The IVF Media GIII Series have been on the market for a number of years and Vitrolife Sweden AB has now made some product changes in order to further improve the robustness of these media. These improved media are called IVF Media G5 Series.

G-MOPSTM is used for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.

G-MOPSTM PLUS is used for handling/manipulating oocytes and embryos in ambient atmosphere.

AI/ML Overview

The provided document is a 510(k) premarket notification summary for an IVF media device (G-MOPS™/G-MOPS™ PLUS). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and studies for a novel device. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and comparative effectiveness studies is not present in this document.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided document. The 510(k) submission generally asserts substantial equivalence based on technological characteristics and intended use, rather than presenting a detailed table of performance metrics against predefined acceptance criteria for a new device.

2. Sample size used for the test set and the data provenance

This information is not available in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device (G-MOPS™ GIII Series, K021893) and does not describe a new clinical or performance test set with a specific sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available in the provided document. As there's no described test set requiring expert ground truth, this detail is absent.

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

This information is not available in the provided document.

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

This information is not applicable and not available in the provided document. The device is IVF media, not an AI-assisted diagnostic tool that would involve human readers.

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

This information is not applicable and not available in the provided document. The device is IVF media, not an algorithm.

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

This information is not available in the provided document. This type of detail would relate to performance studies, which are not explicitly detailed in this 510(k) summary. The "ground truth" for a device attempting to demonstrate substantial equivalence would generally refer to the performance of the predicate device, or in vitro/in vivo studies designed to show similar biological outcomes, but specific methods are not described here.

8. The sample size for the training set

This information is not available in the provided document. This device is not an AI algorithm requiring a training set.

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

This information is not applicable and not available in the provided document.

Summary of what the document does provide:

Device Name: G-MOPSTM / G-MOPSTM PLUS
Intended Use: G-MOPSTM is for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere. G-MOPS™ PLUS is for handling/manipulating oocytes and embryos in ambient atmosphere.
Predicate Device: G-MOPSTM (K021893)
Technological Characteristics Comparison: The document states, "The technological characteristics of G-MOPSTM/G-MOPSTM PLUS are essentially similar to those of the predicate device. None of the differences between the predicate device and G-MOPS™ / G-MOPS™ PLUS do raise any new questions of safety or effectiveness." This is the core argument for substantial equivalence in a 510(k) submission.

In conclusion, the document provided is a premarket notification for demonstrating substantial equivalence for an IVF media. It does not contain the detailed performance study information typically associated with establishing acceptance criteria for a novel device or an AI algorithm.

Summary

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Kornis

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PREMARKET NOTIFICATION SUMMARY x.

SEP 1 7 2008

Submitted by:	Vitrolife Sweden ABFaktorvägen 13SE-434 37 KungsbackaSWEDEN
Contact Person:	Mr Kjell KjörkVitrolife Sweden ABFaktorvägen 13SE-434 37 KungsbackaSWEDENPhone +46 31 721 80 77Fax +46 31 721 80 90Mail kkjork@vitrolife.com
Date Prepared:	3 September 2008
Trade Name:	G-MOPSTM/G-MOPSTM PLUS
Common Name:	IVF Media
Classification Name:	Reproductive Media and Supplements(21 C.F.R. § 884.6180)
Predicate Device:	G-MOPSTM (K021893)
Description of the Device:	The IVF Media GIII Series have been on the market for a number of years and Vitrolife Sweden AB has now made some product changes in order to further improve the robustness of these media. These improved media are called IVF Media G5 Series.G-MOPSTM is used for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.G-MOPSTM PLUS is used for handling/manipulating oocytes and embryos in ambient atmosphere.

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Intended Use:

G-MOPSTM is intended for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.

G-MOPS™ PLUS is intended for handling/manipulating oocytes and embryos in ambient atmosphere.

Technological Characteristics:

G-MOPSTM/G-MOPSTM PLUS is a device used for handling and manipulating oocytes and embryos in ambient atmosphere.

The product G-MOPS™/G-MOPS™ PLUS is a modification of the device G-MOPS™ GIII Series (K021893). The technological characteristics of G-MOPSTM/G-MOPSTM PLUS are essentially similar to those of the predicate device. None of the differences between the predicate device and G-MOPS™ / G-MOPS™ PLUS do raise any new questions of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 2008

Mr. Kjell Kjörk Pharmacist, Regulatory Affairs Manager Vitrolife Sweden AB Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN

Re: K081115

Trade Name: G-MOPSTM and G-MOPSTM PLUS Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: September 5, 2008 Received: September 5, 2008

Dear Mr. Kjörk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jose M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT XI.

510(k) Number (if known): K081115

Device Name:

G-MOPSTM

Indications for Use:

G-MOPS™ is indicated for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_**_
(Per 21 C.F.R. § 801.109)

Over-the Counter Use.

Huld Reume

vision Sign-Off) ivision of Reproductive, Abdomina and Radiological Devices 510(k) Number

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INDICATIONS FOR USE STATEMENT XI.

510(k) Number (if known): K081115

Device Name:

G-MOPS™ PLUS

Indications for Use:

G-MOPS™ PLUS is indicated for handling/manipulating oocytes and embryos in ambient atmosphere.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR
Over-the Counter Use
(Per 21 C.F.R. $ 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K081115

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.