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The EchoSampler™ is a single-use, sterile, disposable curette for:

• Detection of abnormalities of the uterus and endometrium using real-time sonography during injection of sterile saline into the uterine cavity
• Obtaining histological biopsy of the glandular epithelium and superficial uterine endometrial wall or sample extraction of uterine menstrual content for any of the following:
• a) Routine screening for early detection of endometrial carcinoma or other precancerous conditions which could make estrogen therapy inadvisable,
• b) Evaluation of endometrial tissue response in patients receiving estrogen replacement therapy for menopausal symptoms
• c) Endometrial dating and evaluation of uterine pathology associated with infertility, luteal insufficiency, or functional metrorrhagia
• d) Identification of specific uterine pathogens by bacterial culturing of uterine samples
• e) Inadequate imaging of the endometrium by endovaginal sonography
• f) Further evaluation of suspected abnormalities as seen on endovaginal sonography, including focal or diffuse endometrial thickening or debris,
• q) Preoperative and postoperative evaluation of the uterine cavity especially with regard to uterine polyps, myomas and cysts
• h) Congenital abnormalities and/or anatomic variants of the uterine cavity
• i) Infertility and habitual abortion

The EchoSampler™ is a single-use, sterile, disposable curette.

This is an FDA Premarket Notification (510(k)) K041237 for the EchoSampler, an endometrial aspirator. This document is a regulatory clearance letter, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria and performance studies.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning that the FDA has determined it is as safe and effective as a similar device already on the market. This determination is typically based on comparing the new device's design, materials, and technological characteristics to those of the predicate device, rather than requiring new clinical studies with established acceptance criteria and performance metrics described in detail in the 510(k) summary provided to the FDA.

Therefore, I cannot provide the requested information from the provided text.

Specifically, I cannot extract:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts used or their qualifications.
4. Adjudication method.
5. Information about MRMC comparative effectiveness studies or effect sizes.
6. Results from a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures utilizing washed spermatozoa.
The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures and for transcervical GIFT as an introducer.

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This document is a 510(k) premarket notification decision letter from the FDA for several Intrauterine Insemination (IUI) and GIFT catheters manufactured by Gynétics Medical Products N.V.

Based on the provided text, there is no information about acceptance criteria or a study proving that the device meets those criteria.

The document primarily focuses on:

• Substantial Equivalence Determination: The FDA has determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This is a regulatory determination, not an assessment of performance against pre-defined acceptance criteria from a study described in this document.
• Regulatory Information: It details the regulation numbers, product codes, regulatory class, and general controls provisions of the Act that apply to the device.
• Marketing Authorization: It states that the letter allows the applicant to begin marketing their device.
• Indications for Use: It lists the intended uses for three specific devices:
  • IUI #4220: For intra uterine artificial insemination procedures utilizing washed spermatozoa.
  • Smooze #4225: For intra uterine artificial insemination procedures utilizing washed spermatozoa.
  • Seminor #4502: For intra uterine artificial insemination procedures and for transcervical GIFT as an introducer.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. This type of information would typically be detailed in the 510(k) submission itself, not in the FDA's decision letter.

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The Delphin is to be used for embryo transfer and intra uterine insemination procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures.

Emtrac Catheters are to be used for embryo transfer procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures.

Semtrac Sets are to be used for embryo transfer procedures for in Semilac Sets are to be acount. In the substition technology (ART) procedures.

Not Found

I am sorry but this document is a 510(k) clearance letter from the FDA, not a study report. It states that the referenced medical devices (Emtrac, Delfin, and Semtrac Embryo Transfer and IUI Catheters) are substantially equivalent to legally marketed predicate devices.

Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance. It does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Information on experts used for ground truth or adjudication methods.
• Details on MRMC comparative effectiveness studies or standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets or how ground truth for training sets was established.

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A follicle aspiration set used for transvaginal harvesting of oocytes from follicles for IVF and ICSI.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted. The document is a 510(k) premarket notification letter from the FDA to Gynétics Medical Products N.V. regarding their device, FAS SET #4551 Follicle Aspiration Set. It states that the device has been determined to be substantially equivalent to legally marketed predicate devices and outlines the regulatory responsibilities.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given text.

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