(312 days)
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No
The summary describes a liquid paraffin product used in IVF procedures, with no mention of AI or ML technology.
No
This device is described as an overlay to stabilize pH and reduce evaporation during IVF and ICSI procedures, rather than for direct therapeutic intervention on a patient. Its intended use is laboratory-based support for a medical procedure.
No
Explanation: The device, Liquid Paraffin, is described as an overlay to stabilize pH and reduce evaporation during IVF and ICSI procedures. Its function is to support the environment for these procedures, not to diagnose a condition or disease.
No
The device description clearly states "Liquid Paraffin," which is a substance, not software. The intended use also describes a physical process involving this substance.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an overlay to stabilise pH and reduce evaporation during IVF and ICSI procedures." IVF and ICSI are procedures involving the manipulation of human gametes and embryos in vitro (outside the body).
- Device Description: The device is "Medi-Cult Liquid Paraffin." While liquid paraffin itself isn't a diagnostic test, its use in the context of IVF/ICSI procedures falls under the umbrella of supporting in vitro diagnostic or therapeutic processes.
- Intended User / Care Setting: The intended users are "IVF and ART clinics and laboratories." These are settings where in vitro procedures are performed.
Why it fits the definition of an IVD (or a device used in conjunction with IVD procedures):
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 liquid paraffin isn't directly diagnosing a condition, it's a critical component used in vitro to maintain the viability and stability of biological materials (gametes and embryos) during procedures that are part of the diagnostic and therapeutic process of addressing infertility.
Think of it this way: The IVF/ICSI process itself involves in vitro manipulation and assessment of biological materials to achieve a clinical outcome. The liquid paraffin is a necessary reagent/component to ensure the success and reliability of these in vitro steps.
In summary: While the liquid paraffin itself isn't a diagnostic test, its intended use and setting strongly indicate that it is a device used in vitro as part of a process that falls under the scope of IVD regulations. It's a reagent or component essential for the successful execution of in vitro procedures related to human reproduction.
N/A
Intended Use / Indications for Use
Liquid Paraffin is used as an overlay to stabilise pH and reduce evaporation during IVF and ICSI procedures.
Product codes
85 MQL
Device Description
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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
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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
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
1
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 (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/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)
2
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.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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.