K Number
K081116
Device Name
G-IVF G5 SERIES
Date Cleared
2008-09-02

(137 days)

Product Code
Regulation Number
884.6180
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
G-IVFTM/G-IVFTM PLUS is intended for preparation and handling of gametes and for in vitro fertilization
Device Description
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.
More Information

Not Found

No
The summary describes a change to an existing IVF media product, focusing on its composition and intended use in gamete preparation and IVF. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.

No
The device is a culture medium used for preparation and handling of gametes and for in vitro fertilization, which is an ancillary product rather than a device that directly treats a condition or disease.

No
The device, G-IVF™/G-IVF™ PLUS, is described as a media used for the preparation and handling of gametes and for in vitro fertilization. Its intended use is for handling biological materials for a procedure (IVF), not for detecting, diagnosing, or monitoring a disease or condition.

No

The device description clearly states it is a "media" (G-IVFTM/G-IVFTM PLUS), which is a physical substance used in in vitro fertilization. This is not a software-only device.

Based on the provided information, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states "preparation and handling of gametes and for in vitro fertilization". In vitro fertilization is a process performed outside of the living body, involving the manipulation of biological materials (gametes).
  • Device Description: The description confirms it is an "IVF Media" used for "preparation and handling of gametes and for in vitro fertilization". Media used for culturing and manipulating biological samples for diagnostic or therapeutic purposes outside the body fall under the scope of IVDs.
  • Predicate Device: The predicate device, K022245 G-FERTTM GIII Series, is also an IVF media, which are typically classified as IVDs.

While the document doesn't explicitly state "In Vitro Diagnostic Device", the intended use and description clearly align with the definition of an IVD, which are 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. In this case, the media is used in the process of in vitro fertilization, which is a medical procedure addressing infertility.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

MQL

Device Description

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-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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K022245

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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

K081116

PREMARKET NOTIFICATION SUMMARY X.

SEP - 2 2008

| Submitted by: | Vitrolife Sweden AB
Faktorvägen 13
SE-434 37 Kungsbacka
SWEDEN |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr Kjell Kjörk
Vitrolife Sweden AB
Faktorvägen 13
SE-434 37 Kungsbacka
SWEDEN
Phone +46 31 721 80 77
Fax +46 31 721 80 90
Mail 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 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 |
| Intended Use: | G-IVFTM/G-IVFTM PLUS is intended for preparation and handling of gametes and for in vitro fertilization |

1

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.

2

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.

3

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
Other240-276-0100

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

4

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