(151 days)
Not Found
No
The document describes an embryo culture media and does not mention any computational or analytical capabilities, let alone AI/ML.
No
The device is described as media for the culture of embryos, which is a supportive function in the IVF process, not direct therapy.
No
The provided text explicitly states that the device is "intended for culture of embryos" and "used for culture of embryos." There is no mention of it being used to diagnose a condition, disease, or abnormal state.
No
The device description explicitly states "IVF Media GIII Series" and "IVF Media G5 Series," which are culture media, a physical substance, not software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "culture of embryos from the pronucleate stage to day 2 or day 3". This process is performed in vitro (outside the living body) and is a crucial step in assisted reproductive technologies (ART), which are diagnostic and therapeutic procedures.
- Device Description: The description explicitly states it is "used for culture of embryos". Culture media used in IVF are considered IVDs as they are used to support and assess the development of embryos, which provides information about their viability and potential for implantation.
- Predicate Device: The predicate device listed (K022244; G-1TM version 3) is also an IVF culture medium, and such devices are typically classified as IVDs by regulatory bodies like the FDA.
While the document doesn't explicitly state "In Vitro Diagnostic Device", the nature of the intended use and the device type strongly align with the definition of an IVD. IVDs are products used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, the embryo culture provides information about the embryo's development and health, which is used in the diagnostic and decision-making process of IVF.
N/A
Intended Use / Indications for Use
G-1TM v5/G-1TM v5 PLUS is intended for culture of embryos from the pronucleate stage to day 2 or day 3
G-1™ v5 is indicated for the culture of embryos from the pronucleate stage to day 2 or day 3
G-1™ v5 PLUS is indicated for the culture of embryos from the pronucleate stage to day 2 or day 3
Product codes (comma separated list FDA assigned to the subject device)
MQL
Device Description
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 medias are called IVF Media G5 Series. G-1TM v5/G-1TM v5 PLUS is used for culture of embryos from the pronucleate stage to day 2 or day 3
G-1™ v5/G-1™ PLUS is a device used for the culture of embryos from the pronucleate stage to day 2 or day 3.
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
Prescription Use
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.
G-1TM version 3 (K022244)
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
K081114
.
PREMARKET NOTIFICATION SUMMARY X.
:
SEP 1 6 2008
| Submitted by: | Vitrolife Sweden AB
Faktorv\u00e4gen 13
SE-434 37 Kungsbacka
SWEDEN |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr Kjell Kj\u00f6rk
Vitrolife Sweden AB
Faktorv\u00e4gen 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-1TM v5/G-1TM v5 PLUS |
| Common Name: | IVF Media |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. \u00a7 884.6180) |
| Predicate Device: | G-1TM version 3 (K022244) |
| 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 medias are called IVF Media G5 Series.
G-1TM v5/G-1TM v5 PLUS is used for culture of
embryos from the pronucleate stage to day 2 or day 3 |
| Intended Use: | G-1TM v5/G-1TM v5 PLUS is intended for culture of
embryos from the pronucleate stage to day 2 or day 3 |
1
Technological Characteristics:
G-1™ v5/G-1™ PLUS is a device used for the culture of embryos from the pronucleate stage to day 2 or day 3.
The product G-1™ v5/G-1™ v5 PLUS is a modification of the device G-1™ version 3 (K022244). The technological characteristics of G-1™ v5/G-1™ v5 PLUS are essentially similar to those of the predicate device. None of the differences between the predicate device and G-1™ v5/G-1™ v5 PLUS do raise any new questions of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes emanating from its head, representing the department's mission to promote health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2008
Vitrolife Sweden AB c/o Mr. Kjell Kjörk Pharmacist; Regulatory Affairs Manager Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN
K081114 Re:
Trade Name: G-1" v5 and G-1" v5 PLUS Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: August 13, 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, 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.
3
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,
Jozpu 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
4
XI. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K081114
Device Name: G-1™ v5
:
:
Indications for Use:
G-1™ v5 is indicated for the culture of embryos from the pronucleate stage to day 2 or day 3
:
(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) | X |
|---|---|
| OR Over-the Counter Use |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | KD81114 |
|---|---|
| --------------- | --------- |
5
XI. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K081114
Device Name:
G-1™ v5 PLUS
Indications for Use:
G-1™ v5 PLUS is indicated for the culture of embryos from the pronucleate stage to day 2 or day 3
(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) | X |
|---|---|
| OR | |
| Over-the Counter Use |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices,
| 510(k) Number | K081114 |
|---|---|
| --------------- | --------- |