(123 days)
No
The device is a chemical solution (enzyme) used for cell removal, and the description focuses on its chemical properties and performance as a denudation agent. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
A therapeutic device is used to treat or cure a disease or condition. This device is used to prepare oocytes for ICSI, which is a preparatory step for assisted reproductive technology, not a treatment in itself.
No
The device is used to prepare oocytes for ICSI by removing surrounding cells. Its performance testing involves evaluating formulation and shelf life, not diagnostic accuracy.
No
The device description explicitly states it is a "hyaluronidase enzyme solution contained in a 2 ml transparent plastic bottles" and mentions physical testing like pH, Osmolality, and Sterility, indicating it is a physical product, not software.
Based on the provided information, SynVitro® Hyadase is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI." This process is performed in vitro (outside the living body) on biological material (oocytes).
- Device Description: The device is a "hyaluronidase enzyme solution" used for "denudation prior to intracytoplasmic sperm injection (ICSI)." This further confirms its use in a laboratory setting for manipulating biological samples.
- Performance Studies: The non-clinical performance testing includes assays like "Mouse embryo assay (MEA)" and "Hyaluronidase enzyme activity," which are typical tests for evaluating the performance of reagents used in in vitro procedures.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use and description clearly align with the definition of an IVD, which are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. In this case, it's used in the context of assisted reproductive technology, which involves in vitro procedures.
N/A
Intended Use / Indications for Use
SynVitro® Hyadase is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
Product codes
MQL
Device Description
SynVitro® Hyadase is a modified version of the prior cleared SynVitro® Hyadase device and is used for removal of cumulus and corona radiata cells surrounding the oocytes (denudation) prior to intracytoplasmic sperm injection (ICSI).
SynVitro® Hyadase is a clear non-viscous hyaluronidase enzyme solution contained in a 2 ml transparent plastic bottles (containing 1 ml solution) with caps and provided in cardboard boxes containing five bottles. This product has a one-year shelf-life when stored as recommended and can be used for up to seven days after opening.
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)
As part of demonstrating substantial equivalence to the predicate, a risk analysis was completed to identify the risks associated with the SynVitro® Hyadase formulation changes and shelf life claims. Verification testing was conducted to evaluate the modifications. The following tests associated with the device modifications were performed on the subject device according to methods and acceptance criteria outlined in the predicate device (K031228):
- pH testing was conducted per USP (acceptance criterion: pH 7.150-7.449)
- Osmolality testing was conducted per USP (acceptance criterion: 272-288 mOsm/kg)
- Aseptic Processing Validation was conducted per ISO 13408-1:2008 and ISO 13408-2:2018 ●
- Sterility testing was conducted per USP (acceptance criterion: no growth)
- Endotoxin testing was conducted per USP (acceptance criterion: ≤ 0.5 EU/ml)
- Mouse embryo assay (MEA): One-cell mouse embryos were exposed to test article for 15 seconds, followed by a 96-hr culture. For a valid assay it is required that at least 80% of the one-cell stage control embryos develop to blastocysts stage within 96 hours. (acceptance criterion: One-cell: ≥80% developed to the blastocyst stage within 96 hours after a 15second exposure to SynVitro® Hyadase)
- Hyaluronidase enzyme activity – measured by incubation of SynVitro® Hyadase with hyaluronic acid and assessment of turbidity of the resulting sample using a spectrophotometer at 640 nm. (acceptance criterion: 40-120 IU/ml)
- . Shelf-life testing was conducted to ensure that the following product specifications are met at time zero, at the end of the shelf-life (52 weeks), and after seven days of simulated vial opening:
- pH
- -Osmolality
- One-cell MEA -
- -Endotoxin concentration
- -Sterility testing
- -Hyaluronidase activity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, 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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July 17, 2020
Origio a/s, a CooperSurgical Company Monika Bak, Ph.D. Regulatory Affairs Officer Knardrupvej 2 Måløv 2760 Denmark
Re: K200680
Trade/Device Name: SynVitro® Hyadase Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: June 11, 2020 Received: June 19, 2020
Dear Monika Bak:
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.
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 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,
For 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) K200680
Device Name SynVitro® Hyadase
Indications for Use (Describe) SynVitro® Hyadase is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
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
K200680 - SynVitro® Hyadase
| 510(k) SUBMITTER | |
|---|---|
| Company Name: | ORIGIO a/s |
| Company Address: | Knardrupvej 2 |
| 2760 Måløv, | |
| Denmark | |
| CONTACT | |
| Name: | Monika Bak, PhD |
| Telephone: | +45 60190206 |
| Fax: | +45 4679 0300 |
| E-mail: | monika.bak@coopersurgical.com |
Date Prepared: July 15, 2020
Device Identification
| Trade name: | SynVitro® Hyadase |
|---|---|
| Common Name: | Reproductive Media |
| Regulation Number: | 21 CFR 884.6180 |
| Regulation Name: | Reproductive Media and Supplements |
| Product Code: | MQL (Media, Reproductive) |
| Regulatory Class: | Class II |
Predicate Device Information
K031228 - SynVitro Hyadase
The predicate device has not been subject to a design-related recall.
