(120 days)
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:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number of experts used or their qualifications.
- Adjudication method.
- Information about MRMC comparative effectiveness studies or effect sizes.
- Results from a standalone algorithm performance study.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 884.1060 Endometrial aspirator.
(a)
Identification. An endometrial aspirator is a device designed to remove materials from the endometrium (the mucosal lining of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to study endometrial cytology (cells).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(2) Labeling:
(i) Indication: Only to evaluate the endometrium, and
(ii) Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and
(3) The sampling component is covered within vagina.