(428 days)
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No
The device description and performance studies focus on a chemical solution (Hyaluronidase) used in ART procedures. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
The device is used in assisted reproduction techniques to facilitate pregnancy by removing cells to allow access to the oocyte before ICSI, directly aiding in a medical procedure to restore a bodily function (reproduction).
No
Explanation: The device is described as a medium used to remove cumulus and corona radiata cells from oocytes to facilitate access for ICSI, which is a preparatory step in assisted reproduction techniques. Its purpose is to aid in the procedure itself, not to diagnose a condition.
No
The device description clearly states it is a "Sperm Preparation Medium supplemented with Hyaluronidase," which is a chemical solution, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "For use in assisted reproduction techniques, (ART), such as IVF, GIFT or similar in vitro procedure to aid in facilitating pregnancy." and "for the removal of cumulus and corona radiatacells... in order to facilitate access to the oocyte and minimize contamination of the injected needle before ICSI." These procedures are performed in vitro (outside the body) on biological samples (oocytes and sperm).
- Device Description: The device is a "Sperm Preparation Medium supplemented with Hyaluronidase." This is a reagent used in the laboratory setting to process biological samples for diagnostic or therapeutic purposes related to reproduction.
- Care Setting: The intended user/care setting is "Assisted reproduction techniques, (ART), such as IVF, GIFT or similar In Vitro procedure," which are laboratory-based procedures.
While the document doesn't explicitly use the term "diagnostic," the actions performed with the device (processing gametes for ART) are integral to the in vitro process of assessing and facilitating fertilization and pregnancy. The removal of cumulus and corona radiata cells is a necessary step in preparing the oocyte for procedures like ICSI, which are part of the overall diagnostic and therapeutic process of ART.
Therefore, the device fits the definition of an IVD as it is a reagent intended for use in vitro in the examination of specimens derived from the human body (gametes) to provide information for the purpose of monitoring or aiding in the process of achieving pregnancy through ART.
N/A
Intended Use / Indications for Use
"Medi-Cult Hyaluronidase" is used in assisted reproduction techniques, (ART), such as IVF, GIFT or similar In Vitro procedure to aid in facilitating pregnancy.
"Medi-Cult Hyaluronidase" is for the removal of cumulus and corona radiatacells which must be removed in order to facilitate access to the oocytes and minimize contamination of the injected needle before ICSL
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
Sperm Preparation Medium supplemented with Hyaluronidase. It is a HEPES buffered salt solution supplemented with Hyaluronidase. It is ready-to-use and contains Synthetic Serum Replacement (SSR) and Human Serum Albumin (HSA). The Hyaluronidase raw material is derived from Bovine testes in the USA. It contains antibiotics - Penicillin and Streptomycin.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A number of trials have shown that the products performs well, (see Clinical Testing section). A number of publications in peer-reviewed books or journals have presented data using Medi-Cult media. Often more than one procent from Medi-Cult has been used in the studies listed.
The clinical result of a given IVF-clinic will depend on the patient population treated, the clinical procedures, the laboratory routines and on the various culture media used. A comparison of the clinical performance of clinics using only Medi-Cult products for ICSI with other IVP client using similar clinical and laboratory routines will give an indicate on the performance of the Medi-Cult culture media. In countries were we have access to both national data and data from in incul collected clinics, clinics using Medi-Cult products generally performs well.
The IVF-units in the Nordic countries use similar clinical and laboratory protocols and their patient populations are comparable. The clinical data from most Nordic countries are available. In some countries the performance of individual IVF-clinics are available.
The largest IVF clinics in Norway have been using only Medi-Cult media since the end of the 1980'ties and products from Medi-Cult for ICSL The data collected since the introduction of ICSI in Norway in 1996 are shown below as live birth rates per started cycle. Since all clinics (except one) are using products from Medi-Cult, a meaningful comparison to the national average success rate is not meaningful.
Table. Live birth rates per embryo replacement obtained with ICSI in Norway
| Clinic | 1996 | 1997 |
|---|---|---|
| Dept of Ob & Gyn, Univ. of Trondheim | 18,4 | 22,4 |
| The National Hospital, Oslo | 15,9 | 18,4 |
| Haugesund Hospital | 28,6 | 27,1 |
In Sweden, the Carl von Linne Clinic uses only products from Medi-Cult for ICSI and for culture of gametes and embryos. It is the only Swedish clinic using Medi-Cult products. For the year 1997 their birth rate per embryo replacement was 32% their clinical results were the best in Sweden and well above the national average of 25%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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.
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JUN 2 0 2000
Page 1 of 2
510(k) Summary Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
(K991334)
The product:
-"Medi-Cult Hyaluronidase" Cat.No. 1011
Indications for use:
"Medi-Cult Hyaluronidase" is used in assisted reproduction techniques, (ART), such as IVF, GIFT or similar In Vitro procedure to aid in facilitating pregnancy.
