(128 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological compatibility of a cryopreservation storage device, with no mention of AI or ML capabilities.
No.
The device is a storage container for embryos, not a treatment or diagnostic tool for a medical condition.
No
Explanation: The device is described as a cryopreservation storage device for human embryos. Its purpose is to contain and maintain embryos during vitrification procedures, not to diagnose any condition or disease.
No
The device description explicitly states it is a "cryopreservation storage device" composed of a "two-piece polystyrene assembly" including a "hexagonal shaped stick and cap." This describes a physical hardware device, not software.
Based on the provided information, the VitriGuard device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "contain and maintain human 4-8 cell and blastocyst stage embryos" during vitrification procedures. This is a storage and handling function, not a diagnostic test performed in vitro on a specimen to provide information about a patient's health or condition.
- Device Description: The description focuses on the physical characteristics and function of the device as a container for embryos. It doesn't describe any components or processes that would analyze or test the embryos themselves.
- Performance Studies: The performance studies listed (sterilization, packaging integrity, endotoxin, mouse embryo assays for survival and development, etc.) are related to the safety, integrity, and functionality of the device as a storage container and its impact on the viability of the embryos, not on diagnosing a condition.
- Key Metrics: The key metrics (blastocyst development rate, survival rate, endotoxin levels) are measures of the device's ability to maintain the embryos, not diagnostic metrics.
IVD devices are typically used to perform tests on biological samples (like blood, urine, tissue) to detect diseases, conditions, or genetic markers. The VitriGuard device's function is to physically hold and protect embryos during a cryopreservation process.
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)
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. The VitriGuard device is composed of a two-piece polystyrene assembly that includes a hexagonal shaped stick and cap. As part of the vitrification procedure, the embryos to be stored are loaded on the tip, also referred to as the leaf, and capped with a pre-cooled cap for subsequent storage following vitrification. The leaf has a trough area for loading. maintaining, and securing the embryos. The stick and cap include a taper design that creates a hermetic seal, forming a closed system. Markings at the stick and the tip of the device provide visual aid for proper device orientation. The device is provided sterile and is for single use only. The VitriGuard has been designed as a cryopreservation storage device to maintain the integrity of human 4-8 cell and blastocyst stage embryos throughout the cooling. storage, and warming processes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
The VitriGuard device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device:
- Gamma Sterilization Validation per ISO 11137-1:2006/(R)2010 and 11137-2:2013.
- Shipping and Distribution Testing per ISTA 3A 2008
- Package Integrity Testing following accelerated aging per ASTM F1980-07(2011) per AAMI/ANSI/ISO 11607-1:2006/A1:2014 and 11607-2:2006/A1:2014, ASTM F929-15, ASTM F88/F88M-15, and ASTM F1886/F1886M-09(2013)
- Endotoxin Evaluation per ANSI/AAMI ST72:2011/(R)2016 and USP
- Mouse Embryo Assay (MEA)
- Thermal Profile Evaluation: The purpose of this test was to evaluate the cooling and warming rates of the subject device, and to demonstrate that these rates are equivalent, or faster, than the predicate device. Temperature recording and graphing equipment was used to record and document the temperature profile of the devices when used as prescribed in the Instructions for Use (IFU) throughout the cooling and warming portions of the vitrification process. The acceptance criteria were that the subject device warming and cooling rates must be substantially equal to (or greater than in absolute value) to the predicate device. The subject device met the acceptance criteria.
- Mouse Embryo Survival Evaluation: The purpose of this test was to evaluate post-warming survival rates of various mouse embryos after vitrification using the subject device and predicate device. The vitrification process was performed on mouse embryos according to the device IFU. After warming, all embryos were evaluated for survival rate. The acceptance criteria were that the subject device survival rate must be ≥80% for all embryos stages. The subject device met the acceptance criteria.
