(89 days)
No
The device description and performance studies focus on the enzymatic activity and chemical properties of a solution, with no mention of AI or ML technologies.
No
The device is an enzyme solution used to remove cells surrounding an oocyte in preparation for ICSI, which is a preparatory step for a procedure rather than a treatment for a disease or condition itself.
No
The device is an enzyme solution used to remove the cumulus complex and corona radiata from oocytes in preparation for ICSI. It is a tool for a medical procedure, not a diagnostic device that identifies or characterizes a disease or condition.
No
The device description clearly states it is an enzyme solution provided in a polypropylene vial, indicating it is a physical product (a reagent) and not software.
Based on the provided information, it is highly likely that this device 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." ICSI (Intracytoplasmic Sperm Injection) is a laboratory procedure performed in vitro (outside the body) to assist with fertilization. The device is used to prepare a biological sample (the oocyte) for this in vitro procedure.
- Device Description: The device is an "enzyme solution containing recombinant human hyaluronidase" that acts on the oocyte in vitro.
- Performance Studies: The performance studies described, such as pH testing, osmolality, sterility, endotoxin testing, mouse embryo assay (MEA), and hyaluronidase activity, are all tests performed on the product itself or its effect on biological material in vitro. The MEA specifically assesses the product's impact on embryo development in vitro.
- Predicate Device: The predicate device listed, "ICSI Cumulase (K081639)," is also a product used in in vitro fertilization procedures.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use, device description, and the nature of the performance testing strongly indicate that this product is designed to be used in vitro for diagnostic or therapeutic purposes related to human biological samples (oocytes).
Therefore, it fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cumulus Remover is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
Product codes
MQL
Device Description
Cumulus Remover is an enzyme solution containing recombinant human hyaluronidase that digests hyaluronic acid that binds the cumulus and corona cells surrounding oocytes together. This function of hyaluronidase can be used for denuding cumulus and coronal cells from oocytes prior to performing Intracytoplasmic Sperm Injection (ICSI) fertilization procedures. Cumulus Remover is provided in a polypropylene vial (package size 0.5 mL), and five vials are packaged together in a box. This product is aseptically processed and has a shelf-life of six months when stored at 2-8°C. Cumulus Remover is tested for pH, osmolality, endotoxin, sterility, embryotoxicity, and hyaluronidase activity before lot release.
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)
The following studies have been performed to support substantial equivalence to the predicate devices:
- pH testing per USP
- Osmolality per USP
- Aseptic Processing Validation per ISO 13408-1:2015 and ISO 13408-2:2003
- Sterility testing per USP No microbial growth
- Endotoxin testing per USP -
§ 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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October 23, 2018
Kitazato Corporation % Audrey Swearingen Manager. Regulatory Affairs Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746
Re: K182002
Trade/Device Name: Cumulus Remover Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: Class II Product Code: MQL Dated: July 25, 2018 Received: July 26, 2018
Dear Audrey Swearingen:
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 avare 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.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 comprehensive regulatory information about medical devices and radiation-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.
Michael T. Bailey -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) K182002
Device Name Cumulus Remover
Indications for Use (Describe)
Cumulus Remover 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☒ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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510(k) Summary Cumulus Remover K182002
1. Submission Sponsor
Kitazato Corporation 81 Fuji Shizuoka 416-0907 JAPAN Phone number: +(81) 545-66-2202 Contact: Mr. Futoshi Inoue Title: President
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Contact: Audrey Swearingen, RAC Title: Director, Regulatory Affairs
3. Date Prepared
October 23, 2018
4. Device Identification
| Trade name: | Cumulus Remover |
|---|---|
| Common name: | Hyaluronidase Solution |
| Regulation name: | Reproductive Media and Supplements |
| Regulation number: | 21 CFR 884.6180 |
| Product code: | MQL (Media, Reproductive) |
| Regulatory class: | II |
5. Predicate Device
ICSI Cumulase (K081639) manufactured by MediCult a/s. This predicate device is now branded by Origio a/s and has not been subject to any design related recalls.
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6. Device Description
Cumulus Remover is an enzyme solution containing recombinant human hyaluronidase that digests hyaluronic acid that binds the cumulus and corona cells surrounding oocytes together. This function of hyaluronidase can be used for denuding cumulus and coronal cells from oocytes prior to performing Intracytoplasmic Sperm Injection (ICSI) fertilization procedures. Cumulus Remover is provided in a polypropylene vial (package size 0.5 mL), and five vials are packaged together in a box. This product is aseptically processed and has a shelf-life of six months when stored at 2-8°C. Cumulus Remover is tested for pH, osmolality, endotoxin, sterility, embryotoxicity, and hyaluronidase activity before lot release.
7. Indication for Use
Cumulus Remover is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
| Device | K182002 (subject device) | K081639 (predicate device) |
|---|---|---|
| Indications for Use | Cumulus Remover is for the removal of | |
| the cumulus complex and corona radiata | ||
| surrounding the oocyte in preparation | ||
| for ICSI. | ICSI Cumulase is for the removal of | |
| cumulus complex and corona radiata | ||
| surrounding the oocyte in preparation | ||
| for ICSI. | ||
| pH | 7.2-7.6 | Information is not available |
| Osmolality | 270-295 mOsm | Information is not available |
| Hyaluronidase activity | 70-90 units/ml (average 80 units/ml) | 40-120 units/ml (average 80 units/ml) |
| Formulation | Physiological salts | Physiological salts |
| Energy substance | Energy substance | |
| Buffering substance (HEPES) | Buffering substance (HEPES) | |
| Recombinant human hyaluronidase | Recombinant human hyaluronidase | |
| Human albumin | Human albumin | |
| Gentamicin | ||
| Dextran |
8. Substantial Equivalence Discussion
The subject and predicate devices have the same indications for use/intended use; however, there are differences in technological characteristics. Although the subject and predicate devices possess different ranges of hyaluronidase activity, the activity range of the subject device falls within the activity range of the predicate and both devices have the same average hyaluronidase activity (80 units/ml). Regarding formulation, the subject and predicate devices have the same or comparable salts, energy substance, and buffering agents. The subject device is different from the predicate device in that it contains gentamicin and dextran. These differences in formulation do not raise different questions of safety and effectiveness. In addition, the pH and osmolality values for the predicate device are not known; however, differences in pH and osmolality are common in assisted reproduction media products and do not raise different questions of safety and effectiveness. Also, the subject device pH and osmolality ranges are comparable to other assisted reproduction media products.
9. Summary of Non-Clinical Performance Testing
The following studies have been performed to support substantial equivalence to the predicate devices:
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- pH testing per USP See table above .
- Osmolality per USP See table above .
- Aseptic Processing Validation per ISO 13408-1:2015 and ISO 13408-2:2003 .
- Sterility testing per USP No microbial growth .
- . Endotoxin testing per USP -