(276 days)
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No
The provided text describes a kit for vitrification and warming of human blastocysts, which are laboratory procedures. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of AI/ML technology.
No
Explanation: This device is intended for the vitrification, cryostorage, recovery, and rehydration of human blastocysts, which are processes specifically related to assisted reproductive technologies (ART) and not directly for treating a disease or condition in a living organism.
No
The device is described as a kit for vitrification and cryostorage, and subsequent warming and rehydration, of human blastocysts. This process is for preservation, not for diagnosing a disease or condition.
No
The 510(k) summary describes a "Global DMSO Blastocyst Vitrification Kit" and a "Global DMSO Blastocyst Vitrification Warming Kit," which are clearly physical kits containing reagents and likely other materials for the vitrification and warming of human blastocysts. There is no mention of software in the provided text.
Based on the provided information, the Global DMSO Blastocyst Vitrification Kit and Global DMSO Blastocyst Vitrification Warming Kit are likely IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these kits are for the vitrification, cryostorage, recovery, and rehydration of human blastocysts. Blastocysts are human cells/tissue.
- In Vitro: The process of vitrification and warming of blastocysts happens outside of the human body (in vitro).
- Diagnostic Implication (Indirect): While not a direct diagnostic test in the traditional sense (like a blood test), these kits are used in the context of assisted reproductive technologies (ART), which are procedures aimed at achieving pregnancy. The success of these procedures can be influenced by the quality and viability of the blastocysts after vitrification and warming. Therefore, the performance of these kits has an indirect impact on the diagnostic process of determining the potential for successful implantation and pregnancy.
However, it's important to note:
- The provided information is limited. A definitive determination of IVD status often requires a more complete understanding of the device's classification by regulatory bodies (like the FDA in the US).
- The term "diagnostic" in IVD can be broad. It encompasses devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. While these kits don't directly diagnose a disease, they are used in a process that is part of addressing infertility, which can be considered a medical condition.
In conclusion, based on the intended use involving human biological material and the in vitro nature of the process, these kits strongly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Global DMSO Blastocyst Vitrification Kit:
- Intended for the vitrification (ultra-rapid freezing) and cryostorage of human blastocysts.
Global DMSO Blastocyst Vitrification Warming Kit - Intended for the recovery and rehydration of vitrified human blastocysts
- Intended for use with blastocysts that have been vitrified using the Global DMSO Blastocyst Vitrification Kit.
Product codes
MQL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Michael D. Cecchi President GenX International, Inc. 393 Soundview Rd. GUILFORD CT 06437
JUN - 3 2010
Re: K092667 Global DMSO Blastocyst Vitrification Kit and Trade Name: Global DMSO Blastocyst Vitrification Warming Kit Regulation Number: 21 CFR §884. 6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: May 26, 2010 Received: May 27, 2010
Dear Mr. Cecchi:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related
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adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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international, inc.
Indications for Use
| 510 (k) N | Annual Comments of Children Comments of Children |
|---|---|
| LAND RESERVED. LABORE MARK LEASE LEARNER SEAL FOR AND LEASE LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST | |
| i Number (it Known) | - 0 0 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| FREE OF CLANDLE CONNULE CANADA CARTER CARDED CARDEN CARDED CONCENT |
Global DMSO Blastocyst Vitrification Kit:
- Intended for the vitrification (ultra-rapid freezing) and cryostorage of . human blastocysts.
Global DMSQ Blastocyst Vitrification Warming Kit
- . Intended for the recovery and rehydration of vitrified human blastocysts
- Intended for use with blastocysts that have been vitrified using the Global . DMSO Blastocyst Vitrification Kit.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
Over-the Counter Use
Herbert Lemm
or
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number