(88 days)
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.
Recombinant Human Albumin solution. For supplementation of gamete and embryo media.
The provided text is a 510(k) premarket notification summary and an FDA clearance letter for a medical device called "G-MMTM Assisted Reproduction Media." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study in the way a new, higher-risk device would.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details (sample sizes, data provenance, ground truth, experts, adjudication, MRMC, standalone performance), or training set information.
Here's why and what information is available:
- No Acceptance Criteria or Reported Device Performance Table: The 510(k) process focuses on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance metrics for a novel technology. The "performance" assessment is comparative. The text states: "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." This is the general finding, not a report against specific acceptance criteria.
- No Dedicated "Study" for Acceptance Criteria: The provided document states that "analytical, preclinical, and clinical testing" was performed to confirm the new device is "at least as safe and effective as the predicate device." This indicates a comparative approach. Details about these tests (sample sizes, ground truth, experts, etc.) are not included in this summary.
- No Information on Sample Sizes (Test Set or Training Set), Data Provenance, Number of Experts, Adjudication, MRMC, or Standalone Performance: These are all elements typically found in clinical study reports for devices that require extensive performance validation. A 510(k) summary often abridges the detailed study information, focusing on the substantial equivalence argument. For a media like this, "clinical testing" would likely involve in vitro fertilization (IVF) success rates or embryo development outcomes compared to the predicate, but specific details are absent.
- No Information on Ground Truth for Test or Training Sets: Again, this level of detail is not present in the provided 510(k) summary.
In summary, the provided document is a regulatory submission for substantial equivalence, not a detailed clinical study report with acceptance criteria and performance metrics against them.
{0}------------------------------------------------
K02/854
SEP 6 2002
IX. PREMARKET NOTIFICATION SUMMARY
| Submitted by: | Vitrolife Sweden ABMölndalsvägen 30SE-412 63 GothenburgSWEDEN |
|---|---|
| Contact Person: | Mr. Eiler AndersonVitrolife Sweden ABMölndalsvägen 30SE-412 63 GothenburgSWEDEN |
| 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 embryomedia. |
| Intended Use: | G-MM contains Recombinant Human Albuminsolution (50 mg/mL) and is intended for use inassisted reproductive procedures which includegamete and embryo manipulation. Theseprocedures include the use of G-MM as asupplement for culture medium. Not for use as aninjectable product. |
| Technological Characteristics: | The technological characteristics of G-MMTMdiffer slightly from the predicate device.Specifically the G-MM device uses recombinantlyderived albumin instead of human scrum albumin.Analytical, preclinical, and clinical testingperformed on the recombinant albumincomponent of the device confirmed that the G-MM device is at least as safe and effective as thepredicate 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_
§ 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.