(63 days)
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, to perform diagnostic and 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 endoscope used for viewing the adult cervical canal, uterine cavity, or female urinary tract for diagnostic and therapeutic procedures.
Here's an analysis of the provided information regarding its acceptance criteria and supporting studies:
- Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal "acceptance criteria" with specific thresholds or metrics for the device's performance in a table format. However, it does describe the areas of non-clinical performance testing conducted to demonstrate substantial equivalence to its predicate device (K183020). The conclusion states that the results of the testing demonstrate that the subject Endosee System is substantially equivalent to the predicate. This implies that the device met the performance expectations in these tested areas to be considered substantially equivalent.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Design Validation | Designed to meet intended specifications and uses. | Successfully completed. (Implied by substantial equivalence claim) |
| Functional Testing | Maintained functionality after aging. | Successfully completed on 6-month aged samples. |
| * Tip Retention * | Tip securely attached and functional. | Passed. (Implied by substantial equivalence claim) |
| * Instrument Access * | Working channel allowed for instrument insertion. | Passed. (Specific to this device, the working channel allows for both fluid infusion and instrument insertion.) |
| EMC/Electrical Safety | Compliance with relevant electrical safety standards. | Reevaluated with Essential Performance per IEC 60601-2-18. (Implied to have met standards) |
- Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for the test set in the non-clinical performance testing. It also doesn't mention data provenance such as country of origin or whether the data was retrospective or prospective, as the testing described is non-clinical performance (bench testing) rather than clinical studies on patients.
- Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable. The non-clinical performance testing described involved validating the device's design, functional aspects, and safety standards, not comparisons against expert interpretation of medical images or patient outcomes. Therefore, no medical experts were involved in establishing ground truth for this type of testing.
- Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple readers, which is not the type of testing described here.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. The submission focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device, not on comparing reader performance with and without AI assistance.
- Standalone (Algorithm Only) Performance Study:
No standalone (algorithm only) performance study was done. This device is a physical endoscope system, not an AI-powered diagnostic algorithm.
- Type of Ground Truth Used:
For the non-clinical performance testing, the "ground truth" would be the engineering specifications, functional requirements, and safety standards (e.g., IEC 60601-2-18) against which the device's performance was measured. It is not expert consensus, pathology, or outcomes data.
- Sample Size for the Training Set:
This information is not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data.
- How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set for this device.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.