(312 days)
Liquid Paraffin is used as an overlay to stabilise pH and reduce evaporation during IVF and ICSI procedures.
Medi-Cult Liquid Paraffin
The provided text describes a 510(k) submission for "Medi-Cult Liquid Paraffin," a device used in In-Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) procedures. However, the information provided does not contain the details necessary to answer the questions about acceptance criteria, specific studies, sample sizes, expert involvement, or comparative effectiveness.
The submission focuses on establishing substantial equivalence based on prior extensive use and the absence of complaints, rather than presenting a detailed clinical study with performance metrics against defined acceptance criteria.
Therefore, most of the requested information cannot be extracted from the given text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that the product "has been used extensively over a number of years to the satisfaction of the users" and "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." This implies general acceptance and lack of adverse events, but no specific performance metrics or acceptance criteria are defined or reported.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention a specific test set or a study with defined sample sizes. The claim of "extensive use" and "no registered complaints" points to a general observation of real-world usage rather than a structured clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. There is no mention of experts establishing a ground truth for a test set. The "satisfaction of the users at the IVF- and ART- clinics and laboratories" refers to the general professional community, not a structured expert review for a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. This is not a diagnostic imaging device involving human readers or AI assistance. It is a laboratory reagent.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. No formal ground truth definition is mentioned. The implicit "ground truth" for safety and effectiveness is inferred from the lack of complaints and satisfactory use in real-world IVF/ART settings, which could be loosely interpreted as "outcomes data" in a very general sense (successful IVF cycles without product-related adverse events), but it's not explicitly defined or measured in a study.
8. The sample size for the training set
- Cannot be provided. This device does not involve a training set as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable to this device.
In summary, the provided 510(k) summary relies on historical performance and a lack of adverse events for a product that has been used extensively, rather than detailing a specific study with the requested performance metrics and methodological specifics. This approach is common for certain types of medical devices, particularly those seeking substantial equivalence based on long-standing market presence and established safety profiles.
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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 (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)
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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.
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.
§ 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.