(43 days)
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No
The description focuses on the physical design and materials of a cryopreservation device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is a cryopreservation storage device intended to contain and maintain embryos, not to treat a disease or condition in a patient.
No
Explanation: The device is a cryopreservation storage device for embryos. Its purpose is to contain and maintain embryos, not to diagnose a condition or disease. The performance studies focus on embryo viability after storage, not diagnostic accuracy.
No
The device description clearly states it is a physical cryopreservation storage device made of polystyrene, consisting of a stick and cap. It is used to contain and maintain embryos during vitrification and storage in liquid nitrogen. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- VitriGuard's Intended Use: The intended use of VitriGuard is to contain and maintain human 4-8 cell and blastocyst stage embryos during cryopreservation (vitrification). This is a storage and handling function, not a diagnostic test performed on a sample to gain information about a patient's health or condition.
- Device Description: The device description reinforces its role as a storage container for embryos.
- Performance Studies: The performance studies described (MEA, endotoxin testing, packaging integrity) are related to the device's ability to safely store and handle the embryos, not its diagnostic accuracy.
Therefore, VitriGuard falls under the category of a medical device used in assisted reproductive technology procedures, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
VitriGuard 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
VitriGuard 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. It is single-use, disposable, and provided sterile. The device consists of a two-piece polystyrene assembly that includes a hexagonalshaped stick and cap. As part of the vitrification procedure, the embryos to be stored are loaded on the tip, and capped prior to plunging the device in liquid nitrogen and for subsequent storage. The tip has a trough area for loading, maintaining, and securing the embryos. The stick and cap include a taper design that creates a seal when assembled. Markings at the end of the stick and the tip of the device provide visual aid for proper device orientation.
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 Performance Testing:
- MEA (Mouse Embryo Assay) was performed on VitriGuard devices that were unaged and after one year of accelerated aging per ASTM F1980-07(2011). One-cell mouse embryos were exposed to subject devices and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage within 96 hours were assessed in comparison with the control group. The subject device met the predetermined acceptance criteria (≥80% blastocyst at 96h).
- Risk assessment to apply sterilization validation and bioburden testing on the predicate device to the subject device.
- Shipping and Distribution Testing per ISTA 3A 2008.
- Package Integrity Testing Following Accelerated Aging (ASTM F1980-07(2011), ASTM F1929-15, ASTM F88/F88M-15, ASTM F1886/F1866M-09(2013)).
Key results: The results of the performance testing provided demonstrated that the subject devices are as safe and effective as the predicate devices and supports substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mouse Embryo Assay (MEA): ≥80% blastocyst at 96h.
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).
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§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
May 4, 2018
ORIGIO a/s % Roaida Johnson Director, RA New Product Development CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611
Re: K180740
Trade/Device Name: VitriGuard™ Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MOK Dated: April 24, 2018 Received: April 25, 2018
Dear Roaida Johnson:
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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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 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 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
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| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: 06/30/2020 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K180740 |
|---|---|
| Device Name | VitriGuard™ |
| Indications for Use (Describe) | VitriGuard 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) |
|---|---|
| ----------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/1 description: The image shows the logo for "origio", which is written in a stylized purple font. To the right of the logo, it says "a CooperSurgical company" in a smaller, also purple, font. The logo is simple and modern.
510(k) Summary K180740
Submitter Information
| Company Name: | ORIGIO a/s |
|---|---|
| Company Address: | Knardrupvej 2 |
| 2760 Måløv | |
| Denmark | |
| Telephone: +45 46 79 02 00 | |
| Fax: +45 46 79 03 02 |
Submission Correspondent Information
| Company Name: | CooperSurgical Inc. |
|---|---|
| Company Address: | 95 Corporate Drive |
| Trumbull, CT 06611 | |
| Telephone: | 203-601-5200 Ext. 3325 |
| Fax: | 203-601-9870 |
Contact Person: Roaida Johnson
Date Prepared: May 3, 2018
Device Information
| Trade Name: | VitriGuard™ |
|---|---|
| Common Name: | Cryopreservation Storage Device |
| Regulation Number: | 21 CFR 884.6160 |
| Regulation Name: | Assisted Reproduction Labware |
| Product Code: | MQK (Labware, Assisted Reproduction) |
| Regulatory Class: | II |
Predicate Device Information
ORIGIO a/s VitriGuard (K162833).
