(381 days)
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No
The device is a sperm preparation medium, a chemical formulation, and the summary focuses on its composition and clinical performance in IVF procedures, with no mention of AI/ML.
Yes
The device (Medi-Cult Sperm Preparation Medium) is used for sperm washing and separation to facilitate capacitation and increase the likelihood of fertilization, as well as holding oocytes before ICSI, which directly supports reproductive therapeutic procedures.
No
Explanation: The device is a sperm preparation medium, used for washing and separating sperm to facilitate capacitation and for use as a holding medium for oocytes. It is a consumable product used in fertility treatments, not a device that diagnoses a condition or disease.
No
The device description clearly indicates a physical product (culture medium) with a specific chemical formulation and associated physical testing controls. It is not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for sperm washing and for sperm separation by swim-up method" and "as holding medium for the oocytes before ICSI." These are procedures performed in vitro (outside the body) on biological samples (sperm and oocytes) to aid in the process of fertilization.
- Device Description: The product is a "Sperm Preparation Medium," which is a reagent or solution used in laboratory procedures involving biological samples.
- Performance Studies: The performance studies discuss clinical outcomes (live birth rates, pregnancy rates) related to the use of the medium in IVF (In Vitro Fertilization) and IUI (Intrauterine Insemination) procedures, which are laboratory-based techniques.
While the document doesn't explicitly use the term "In Vitro Diagnostic," the nature of the product, its intended use in laboratory procedures involving biological samples for medical purposes (infertility treatment), and the performance data presented strongly align with the definition of an IVD.
N/A
Intended Use / Indications for Use
"Medi-Cult Sperm Preparation Medium" is for sperm washing and for sperm separation by swim-up method. The "Medi-Cult Sperm Preparation Medium" is also used as holding medium for the occytes before ICSL
The intended use of Medi-Cult Sperm Preparation Medium is for sperm washing and for sperm separation by swim-up method, since seminal plasma must be separated from the spermatozoa in order to facilitate capacitation. The selection of motil spermatozoa is done in order to increase the likelihood of fertilization.
The Sperm Preparation Medium is also used as holding medium for the oocytes before ICSI.
Product codes
85 MQL
Device Description
Product formulation: Earl's Balanced Salt Solution (EBSS) Sodium Pyruvate Synthetic Serum Replacement (SSR) 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, QC-test
- -Sperm Survival, QC-test
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
The culture media from Medi-Cult have been used by many European IVF-units since the end of 1980.
A number of publications in peer- reviewed books or journals have presented data using Medi-Cult media.
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 | 99.9 And for a loss | c Carola Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara And lest in days | 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 Fertilisation 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.
| 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 |
Some clinical data are available from clinics using Medi-Cult sperm preparation medium for in conjunction with intrauterine insemination. The outcome after insemination with husbands sperm (AIH) at the IVF-Unit University of Trondheim, Norway in the period 1988-1998.
| Number of inseminations | Clinical pregnancies | Pregnancy rate per insemination |
|---|---|---|
| 877 | 117 | 13.4 |
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
(K991332)
The products:
- -"Medi-Cult Sperm Preparation Medium" Cat.No. 1070
- -"Medi-Cult Sperm Preparation Medium w/o Pen/Strep." Cat.No 1068
- . "Medi-Cult Sperm Preparation Medium w/o Phenol Red" Cat.No 1069
Indication for use:
"Medi-Cult Sperm Preparation Medium" is for sperm washing and for sperm separation by swim-up method. The "Medi-Cult Sperm Preparation Medium" is also used as holding medium for the occytes before ICSL
Product formulation: Earl's Balanced Salt Solution (EBSS) Sodium Pyruvate Synthetic Serum Replacement (SSR) 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, QC-test
- -Sperm Survival, 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 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 waters of 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 performance of give an indicate on the performance of the Medi-Culture media. In countries were we have access to both national data and data from individual clinics, clinics using Medi-Cult media 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 and their patient of 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 | 99.9 | ||||
| And for a loss | c Carola Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara | ||||
| And lest in days | 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. Live birth rates per started cycle obtained in IVF units in Norway
1
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 Fertilisation 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 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 |
Data from insemination are not reported along the same lines as that of IVF/ICSI National data is therefore difficult to obtain. Many studies using the Medi-Cult sperm preparation medium have been published.
Some clinical data are available from clinics using Medi-Cult sperm preparation medium for in conjunction with intrauterine insemination. The outcome after insemination with husbands sperm (AIH) at the IVF-Unit University of Trondheim, Norway in the period 1988-1998.
| Number of
inseminations | Clinical pregnancies | Pregnancy rate per
insemination |
|----------------------------|----------------------|------------------------------------|
| 877 | 117 | 13.4 |
There have been no registered complaints on the product and there is no evidence in the last 1.5 year that the product has been the cause of any serious adverse events in connection with its intent 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 Lly-Vitro Fertilization and Related Assisted Reproduction Procedures" effective on October 13, 1998 and the upportive 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
President, R & R Registrations P.O. Box 262069, San Diego CA 92196 1-858-586-0751
Date
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three wavy lines representing the agency's mission to promote health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
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: K991332 Medi-Cult Sperm Preparation Medium Dated: April 20, 2000 Received: April 21, 2000 Requlatory 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 Ookland (for the indications for use stated in the enclosure) to legally marketed predicate devices device is Substantially equivality (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, nave been reclassince in acoordance that the provisions of the Act. The general controls provisions of the Act include mante the device, subject to the general senses, 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 such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Such additional Controls. Externination 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 requirements, as set form in the Quant Nogalar (FDA) will verify such assumptions. Failure to complions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish futher 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 Podrial Regions 531 through 542 of the Act for devices under the Electronic 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 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 and additionally 809.10 for in vites if you done specific device for your do habbing e at (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, "Mishranding by reference to premarket notification" (21CFR 807.97) Other general information on your responsibilities under the mission of Childred 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/dsma/dsmamain.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 Radiolonical Health
Enclosure(s)
3
B4. Indication for Use Statement
510(k) Number (if know)$^h$ K991332
Device Name: Medi-Cult Sperm Preparation -- Medium
Indications for use:
The intended use of Medi-Cult Sperm Preparation Medium is for sperm washing and for sperm separation by swim-up method, since seminal plasma must be separated from the spermatozoa in order to facilitate capacitation. The selection of motil spermatozoa is done in order to increase the likelihood of fertilization.
The Sperm Preparation Medium is also used as holding medium for the oocytes 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 | K991332 |