The Nest VT Vitrification Device is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos.

Device Description

The subject devices, Cook Nest VT Vitrification Devices, are sterile, single-use assisted reproduction storage devices for use in vitrification procedures to contain and maintain oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos. The Cook Nest VT Vitrification Devices are composed of a stick (124.5 mm) and cap (38.5 mm) design with a combined length of 136.5 mm, a 35 mm space for notations, and a 6 mm long loading well. Visible marks are on the distal tip end, on the body of the stick and at the opening of the cap, which are created through laser etching to indicate the location of the tip, the upright orientation of the device and the opening of the cap, respectively. The stick and cap include a taper design that create a seal when assembled. All the subject devices included in this submission are identical except for their color. There are 5 different colors: blue, purple, red, yellow, and green. The subject devices are sterilized using gamma radiation to a sterilization assurance level of 10-9, are one-time use, and have a 2 year shelf-life. During the vitrification procedure, the oocytes or embryos are loaded on the tip of the stick and the stick is capped prior to plunging the device in liquid nitrogen and for subsequent storage.

AI/ML Overview

The provided document is a 510(k) summary for the "Nest VT Vitrification Device". It outlines the device's indications for use, comparison to a predicate device, and a summary of non-clinical performance testing. However, it does not contain information on a study proving the device meets acceptance criteria related to AI/algorithm performance, human reader improvement with AI assistance, or the establishment of ground truth by multiple experts.

The document describes the device as a "cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos." The performance testing discussed (sterilization, endotoxin, cooling/warming rates, MEA testing, package integrity, mechanical performance) are related to the physical and biological compatibility of the device itself, not to an AI or diagnostic algorithm's performance.

Therefore, I cannot fulfill your request as the provided text does not describe a study involving an AI or algorithm, nor does it detail acceptance criteria and performance data for such a system. The questions you posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are relevant to the evaluation of AI/ML-based medical devices, which this document does not concern.

Summary

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March 8, 2024

Cook Incorporated Christopher Sontag Regulatory Scientist 1 750 Daniels Way Bloomington, Indiana 47404

Re: K233177 Trade/Device Name: Nest VT Vitrification Device Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MQK Received: February 9, 2024

Dear Christopher Sontag:

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 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.

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 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

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Indications for Use

510(k) Number (if known) K233177

Device Name Nest VT 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 K233177

1. Submitter Information

Applicant:	Cook Inc.
Address:	750 Daniels WayP.O. Box 489Bloomington, IN 47402

2. Submission Correspondent

Contact:	Christopher Sontag
Email:	Chris.Sontag@CookMedical.com
	RegSubmissions@cookmedical.com

3. Date prepared: March 7, 2024

4. Device Information

Device Name:	Nest VT Vitrification Device
Common Name:	Cryopreservation Storage Device
Regulation Number:	21 CFR 884.6160
Regulation Name:	Assisted Reproduction Labware
Product Code:	MQK (Labware, Assisted Reproduction)
Regulatory Class:	Class II

5. Predicate Device Information

Device Name:	VitriGuard
510(k) Number:	K200815
Sponsor:	CooperSurgical Inc.

The predicate device has not been subject to a design-related recall.

6. Device Description

The Cook Nest VT Vitrification Devices are composed of a stick (124.5 mm) and cap (38.5 mm) design with a combined length of 136.5 mm, a 35 mm space for notations, and a 6 mm long loading well. Visible marks are on the distal tip end, on the body of the stick and at the opening of the cap, which are created through laser etching to indicate the location of the tip, the upright orientation of the device and the opening of the cap, respectively. The stick and cap include a taper design that create a seal when assembled. All the subject devices included in this submission are identical except

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for their color. There are 5 different colors: blue, purple, red, yellow, and green. The subject devices are sterilized using gamma radiation to a sterilization assurance level of 10-9, are one-time use, and have a 2 year shelf-life.

