(463 days)
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No
The device description and performance studies focus on the chemical composition and clinical performance of a culture medium, with no mention of AI or ML technologies.
No.
The product is an IVF medium used for fertilisation and culture of oocytes and as a vehicle during embryo transfer, but it does not directly treat or prevent a disease or condition in a patient.
No
Explanation: This device is a culture medium used for fertilisation and culture of human oocytes and as a vehicle during embryo transfer. It is not designed to diagnose a condition, but rather to facilitate a biological process.
No
The device description clearly indicates the product is a physical substance (culture medium) composed of various chemical components, 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 fertilisation of human oocytes and culture of fertilised oocytes". This process is performed in vitro (outside the body) to aid in diagnosis and treatment of infertility.
- Device Description: The device is a culture medium, which is a reagent used in laboratory procedures.
- Context: The device is intended for use in "IVF-units", which are clinical laboratories performing in vitro fertilization procedures.
While the description doesn't explicitly use the term "diagnostic," the function of supporting the fertilization and early development of human embryos in vitro is a key component of the diagnostic and treatment pathway for infertility. Culture media used in IVF are generally classified as IVDs because they are essential reagents for performing a diagnostic and therapeutic procedure.
N/A
Intended Use / Indications for Use
"Medi-Cult Universal IVF Medium" is for fertilisation of human oocytes and culture of fertilised oocytes up to the 4-6-cell stage (day 2 after insemination). "Medi-Cult Universal IVF Medium" can also be used as vehicle during embryo transfer.
Medi-Cult Universal IVF Medium is used for the fertilization of human oocytes and culture of fertilized oocytes up to the 4-6-cell stage {day 2 after insemination).
Medi-Cult Universal IVF Medium can also be used as vehicle during embryo transfer.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
The products:
- "Medi-Cult Universal IVF Medium" Cat.No. 1031 -
- "Medi-Cult Universal IVF Medium w/o Phenol" Cat.No. 1030 -
- "Medi-Cult Universal IVF Medium w/o Pen/Strep" Cat.No. 1095 -
Product formulation:
Earl's Balanced Salt Solution (EBSS) Sodium Pyruvate Assisted Reproduction Technology Supplement (ARTS) Sodium Bicarbonate Human Serum Albumin (HSA) Penicillin (Except product 1095) Streptomycin (Except product 1095) Phenol Red (Except product 1030)
Product testing control contents:
- Bioburden, production-test -
- Integrity filter testing, production-test -
- ー Sterility. QC-test
- pH, QC-test
- Osmolarity, QC-test -
- -Endotoxin, QC-test
- Mouse Embryo, (two cells assay; > 80% hatched) QC-test -
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A number of prospective randomized trials have shown that The Medi-Cult-IVF-medium performs equally well or better than altemative culture media. A number of publications in peerreviewed books or journals have presented data using Medi-Cult media.
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's. The data collected in the years from 1992 to 1996 are shown below as live birth rates per started cycle.
| Clinic | 1992 | 1993 | 1994 | 1995 | 1996 |
|---|---|---|---|---|---|
| Dept of Ob & Gyn, Univ of Trondheim | 22.2 | 22.2 | 19.8 | 25.35 | 18.4 |
| The National Hospital, Oslo | 13.3 | 19.0 | 15.8 | 11.42 | 17.4 |
| National average | 14.6 | 17.5 | 17.9 | 16.84 | 16.3 |
Table 1. Live birth rates per started cycle obtained in IVF units in Norway
In Sweden, the Carl von Linne Clinic uses only products from Medi-Cult for culture of gametes and embryos. For the vear 1997 their birth rate per embryo replacement was 34% their clinical results were the best in Sweden and well above the national average of 25.8%.
The Human Fertilization and Embryology Authority (HFEA) in the UK collects clinical data from all centers licensed to offer treatment for infectility by assisted reproduction. HFEA publishes these data in a booklet and on the web. The clinical data are presented both unadjusted and adjusted for the demographics of the clinics patient population.
