(162 days)
No
The device description and performance studies focus on the physical characteristics, sterilization, and biological compatibility of a cryopreservation storage device. There is no mention of any computational or analytical functions that would suggest the use of AI/ML.
No.
The device is a cryopreservation storage device for human oocytes and embryos, used in vitrification procedures to contain and maintain them, rather than to treat or diagnose a medical condition.
No
Explanation: The device is a cryopreservation storage device used to contain and maintain human oocytes and embryos. It is not described as analyzing or interpreting biological signals or data to diagnose a condition.
No
The device description clearly states it is a physical, sterile, single-use assisted reproduction storage device made of a stick and cap, intended for containing and maintaining oocytes/embryos during vitrification. It undergoes physical testing like sterilization, mechanical performance, and cooling/warming rate analysis.
Based on the provided information, the Nest VT Vitrification Device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos" during vitrification procedures. This describes a device used for the storage and handling of biological samples, not for performing a diagnostic test on those samples.
- Device Description: The description details a physical storage device (stick and cap) designed for holding and protecting the embryos/oocytes during cryopreservation. It doesn't mention any reagents, analytical components, or processes that would be used to diagnose a condition or provide information about a patient's health.
- Performance Studies: The performance studies focus on the physical integrity, sterility, and functionality of the device itself (cooling/warming rates, seal integrity, mechanical performance, endotoxin levels, and biocompatibility via mouse embryo assay). These are tests to ensure the device is safe and effective for its intended storage purpose, not to validate a diagnostic measurement.
- Lack of Diagnostic Elements: There is no mention of analyzing the embryos/oocytes, detecting specific markers, or providing any diagnostic information based on the contents of the device.
In summary, the Nest VT Vitrification Device is a medical device used in assisted reproduction technology for the cryopreservation of embryos and oocytes. It serves as a container and protective mechanism during this process, but it does not perform a diagnostic function.
N/A
Intended Use / Indications for Use
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.
Product codes
MQK
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.
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)
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 10-6. 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.
- Package Integrity Testing:
- F1886/F1886M-16
- ASTM F88/F88M-15
- ASTM F1929-15
- Mechanical Performance Testing:
- Dimensional testing
- Examination following cryostorage
- Seal integrity and leakage assessment following cryostorage
- Capping force and torque testing
- Uncapping force and torque testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Endotoxin: The acceptance criterion was ≤ 2 EU/device.
MEA: The acceptance criterion for the 1-Cell MEA was ≥80% embryos expanded to blastocyst at 96 hours.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
1
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)
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.
| 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 Way |
| P.O. Box 489 | |
| Bloomington, 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 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
4
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
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.
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 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. | VitriGuard is | ||
| intended for use | |||
| as a | |||
| cryopreservation | |||
| storage device in | |||
| vitrification | |||
| procedures and | |||
| indicated to | |||
| contain and | |||
| maintain human | |||
| oocytes (MII), 4-8 | |||
| cell embryos and | |||
| blastocyst stage | |||
| embryos. | Same intended use | ||
| Design | Stick with cap, design | ||
| feature to allow | |||
| handling with forceps | Stick with cap, | ||
| design feature to | |||
| allow handling | |||
| with forceps | Same | ||
| Marks/etching | Marks on distal tip | ||
| end, on body of the | |||
| stick and at the | |||
| opening of the cap | Black markings at | ||
| the end of the | |||
| stick and the tip of | |||
| the device | Different | ||
| Stick material | MBS Copolymer | Polystyrene | Different |
| Cap material | MBS Copolymer | Polystyrene | Different |
| Media Loading | |||
| volume | 1.0 microliter |