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510(k) Data Aggregation
(22 days)
CrossGlide ETS Plus
The CrossGlide™ ETS Plus is indicated for use for sonohysterography and to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy.
The CrossGlide™ ETS Plus is a sterile, disposable, single-use device which enables saline infusion sonohysteroraphy and the removal of mucosal tissue from the uterus for histological biopsy. The CrossGlide™ ETS Plus contains a Delivery Catheter with an everting Membrane, an Inner Aspiration Catheter that contains a lumen for saline infusion and aspiration. The everting Membrane places the Inner Aspiration Catheter into the uterine cavity. A proximal luer connector allows a 10cc luer lock syringe to infuse saline into the uterine cavity for sonohysterography. The 10cc syringe can be used to remove the saline from the uterine cavity and create negative pressure. Movement of the CrossGlide™ ETS Plus device, after creating negative pressure with the 10cc syringe, removes material and tissue from the uterine cavity.
This document is a 510(k) summary for the CrossGlide™ ETS Plus, an endometrial suction curette and accessories. It focuses on demonstrating substantial equivalence to a predicate device, the CrossBay™ Endometrial Tissue Sampler (K192534), and references another device, the CrossBay SonoSure™ Sonohysterography and Endometrial Sampling Device (K133144).
The provided text does not include a study describing the acceptance criteria and performance of an AI-powered device. Instead, it discusses a medical device and its performance through various physical and functional tests, biocompatibility testing, sterilization validation, and packaging/shipping validation.
Therefore, I cannot fulfill your request to provide information about the acceptance criteria and study proving an AI device meets those criteria, or details regarding sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not present in the provided document.
The document describes the following for the CrossGlide™ ETS Plus:
1. A table of acceptance criteria and the reported device performance:
There is no specific table of acceptance criteria for a new AI device's performance. Instead, the document discusses performance data for the CrossGlide™ ETS Plus physical device.
| Test Type | Description of Performance |
|---|---|
| Bench Testing | Confirmed the device performs according to product specifications. Mechanical (tensile, pressurization) testing was conducted to determine if pinch clamps operate under expected functional conditions and if the 10cc syringe maintains adequate negative pressure for sample collection. The subject device successfully passed all functional bench testing (i.e., met predefined acceptance criteria). |
| Biocompatibility | Utilizes identical materials and manufacturing as the predicate device. Biocompatibility testing on the predicate device (according to ISO 10993-1 and FDA guidance) showed passing results for Cytotoxicity, Vaginal Irritation, and Sensitization. |
| Sterilization | Utilizes the same product design and packaging as the predicate device. Evaluated for adoption into the predicate's ethylene oxide (EO) sterilization cycle (validated per ANSI/AAMI/ISO 11135:2014 via overkill method). Evaluation confirmed the subject device could be adopted into the previously validated cycle. |
| Packaging, Shipping, and Shelf-Life | Utilizes the same product design and packaging as the predicate device. Studies conducted per ASTM F88/F88M - 15, ASTM F 2096-11, and ASTM D4169-16 (Distribution Cycle 13). Shelf-life supported by packaging and performance tests on samples exposed to accelerated aging per ASTM F1980 - 16. |
The remaining requested information (2-9 pertaining to AI studies) is not available in the provided text.
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