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The Endosee System is used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures The types of procedures where the Endosee System could offer visualization include:

• Abnormal bleeding
• Infertility and pregnancy wastage
• · Evaluation of abnormal hysterosalpingogram
• · Intrauterine foreign body
• · Amenorrhea
• · Pelvic pain
• · Directed biopsy
• Removal of fibroids and polyps
• · Transection of intrauterine adhesions
• · Transection of intrauterine septa

The Endosee System can also be used to permit viewing of the adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.

The Endosee System is a handheld, battery-operated, portable endoscope that consists of a reusable Display Module with an LCD touchscreen monitor and a sterile, single-use cannula. It is intended for use in viewing the adult cervical canal, uterine cavity, or female urinary tract, including the bladder, during diagnostic or therapeutic hysteroscopy or cystoscopy procedures in an operating room, outpatient, or office setting. The Cannula has a light source and camera at the distal end, which are used for visualization and to capture image and video of the diagnostic area. The image and video signals are electronically transferred from the Cannula to the Display module via an electrical connector and cable, and the LCD monitor is used for viewing. The Endosee is provided with a Docking Station that recharges the battery in the Display Module and allows the user to download images/video from the internal device memory to an external computer.

The Endosee System is a handheld, battery-operated, portable endoscope used for viewing the adult cervical canal, uterine cavity, or female urinary tract during diagnostic or therapeutic procedures. The device under review (K200038) is a modification of a previously cleared device (K190639), with the primary changes being to indirect patient-contacting materials and additional shielding on the cannula board.

Here's the information regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the numerical sample size for each specific non-clinical test conducted. However, it indicates tests were performed on "samples accelerated aged to 6-months per ASTM F1980-16." This implies that a sufficient number of devices were tested to draw statistically sound conclusions, in accordance with the specified standard.

The data provenance for the tests is entirely non-clinical bench testing. There is no mention of human patient data (retrospective or prospective) being used to evaluate the device's performance in this submission, as the submission focuses on demonstrating substantial equivalence through engineering and laboratory testing related to the physical changes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This submission is for a medical device that does not involve algorithmic diagnostic or prognostic capabilities requiring expert interpretation for ground truth establishment. The ground truth for the non-clinical tests is based on established engineering and materials standards (e.g., ISO, ASTM, IEC).

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication method (e.g., 2+1, 3+1) was used as the evaluation was based on objective, quantifiable non-clinical test results against established engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This device is a physical medical instrument, not an AI or imaging diagnostic tool that would typically involve human readers interpreting cases.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The Endosee System is a physical endoscope, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant to this submission.

7. The Type of Ground Truth Used:

The ground truth used for proving the device meets the acceptance criteria is established engineering and materials standards, along with internal company specifications for performance. These include:

• ISO 11135:2014 (Sterilization)
• ISO 11737-1:2018 (Bioburden)
• ISO 10993 (Biocompatibility series: -5, -10, -7)
• ASTM F1980-16 (Accelerated Aging)
• ISTA 3A:2008 (Ship Testing)
• ASTM 2096-11 (Bubble Leak)
• ANSI/AAMI ES 60601-1:2005/(R)2012 (Electrical Safety)
• IEC 60601-2-18:2009 (Electrical Safety for Endoscopes)
• IEC 60601-1-2:2014 (EMC)
• IEC 60601-1-15 (Drop Test)
• IEC 60529:2004 (IPX2 Ingress Test)
• IEC 62304:2006 (Software Verification)

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI or machine learning model. There is no concept of a "training set" for the type of evaluation presented in this submission.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set, there is no ground truth established for it in the context of this device.

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