(87 days)
No
The device description and performance studies focus on the physical characteristics and biological outcomes of a cryopreservation storage device, with no mention of AI or ML technologies.
No
The device is described as a cryopreservation storage device for human oocytes and embryos, which is a storage function, not a therapeutic intervention.
No
The device is a storage device for cryopreservation, not a diagnostic tool used to identify or analyze a condition or disease.
No
The device description clearly outlines a physical, sterile, single-use device made of polystyrene with a stick and cap assembly. The performance studies focus on physical characteristics and biological outcomes related to the device's function as a cryopreservation storage container, not software performance.
Based on the provided information, the VitriGuard device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the cryopreservation storage of human oocytes and embryos. This is a process of preserving biological material, not a diagnostic test performed in vitro to provide information about a patient's health or condition.
- Device Description: The device is a storage container. It doesn't perform any analysis or measurement on the biological samples.
- Performance Studies: The performance studies focus on the survival and development of the oocytes and embryos after cryopreservation, which relates to the effectiveness of the storage method, not a diagnostic outcome.
- Lack of Diagnostic Elements: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic within the biological samples for diagnostic purposes.
IVDs are typically used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The VitriGuard's function is purely for the physical preservation of these biological materials.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MQK
Device Description
VitriGuard is a sterile, single-use device that is intended for use as a cryopreservation storage device in vitrification procedures. The device consists of a two-piece polystyrene assembly that includes a hexagonal-shaped stick and cap. As part of the vitrification procedure, the oocytes or embryos are loaded on the tip of the stick is capped prior to plunging the device in liquid nitrogen and for subsequent storage. The tip has a trough area for loading, maintaining and securing oocytes or embryos. The stick and cap include a taper design that create a seal when assembled. Black markings at the end of the stick and the tip of the device provide visual aid for proper device orientation. All VitriGuard devices have a blue cap and the sticks are available in eight (8) translucent colors: clear, blue, green, yellow, lime green, purple, orange and pink.
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 was leveraged from the original VitriGuard (K162833) and included:
- Sterilization: Validation per ISO 11137-1:2006/(R)2010 and ISO 11137-2:2013; Bioburden per ISO 11737-1:2006/(R)2011 and ISO 11737-2:2009.
- Shelf Life Testing: Accelerated aging per ASTM F1980-07(2011); Package Integrity Testing following accelerated aging including Dye Penetration Testing per ASTM F2096-11, Seal Tensile Strength Testing per ASTM F88/F88M-15, and Seal Peel Testing per ASTM F1886/F1866M-09(2013).
- Ship Testing per ISTA 3A:2008.
- Endotoxin per USP and ANSI/AAMI ST72:2002/(R)2010.
- Mouse Embryo Assay (MEA).
- Thermal Profile Evaluation: Assessment of warming and cooling rates; Comparison of warming and cooling rates to other devices cleared for oocyte and embryo vitrification.
- Mouse Embryo Survival Evaluation.
- Mouse Embryo Development Evaluation.
- Container and Closure Integrity: Bacterial/Immersion; Bacterial Contaminated LN2.
- Durability Testing.
- Product Evaluation.
Published literature review to support the use of VitriGuard for MII oocyte vitrification:
- Literature 1: Evaluated efficacy of a closed-system vitrification device (similar to subject device) for oocyte vitrification vs. open-system. Results: 93.9% survival rate, 80.6% fertilization rate, 96% cleavage rate, and 72% blastocyst development rate (n=33 vitrified/warmed donated oocytes).
- Literature 2: Evaluated efficacy of a closed-system vitrification device (similar to subject device) for oocyte vitrification vs. open-system. Results: 94.5% survival rate, 57.1% fertilization rate, 24.2% implantation rate, 40% clinical pregnancy rate, and 37.5% live birth rate (n=498 vitrified/warmed donated oocytes, transferred to 40 recipients).
