(88 days)
K98354
Not Found
No
The 510(k) summary describes a recombinant human albumin solution used as a supplement for culture medium in assisted reproductive procedures. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The predicate device is also a human serum albumin product, further indicating a non-AI/ML technology.
No
The device is described as a supplement for culture media in assisted reproductive procedures, not a device used for treating a disease or condition in a patient.
No
The device is a supplement for culture medium used in assisted reproductive procedures, not a diagnostic tool for identifying a disease or condition.
No
The device description clearly states it is a "Recombinant Human Albumin solution," which is 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 explicitly states it's for "assisted reproductive procedures which include gamete and embryo manipulation." This involves working with biological samples (gametes and embryos) outside of the human body.
- Device Description: It's described as a "Recombinant Human Albumin solution. For supplementation of gamete and embryo media." This further reinforces its use in a laboratory setting for manipulating biological materials.
- Not for use as an injectable product: This explicitly excludes it from being a therapeutic or in-vivo device.
- Predicate Device: The predicate device is "Human Serum Albumin™," which is commonly used in laboratory settings for similar purposes.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use and device description strongly align with the definition of an IVD, which are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, the information is related to the viability and development of gametes and embryos.
N/A
Intended Use / Indications for Use
G-MM contains Recombinant Human Albumin solution (50 mg/mL) and is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of G-MM as a supplement for culture medium. Not for use as an injectable product.
Product codes
85 MQL
Device Description
Recombinant Human Albumin solution. For supplementation of gamete and embryo media.
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)
Analytical, preclinical, and clinical testing performed on the recombinant albumin component of the device confirmed that the G-MM device is at least as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Human Serum Albumin™ (510(k) # K98354)
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
K02/854
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: | June 7, 2002 |
| Trade Name: | G-MMTM |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Device: | Human Serum Albumin™ (510(k) # K98354) |
| Description of the Device: | Recombinant Human Albumin solution.
For supplementation of gamete and embryo
media. |
| Intended Use: | G-MM contains Recombinant Human Albumin
solution (50 mg/mL) and is intended for use in
assisted reproductive procedures which include
gamete and embryo manipulation. These
procedures include the use of G-MM as a
supplement for culture medium. Not for use as an
injectable product. |
| Technological Characteristics: | The technological characteristics of G-MMTM
differ slightly from the predicate device.
Specifically the G-MM device uses recombinantly
derived albumin instead of human scrum albumin.
Analytical, preclinical, and clinical testing
performed on the recombinant albumin
component of the device confirmed that the G-
MM device is at least as safe and effective as the
predicate device. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Vitrolife Sweden AB % Mr. Gary L. Yingling Kirkpatrick & Lockhart 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K021894
Trade/Device Name: G-MMTM Assisted Reproduction Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: June 7, 2002 Received: June 10, 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.
Image /page/1/Picture/11 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the body and wings.
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,
Nancy C. Snogdon
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:
Device Name:
G-MM™M Assisted Reproduction Media
Indications for Use:
G-MM contains Recombinant Human Albumin solution (50 mg/mL) and is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of G-MM as a supplement for culture medium. Not for use as an injectable product.
Rata Phillips h NCS
(Division Sign-Off) Division of Reproductive, Abdomi 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)
( ) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Prescription Use (Per 21 C.F.R. § 801.109)
Over-the Counter Use_