During the vitrification procedure, the oocytes or embryos are loaded on the tip of the stick and the stick is capped prior to plunging the device in liquid nitrogen and for subsequent storage.

7. Indications for Use Statement

8. 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.

	K233177	K200815	Comparison
Regulation Number	21 CFR 884.6160	21 CFR 884.6160	Same
Product Code	MQK	MQK	Same
Classification	Class II	Class II	Same
Indications for Use	The Nest VTVitrification Device isa cryopreservationstorage deviceintended for use invitrificationprocedures to containand maintain humanoocytes (MII), 4-8 cellembryos andblastocyst stageembryos.	VitriGuard isintended for useas acryopreservationstorage device invitrificationprocedures andindicated tocontain andmaintain humanoocytes (MII), 4-8cell embryos andblastocyst stageembryos.	Same intended use
Design	Stick with cap, designfeature to allowhandling with forceps	Stick with cap,design feature toallow handlingwith forceps	Same
Marks/etching	Marks on distal tipend, on body of thestick and at theopening of the cap	Black markings atthe end of thestick and the tip ofthe device	Different
Stick material	MBS Copolymer	Polystyrene	Different
Cap material	MBS Copolymer	Polystyrene	Different
Media Loadingvolume	1.0 microliter	<0.5 microliter	Different
Vitrification system	Closed	Closed	Same

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Cooling rate	-1744 °C/min	-2271°C/min	Different
Warming rate	48818 °C/min	36377 °C/min	Different
Single use	Yes	Yes	Same
Sterilization method	Gamma	Gamma	Same
Sterilizationassurance level	SAL 10-6	SAL 10-6	Same
Endotoxin tested	<2 EU/device	<2 EU/device	Same
MEA testing	1-Cell MEA was≥80% embryosexpanded to blastocystat 96 hours	Yes, ≥80%expand blastwithin 96 hours	Same

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 (i.e., vitrification and storage of human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos).

The subject and predicate devices also have differences in technological characteristics, including cooling/warming rate, stick composition, loading volume, and available markings. These technological differences do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Sterilization Testing:

Sterilization information was provided in accordance with the 2016 FDA guidance "Submission and Review of Sterility Information in Premarket Notification (510(k) Submissions for Devices Labeled as Sterile." The subject devices are subjected to a Gamma sterilization process to achieve a Sterility Assurance Level (SAL) of 10 %. The sterilization cycle was validated per VDmax25 (for 25 kGy dose) in accordance with ISO 11137-1:2006 and 11137-2:2013.

Simulated Transportation:

Simulated transportation was performed after accelerated aging per ASTM D4169-22.

Endotoxin

Evaluation performed on unaged devices using the Gel-Clot Limulus Amoebocyte Lysate (LAL) method per ANSI/AAMI ST72:2011. The acceptance criterion was ≤ 2 EU/device.

Cooling/warming rate

A comparative analysis was provided on unaged subject devices against the predicate, K200815, to verify cooling/warming rates for closed vitrification storage after immersion and removal from liquid nitrogen. The subject device performed within the specifications noted in the table above.

Stability and Shelf Life:

The following tests were completed to demonstrate that the subject devices maintained their performance in newly manufactured devices and after 2-years of accelerated aging per ASTM F1980-21 and simulated transportation:

Mouse embryo assay (MEA) - Testing conducted in accordance with the 2021 FDA guidance "Mouse Embryo Assay for Assisted Reproduction Technology Devices." The acceptance criterion for the 1-Cell MEA was ≥80% embryos expanded to blastocyst at 96 hours.

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Package Integrity Testing: ●
- F1886/F1886M-16 o
- o ASTM F88/F88M-15
- ASTM F1929-15 o
Mechanical Performance Testing:
- Dimensional testing O
- Examination following cryostorage O
- Seal integrity and leakage assessment following cryostorage O
- Capping force and torque testing O
- Uncapping force and torque testing O

10. Conclusion

The results of the performance testing described above demonstrate that the subject devices are as safe and effective as the predicate device and support 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.