- Literature 3: Analyzed oocyte survival and birth outcome with a closed-system device (similar to subject device). Results: 94.2% survival rate, 80.4% fertilization rate, 95.1% cleavage rate, 36.1% blastocyst development rate, and 57.1% live birth rate (n=190 vitrified/warmed autologous oocytes, transferred to 14 mothers).
- Literature 4: Reported clinical experience with a closed-system device (similar to subject device) for oocyte vitrification. Overall results: 90.5% survival rate, 64.2% fertilization rate, 90.4% cleavage rate, 32.7% implantation rate, and 40.9% clinical pregnancy rate.
- Literature 5: Evaluated efficacy of a closed-system vitrification device (similar to subject device) vs. open-system based on donated oocytes. Results: 92.1% survival rate (n=89 vitrified/warmed donated oocytes).
- Literature 6: Evaluated long-term cryopreservation using a closed-system vitrification device (similar to subject device). Results: 80.4% survival rate, 72.8% fertilization rate, 54.5% blastocyst development rate, 65% implantation rate, 62.5% clinical pregnancy rate, and 62.5% live birth rate (n=33 patients, 16 embryo transfer cycles).
The published data for closed-system vitrification devices similar to the subject device demonstrates safe and effective use for oocyte cryopreservation and storage. A cooling/warming rate comparison showed the subject device has similar rates to other cleared devices. These results support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MEA (1-Cell): >=80% embryos developed to expanded blastocyst at 96h.
Survival Rates: 93.9% (Literature 1), 94.5% (Literature 2), 94.2% (Literature 3), 90.5% (Literature 4), 92.1% (Literature 5), 80.4% (Literature 6).
Fertilization Rates: 80.6% (Literature 1), 57.1% (Literature 2), 80.4% (Literature 3), 64.2% (Literature 4), 72.8% (Literature 6).
Cleavage Rates: 96% (Literature 1), 95.1% (Literature 3), 90.4% (Literature 4).
Blastocyst Development Rates: 72% (Literature 1), 36.1% (Literature 3), 54.5% (Literature 6).
Implantation Rates: 24.2% (Literature 2), 32.7% (Literature 4), 65% (Literature 6).
Clinical Pregnancy Rates: 40% (Literature 2), 40.9% (Literature 4), 62.5% (Literature 6).
Live Birth Rates: 37.5% (Literature 2), 57.1% (Literature 3), 62.5% (Literature 6).
Endotoxin:
§ 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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June 25, 2020
ORIGIO a/s % Christine Kupchick Regulatory Affairs Associate CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611
Re: K200815 Trade/Device Name: VitriGuard Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MQK Dated: March 27, 2020 Received: March 30, 2020
Dear Christine Kupchick:
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. 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 located 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.
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 4, Subpart A) for combination products; 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 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,
Monica D. Garcia, Ph.D. Acting 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
510(k) Number (if known) K200815
Device Name VitriGuard
Indications for Use (Describe)
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.
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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a CooperSurgical company
510(k) SUMMARY K200815
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
| Company Name: | CooperSurgical Inc. |
|---|---|
| Company Address: | 95 Corporate Drive |
| Trumbull, CT 06611 |
Submission Contact
| Name: | Christine Kupchick |
|---|---|
| Telephone: | 203-601-5200 Ext. 3370 |
| Fax: | 203-601-9870 |
| Email: | christine.kupchick@coopersurgical.com |
Date Prepared: June 24, 2020
Device Identification
| 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: | Class II |
| Review Panel: | Obstetrics/Gynecology |
Predicate Device Information Vitrolife Rapid-I (K181461).
The predicate device has not been subject to a design-related recall.
Device Description
VitriGuard is a sterile, single-use device that is intended for use as a cryopreservation storage device in vitrification procedures. The device consists of a two-piece polystyrene assembly that includes a hexagonal-shaped stick and cap. As part of the vitrification procedure, the oocytes or embryos are loaded on the tip of the stick is capped prior to plunging the device in liquid nitrogen and for subsequent storage. The tip has a trough area for loading, maintaining and securing oocytes or embryos. The stick and cap include a taper design that create a seal when assembled. Black markings at
4
the end of the stick and the tip of the device provide visual aid for proper device orientation. All VitriGuard devices have a blue cap and the sticks are available in eight (8) translucent colors: clear, blue, green, yellow, lime green, purple, orange and pink.