- Mouse Embryo Development Evaluation: The purpose of this evaluation was to evaluate the post-warming development competence of various mouse embryos after vitrification using the subject device and the predicate device. Embryos were cultured to the blastocyst stage. The acceptance criteria were that the subject device blastocyst development rate must be ≥80% for all embryo stages. The subject device met the acceptance criteria.
- Container and Closure Integrity - Bacterial/Immersion: The purpose of this test was to evaluate the microbial barrier of the closure system of the subject device and predicate device. Test samples were transferred to bacterial culture and transferred to an incubator for immersion. After immersion, test samples were removed and examined for growth/turbidity. The acceptance criteria were that the subject device must be negative for growth of the challenge organism. The subject device met the acceptance criteria.
- Container and Closure Integrity Bacterial Contaminated LN2: The purpose of this test was to evaluate seal integrity through device exposure to bacterial contaminated Liquid Nitrogen (LN2). The samples were capped as prescribed in the IFU and transferred to contaminated LN5. Samples were incubated and observed for growth. The acceptance criteria were that the test samples do not show presence or growth of the challenge organism. The subject device met the acceptance criteria. No leakage of LN2 was observed in the device.
- Durability Testing: The purpose of this test was to compare the seal integrity of the subject device to the predicate device by characterizing the seal integrity through exposure to Liquid Nitrogen (LN2). The samples were assembled as prescribed in the IFU and submerged in LN2. The test samples were then exposed to 37℃ temperatures. The acceptance criteria were that the subject device must not exhibit any cap expulsion during this process. The subject device met the acceptance criteria. No leakage of LN2 was observed in the device.
- Product Evaluation: The purpose of this test was to evaluate the subject device with regards to loading, vitrification, and unloading, following the steps prescribed by the IFU. The acceptance criteria were that that device passes the predetermined design requirements. The subject device met the acceptance criteria.
- Shelf Life Testing - accelerated aging per ASTM F1980-07(2011) (includes Mouse Embryo Assay (MEA), Container and Closure Integrity Bacterial/Immersion, Container and Closure Integrity Bacterial Contaminated LN2, Durability Testing, Product Evaluation).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Endotoxin: = 80% blastocyst at 96 hours (1-cell)
- Cooling rate: -2,271°C/min
- Warming rate: 36,377°C/min
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).
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2017
ORIGIO a/s % Roaida Johnson Director, RA New Product Development CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611
Re: K162833 Trade/Device Name: VitriGuard™ Regulation Number: 21 CFR& 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MQK Dated: January 17, 2017 Received: January 18, 2017
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 mav 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.
1
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Joyce M. Whang-S
for
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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Indications for Use
510(k) Number (if known) K162833
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K162833 - VitriGuard™ Cryopreservation Storage Device
Submission Sponsor Information
| Company Name: | ORIGIO a/s |
|---|---|
| Company Address: | Knardrupvej 2 |
| 2760 Måløv | |
| Denmark | |
| Telephone: +45 46790200 | |
| Fax: +45 46790302 |
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: | February 15, 2017 |
Device Information
| Trade Name: | VitriGuard™ |
|---|---|
| Common Name: | Cryopreservation Storage Device |
| Device Class: | II |
| Classification Number: | 21 CFR 884.6160 |
| Classification Name: | Assisted Reproduction Labware |
| Product Code: | MQK (Labware, Assisted Reproduction) |
Predicate Device Information
The CooperSurgical VitriGuard cryopreservation storage device is substantially equivalent to the following predicate:
Primary Predicate: CRYOLOCK™ cryopreservation storage device (K122982)
The predicate device has not been subject to a design-related recall.