Device Description
SynVitro® Hyadase is a modified version of the prior cleared SynVitro® Hyadase device and is used for removal of cumulus and corona radiata cells surrounding the oocytes (denudation) prior to intracytoplasmic sperm injection (ICSI).
SynVitro® Hyadase is a clear non-viscous hyaluronidase enzyme solution contained in a 2 ml transparent plastic bottles (containing 1 ml solution) with caps and provided in cardboard boxes containing five bottles. This product has a one-year shelf-life when stored as recommended and can be used for up to seven days after opening.
Indications for Use
SynVitro® Hyadase is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
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Table 1: Substantial Equivalence Comparison
| Attribute | K200680
Subject Device:
SynVitro® Hyadase | K031228
Predicate Device:
SynVitro® Hyadase | Comparison |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | ORIGIO a/s | ORIGIO a/s
(formerly MediCult a/s) | Same |
| Indications for Use | SynVitro® Hyadase is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI. | For the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI. | Same |
| Product Design | Clear non-viscous solution contained in 2 ml transparent plastic bottles (containing 1 ml solution) with caps, with five bottles provided per box. | Clear non-viscous solution contained in 2 ml transparent plastic bottles (containing 1 ml solution) with caps, with five bottles provided per box. | Same |
| Formulation | Hyaluronidase 80 IU/ml (non-bovine source) Glucose Sodium pyruvate Calcium chloride Magnesium sulphate Sodium chloride HEPES | Hyaluronidase 80 IU/ml (non-bovine source) ART supplement Glucose Sodium pyruvate Calcium chloride Magnesium sulphate Sodium chloride Sodium bicarbonate HEPES | Different |
| pH | 7.150-7.449 | 7.150-7.449 | Same |
| Osmolality | 272-288 mOsm/kg | 272-288 mOsm/kg | Same |
| Endotoxin | ≤0.5 EU/ml | Meets requirements per USP | Different |
| Hyaluronidase activity | 80 IU/ml | 80 IU/ml | Same |
| Mouse Embryo Assay | One-cell: ≥80% developed to the blastocyst stage within 96 hours after a 15-second exposure to SynVitro® Hyadase | One-cell: ≥80% developed to the blastocyst stage within 96 hours after a 15-second exposure to SynVitro® Hyadase | Same |
| Shelf Life | 7 days (Open Vial)
52 weeks shelf life | Single use (Open vial)
15 weeks shelf life | Different |
The subject and predicate devices have the same indications for use/intended use for removal of cumulus complex and corona radiata cells surrounding the oocyte in preparation for ICSI. In addition, the subject and predicate devices have the same hyaluronidase activity and specifications for pH, mouse embryo assay (MEA), and osmolality. However, differences exist in formulation,
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endotoxin, and device shelf-life. 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, a risk analysis was completed to identify the risks associated with the SynVitro® Hyadase formulation changes and shelf life claims. Verification testing was conducted to evaluate the modifications. The following tests associated with the device modifications were performed on the subject device according to methods and acceptance criteria outlined in the predicate device (K031228):
- pH testing was conducted per USP (acceptance criterion: pH 7.150-7.449)
- Osmolality testing was conducted per USP (acceptance criterion: 272-288 mOsm/kg)
- Aseptic Processing Validation was conducted per ISO 13408-1:2008 and ISO 13408-2:2018 ●
- Sterility testing was conducted per USP (acceptance criterion: no growth)
- Endotoxin testing was conducted per USP (acceptance criterion: ≤ 0.5 EU/ml)
- Mouse embryo assay (MEA): One-cell mouse embryos were exposed to test article for 15 seconds, followed by a 96-hr culture. For a valid assay it is required that at least 80% of the one-cell stage control embryos develop to blastocysts stage within 96 hours. (acceptance criterion: One-cell: ≥80% developed to the blastocyst stage within 96 hours after a 15second exposure to SynVitro® Hyadase)
- Hyaluronidase enzyme activity – measured by incubation of SynVitro® Hyadase with hyaluronic acid and assessment of turbidity of the resulting sample using a spectrophotometer at 640 nm. (acceptance criterion: 40-120 IU/ml)
- . Shelf-life testing was conducted to ensure that the following product specifications are met at time zero, at the end of the shelf-life (52 weeks), and after seven days of simulated vial opening:
- pH
- -Osmolality
- One-cell MEA -
- -Endotoxin concentration
- -Sterility testing
- -Hyaluronidase activity
Conclusion
The subject and predicate device have the same intended use and comparable technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.