MEDI-CULT LIQUID PARAFFIN

K991330 · Medicult A/S · MQL · Feb 25, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K991330
• Device Name: MEDI-CULT LIQUID PARAFFIN
• Applicant: Medicult A/S
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Feb 25, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Liquid Paraffin is used as an overlay to stabilise pH and reduce evaporation during IVF and ICSI procedures.

Device Story

Medi-Cult Liquid Paraffin functions as a physical overlay medium in IVF and ICSI laboratory procedures; applied to culture dishes to prevent evaporation of culture media and maintain stable pH levels for gametes and embryos. Used by embryologists and laboratory technicians in clinical IVF/ART settings. Device provides a protective barrier; ensures environmental stability for sensitive reproductive cells during incubation. No automated processing or electronic components involved.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by historical usage in IVF/ART clinics and laboratories with no reported adverse events or complaints over a 1.5-year period.

Technological Characteristics

Liquid paraffin (mineral oil) used as a chemical overlay. Non-electronic, non-software, standalone reagent. No specific material standards or energy sources required.

Indications for Use

Indicated for use as an overlay to stabilize pH and reduce evaporation during in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) procedures.

Regulatory Classification

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.).

Special Controls

*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.

Submission Summary (Full Text)

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K991330

## B5. 510(k) Summary

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

The product "Medi-Cult Liquid Paraffin " for support of In-Vitro fertilisation has been used extensively over a number of years to the satisfaction of the users at the IVF- and ART- clinics and laboratories.

There have been no registered complaints on 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 C. Koonardi, Ph. D. 4/16/99
Date

Ronald G. Leonardi, Ph. D President R&R Registrations P.O. Box 262069 San Diego CA 92196 1-619-586-0751

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Public Health Service

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 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: K991330

Medi-Cult Liquid Paraffin Dated: November 30, 1999 Received: December 1, 1999 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 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 practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or 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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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. 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 have under sections 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 vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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## B4. Indication for Use Statement

K991330 510(k) Number (if know

Device Name: Medi-Cult Liquid Paraffin

Indications for use:

Liquid Paraffin is used as an overlay to stabilise pH and reduce evaporation during IVF and ICSI procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optignal Format 1-2-96)

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