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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. The VitriGuard device is composed of a two-piece polystyrene assembly that includes a hexagonal shaped stick and cap. As part of the vitrification procedure, the embryos to be stored are loaded on the tip, also referred to as the leaf, and capped with a pre-cooled cap for subsequent storage following vitrification. The leaf has a trough area for loading. maintaining, and securing the embryos. The stick and cap include a taper design that creates a hermetic seal, forming a closed system. Markings at the stick and the tip of the device provide visual aid for proper device orientation. The device is provided sterile and is for single use only. The VitriGuard has been designed as a cryopreservation storage device to maintain the integrity of human 4-8 cell and blastocyst stage embryos throughout the cooling. storage, and warming processes.
| Parameter | Specification |
|---|---|
| Cooling rate | -2,271°C/min |
| Warming rate | 36,377°C/min |
| Sterilization | Radiation, SAL 10-6 |
| Endotoxin | $\leq$ 2.0 EU/device |
| MEA | $\geq$ 80% blastocyst at 96 hours |
| (1-cell) |
Product specifications are listed in the table below:
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
The substantial equivalence of the subject device to the predicate is discussed below in Table 1 in respect to: indications for use, principles of operation, technological characteristics, materials, and performance.
| Table 1. Comparison of VitriGuard to the Predicate Device | |||
|---|---|---|---|
| Property | Subject Device | ||
| VitriGuard™ | Predicate | ||
| CRYOLOCK™ | Significant | ||
| Differences | |||
| 510(k) Number | K162833 | K122982 | N/A |
| 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 | The CRYOLOCK™ is | ||
| a cryopreservation | |||
| storage device that is | |||
| intended for use in | |||
| vitrification procedures | |||
| to contain and maintain | |||
| human 1-cell stage | |||
| embryos | Similar. Although | ||
| the predicate device | |||
| is only indicated for | |||
| use for 1-cell stage | |||
| embryos, the | |||
| predicate and subject | |||
| device have the same | |||
| intended use – | |||
| vitrification and | |||
| storage of human | |||
| embryos. | |||
| Technology | |||
| Overview | The device is designed to | ||
| contain, vitrify and | |||
| maintain human embryos. | |||
| The device is composed of | |||
| a two-piece assembly with | |||
| the main stick containing a | |||
| fine tip area, called the | |||
| "leaf," and a cap. The | |||
| handle shaft and cap are | |||
| designed to be a | |||
| hermetically sealed closed | |||
| system. | The device is designed | ||
| to contain, vitrify and | |||
| maintain human | |||
| embryos. The device is | |||
| composed of a two- | |||
| piece assembly with | |||
| the main stick | |||
| containing a fine tip | |||
| area, called the "leaf," | |||
| and a cap. The handle | |||
| shaft and cap are | |||
| designed to be a | |||
| hermetically sealed | |||
| closed system. | Same | ||
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Same |
| Sterilization | |||
| Method | Radiation | Radiation | Same |
| Number of Uses | Single Use, Disposable | Single Use, Disposable | Same |
| Shelf Life | 2 Years | 3 Years | Different. The |
| subject device has a | |||
| shorter shelf life, | |||
| which does not raise | |||
| different questions of | |||
| safety and | |||
| effectiveness. | |||
| Material | |||
| Composition | Polystyrene | Polystyrene | Same |
| Cooling Rate | -2,271°C/min | -1,494°C/min | Different. However, |
| both devices have | |||
| cooling rates that are | |||
| typical for these | |||
| types of devices, and | |||
| do not raise different | |||
| questions of safety | |||
| and effectiveness. | |||
| Rewarming Rate | 36,377°C/min | 21,000°C/min | Different. However, |
| both devices have | |||
| warming rates that | |||
| are typical for these | |||
| types of devices, and | |||
| do not raise different | |||
| questions of safety | |||
| and effectiveness. | |||
| Endotoxin Testing | ≤2.0 EU/device | ≤2.0 EU/device | Same |
| Mouse Embryo | |||
| Testing | ≥80% blastocyst at 96 | ||
| hours (1 cell) | ≥80% blastocyst at 96 | ||
| hours (1 cell) | Same |
Table 1: Comparison of VitriGuard to the Predicate Device
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Non-Clinical Performance Testing
As part of demonstrating substantial equivalence to the predicate device, the following nonclinical performance tests were conducted. The VitriGuard device meets all requirements for overall design, sterilization, and performance testing results, confirming that the design outputs meet the design inputs and specifications for the device.
