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Hysteroscopy: The LUMINELLE DTx System is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures. Generally recognized indications for diagnostic hysteroscopy include: Abnormal bleeding, Infertility and pregnancy wastage, Evaluation of abnormal hysterosalpingogram, Intrauterine foreign body, Amenorrhea, Pelvic pain. Generally recognized indications for use for operative hysteroscopy include: Directed endometrial biopsy, Polypectomy, Submucous myomectomy, Transection of intrauterine adhesions, Transection of intrauterine septa, Endometrial ablation. Cystoscopy: The LUMINELLE DTx System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures. NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. NOTE: When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.

The LUMINELLE DTx System, previously known as the LUMINELLE DTx Hysteroscope System, originally received 510(k) clearance in 2018 as a hysteroscopic system (K181909). In addition, LUMINELLE DTx Hysteroscopy System received 510(k) clearance in 2019 for the addition of a sheath component, LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid to the system (K190827) and LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) (K19227). The LUMINELLE DTx System permits viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. The LUMINELLE DTx System is intended for use in endoscopic access to the examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the LUMINELLE DTx System allows the user to perform various diagnostic and therapeutic procedures. The LUMINELLE DTx System is comprised of the following components: LUMINELLE DTx Scope; LUMINELLE Communication Cable; LUMINELLE Control Hub: USB cable: HDMI cable, and; power cord. UVision360, Inc. (hereafter UVision360) designed a new accessory, the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) that is compatible with the LUMINELLE DTx System that permits direct viewing of the cervical canal and uterine cavity during biopsy procedures. LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) is a single use accessory and is made of the same materials as the previously cleared sheaths (K190827, K192278). The LUMINELLE DTx Scope is reprocessed after each use, depending on the procedure. High Level Disinfection (HLD) solutions can be used to reprocess the LUMINELLE DTx Scope when used with a cystoscopy procedure. 0.6% Ortho-Phthalaldehyde (OPA), a chemical disinfectant, has been previously cleared for HLD. However, UVision360 has verified and validated an additional chemical, Steris Revital-Ox™ RESERT® High Level Disinfectant, for HLD with the LUMINELLE DTx System. Steris Revital Ox™ RESERT® High Level Disinfectant has been tested in order to determine that it identically cleans the LUMINELLE DTx Scope as 0.6% OPA and does not adversely affect the functionality of the LUMINELLE DTx System. Before a hysteroscope procedure, the LUMINELLE DTx Scope must be sterilized to be reprocessed. In the previous submissions, Ethylene Oxide, qualified by Andersen Scientific, Inc., has been used to sterilize the LUMINELLE DTx Scope. An additional sterilization method, V-PRO® Low Temperature Sterilization, qualified by Steris located in Mentor, OH, has been validated and verified as an additional sterilization method to ensure that it properly sterilizes the LUMINELLE DTx Scope.

The Cook® Sonohysterography Biopsy Catheter is used to access the uterine cavily for sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device. The device is a single catheter designed to perform saline infusion sonohysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use.

The Cook® Sonohysterography Biopsy Catheter is used to access the uterine cavity for sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device. The device is a single catheter designed to perform saline infusion sonohysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use. The materials used in the construction of the Cook® Sonohysterography Biopsy Device are well known in the medical field. Biocompatibility, Ethylene Oxide Residual, and Functional testing have shown that the materials and the device meet the test requirements and are safe and effective. Literary articles prove the usefulness of this type of device to the clinician and patient population.

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.