(381 days)
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Not Found
No
The device is a flushing medium, a chemical solution, and the description does not mention any computational or analytical capabilities.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is a medium used for oocyte retrieval, washing, and holding, which are steps in assisted reproduction, not a treatment itself.
No
The device is a flushing medium used for oocyte retrieval, washing, and holding, indicating it is a laboratory reagent or medium, not a diagnostic tool that identifies or assesses a disease or condition.
No
The device description clearly states the product is a "Flushing Medium" with a specific chemical formulation, indicating it is a physical substance, not software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for oocyte retrieval and oocyte washing and for holding throughout oocyte recovery." This involves handling human biological material (oocytes) in vitro (outside the body) for a medical purpose (assisted reproduction).
- Device Description: The product is a "Flushing Medium" with a specific chemical formulation. This type of medium is used to maintain the viability and integrity of biological samples in vitro.
- Performance Studies: The performance studies focus on clinical outcomes related to assisted reproduction (live birth rates), which are directly linked to the quality and effectiveness of the medium in handling the biological samples.
- Intended User/Care Setting: The intended user is an "Embryology laboratory," which is a setting where in vitro procedures involving human biological material are performed.
While the document doesn't explicitly state "In Vitro Diagnostic," the nature of the product, its intended use, and the context of its use strongly align with the definition of an IVD. IVDs are products used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, the medium is used to handle and maintain human oocytes in vitro as part of an assisted reproduction process, which is a medical procedure.
N/A
Intended Use / Indications for Use
"Medi-Cult Flushing Medium" is used for retrieval and washing of human oocytes and holding throughout oocytes recovery.
A specially designed culture medium is necessary to ensure that the oocytes are contained in a solution with stable pH and temperature during oocytes retrieval and transport of oocytes from the operating theatre to the embryology laboratory. Thus enabling successful future fertilisation of human oocytes.
Flushing Medium is used for oocyte retrieval and oocyte washing and for holding throughout oocyte recovery.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
The product formulation: Earl's Balanced Salt Solution (EBSS) Sodium Pyruvate Assisted Reproduction Technology Supplement (ARTS) HEPES Sodium Bicarbonate Human Serum Albumin (HSA) Penicillin Streptomycin Phenol Red
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)
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 alternative culture media. A number of publications in peer- reviewed 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, the 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 were we have access to both national data and data from individual clinics, clinics using Medi-Cult media generally perform 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 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.
In Sweden, the Carl von Linne Clinic uses only products from Medi-Cult for culture of gametes and embryos, For the year 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 centres licensed to offer treatment for infertility by assisted reproduction. HFEA publishes these data in a booklet and on the web. The clinical data are presented both unadjusted 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.
There have been no registered complaints on the product and 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
MAY - 4 2000
510(k) Summary Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination (K991327)
The products:
- "Medi-Cult Flushing Medium" Cat.No. 1084, .
- "Medi-Cult Flushing Medium w/o Pen/Strep." Cat.No. 1087 -
- "Medi-Cult Flushing Medium w/o Phenol Red" Cat.No. 1082 -
- -"Medi-Cult Flushing Medium w/o Phenol Red & Pen/Strep." Cat.No. 1080
The indication for use:
"Medi-Cult Flushing Medium" is used for retrieval and washing of human oocytes and holding throughout oocytes recovery.
A specially designed culture medium is necessary to ensure that the oocytes are contained in a solution with stable pH and temperature during oocytes retrieval and transport of oocytes from the operating theatre to the embryology laboratory. Thus enabling successful future fertilisation of human oocytes.
The product formulation: Earl's Balanced Salt Solution (EBSS) Sodium Pyruvate Assisted Reproduction Technology Supplement (ARTS) HEPES Sodium Bicarbonate Human Serum Albumin (HSA) Penicillin Streptomycin Phenol Red
Product testing control contents:
- -Bioburden, production-test
- -Integrity filter testing, production-test
- -Sterility, QC-test
- pH, QC-test
- -Osmolarity, QC-test
- -Endotoxin, OC-test
- Mouse Embryo, QC-test (Two cell assay >80 % hatching) -
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 alternative culture media. A number of publications in peer- reviewed 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, the 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 were we have access to both national data and data from individual clinics, clinics using Medi-Cult media generally perform 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 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.
1
| Table 1. Live birth rates per started cycle obtained in IVF units in Norway. | Comments of the program and the commend of the comments of the large of the later of the comments of the comments of the comments of the comments of the comments of the contr | |
|---|---|---|
| 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 |
In Sweden, the Carl von Linne Clinic uses only products from Medi-Cult for culture of gametes and embryos, For the year 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 centres licensed to offer treatment for infertility by assisted reproduction. HFEA publishes these data in a booklet and on the web. The clinical data are presented both unadjusted 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 TVF units in the UK in the period April 1* 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 no registered complaints on the product and 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.
Thus based on the Federal Register Notice (Final Rule, Vol. 63, No. 175, page 48429, September 10, 1998, "Obstetric and Gynaecologic Devices; Reclassification and Classification of Medical Devices Used for In-Vitro Fertilization and Related 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:
Rute Nunes-Lemadeira 4/20/
Ronald G. Leonardi, Ph. D President R & R REGISTRATIONS P.O. Box 262069 San Diego, CA 92131 619-586-0751
Date
2
Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes extending to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY = 4 2000
Medi-Cult A/S c/o Ronald G. Leonardi, Ph.D. President R & R Registrations P.O. Box 262069 San Diego, CA 92196
Re: K991327 Medi-Cult Flushing Medium Dated: April 20, 2000 Received: April 24, 2000
21 CFR §884.6180/Procode: 85 MQL
Requiatory Class: Il
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 provisions of the Federal Food, Drug, and Cosmetic 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 registration, 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 equivalent determination 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 requlation may result in requlation. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 Compiance 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) 443-5597 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
510(k) Number (if known) K991327
Medi-Cult Flushing Medium Device Name:
Indications for Use:
Flushing Medium is used for oocyte retrieval and oocyte washing and for holding throughout oocyte recovery.
(PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) ਾ (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number _