The VitriGuard device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device:
- Gamma Sterilization Validation per ISO 11137-1:2006/(R)2010 and 11137-2:2013 .
- . Shipping and Distribution Testing per ISTA 3A 2008
- . Package Integrity Testing following accelerated aging per ASTM F1980-07(2011) per AAMI/ANSI/ISO 11607-1:2006/A1:2014 and 11607-2:2006/A1:2014, ASTM F929-15, ASTM F88/F88M-15, and ASTM F1886/F1886M-09(2013)
- . Endotoxin Evaluation per ANSI/AAMI ST72:2011/(R)2016 and USP
- Mouse Embryo Assay (MEA) ●
- Thermal Profile Evaluation .
- The purpose of this test was to evaluate the cooling and warming rates of the o subject device, and to demonstrate that these rates are equivalent, or faster, than the predicate device. Temperature recording and graphing equipment was used to record and document the temperature profile of the devices when used as prescribed in the Instructions for Use (IFU) throughout the cooling and warming portions of the vitrification process. The acceptance criteria were that the subject device warming and cooling rates must be substantially equal to (or greater than in absolute value) to the predicate device. The subject device met the acceptance criteria.
- Mouse Embryo Survival Evaluation ●
- The purpose of this test was to evaluate post-warming survival rates of O various mouse embryos after vitrification using the subject device and predicate device. The vitrification process was performed on mouse embryos according to the device IFU. After warming, all embryos were evaluated for survival rate. The acceptance criteria were that the subject device survival rate must be ≥80% for all embryos stages. The subject device met the acceptance criteria.
- Mouse Embryo Development Evaluation
- The purpose of this evaluation was to evaluate the post-warming development O competence of various mouse embryos after vitrification using the subject device and the predicate device. Embryos were cultured to the blastocyst stage. The acceptance criteria were that the subject device blastocyst development rate must be ≥80% for all embryo stages. The subject device met the acceptance criteria.
- . Container and Closure Integrity - Bacterial/Immersion
- The purpose of this test was to evaluate the microbial barrier of the closure O system of the subject device and predicate device. Test samples were transferred to bacterial culture and transferred to an incubator for immersion. After immersion, test samples were removed and examined for growth/turbidity. The acceptance criteria were that the subject device must be
7
negative for growth of the challenge organism. The subject device met the acceptance criteria.
- Container and Closure Integrity Bacterial Contaminated LN2 .
- o The purpose of this test was to evaluate seal integrity through device exposure to bacterial contaminated Liquid Nitrogen (LN2). The samples were capped as prescribed in the IFU and transferred to contaminated LN5. Samples were incubated and observed for growth. The acceptance criteria were that the test samples do not show presence or growth of the challenge organism. The subject device met the acceptance criteria. No leakage of LN2 was observed in the device.
- . Durability Testing
- The purpose of this test was to compare the seal integrity of the subject o device to the predicate device by characterizing the seal integrity through exposure to Liquid Nitrogen (LN2). The samples were assembled as prescribed in the IFU and submerged in LN2. The test samples were then exposed to 37℃ temperatures. The acceptance criteria were that the subject device must not exhibit any cap expulsion during this process. The subject device met the acceptance criteria. No leakage of LN2 was observed in the device.
- Product Evaluation
- The purpose of this test was to evaluate the subject device with regards to o loading, vitrification, and unloading, following the steps prescribed by the IFU. The acceptance criteria were that that device passes the predetermined design requirements. The subject device met the acceptance criteria.
- Shelf Life Testing - accelerated aging per ASTM F1980-07(2011)
- Mouse Embryo Assay (MEA) O
- Container and Closure Integrity Bacterial/Immersion о
- Container and Closure Integrity Bacterial Contaminated LN2 O
- Durability Testing O
- O Product Evaluation
Conclusion
The results of the testing described above demonstrate that the VitriGuard is as safe and effective as the predicate device and supports a determination of substantial equivalence.