(56 days)
G1.2TM
Not Found
No
The summary describes a culture medium and does not mention any computational or analytical capabilities, let alone AI/ML.
No
The device is a medium for culturing embryos, which is a laboratory tool for biological processes and not a device used for treating a disease or medical condition in a living organism.
No
Explanation: The device is described as a "medium for culture of embryos" and is used for culturing biological samples, not for identifying a disease or condition in a patient.
No
The device description clearly states it is a "Bicarbonate buffered medium containing Hyaluronan," which is a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Medium for culture of embryos from the pronucleate stage to day 2 or day 3." This clearly indicates that the device is used in vitro (outside the body) to support the growth and development of biological material (embryos).
- Device Description: The description confirms it's a "Bicarbonate buffered medium containing Hyaluronan." This is a substance used to create a controlled environment for biological processes in vitro.
IVDs are defined as 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. While this specific device isn't directly diagnosing a disease, it's a critical component in the process of in vitro fertilization (IVF), which is a medical procedure involving the manipulation of biological material in vitro for reproductive purposes. Devices used in IVF procedures, particularly culture media, are typically regulated as IVDs.
The absence of information about image processing, AI, anatomical site, patient age, user, training/test sets, performance studies, and key metrics is expected for a culture medium and does not negate its classification as an IVD. The presence of a predicate device (G1.2TM) further supports its regulatory classification, as predicate devices are used to demonstrate substantial equivalence for regulatory clearance, often within the same regulatory category (like IVDs).
N/A
Intended Use / Indications for Use
Medium for culture of embryos from the pronucleate stage to day 2 or day 3.
Product codes (comma separated list FDA assigned to the subject device)
85 MOL
Device Description
Bicarbonate buffered medium containing Hyaluronan. For use after the addition of G-MMTM or HSA-solution™ and pre-equilibration at +37°C and 6% CO2.
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.
G1.2TM
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
SEP 6 2002
IX. PREMARKET NOTIFICATION SUMMARY
| Submitted by: | Vitrolife Sweden AB
Mölndalsvägen 30
SE-412 63 Gothenburg
SWEDEN |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Eiler Anderson
Vitrolife Sweden AB
Mölndalsvägen 30
SE-412 63 Gothenburg
SWEDEN |
| Date Prepared: | July 10, 2002 |
| Trade Name: | G-1TM version 3 |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Device: | G1.2TM |
| Description of the Device: | Bicarbonate buffered medium containing
Hyaluronan. For use after the addition of G-
MMTM or HSA-solution™ and pre-equilibration at
+37°C and 6% CO2. |
| Intended Use: | Medium for In Vitro Fertilization Procedures |
| Technological Characteristics: | The technological characteristics of G-1TM are
essentially similar to those of the predicate device.
The G-1 is a modification of the predicate device
and is intended to be supplemented with albumin
prior to use. Other formulation changes were
made to improve the performance of the G-1
device. None of these differences raise new
questions of safety or effectiveness. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is black against a white background. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line.
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
6 2002
Vitrolife Sweden AB % Mr. Gary L. Yingling Kirkpatrick & Lockhart 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K022244
Trade/Device Name: G-1TM version 3 Assisted Reproduction Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MOL Dated: July 10, 2002 Received: July 12, 2002
Dear Mr. Yingling:
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 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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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2
Page 2
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.
,但是一个人的人的人的人
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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
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
3
X. - INDICATIONS FOR USE STATEMENT
510(k) Number:
022244
Device Name:
11:00:00 :
G-1TM version 3 Assisted Reproduction Media
Indications For Use:
Medium for culture of embryos from the pronucleate stage to day 2 or day 3.
Rate Phillips f NCS
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use_ (Per 21 C.F.R. § 801.109)
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()ver-the Counter Use_________________________________________________________________________________________________________________________________________________________