(56 days)
85 MQL
Not Found
No
The summary describes a chemical medium for IVF and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a medium for preparing and handling gametes for in vitro fertilization, which is a laboratory process, not direct treatment of a patient. While it's part of a therapeutic process, the device itself is a reagent and not therapeutic.
No
This device is a medium used for the preparation and handling of gametes and for in vitro fertilization, which are procedures, not diagnostic activities. It aids in the process of IVF rather than diagnosing a condition.
No
The device description clearly states it is a "medium" containing chemical components, indicating it 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 explicitly states "Medium for preparation and handling of gametes and for in vitro fertilization." This clearly indicates that the device is intended for use in vitro (outside the living body) to examine specimens (gametes) and aid in a diagnostic or therapeutic process (in vitro fertilization).
- Device Description: The description of the medium and its use in preparing gametes for IVF further supports its role in an in vitro procedure.
- Predicate Device: The mention of "IVF™" as a predicate device strongly suggests that this device falls under the same regulatory category, which for IVF-related products is typically IVD.
While the document lacks information about image processing, AI, patient demographics, or performance studies, the core intended use and the nature of the device as a medium for handling gametes for IVF are the key indicators that classify it as an IVD.
N/A
Intended Use / Indications for Use
Medium for In Vitro Fertilization Procedures
Product codes
85 MQL
Device Description
Bicarbonate buffered medium containing Hyaluronan. For use after the addition of G-MM™ 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
IVF™
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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-FERT™ |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Device: | IVF™ |
| Description of the Device: | Bicarbonate buffered medium containing
Hyaluronan. For use after the addition of G-MM™
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-FERT™
are essentially similar to those of the predicate
device. The G-FERT 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-FERT 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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 6 200
Vitrolife Sweden AB % Mr. Gary L. Yingling Kirkpatrick & Lockhart 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K022245 Trade/Device Name: G-FERT™ Assisted Reproduction Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL 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 (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.
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.
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,
Henry C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT X. . :
510(k) Number:
and the same of the same of the same
.
.
KD2245
Device Name:
G-FERTTM Assisted Reproduction Media
Indications For Use:
Medium for preparation and handling of gametes and for in vitro fertilization.
Rate Phillips f NCB
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 5 D(k) Number ________________________________________________________________________________________________________________________________________________________________
(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)
( ) IR
()ver-the Counter Use______________________________