"Medi-Cult Hyaluronidase" is for the removal of cumulus and corona radiatacells which must be removed in order to facilitate access to the oocytes and minimize contamination of the injected needle before ICSL
Product formulation:
Sperm Preparation Medium supplemented with Hyaluronidase. It is a HEPES buffered salt solution supplemented with Hyaluronidase. It is ready-to-use and contains Synthetic Serum Replacement (SSR) and Human Serum Albumin (HSA). The Hyaluronidase raw material is derived from Bovine testes in the USA. It contains antibiotics - Penicillin and Streptomycin.
A number of trials have shown that the products performs well, (see Clinical Testing section). A number of publications in peer-reviewed books or journals have presented data using Medi-Cult media. Often more than one procent from Medi-Cult has been used in the studies listed.
Product testing control contents:
- Bioburden, production-test ・
- -Integrity filter testing, production-test
- -Sterility, QC-test
- pH, QC-test
- -Osmolarity, QC-test
- -Endotoxin, QC-test
The culture media from Medi-Cult have been used by many European IVF-units since the end of the 1980's. (Produced and distributed by GEA-Biotech 1987 to 1989 and by Medi-Cult als from 1989). The first Medi-Cult products for use in conjunction with Intra Cytoplasmic Sperm Injection (ICSI) were introduced in 1993. These products were designed in accordance with the specification of the clinic that developed ICSI (Palermo et al. Lancet 1992 340 8810 17-18).
A number of publications in peer- reviewed books or journals have presented data using Medi-Cult products for ICSI. Often more than one product from Medi-Cult has been used in the studies.
The clinical result of a given IVF-clinic will depend on the patient population treated, the clinical procedures, the laboratory routines and on the various culture media used. A comparison of the clinical performance of clinics using only Medi-Cult products for ICSI with other IVP client using similar clinical and laboratory routines will give an indicate on the performance of the Medi-Cult culture media. In countries were we have access to both national data and data from in incul collected clinics, clinics using Medi-Cult products generally performs well.
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K991334
Page 2 of 2
The IVF-units in the Nordic countries use similar clinical and laboratory protocols and their patient populations are comparable. The clinical data from most Nordic countries are available. In some countries the performance of individual IVF-clinics are available.
The largest IVF clinics in Norway have been using only Medi-Cult media since the end of the 1980'ties and products from Medi-Cult for ICSL The data collected since the introduction of ICSI in Norway in 1996 are shown below as live birth rates per started cycle. Since all clinics (except one) are using products from Medi-Cult, a meaningful comparison to the national average success rate is not meaningful.
Table. Live birth rates per embryo replacement obtained with ICSI in Norway
| Clinic | 1996 | 1997 |
|---|---|---|
| Dept of Ob & Gyn, Univ. of Trondheim | 18,4 | 22,4 |
| The National Hospital, Oslo | 15,9 | 18,4 |
| Haugesund Hospital | 28,6 | 27,1 |
In Sweden, the Carl von Linne Clinic uses only products from Medi-Cult for ICSI and for culture of gametes and embryos. It is the only Swedish clinic using Medi-Cult products. For the year 1997 their birth rate per embryo replacement was 32% their clinical results were the best in Sweden and well above the national average of 25%.
There have been no registered complaints for the product and no evidence in the last 1.5 year that the product has been the cause of any serious adverse events in connection with its intended use.
Thus based on the Federal Register Notice (Final Rule, Vol. 63, No. 175, page 48429, September 10, 1998), "Obstetric and Gynecologic Devices; Reclassification and Classification of Medical Devices Used for In-Vitro Fertilization and Related Assisted Reproduction Procedures" effective on October 13, 1998 and the supportive clinical data we feel that the safety and effectiveness of the product for its intended use is shown in the present submission.
Prepared and Submitted by:
Ronald G. Leonardi, Ph. D. 12/14/99
Date
Ronald &. Leonardi, Ph. D. President R & R Registrations P.O. Box 262069 San Diego CA 92196 1-619-586-0751
2
Image /page/2/Picture/15 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
JUN 2 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medi-Cult A/S c/o Ronald G. Leonardi, Ph.D. President R & R Registrations P.O. Box 262069 San Diego, CA 92196-2069
Re: K991334 Medi-Cult Hyaluronidase Dated: May 22, 2000 Received: May 23, 2000 Requiatory Class: II 21 CFR §884.6180/Procode: 85 MQL
Dear Dr. Leonardi:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 Federal Food, Grug, and Cosmelic Act (Act). 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 recistration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notfication submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
B4. Indication for Use Statement
510(k) Number (if know) K991334
Device Name: Medi-Cult Hyaluronidase
Indications for use:
For use in assisted reproduction techniques, (ART), such as IVF, GIFT or similar in vitro procedure to aid in facilitating pregnancy.
Medi-Cult Hyaluronidase is for the removal of cumulus and corona radiatacells which must be removed in order to facilitate access to the oocyte and minimize contamination of the injected needle before ICSI.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | ✓ |
| (Per 21 CFR 801.109) | OR |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices |
510(k) Number K991334