(100 days)
ICSI Cumulase® is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
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.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate device equivalence) | Reported Device Performance (ICSI Cumulase®) |
|---|---|---|
| Safety | Equivalent to predicate devices (SynVitro® Cumulase® & Cumulase®) | Product is effective and safe. |
| Effectiveness/Functionality | Equivalent to predicate devices for intended use | Product is effective and safe. Performs the intended use. |
| Technological Characteristics | Similar to predicate devices: same intended use, contains recombinant human hyaluronidase enzyme (Cumulase®). | Essentially similar to predicate devices. |
| Product Testing Controls | Sterility (Ph. Eur. & USP) | Each batch tested to Ph. Eur. & USP. |
| Osmolarity (Ph. Eur. & USP) | Each batch tested to Ph. Eur. & USP. | |
| pH (Ph. Eur. & USP) | Each batch tested to Ph. Eur. & USP. | |
| Endotoxin (Ph. Eur. & USP) | Each batch tested to Ph. Eur. & USP. | |
| Enzyme Activity (Ph. Eur. & USP) | Each batch tested to Ph. Eur. & USP. | |
| Mouse Embryo Assay (MEA) | Each batch tested. | |
| Stability | Demonstrated stability | Stability studies performed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "test set" sample size in the traditional sense of a clinical trial. Instead, the evaluation relies on a literature review of existing data for the Cumulase® enzyme.
- Data Provenance: The data provenance is described as "an evaluation of all relevant preclinical and clinical literature regarding the use of the Cumulase® enzyme." This indicates the data is retrospective, drawn from already published or available studies concerning the active enzyme. The country of origin for this literature is not specified, but the device manufacturer is Danish.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The evaluation was based on a literature review, not a new study with expert-labeled ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable/not provided. There was no new test set requiring expert adjudication in the context of this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This device is a medical media intended for laboratory use, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a biochemical solution (enzyme) used in a laboratory procedure, not an algorithm. The assessment focused on the safety and effectiveness of the media itself.
7. The Type of Ground Truth Used
- The "ground truth" for the safety and effectiveness determination was established through a review of existing preclinical and clinical literature on the Cumulase® enzyme. This literature would contain outcomes data from previous studies where the enzyme was used. The claim of "effective and safe" is based on the findings within this body of literature.
8. The Sample Size for the Training Set
- This information is not applicable/not provided. There is no "training set" in the context of this device, as it is not an AI/machine learning product. The evaluation relies on existing scientific literature, not a newly trained model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no training set for this type of device. The ground truth for the overall safety and effectiveness claim was established via a literature review of existing studies on the Cumulase® enzyme.
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SEP 1 9 2008
510(K) SUMMARY Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
| Submitted by: | MediCult a/sMøllehaven 124040 JyllingeDenmarkTelephone: + 45 46 79 02 00Fax: + 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.
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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).
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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.
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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
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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
§ 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.