In the Table below the clinical data from some UK-clinics that use only Medi-Cult products is shown. These clinics have all given their consent to be presented as clinics using only Medi-Cult products.
Table 2. Live birth rates per embryo replacement obtained in IVF units in the period April 186 1996 to March 31, 1997.
| Name of clinic | Number of IVF- cycles | Live birth rate per embryo replacement % |
|---|---|---|
| Northamptonshire Fertility service | 503 | 26.0 |
| The Bridge Centre | 852 | 27.2 |
| Chelsea and Westminster Hospital | 388 | 22.3 |
| CARE at Park Hospital | 650 | 34.5 |
| BMI Ross Hall Hospital | 68 | 27.5 |
| The Woking Nuffield Hospital | 163 | 32.6 |
| Leeds General Infirmary | 1434 | 24.0 |
| Nurture | 1245 | 28.8 |
| Holly House Fertility and IVF | 333 | 30.5 |
| Guy's and St Thomas Assisted Conception Unit | 651 | 27.1 |
| UK national average | 33520 | 21.8 |
There have been some registered complaints on the product but there is no evidence in the last 1.5 years that the product has been the cause of any serious adverse events in connection with its intended use.
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.
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
510(k) Summary Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination (K991279)
Page 1 of 3
The products:
- "Medi-Cult Universal IVF Medium" Cat.No. 1031 -
- "Medi-Cult Universal IVF Medium w/o Phenol" Cat.No. 1030 -
- "Medi-Cult Universal IVF Medium w/o Pen/Strep" Cat.No. 1095 -
Indications for use:
"Medi-Cult Universal IVF Medium" is for fertilisation of human oocytes and culture of fertilised oocytes up to the 4-6-cell stage (day 2 after insemination). "Medi-Cult Universal IVF Medium" can also be used as vehicle during embryo transfer.
Product formulation:
Earl's Balanced Salt Solution (EBSS) Sodium Pyruvate Assisted Reproduction Technology Supplement (ARTS) Sodium Bicarbonate Human Serum Albumin (HSA) Penicillin (Except product 1095) Streptomycin (Except product 1095) Phenol Red (Except product 1030)
Product testing control contents:
- Bioburden, production-test -
- Integrity filter testing, production-test -
- ー Sterility. QC-test
- pH, QC-test
- Osmolarity, QC-test -
- -Endotoxin, QC-test
- Mouse Embryo, (two cells assay; > 80% hatched) QC-test -
The culture media from Medi-Cult have been used by many European IVF-units since the end of 1980. (Produced and distributed by GEA-Biotech 1987 to 1989 and by Medi-Cult a/s from 1989). The Medi-Cult media were at that time introduced as a replacement for in-house prepared culture media.
A number of prospective randomized trials have shown that The Medi-Cult-IVF-medium performs equally well or better than altemative culture media. A number of publications in peerreviewed books or journals have presented data using Medi-Cult media.
The clinical result of a given IVF-clinic will depend on the patient population treated, the clinical procedures, laboratory routines and on the various culture media used. A comparison of the clinical performance of clinics using only Medi-Cult media with other IVF-clinics using similar clinical and laboratory routines will give an indication on the performance of the Medi-Cult culture media. In countries where we have access to both national data from individual clinics, clinics using Medi-Cult media generally perform well.
1
K 991279
Page 2 of 3
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's. The data collected in the years from 1992 to 1996 are shown below as live birth rates per started cycle.
| Clinic | 1992 | 1993 | 1994 | 1995 | 1996 |
|---|---|---|---|---|---|
| Dept of Ob & Gyn, Univ of Trondheim | 22.2 | 22.2 | 19.8 | 25.35 | 18.4 |
| The National Hospital, Oslo | 13.3 | 19.0 | 15.8 | 11.42 | 17.4 |
| National average | 14.6 | 17.5 | 17.9 | 16.84 | 16.3 |
| Table 1. Live birth rates per started cycle obtained in IVF units in Norway | |||
|---|---|---|---|
| ----------------------------------------------------------------------------- | -- | -- | -- |
In Sweden, the Carl von Linne Clinic uses only products from Medi-Cult for culture of gametes and embryos. For the vear 1997 their birth rate per embryo replacement was 34% their clinical results were the best in Sweden and well above the national average of 25.8%.
