K Number
K991331
Device Name
MEDI-CULT M3 MEDIUM
Manufacturer
Date Cleared
2000-06-20

(428 days)

Product Code
Regulation Number
884.6180
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
"Medi-Cult M3 Medium" is intended for the culture of embryos from day 3 and up to day 7.
Device Description
"Medi-Cult M3 Medium" is based on MCDB 302; a modification of HAM's F10 and F12 composed of amino acids, vitamins, inorganic salts and glucose supplemented with: Assisted Reproduction Technique Supplement (ARTS) Sodium Bicarbonate Human Serum Albumin (HSA) (obtained from a licensed source, U.S. license No. 140) Penicillin (Except product 1032) Streptomycin (Except product 1032) Phenol Red (Except product 1037)
More Information

Not Found

Not Found

No
The device description and performance studies focus on the chemical composition and biological performance of a cell culture medium, with no mention of AI or ML technologies.

No
The device is a culture medium for embryos, which facilitates their growth, rather than directly treating a medical condition or disease.

No

Explanation: The device is an embryo culture medium used for growing embryos from day 3 to day 7. It is not described as diagnosing any condition or disease.

No

The device description clearly indicates it is a culture medium composed of various chemical components, not software.

Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "for the culture of embryos from day 3 and up to day 7." This process of culturing embryos is performed in vitro (outside the living body) to aid in diagnosis or treatment related to fertility. While the medium itself isn't directly diagnosing a condition, it's a critical component used in a diagnostic or therapeutic procedure performed in vitro.
  • Device Description: The description details the chemical composition of the medium, which is designed to support the growth and development of embryos in vitro.
  • Performance Studies: The performance studies describe comparisons of the medium's effectiveness in supporting blastocyst formation, which is an in vitro outcome relevant to the success of assisted reproductive technologies.

IVDs are defined as 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 medium isn't directly diagnosing a disease, it's an essential tool used in the in vitro process of assisted reproduction, which is a medical intervention related to a health condition (infertility).

Therefore, "Medi-Cult M3 Medium" fits the definition of an IVD because it is a reagent used in vitro as part of a process related to a health condition.

N/A

Intended Use / Indications for Use

"Medi-Cult M3 Medium" is intended for the culture of embryos from day 3 and up to day 7.

Product codes

85 MQL

Device Description

"Medi-Cult M3 Medium" is based on MCDB 302; a modification of HAM's F10 and F12 composed of amino acids, vitamins, inorganic salts and glucose supplemented with: Assisted Reproduction Technique Supplement (ARTS) Sodium Bicarbonate Human Serum Albumin (HSA) (obtained from a licensed source, U.S. license No. 140) Penicillin (Except product 1032) Streptomycin (Except product 1032) Phenol Red (Except product 1037)

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

Not Found

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

Not Found

Summary of Performance Studies

One center performed a prospective randomised study comparing the Medi-Cult M3 medium with the Scandinavian Science S2 medium. They found a similar rate of blastocyst formation (Source Dr. Anita Sjogren the Dept of Ob. & Gyn., Sahlgrenska hospital in Gothenburg, Sweden, data presented as poster at The world IVF meeting in Boston 1995).

The Jones Institute for Reproductive Medicine, Eastern Virginia Medical school, Norfolk, USA, has performed a prospective randomised study comparing the rate of blastocyst formation when human embryos are cultured in two different commercially available culture systems. The embryos were cultured either in the Medi-Cult universal IVF-medium for 2 days followed by The Medi-Cult M3 or in S1 for 2 days followed by S2 from Scandinavian IVF Science. The rate of blastocyst formation was similar in both groups (26% vs 27% respectively).

Key Metrics

Not Found

Predicate Device(s)

Not Found

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

Page 1 of 2

510(k) Summary Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination (K991331)

The products:

  • "Medi-Cult M3 Medium" Cat.No. 1033 -
  • "Medi-Cult M3 Medium w/o Pen/Strep." Cat.No. 1032 ﮯ
  • -"Medi-Cult M3 Medium w/o Phenol Red" Cat.No. 1037

Indication of use:

"Medi-Cult M3 Medium" is intended for the culture of embryos from day 3 and up to day 7.

Product formulation:

"Medi-Cult M3 Medium" is based on MCDB 302; a modification of HAM's F10 and F12 composed of amino acids, vitamins, inorganic salts and glucose supplemented with:

Assisted Reproduction Technique Supplement (ARTS) Sodium Bicarbonate Human Serum Albumin (HSA) (obtained from a licensed source, U.S. license No. 140) Penicillin (Except product 1032) Streptomycin (Except product 1032) Phenol Red (Except product 1037)

Products testing control contents:

  • Bioburden, production-test -
  • Integrity filter testing, production-test -
  • -Sterility, QC-test
  • pH, QC-test -
  • -Osmolarity, QC-test
  • -Endotoxin, OC-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 a/s from 1989)

The Medi-Cult M3 medium was introduced in 1992 to allow extended culture of embryos beyond day 2/3 after fertilisation. The Medi-Cult M3 medium has been used by several clinics obtaining good morula/blastocyst formation and good pregnancy rates.

A few prospective randomised studies have been performed showing that the Medi-Cult M3 medium performs equally well as other products available for extended culture.

1

K991331
Page 2 of 2

One center performed a prospective randomised study comparing the Medi-Cult M3 medium with the Scandinavian Science S2 medium. They found a similar rate of blastocyst formation (Source Dr. Anita Sjogren the Dept of Ob. & Gyn., Sahlgrenska hospital in Gothenburg, Sweden, data presented as poster at The world IVF meeting in Boston 1995).

The Jones Institute for Reproductive Medicine, Eastern Virginia Medical school, Norfolk, USA, has performed a prospective randomised study comparing the rate of blastocyst formation when human embryos are cultured in two different commercially available culture systems. The embryos were cultured either in the Medi-Cult universal IVF-medium for 2 days followed by The Medi-Cult M3 or in S1 for 2 days followed by S2 from Scandinavian IVF Science. The rate of blastocyst formation was similar in both groups (26% vs 27% respectively).

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 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:

Rute Wicheep. Lenardi 1/22/02

Ronald G. Leonardi, Ph. D. Date

Ronald G. Leonardi, Ph. D. President R & R Registrations P.O. Box 262069 San Diego CA 92196 1-858-586-0751

2

Image /page/2/Picture/1 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 fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2000

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: K991331 Medi-Cult M3 Medium Dated: May 22, 2000 Received: May 23, 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 device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror to May 20, 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 indude 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 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 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 regulator, In addition, 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 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 vitro diagnostic devices), please contact the Office of Compliance 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, "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/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 Radiological Health

Enclosure(s)

3

510(k) Number (if known) K991331

Device Name: Medi-Cult M3 Medium

Indications for Use:

M3 Medium is used for the culture of embryos from day 3 and up to day 7.

(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

(Optional Format 1-2-96)

David A. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number