Search Results

Ask a specific question about this device

Ask a specific question about this device

Water for Tissue Culture is to be used for tissue culture in assisted reproduction procedures.

Water for Tissue Culture 500mL

This document is a letter from the FDA regarding a 510(k) premarket notification for "Water for Tissue Culture" by Advanced Reproductive Technologies, Inc. It details the FDA's determination of substantial equivalence to a legally marketed predicate device.

There is no information in the provided text that describes acceptance criteria, device performance, sampling methods, expert qualifications, ground truth establishment, or any study details as requested in your prompt.

The document primarily focuses on regulatory approval, classification, and general controls applicable to the device. It states the intended "Indications For Use" for the device: "Water for Tissue Culture is to be used for tissue culture in assisted reproduction procedures." However, it does not include any performance metrics or study results.

Ask a specific question about this device

Hyaluronidase is used prior to intracytoplasmic sperm injections (ICSI) procedures to digest the hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.

Not Found

This is a 510(k) premarket notification decision letter from the FDA regarding a medical device called "Hyaluronidase." This type of document does not typically contain the detailed information required to answer your specific questions about acceptance criteria and device study data.

The letter primarily:

• Confirms that the FDA has reviewed the 510(k) notification.
• Determines that the device is "substantially equivalent" to legally marketed predicate devices.
• States the regulatory class of the device and its procode.
• Outlines general regulatory requirements the manufacturer must adhere to.
• Provides contact information for further regulatory questions.

The attached "Indications For Use" form simply states the intended purpose of the device.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This level of detail is found in the actual 510(k) submission, not the FDA's decision letter.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not present.
4. Adjudication method for the test set: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present.
6. If a standalone performance (algorithm only) was done: Not applicable for a drug/biological product like Hyaluronidase.
7. The type of ground truth used: Not applicable in the context of this device's function.
8. The sample size for the training set: Not applicable for a drug/biological product.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory approval letter and does not include the detailed technical and clinical study information you are seeking. To find that information, you would need to access the full 510(k) submission document (K991393) itself, which is often available through the FDA's public access policies or databases.

Ask a specific question about this device

Cryopreservation Media is used for assisted reproduction procedures, for the purposes of preparation of the human embryos for cryopreservation. They are used during the cryopreservation process of preserving embryos, both for freezing and thawing during assisted reproduction procedures.

Cryopreservation Media

The provided text is a 510(k) summary for Quinn's ® Cryopreservation Media. It is a regulatory document from the FDA granting substantial equivalence for the device. It does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

Therefore, I cannot provide the requested information based only on the input text. The document is a clearance letter, not a study report or a detailed description of performance claims.

Ask a specific question about this device

Phosphate Buffered Saline (PBS) and Phosphate Buffered Saline, with calcium, magnesium, glucose, pyruvate and phenol red are for in vitro procedures involving the manipulations of gametes and embryos such as oocyte retrieval or embryo transfer, gamete washing, or micromanipulation. They may also be used for cryopreservation of qametes and embryos after the addition of appropriate cryopreservation agent(s).

Phosphate Buffered Saline (PBS) and PBS with calcium, magnesium, glucose, pyruvate and phenol red Medium

This document is a 510(k) clearance letter from the FDA for Phosphate Buffered Saline (PBS) and PBS with additional components, intended for use in in-vitro procedures involving gametes and embryos.

The provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input text. The letter is a regulatory approval document and not a performance study report.

Ask a specific question about this device