The Human Fertilization and Embryology Authority (HFEA) in the UK collects clinical data from all centers licensed to offer treatment for infectility by assisted reproduction. HFEA publishes these data in a booklet and on the web. The clinical data are presented both unadjusted and adjusted for the demographics of the clinics patient population.
In the Table below the clinical data from some UK-clinics that use only Medi-Cult products is shown. These clinics have all given their consent to be presented as clinics using only Medi-Cult products.
Table 2. Live birth rates per embryo replacement obtained in IVF units in the period April 186 1996 to March 31, 1997.
| Name of clinic | Number of | Live birth rate per |
|---|---|---|
| IVF- cycles | embryo replacement % | |
| Northamptonshire Fertility service | 503 | 26.0 |
| The Bridge Centre | 852 | 27.2 |
| Chelsea and Westminster Hospital | 388 | 22.3 |
| CARE at Park Hospital | 650 | 34.5 |
| BMI Ross Hall Hospital | 68 | 27.5 |
| The Woking Nuffield Hospital | 163 | 32.6 |
| Leeds General Infirmary | 1434 | 24.0 |
| Nurture | 1245 | 28.8 |
| Holly House Fertility and IVF | 333 | 30.5 |
| Guy's and St Thomas Assisted Conception Unit | 651 | 27.1 |
| UK national average | 33520 | 21.8 |
There have been some registered complaints on the product but there is no evidence in the last 1.5 years that the product has been the cause of any serious adverse events in connection with its intended use.
2
K991279
Page 3 of 3
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:
Rune Wilhe-Leonardi 4/21/00
Ronald G. Leonardi, Ph. D. Date
Ronald G. Leonardi, Ph. D. President R & R Registrations P.O. Box 262069 San Diego CA 92196 858-586-0751
3
Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is composed of three curved lines, and there are three wavy lines below the eagle, possibly representing water.
Public Health Service
JUL 2 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medi-Cult, A/S c/o Ronald G. Leonardi, Ph.D. R & R Registrations P.O. Box 262069 San Diego, California 92196-2069 Re: K991279 Medi-Cult Universal IVF-Medium-Assisted Reproduction Technology Supplement (ARTS) Dated: April 20, 2000 Received: April 21, 2000 Regulatory 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 we have reviewed your Occared or requireditions for use stated in the enclosure) to legally marketed predicate devices device is substantially equivately (10 the moducal of the Medical Device Amendments, or to devices that maneted in interstate conmisions of the Federal Food, Orug, and Cosmetic Act (Act (Act (Act (Act, You may, therefore, nave occh receasured in acorrance that all players of the Act. The general controls provisions of the Act Include mants the october to the goned condevies, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to il your device (see above) in oknier also title base the pyrum in the Code of Federal Requilations, This 21, Such additions Confiness Existing major regulations and the Current Good Manufacting Practice r ans oo oo oos. A Substantant Squalition (QS) for Medical Devices: General regulation (21 CFR Part 820) and requirements, as sections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might the Edefarmediate. Thease note the responses to Joines under the Electionic Product 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 r no to the nequivalence 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.
11 for in esire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for incritor ir you desire specific article for your do hassing of (301) 594-4591. Additionally, for questions on the promotion 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 million and be obtained to pivision 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 C. Schultz, M.D.
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)
4
510(k) Number (if known): K991279
Device Name: Medi-Cult Universal IVF Medium
Indications for Use:
Medi-Cult Universal IVF Medium is used for the fertilization of human oocytes and culture of fertilized oocytes up to the 4-6-cell stage {day 2 after insemination).
Medi-Cult Universal IVF Medium can also be used as vehicle during embryo transfer.
(PLEASE DO NO 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 _________________________________________________________________________________________________________________________________________________________
David A. Elgerson
(Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number