(298 days)
Not Found
No
The device description is for a thawing media, and there is no mention of AI, ML, image processing, or any other computational technology.
No
This device is a media for thawing blastocyst stage embryos, which is a laboratory reagent rather than a device used for therapeutic purposes on a patient.
No
The device is described as "Media for thawing of blastocyst stage embryos" and "MOPS buffered media." It is used in a sequence for embryo preparation, not for detecting or diagnosing a disease or condition.
No
The device description clearly states it is "MOPS buffered media," which is a chemical 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 "Media for thawing of blastocyst stage embryos." This process is performed in vitro (outside the body) to prepare embryos for transfer, which is a diagnostic or therapeutic procedure related to fertility.
- Device Description: The description of the media and its use in a sequence after other solutions further supports its role in an in vitro process.
- Predicate Device: The mention of a predicate device, "K000309 Blastocyst Thaw Media Kit," strongly indicates that this type of product is regulated as a medical device, and specifically, the "Kit" aspect often points towards IVD classification for components used in laboratory procedures.
While the information provided doesn't explicitly state "In Vitro Diagnostic," the nature of the intended use and the comparison to a predicate device classified as a "Kit" for a laboratory procedure strongly suggest it falls under the IVD category.
N/A
Intended Use / Indications for Use
Intended Use: Medium for In Vitro Fertilization Procedures
Indications for Use: Media for thawing of blastocyst stage embryos
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
Description of the Device: MOPS buffered media. For use in sequence after the addition of G-MM™ or HSA-solution™ and pre-equilibration at +20 ± 5°C and ambient atmosphere.
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.
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
Ko32155
MAY = 7 2004
X. PREMARKET NOTIFICATION SUMMARY
| Submitted by: | Vitrolife Sweden AB
Faktorvägen 13
SE-434 37 Kungsbacka
SWEDEN |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Nina Arvidsson
Vitrolife Sweden AB
Faktorvägen 13
SE-434 37 Kungsbacka
SWEDEN |
| | Mr. Gary L. Yingling
Mr. Michael H. Hinckle
Kirkpatrick & Lockhart, LLP
1800 Massachusetts Avenue, NW
Washington, DC 20036-1800 |
| Date Prepared: | July 10, 2003 |
| Trade Name: | G-ThawKit Blast™ |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements
(21 CF.R. § 884.6180) |
| Predicate Device: | Blastocyst Thaw Media Kit (K000309) |
| Description of the Device: | MOPS buffered media. For use in sequence after
the addition of G-MM™ or HSA-solution™ and
pre-equilibration at +20 ± 5°C and ambient
atmosphere. |
| Intended Use: | Medium for In Vitro Fertilization Procedures |
| Indications for Use: | Media for thawing of blastocyst stage embryos |
Technological Characteristics:
The technological characteristics of G-ThawKit Blast™ are similar to those of the predicate device. Some modifications were made to improve the performance of the device. The G-ThawKit Blast™ contains three thawing solutions. Two of the solutions contain Glycerol which has been included to improve a slow diffusion of Glycerol out of the cells. In combination with G-FreezeKit Blast™ , the thawing solutions provide an equal concentration gradient of Glycerol and Sucrose in a step up - step down protocol for freezing and thawing of human blastocysts. The G-ThawKit Blast™ also contains Penicillin G as antibiotic instead of Gentamicin.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized depiction of the department's emblem, which consists of a caduceus-like symbol with three wavy lines representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY = 7 2004
Vitrolife Sweden AB % Gary L. Yingling, Esq. Consultant Kirkpatrick & Lockhart, L.L.P. 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K032155 Trade/Device Name: G-ThawKit Blast™ - Assisted Reproductive Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: February 19, 2004 Received: February 23, 2004
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 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.
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
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 the 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" (21CFR Part 807.97) you may obtain. 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. Brygdon
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
510(k) Number (if known): K032155
Device Name: G-ThawKit Blast™ Assisted Reproduction Media
Indications For Use: Media for thawing of blastocyst stage embryos
Prescription Use __x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
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