(312 days)
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No
The summary describes a chemical medium used in IVF procedures and makes no mention of software, algorithms, or any technology related to AI or ML.
No
The device is used to process sperm before ICSI, which is an assisted reproductive technology procedure. It does not directly treat a disease or medical condition in a living organism. Its function is to prepare biological material for a medical procedure.
No
The device is described as being used for "decreasing the motility and movements of sperm before ICSI," which indicates a functional intervention rather than a diagnostic assessment of sperm motility or other biological parameters.
No
The device description explicitly states "Medi-Cult PVP Medium and Medi-Cult PVP, Clinical Grade," which are chemical substances (media) and not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "decreasing the motility and movements of sperm before ICSI." ICSI (Intracytoplasmic Sperm Injection) is a laboratory procedure performed on sperm in vitro (outside the body) as part of assisted reproductive technology (ART).
- Device Description: The device is a "Medium" and "Clinical Grade" product, which are typical descriptions for reagents or solutions used in laboratory procedures.
- Intended User / Care Setting: The intended users are "IVF- and ART- clinics and laboratories," which are settings where in vitro diagnostic procedures are performed.
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 product isn't directly diagnosing a disease, it is a critical component used in vitro to prepare biological samples (sperm) for a medical procedure (ICSI) that is part of the treatment for infertility. This falls under the scope of IVDs as they are used in the assessment of a biological sample in vitro to inform a medical decision or procedure.
N/A
Intended Use / Indications for Use
Medi-Cult PVP products are used for decreasing the motility and movements of sperm before ICSI.
Product codes
85 MQL
Device Description
The media "Medi-Cult PVP Medium" 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.
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
A number of trials have shown that the Medi-Cult PVP Medium and other products performs well. (see Clinical Testing section reference list). A number of publications in peer- reviewed books or journals have presented data using Medi-Cult media. Often more than one product from Medi-Cult has been used in the studies listed.
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
K991329
B5. 510(k) Summary
510(k) Summary Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The media "Medi-Cult PVP Medium" 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 some registered complaints on the product, but 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.
A number of trials have shown that the Medi-Cult PVP Medium and other products performs well. (see Clinical Testing section reference list). A number of publications in peer- reviewed books or journals have presented data using Medi-Cult media. Often more than one product from Medi-Cult has been used in the studies listed.
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:
Karl B. Kennonh 8/16/
Ronald G. Leonardi, Ph. D. President R & R Registrations P.O. Box 262069 San Diego CA 92196 1-619-586-0751
Date
1
Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is all capitalized and evenly spaced. The words are arranged on a single line and centered.
Public Health Service
Image /page/1/Picture/2 description: The image shows the date February 25, 2000. The text is in a simple, sans-serif font and is horizontally aligned. The date is written in the format of month, day, and year.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medi-Cult A/S c/o Ronald G. Leonardi, Ph.D. President R & R Registrations P.O. Box 262069 San Diego, CA 92196
Re: K991329
Medi-Cult PVP, Medium and Medi-Cult PVP, Clinical Grade Dated: November 30, 1999 Received: December 1, 1999 Requiatory 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 require 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,
Sincerely yours,
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
510(k) Number (if know) K9911329
Device Name: Medi-Cult PVP Medium
Indications for use:
Medi-Cult PVP products are used for decreasing the motility and movements of sperm 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 v (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sir Division of Rop. criterial, Andominal, ENT, and Kaskings de 510 ( Namost