(476 days)
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.
Not Found
The provided document is a 510(k) summary for the global® Blastocyst Fast Freeze Kit and global® Blastocyst Fast Freeze Thawing Kit. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device and does not typically include detailed studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies as would be found in a clinical trial report or an academic publication on a diagnostic AI device.
Therefore, most of the information requested in your prompt is not present in this 510(k) submission.
Here's what can be inferred or stated based on the provided text, and where information is explicitly missing:
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A table of acceptance criteria and the reported device performance:
- Not present. The document does not provide a table of acceptance criteria or performance metrics. The 510(k) process is about demonstrating substantial equivalence, not necessarily meeting pre-defined performance acceptance criteria with detailed statistical analysis.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not present. There is no mention of a "test set" or any specific study data that would detail sample sizes, data provenance, or study design (retrospective/prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not present. As there's no mention of a test set or a study involving establishing ground truth, this information is not available.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not present. No information on an adjudication method is available.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not present. The device described is a cryopreservation and thawing media kit for blastocysts, not an AI-powered diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this product.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not present. This device is not an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not present. No specific ground truth methodology is mentioned as it's not relevant to this type of device submission. Performance claim, if any, would typically be related to viability post-thaw or pregnancy rates, which would be direct outcomes, but no such study is detailed here.
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The sample size for the training set:
- Not present. The device is not an AI/ML algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not present. Not applicable for this device.
In summary: The provided document is an FDA 510(k) clearance letter and an "Indications for Use" statement for a reproductive media kit. It does not contain the detailed study information, acceptance criteria, or performance data typically associated with the evaluation of AI or diagnostic devices, which your questions are geared towards. The focus of this document is regulatory clearance based on substantial equivalence to predicate devices, not on proving device performance through specific clinical studies with defined endpoints and ground truth.
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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
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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,
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
§ 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.