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Hysteroscopy: The LUMINELLE DTx Hysteroscopy 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 Hysteroscopy System is specifically used with the LUMINELLE Dx 360 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.

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 Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the blader. When combined with accessory instruments, the user to perform various diagnostic and therapeutic procedures.

NOTE: When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.

The LUMINELLE DTx Hysteroscopy System originally received 510(k) clearance in 2018 as a hvsteroscopic and cvstoscopic svstem (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).

Based on user feedback for a thinner option for the disposable sheath for only diagnostic use, UVision360, Inc. (hereafter UVision) proposes the addition of a new accessory, the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), as part of an engineering performance change.

The LUMINELLE DTx Hysteroscopy System indications for use is identical to the previously cleared indications for use for the system. However, when the system is used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the indications for use are limited to diagnostic use only.

No changes are proposed for the previously cleared components of the LUMINELLE DTx Hysteroscopy System. The new LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) accessory is a modification of the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid component of the previously cleared LUMINELLE DTx Hysteroscopy System (K190827) with the following main changes:

• . The new accessory has one fluid line rather than the two fluid lines of the previously cleared component.
• . The new accessory has a combined channel for the scope and the fluid line rather than the separate channels of the previously cleared component.
• The new accessory has no operative channel available unlike the previously cleared . component, due to the fact that it is for diagnostic use only.

The provided text describes a 510(k) submission for the LUMINELLE DTx Hysteroscopy System, which includes the addition of a new accessory, the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic).

The study aims to demonstrate substantial equivalence to a previously cleared predicate device (LUMINELLE DTx Hysteroscopy System, K190827).

Summary of Acceptance Criteria and Device Performance:

The document primarily focuses on verifying the safety and effectiveness of the new accessory by demonstrating that the modified device remains as safe and effective as the predicate. It does not provide specific quantitative acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity for detecting specific conditions) for the new diagnostic sheath, as the intent of this 510(k) is an engineering performance change and limitation of use for the new accessory rather than a new diagnostic claim. Instead, the "acceptance criteria" are implied through the successful completion of various engineering, biocompatibility, and usability tests.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Detailed Information about the Study:

1. A table of acceptance criteria and the reported device performance: Refer to the table above.

   • Note: The document does not specify quantitative diagnostic performance metrics because the submission is for an engineering change and a limitation of use for an accessory, not a new diagnostic claim that would require clinical performance study. The "acceptance criteria" are primarily related to safety, sterility, shelf life, and basic functionality as a medical device to ensure equivalence to the predicate.

2. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: The document does not explicitly state specific sample sizes for the various tests (e.g., how many sheaths were tested for accelerated aging, how many "in vivo models" were used for usability). It refers to "all samples met specifications" or "packages were confirmed."
   • Data Provenance: The information provided is retrospective in nature, as it's a summary of testing already performed for a 510(k) submission. The country of origin for the data is implied to be within the scope of UVision360 Inc.'s operations (Raleigh, NC, USA), but not explicitly stated for the testing sites.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of submission. The "ground truth" for these engineering, biocompatibility, and usability tests is established by adherence to recognized standards (e.g., AAMI TIR28, ASTM F1980-16, ASTM D4169-16, ASTM F88-15, ASTM F2096-11, ISO 10993-10:2016, ISO 10993-5:2009) and predefined acceptance criteria set during the device's development and validation. Experts in relevant engineering, toxicology, and quality assurance fields would have designed and overseen these tests, but their specific number and qualifications are not detailed in this regulatory summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This document describes technical device performance testing (e.g., sterility, shelf life, biocompatibility, mechanical function), not clinical diagnostic performance requiring expert adjudication of patient cases.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML-enabled device and no MRMC study was performed or needed for this type of submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML-enabled device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" for the tests described is the adherence to specified technical and safety standards (e.g., ISO, ASTM standards for biocompatibility, packaging integrity, and accelerated aging) and predefined functional specifications for the device. For the usability and design validation, it implicitly relies on objective performance measures and user feedback in "in vivo models" compared against "predefined acceptance criteria."

8. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established: Not applicable.

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