MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE by MEDICULT A/S

This K991329 submission for "Medi-Cult PVP Medium" appears to be for a medical device (a medium for in-vitro fertilization), not a diagnostic AI system. Therefore, most of the requested information about acceptance criteria for an AI device and a study proving device performance in the context of AI (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) is not applicable to this submission.

The provided text describes a 510(k) summary for a fluid medium used in IVF procedures. The "acceptance criteria" and "study" mentioned in the input are framed around the regulatory approval process for this type of medical device, primarily focusing on safety and effectiveness for its intended use, rather than analytical performance metrics typical of AI medical devices.

Here's how to interpret the available information in the context of the provided document:

1. A table of acceptance criteria and the reported device performance

Since this is a non-AI medical device, the "acceptance criteria" are not performance metrics like sensitivity/specificity but rather regulatory satisfaction based on historical usage and absence of serious adverse events.

Acceptance Criteria (Implied Regulatory)	Reported Device Performance
Satisfaction of users	"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."
Absence of serious adverse events	"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."
Performance in trials/publications	"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."
Substantial Equivalence to predicate	The FDA's letter explicitly states: "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... to legally marketed predicate devices..."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for an AI device. For this IVF medium, the "data" consists of historical usage and outcomes. The submission refers to "extensive use over a number of years" and "a number of trials" and "publications." Specific sample sizes, details of test sets, or data provenance (country, retrospective/prospective) are not provided in this 510(k) summary, as they are not the primary focus for this type of device. The assessment is based on a broad history of safe and effective use.

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)

Not applicable for an AI device. This information is not relevant to the approval of an IVF medium. "Ground truth" in this context would implicitly be the observed clinical outcomes of IVF procedures using the medium, as reported by IVF/ART clinics and in published trials.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for an AI device. This concept does not apply to the regulatory submission for an IVF medium.

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

Not applicable. This is a non-AI medical device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a non-AI medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" or evidence of performance is primarily based on:
- User satisfaction: Implied by "satisfaction of the users at the IVF- and ART- clinics and laboratories."
- Absence of serious adverse events: Explicitly stated as "no evidence...that the product has been the cause of any serious adverse events."
- Outcomes data in clinical trials and publications: "A number of trials have shown that the Medi-Cult PVP Medium and other products performs well." and "A number of publications...have presented data using Medi-Cult media." This would likely encompass various metrics of IVF success and safety.

8. The sample size for the training set

Not applicable for an AI device. There is no "training set" in the context of an IVF medium.

9. How the ground truth for the training set was established

Not applicable for an AI device. There is no "training set" or a separate establishment of "ground truth" for it in this context.

Summary

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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

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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,

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

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)

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sir Division of Rop. criterial, Andominal, ENT, and Kaskings de 510 ( Namost

Regulation Number and Section

§ 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.