The predicate device has not been subject to a design-related recall.
Device Description
VitriGuard 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. It is single-use, disposable, and provided sterile. The device consists of a two-piece polystyrene assembly that includes a hexagonalshaped stick and cap. As part of the vitrification procedure, the embryos to be stored are loaded on the tip, and capped prior to plunging the device in liquid nitrogen and for subsequent storage. The tip has a trough
4
area for loading, maintaining, and securing the embryos. The stick and cap include a taper design that creates a seal when assembled. Markings at the end of the stick and the tip of the device provide visual aid for proper device orientation.
Product specifications are listed in Table 1 below:
Table 1: Product Specifications
| Parameter | Specification |
|---|---|
| Cooling rate | -2,271°C/min |
| Warming rate | 36,377°C/min |
| Sterilization | Radiation, SAL 10-6 |
| Endotoxin | ≤2.0 EU/device |
| Mouse Embryo Assay (MEA) | ≥80% blastocyst at 96h |
Indications for Use
VitriGuard 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.
Substantial Equivalence Discussion
Table 2 provides a comparison of the subject and predicate device.
| Property | Subject VitriGuard | Predicate VitriGuard |
|---|---|---|
| 510(k) Number | K180740 | K162833 |
| Indications for Use | VitriGuard 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 | Same | |
| Fundamental | ||
| Scientific Technology | The device is composed of a two-piece | |
| assembly that includes a stick and cap. | ||
| As part of the vitrification procedure, | ||
| the embryos to be stored are loaded on | ||
| the tip of the stick and capped for | ||
| subsequent storage. | Same | |
| Material | Polystyrene (clear, blue, green, yellow, | |
| orange, pink, lime green, and purple) | Polystyrene (clear, blue, green, | |
| and yellow) | ||
| Black marker bands | Black marker bands | |
| Sterilization Method | Radiation | Same |
| Number of Uses | Single Use, Disposable | Same |
| Packaging | Box of 20 (individually pouched) or | |
| box of 50 (5 per pouch) | Box of 20 (individually | |
| pouched) | ||
| Shelf Life | One Year | Three Years |
Table 2: Comparison of the Subject VitriGuard to the Predicate VitriGuard
The subject and predicate devices have intended use and are technologically comparable. Differences between the predicate and subject device includes the subject device having additional color
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options of the stick component, a package configuration including five VitriGuard devices in a pouch, and a reduced shelf-life as compared to the predicate device. These differences do not raise different questions of safety and effectiveness as compared to the predicate device.
Non-Clinical Performance Testing
As part of demonstrating substantial equivalence to the predicate, the following tests were performed:
- . MEA was performed on VitriGuard devices that were unaged and after one year of accelerated aging per ASTM F1980-07(2011). One-cell mouse embryos were exposed to subject devices and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage within 96 hours were assessed in comparison with the control group. The subject device met the predetermined acceptance criteria (see Table 1).
- Risk assessment to apply sterilization validation and bioburden testing on the predicate device to the subject device
- Shipping and Distribution Testing per ISTA 3A 2008
- . Package Integrity Testing Following Accelerated Aging
- ASTM F1980-07(2011) o
- O ASTM F1929-15
- ASTM F88/F88M-15 O
- o ASTM F1886/F1866M-09(2013)
Conclusion
The results of the performance testing provided demonstrated that the subject devices are as safe and effective as the predicate devices and supports substantial equivalence.