(55 days)
SynVitro Cumulase™ is used by professionals within assisted reproduction for the removal of the cell complex (cumulus and corona radiata) surrounding the oocyte in the preparation for intracytoplasmatic sperm injection (ICSI).
SynVitro Cumulase™ is indicated for the removal of the cell complex (cumulus and corona radiate) surrounding the oocyte in preparation for the ICSI procedure.
SynVitro®Cumulase™ is a sterile non preserved solution containing 80 U/mL of recombinant Synther Camandase (rHuPH20) in a HEPES buffered salt solution with SSR (Synthetic serum replacement) added.
The provided document describes the acceptance criteria and the study for the SynVitro®Cumulase™ device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Efficacy in removing cumulus cells prior to ICSI (compared to predicate device) | The study showed that SynVitro®Cumulase™ and the predicate device (MediCult's SynVitro®Hyadase) were equally effective for removal of cumulus cells prior to ICSI. |
| Biocompatibility (as it is not in contact with the patient) | Not applicable, as the product is not in contact with the patient. |
| Cytotoxicity | Each batch is cytotoxicity tested. |
| Sterility (Ph. Eur. and USP) | Each batch is tested according to Ph. Eur. and USP for sterility. |
| Osmolality | Each batch is tested for osmolality. |
| pH | Each batch is tested for pH. |
| Stability | Stability studies have been performed. |
| Absence of serious adverse events or registered complaints | There have been no registered complaints and no evidence of any serious adverse events in connection with the intended use during the studies. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "The efficiency of removing the cumulus from the oocytes have been compared to the predicated device in a prospective, randomised clinical study."
- Sample Size for Test Set: The specific sample size (number of patients or oocytes) for this clinical study is not explicitly mentioned in the provided text.
- Data Provenance: The study was a "prospective, randomised clinical study," indicating that data was collected specifically for this study in a prospective manner. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number of experts used or their qualifications to establish ground truth for the clinical study. The assessment of "efficiency of removing the cumulus from the oocytes" would typically involve embryologists or fertility specialists, but this is not detailed.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for evaluating the results of the clinical study.
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:
This device is a medical product (a solution/reagent) used in assisted reproduction, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this submission and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This device is a chemical reagent, not a standalone algorithm. Therefore, a standalone performance study as described is not applicable and was not performed.
7. The Type of Ground Truth Used:
For the primary efficacy endpoint (efficiency of cumulus removal), the ground truth was likely established through direct observation and evaluation by trained professionals (e.g., embryologists) in the context of the prospective clinical study. This would fall under expert observation/assessment based on established laboratory protocols in assisted reproduction.
8. The Sample Size for the Training Set:
This device is a chemical reagent, not a machine learning algorithm that requires a "training set." Therefore, the concept of a training set sample size is not applicable.
9. How the Ground Truth for the Training Set was Established:
As explained above, a "training set" is not applicable for this type of device.
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MAY 10
510(K) SUMMARY Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
SynVitro®Cumulase™ is a sterile non preserved solution containing 80 U/mL of recombinant Synther Camandase (rHuPH20) in a HEPES buffered salt solution with SSR (Synthetic serum replacement) added.
Intended Use
SynVitro Cumulase™ is used by professionals within assisted reproduction for the removal of the cell complex (cumulus and corona radiata) surrounding the oocyte in the preparation for intracytoplasmatic sperm injection (ICSI).
Biocompatibility testing
The product is not in contact with the patient, thus, biocompatibility studies have not been performed.
Product Testing Controls
SynVitro Cumulase™ has been cytotoxicity tested. Each batch is tested according to Ph. Eur. and USP for sterility, osmolality, pH and cytotoxicity using the Mouse embryo Assay (MEA). Stability studies have been performed.
Clinical Documentation
Chilical Doculidentation
The predicated device is MediCult's SynVitro®Hyadase (K031228). The efficiency of removing the cumulus from the oocytes have been compared to the predicated device in a prospective, randomised clinical study .The study showed that the two products were equally effective for removal of cumulus cells prior to ICSI.
There has been no registered complaints and no evidence of any serious adverse events in connection with the intended use, during these studies.
It is concluded that SynVitro™Cumulase is substantially equivalent to the predicated device SynVitro Hyadase.
Prevared and Submitted for Medi
March 14, 2006
Date
Ronald G. Leonardi, Ph.D. President R & R REGISTRATIONS P.O. Box 262069 San Diego, Ca 92131 858-586-0751
011
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 10 2006
MediCult a/s % Ronald G. Leonardi, Ph.D. President R&R Registrations 9915 Cam. Chirimolla SAN DIEGO CA 92131
Re: K060699
Trade/Device Name: SynVitro® Cumulase™ Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: March 14, 2006 Received: March 17, 2006
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 (Premarket Approval), 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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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 (OS) 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K060.699
Indications for Use
510(k) Number (if known):
Device Name:
SynVitro®Cumulase™
Indications For Use:
SynVitro Cumulase™ is indicated for the removal of the cell complex (cumulus and corona radiate) surrounding the oocyte in preparation for the ICSI procedure.
60699
AND/OR Over-The-Counter Use _ Prescription Use × (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
Nancy C. Broadon
Division Sign-Off Division of Reprod ctive. and Radiological Dev 510(k) Number
010
§ 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.