Indications for Use
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.
Substantial Equivalence Discussion
The table below provides a comparison of the intended use and technological characteristics of the subject and predicate device.
| Attribute | Subject VitriGuard | Predicate Rapid-I (K181461) |
|---|---|---|
| Indications for Use | 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. | Cryopreservation device intended | |
| to be used to contain, vitrify and | ||
| maintain human embryos and/or | ||
| oocytes (MII). | ||
| Fundamental | ||
| Technology | The device is composed of a two- | |
| piece assembly that includes a | ||
| stick and cap. As part of the | ||
| vitrification procedure, | ||
| specimens to be stored are | ||
| loaded on the tip of the stick and | ||
| the stick is inserted into the pre- | ||
| cooled cap to seal and to vitrify | ||
| samples for subsequent storage | ||
| in LN. | The stick has a tip where the | |
| samples are loaded. The stick is | ||
| sealed within a pre-cooled straw | ||
| that contains a stainless-steel | ||
| weight to maintain device | ||
| orientation in LN. The stick is | ||
| inserted into the pre-cooled straw | ||
| (after steel rod removal) to vitrify | ||
| samples. The end of the straw is | ||
| sealed, and the device is stored in | ||
| LN. | ||
| Warming Rate | -2,271°C/min | -1,400°C/min |
| Cooling Rate | 36,377°C/min | 10,000°C/min |
| Endotoxin | ≤2.0 EU/device | ≤1.0 EU/device |
| MEA (1-Cell) | ≥80% embryos developed to | |
| expanded blastocyst at 96h | ≥80% embryos developed to | |
| expanded blastocyst at 96h | ||
| Materials | Polystyrene (clear, blue, green, | |
| yellow, orange, pink, lime green, | ||
| and purple) with black marker | ||
| bands | Polymethyl methacrylate (PMMA) | |
| Mediprene | ||
| Stainless steel | ||
| Sterilization | ||
| Method | Radiation, SAL 10-6 | Ethylene Oxide, SAL 10-6 |
| Number of Uses | Single-use, disposable | Single-use, disposable |
Substantial Equivalence Comparison
The subject and predicate device have similar indications for use statements and have the same intended use – the vitrification and storage of human oocytes (MII) and embryos.
The subject and predicate device have comparable technological characteristics: samples are loaded at the tip, the stick is inserted into a pre-cooled device component, samples are vitrified, and the sealed device with the vitrified samples is placed in Liquid Nitrogen for subsequent storage. The subject device is identical to the predicate in MEA specifications, SAL, and number of uses. The subject device differs
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from the predicate in cooling/warming rates, endotoxin specifications, materials, and sterilization method, however, these differences do not raise different questions of safety and effectiveness.
Non-clinical performance testing
The following performance testing was leveraged from the original VitriGuard (K162833) to support the performance of the subject device.
