(476 days)
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No
The provided text describes cryopreservation and thawing media for human blastocysts and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device provides media for cryopreservation and thawing of human blastocysts, which are processes for preservation and recovery, not for treating a disease or condition.
No
The device descriptions indicate that the products are media for the cryopreservation, thawing, and recovery of human blastocysts. These are used for preservation, not for diagnosing a condition or disease.
No
The 510(k) summary describes a "Kit" containing "Media" intended for cryopreservation and thawing of human blastocysts. This clearly indicates a physical product (media and potentially other kit components) and not a software-only device.
Based on the provided information, the devices described are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that the media are for the cryopreservation, thawing, and recovery of human blastocysts. This process is performed in vitro (outside the human body) and is directly related to diagnostic or therapeutic procedures involving human reproductive cells.
- Nature of the Device: The devices are described as "Media," which are substances used to support the life and growth of cells or tissues in a laboratory setting. This is a common characteristic of IVD products used in procedures like assisted reproductive technology (ART).
While the document lacks information on device description, image processing, AI, etc., the core intended use and the nature of the product as media for handling human blastocysts strongly indicate that these are IVD devices.
N/A
Intended Use / Indications for Use
8-global® Blastocyst Fast Freeze Kit - Based on S3:
- Media Intended for cryopreservation of human blastocysts. .
12-global® Blastocyst Fast Freeze Thawing Kit - Based on S3 - Media intended for the thawing and recovery of human blastocysts that . have been cryopreserved using the &-global® Blastocyst Fast Freeze Kit - Based on $3.
Product codes
MOL
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): 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.
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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.
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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).
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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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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 Road GUILFORD CT 06437
JAN 1 4 201
Re: K092963
Trade Name: global® Blastocyst Fast Freeze Kit - Based on S3 global® Blastocyst Fast Freeze Thawing Kit - Based on So Regulation Number: 21 CFR $884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: January 7, 2011 Received: January 12, 2011
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 regilations 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
1
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,
Herbert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health .
Enclosure
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international, inc. 510(K) Submission (K092963)
Indications for Use
510 (k) Number (if known) K092963
8-global® Blastocyst Fast Freeze Kit - Based on S3:
-
Media Intended for cryopreservation of human blastocysts. .
12-global® Blastocyst Fast Freeze Thawing Kit - Based on S3 -
Media intended for the thawing and recovery of human blastocysts that . have been cryopreserved using the &-global® Blastocyst Fast Freeze Kit - Based on $3.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_X
Over-the Counter Use
Tony B. Why
B