 96 hours	≥ 80% embryos developedto expanded blastocyst at96h	Same
Single-Use	Yes	Yes	Same
Shelf Life	1 year	Unknown	Different: Differences inshelf-life between the subjectand predicate device do notraise different questions ofS&E.
Sterile	Radiation, SterilityAssurance Level (SAL) 10-6	Radiation, SterilityAssurance Level (SAL)10-6	Same

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As shown in the table above, there are differences in the subject and predicate device indications for use statements; however, they have the same intended use. The subject and predicate devices also have differences in technological characteristics, including cooling/warming rate, materials, and shelf-life. These technological differences do not raise different questions of safety and effectiveness.

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Non-Clinical Performance Data

The following studies have been performed to support substantial equivalence to the predicate device:

Sterilization Testing:

Radiation sterilization and validation was conducted in accordance with ISO 11137-1:2018, 11137-2:2015, and the 2024 FDA quidance Submission and Review of Sterility Information in Premarket Notification (510(k) Submissions for Devices Labeled as Sterile. The subject devices have a Sterility Assurance Level (SAL) of 10-6.

Simulated Transportation/Package Integrity:

Simulated transportation and package integrity testing was performed after accelerated aging to the end of the stated one-year shelf-life per ASTM F1980-21. The simulated transportation and package integrity assessments conducted are shown below:

Simulated transportation conditioning per ASTM D4169-22 ●
Visual inspection of packaging ●
Dye penetration testing per ASTM F1929-23 ●
Seal strength (peel) testing per ASTM F88/F88M-21 ●

The testing above demonstrated that devices can withstand the rigors of shipping and maintain the sterile barrier over the stated shelf-life duration.

Shelf Life:

The following tests were completed and demonstrated that the subject devices maintained their performance in newly manufactured devices and after one year of accelerated aging per ASTM F1980-21:

Cooling/warming rate testing ●
Dimensional testing
Durability testing following exposure to liquid nitrogen (cracks, deformation, ● discoloration or other damage)
Seal integrity/leakage testing following exposure to liquid nitrogen ●
Capping and de-capping force testing
Ink marker resistance testing
Endotoxin Test: ≤ 2 EU/ device according to USP<85>, < 161> ●
Mouse Embryo Assay: ≥ 80% expanded blastocyst within 96 hours in accordance . with the 2021 FDA guidance, Mouse Embryo Assay for Assisted Reproduction Technology Devices.

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Summary:

The results of the performance testing described above demonstrate that the cryo-GO Vitrification Device is as safe and effective as the predicate device and supports the 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.