(55 days)
Not Found
No
The device description and intended use describe a chemical solution for removing cells, with no mention of software, algorithms, or any technology related to AI/ML. The performance study compares the effectiveness of this solution to a predicate device, not the performance of an AI/ML algorithm.
No.
The device is used for in-vitro manipulation of reproductive cells (oocytes) and not for treating a disease or condition in a patient. It is a reagent used in the preparation for a medical procedure (ICSI).
No
Explanation: The device, SynVitro Cumulase™, is used for the removal of cell complexes surrounding an oocyte in preparation for intracytoplasmatic sperm injection (ICSI). This is a preparatory step for a medical procedure, not a diagnostic one.
No
The device description explicitly states it 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," indicating it is a chemical solution, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that SynVitro Cumulase™ is used for the "removal of the cell complex (cumulus and corona radiata) surrounding the oocyte in the preparation for intracytoplasmatic sperm injection (ICSI)." This process is performed in vitro (outside the body) on biological material (oocytes).
- Device Description: The device is a "sterile non preserved solution" used to act on the oocyte. This is consistent with the nature of reagents and solutions used in in vitro procedures.
- User: The intended users are "professionals within assisted reproduction," which aligns with the specialized nature of in vitro fertilization procedures.
The definition of an IVD generally includes 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. While this device isn't directly diagnosing a disease, it is a critical component in a procedure (ICSI) that is used to address infertility, which is considered a medical condition. The preparation of the oocyte is an in vitro step essential for the success of the ICSI procedure.
Therefore, based on its intended use and the nature of the device, SynVitro Cumulase™ fits the criteria of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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).
SynVitro®Cumulase™ is indicated for the removal of the cell complex (cumulus and corona radiate) surrounding the oocyte in preparation for the ICSI procedure.
Product codes
MQL
Device Description
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.
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
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.
Summary of Performance Studies
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.
Key Metrics
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.
0
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
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is in a sans-serif font.
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.
Image /page/1/Picture/10 description: The image shows a logo with the letters FDA in bold, surrounded by the words "Centennial" and "2006-2006". There are three stars below the word Centennial. The logo is surrounded by a circular border with text. Below the logo is the phrase "Protecting and Promoting Public Health".
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 (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
3
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