The IVF Media G-FERTTM in the so called GIII Series has 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 this media. This improved media is called G-IVFTM/G-IVFTM PLUS. G-IVFTM/G-IVFTM PLUS is used for preparation and handling of gametes and for in vitro fertilization. G-IVF™ PLUS contains HSA which has been added during the manufacturing, while HSA has to be added to G-IVF™ by the clinics before use.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (IVF Media), not an AI/ML SaMD. Therefore, many of the requested categories are not applicable. The provided text describes the device, its intended use, and its substantial equivalence to a predicate device, focusing on regulatory approval for manufacturing and marketing rather than a performance study with detailed acceptance criteria and ground truth in the context of an AI/ML model.

Here's the information that can be extracted or that is not applicable given the nature of the document:

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

Acceptance Criteria	Reported Device Performance
Not explicit in document. The document focuses on showing substantial equivalence to a predicate device, suggesting an implicit acceptance criterion of being "essentially similar" to the predicate device in terms of safety and effectiveness.	The device, G-IVF™/G-IVF™ PLUS, is a modification of G-FERT™ (K022245). The technological characteristics are "essentially similar" to the predicate device. "None of the differences between the predicate device and G-IVFTM /G-IVFTM PLUS do raise any new questions of safety or effectiveness."

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. This document describes a 510(k) premarket notification for an IVF media, not a device that involves statistical testing with a "test set" in the context of AI/ML performance. The review focuses on substantial equivalence based on product formulation and intended 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. There is no "ground truth" establishment in the context of AI/ML evaluation for this type of medical device submission. The assessment is based on comparison to an existing predicate device and regulatory requirements for manufacturing and product characteristics.

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

Not applicable. This concept does not apply to a 510(k) submission for IVF media.

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 not an AI/ML enabled device, so no MRMC study would be conducted.

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

Not applicable. This device is a culture media, not an algorithm.

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

Not applicable. The "truth" in this context is established through demonstrating that the modified IVF media (G-IVF™/G-IVF™ PLUS) performs its intended function (preparation and handling of gametes and in vitro fertilization) without raising new safety or effectiveness concerns compared to the legally marketed predicate device (G-FERT™ GIII Series). This is a regulatory assessment, not a data-driven ground truthing for an AI model.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" and associated ground truth for this type of device submission.

Summary

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K081116

PREMARKET NOTIFICATION SUMMARY X.

SEP - 2 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:	7 July 2008
Trade Name:	G-IVFTM/G-IVFTM PLUS
Common Name:	IVF Media
Classification Name:	Reproductive Media and Supplements(21 C.F.R. § 884.6180)
Predicate Device:	G-FERTTM GIII Series (K022245)
Description of the Device:	The IVF Media G-FERTTM in the so called GIII Serieshas been on the market for a number of years andVitrolife Sweden AB has now made some productchanges in order to further improve the robustness ofthis media. This improved media is called G-IVFTM/G-IVFTM PLUSG-IVFTM/G-IVFTM PLUS is used for preparation and handling of gametes and for in vitro fertilization
Intended Use:	G-IVFTM/G-IVFTM PLUS is intended for preparation and handling of gametes and for in vitro fertilization

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Technological Characteristics:

G-IVFTM/G-IVFTM PLUS is a device used for preparation and handling of gametes and for in vitto fertilization. G-IVF™ PLUS contains HSA which has been added during the manufacturing, while HSA has to be added to G-IVF™ by the clinics before use.

G-IVF™/G-IVF™ PLUS is a modification of the device G-FERT™ (K022245). The technological characteristics of G-IVF™/G-IVF™ PLUS are essentially similar to those of the predicate device. None of the differences between the predicate device and G-IVFTM /G-IVFTM PLUS do raise any new questions of safety or effectiveness.

For the new product G-IVF™/G-IVFTM PLUS a name change (from G-FERT™) has been made in order to avoid a mix-up between the two versions.

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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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2008

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

Re: K081116

Trade/Devices Name: G-IVFTM PLUS Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: August 12, 2008 Received: August 15, 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. Ilsting 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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(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 Biometric's (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/cdrb/industry/support/index.html.

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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XI. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K081116

Device Name:

G-IVF™ PLUS

Indications for Use:

G-IVF™ PLUS is indicated for preparation and handling of gametes and for in vitro fertilization

(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)

OR Over-the Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K081116

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.