(100 days)
Not Found
No
The description focuses on a chemical solution (enzyme) for removing cellular layers around an oocyte, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for the removal of the cumulus complex and corona radiata surrounding the oocyte, which is a preparation step for a procedure (ICSI) rather than a treatment for a disease or condition itself.
No
Explanation: The device description states its intended use is for the "removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI." This is a preparation step for a medical procedure, not a diagnostic act of identifying a disease or condition.
No
The device description clearly states it is a "defined sterile, ready to use media" supplied in "polypropylene plastic vials," indicating it is a physical substance and container, 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." This process is performed in vitro (outside the body) on biological material (oocytes).
- Device Description: The device is described as a "defined sterile, ready to use media used by professionals within assisted reproduction." It contains a "recombinant hyaluronidase and HSA," which are biological components used to act on the oocyte in vitro.
- Care Setting: The intended users are "professionals within assisted reproduction," which aligns with the use of IVD products in a laboratory or clinical setting.
- Predicate Devices: The predicate devices listed, SynVitro®Cumulase® (K060699) and Cumulase® (K042495), are also products used in assisted reproduction for similar purposes, and are likely classified as IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic," the nature of the device, its intended use, and the context of assisted reproduction strongly indicate that it falls under the definition of an IVD. It is a reagent or media used to prepare a biological sample (oocyte) for a medical procedure (ICSI) performed in vitro.
N/A
Intended Use / Indications for Use
The removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL, MOL
Device Description
ICSI Cumulase is a defined sterile, ready to use media used by professionals within assisted reproduction and intended for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
ICSI Cumulase is a modified version of SynVitro® Cumulase (K060699) and is based on a salt solution containing a recombinant hyaluronidase and HSA (US license No 1716). ICSI Cumulase is supplied in transparent polypropylene plastic vials with screw top closures in a volume of 0.5 ml.
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
Professionals within assisted reproduction
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)
In order to evaluate the safety and efficiency of ICSI Cumulase an evaluation of all relevant preclinical and clinical literature regarding the use of the Cumulase® enzyme has been performed. The review showed that the product is effective and safe for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 884.6180 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.
0
SEP 1 9 2008
510(K) SUMMARY Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
| Submitted by: | MediCult a/s
Møllehaven 12
4040 Jyllinge
Denmark
Telephone: + 45 46 79 02 00
Fax: + 45 46 79 03 00 |
|-----------------|-------------------------------------------------------------------------------------------------------------------|
| | K-30 |
| Contact person: | Ronald G. Leonardi, Ph.D. |
| | R&R Registrations |
| | 9919 Cam. Chirimolla |
| | FDA CDRH DMC |
| | San Diego CA 92131 |
| | JUN 1 1 2008 |
| | Received |
| | Date Submitted: June 2, 2008 |
Device Identification
Trade name: ICSI Cumulase® Common name: ICSI Cumulase® Classification name: Reproductive media and supplements (21 CFR 884.6180, Product Code 85 MQL)
Predicate devices:
SynVitro®Cumulase® (K060699) from MediCult a/s and Cumulase® (K042495) from Halozyme.
Description
ICSI Cumulase is a defined sterile, ready to use media used by professionals within assisted reproduction and intended for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
ICSI Cumulase is a modified version of SynVitro® Cumulase ( K060699) and is based on a salt solution containing a recombinant hyaluronidase and HSA (US license No 1716). ICSI Cumulase is supplied in transparent polypropylene plastic vials with screw top closures in a volume of 0.5 ml.
Intended use
The removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
Technological Characteristics
The technological characteristics of ICSI Cumulase® are essentially similar to those of the predicate devices. They have the same intended use and contain the recombinant human hyaluronidase enzyme Cumulase®.
Performance data
In order to evaluate the safety and efficiency of ICSI Cumulase an evaluation of all relevant preclinical and clinical literature regarding the use of the Cumulase® enzyme has been performed. The review showed that the product is effective and safe for its intended use.
1
Product Testing Controls
Each batch is tested according to Ph. Eur. and USP for sterility, osmolality, pH, endotoxin, enzyme activity and Mouse Embryo Assay (MEA). Stability studies have been performed.
Conclusion
It is concluded that the safety and the effectiveness of the product for its intended use is shown in the present submission and that the products are substantially equivalent to the predicate devices MediCult's SynVitro®Cumulase® (K060699) and Halozyme's Cumulase® (K042495).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2008
Medicult a/s % Ronald G. Leonardi, Ph.D. President R & R Registrations 9915 Cam. Chirimolla SAN DIEGO CALIFORNIA 92131
Re: K081639
Trade Name: ICSI Cumulase® Regulation Number: 21 CFR $884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: September 3, 2008 Received: September 4, 2008
Dear Dr. Leonardi:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jose M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
ICSI Cumulase®
Indications For Use:
ICSI Cumulase® is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use x x (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Helena Plumer
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number