- . Sterilization
- Validation per ISO 11137-1:2006/(R)2010 and ISO 11137-2:2013 O
- Bioburden per ISO 11737-1:2006/(R)2011 and ISO 11737-2:2009 O
- Shelf Life Testing ●
- Accelerated aging per ASTM F1980-07(2011) o
- Package Integrity Testing following accelerated aging o
- l Dye Penetration Testing per ASTM F2096-11
- . Seal Tensile Strength Testing per ASTM F88/F88M-15
- . Seal Peel Testing per ASTM F1886/F1866M-09(2013)
- Ship Testing per ISTA 3A:2008
- Endotoxin per USP and ANSI/AAMI ST72:2002/(R)2010
- . Mouse Embryo Assay (MEA)
- Thermal Profile Evaluation
- O Assessment of warming and cooling rates
- Comparison of warming and cooling rates to other devices cleared for oocyte and embryo O vitrification
- Mouse Embryo Survival Evaluation
- Mouse Embryo Development Evaluation
- Container and Closure Integrity
- O Bacterial/Immersion
- O Bacterial Contaminated LN2
- . Durability Testing
- Product Evaluation
Published literature review
To support the use of the VitriGuard for the vitrification of MII oocytes, published literature was summarized to assess the VitriGuard, as well as other legally marketed, closed-system devices similar to the subject device in technological characteristics and indicated to contain and maintain human oocytes during vitrification procedures. A summary of the results is shown below:
- Literature 1: This study evaluated the efficacy of a closed-system vitrification device for oocyte vitrification as compared to an open-system device. The results of the study show a 93.9% survival rate, 80.6% fertilization rate, 96% cleavage rate and 72% blastocyst development rate after using a closed- system device similar to the subject device. Results are based on 33 vitrified/ warmed donated oocytes using the closed-system device.2
- Literature 2: This study evaluated the efficacy of a closed-system vitrification device for oocyte vitrification as compared to an open-system device. The results of the study show a 94.5% survival rate, 57.1% fertilization rate, 24.2% implantation rate, 40% clinical pregnancy rate and 37.5% live birth rate after using a closed-system vitrification device similar to the subject device.
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Results are based on 498 vitrified/warmed donated oocytes using the closed-system device, which were fertilized/ cultured and transferred to 40 recipients.2
- Literature 3: This study analyzed oocyte survival rates after warming, and birth outcome of a vitrification protocol in conjunction with a closed-system device. The results of the study show a 94.2% survival rate, 80.4% fertilization rate, 95.1% cleavage rate, 36.1% blastocyst development rate, and 57.1% live birth rate after using a closed-system vitrification device similar to the subject device. Results are based on 190 vitrified/warmed autologous oocytes using the closedsystem device, which were fertilized/ cultured and transferred back to the mother (N=14). 3
- Literature 4: This study reported on clinical experience after introducing a closed-system device for oocyte vitrification in daily routine. The overall results of the study show a 90.5% survival rate, 64.2% fertilization rate, 90.4% cleavage rate, 32.7% implantation rate, and 40.9% clinical pregnancy rate after using a closed-system vitrification device similar to the subject device; with results varying depending on maternal age (1 Inoue (2014) Efficiency of a closed vitrification system with oocytes and blastocysts.
² Pujol (2019) Comparison of two different oocyte vitrification methods: a prospective, paired study on the same genetic background and stimulation protocol.
3 Perez et al (2018) Oocyte vitrification using a new vitrification medium and a new closed vitrification device. A sibling oocyte study. 4 Gook et al (2016) Closed vitrification of human oocytes and blastocysts: outcomes from a series of clinical cases.
5 Pinasco et al (2012) Oocyte vitrification freeze/thaw survival rates using an open versus closed system.
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- Literature 6: This study evaluated if long-term cryopreservation (median 3.5 years storage) of human oocytes affects oocyte developmental competence, blastocyst euploidy, or live-birth rates. The results of the study show an overall 80.4% survival rate, 72.8% fertilization rate, 54.5% blastocyst development rate, 65% implantation rate, 62.5% clinical pregnancy rate and 62.5% live birth rate (including some ongoing pregnancies). Data include the use of a closedsystem vitrification device similar to the subject device. Results are based on total 33 patients ending up with 16 embryo transfer cycles.6
The published data summarized for closed-system vitrification devices similar to the subject device demonstrates the safe and effective use of the closed-system vitrification devices for oocyte cryopreservation and storage. Furthermore, a cooling/warming rate comparison demonstrates that the subject device has similar cooling/warming rates to other devices that have been cleared for oocyte vitrification and storage. Therefore, the clinical information provided above can be leveraged to demonstrate substantial equivalence to the predicate device and supports the safe and effective use of the subject device for oocyte cryopreservation and storage.
Conclusion
The results of the performance testing described above demonstrate that the VitriGuard is as safe and effective as the predicate device and supports a determination of substantial equivalence
6 Goldman et al (2015) Long-term crypreservation of human oocytes does not increase embryonic aneuploidy.