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Bioteque's HSG catheter sets are indicated to evaluate the causes of abnormal uterine bleeding, menstrual disorders, recurring pregnancy loss, or unexplained infertility. They can also be used to assess uterine pathology and patients on tamoxifan therapy.

HSG type catheter sets are used to infuse a fluid (either a contrast media or a sterile saline) into the uterine cavity while blocking the external cervical OS to retain the fluid in the uterus during the procedure.

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I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device (HSG Catheter Set). It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document. The letter simply states that the FDA has found the device substantially equivalent to legally marketed predicate devices.

To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) summary that includes performance data.

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An endometrial suction curette, such as Bioteque's Curelle, Preferved Corelle, or Coteq 2.5, are devices used to remove samples of materials from the uterus and from the mucosal lining of thee uterus by scraping or vacuum suction These devices obtain tissue samples for purpos of biopsy & precancer screening or they can be used for menstrual extraction.

An endometrial suction curette, such as Bioteque's Curelle, Preferved Corelle, or Coteq 2.5

I am sorry, but the provided text only contains regulatory information about FDA clearance for endometrial suction curettes. It does not include any details about acceptance criteria, study designs, performance data, or ground truth establishment for a medical device. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input.

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Bioteque's vaginal pessaries are indicated as removable devices placed in the vaginal cavity to provide a non-surgical alternative for the treatment of organ prolapse and to relieve the symptoms of pelvic relaxation with and without urinary incontinence.

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I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance. The text is a 510(k) clearance letter from the FDA for a Bioteque Vaginal Pessary, indicating that the device is substantially equivalent to a legally marketed predicate device.

The letter discusses regulatory aspects, such as compliance with the Federal Food, Drug, and Cosmetic Act, and general controls provisions. It also includes the specific indications for use of the Bioteque Vaginal Pessary. However, it does not detail any specific acceptance criteria for performance, nor does it describe a study that was conducted to demonstrate the device meets such criteria. Therefore, I cannot accurately fill in the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, or types of ground truth.

Ask a specific question about this device

Ask a specific question about this device