(336 days)
The U-Scope 8000 HSC+EMB Cannula is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic and histologic diagnosis. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.
The U-Scope 8000 HSC+EMB Cannula is a handheld, battery-operated portable hysteroscope. It includes a sterile single use disposable endometrial biopsy cannula (the U-Scope 8000 HSC+EMB cannula) and a reusable HandTower (U-Scope 8000). The disposable U-Scope 8000 HSC+EMB cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and two channels for infusion of irrigating fluid and aspiration of tissue. Adjacent to the tip of the cannula is a curette that facilitates collection of tissue during the biopsy procedure. The disposable cannula is sterilized and packaged in a sealed pouch. The HandTower is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the U-Scope 8000 HSC+EMB cannula. The HandTower contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or start/stop a video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.
Here's a breakdown of the acceptance criteria and the study information for the U-Scope 8000 HSC+EMB Cannula, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Specified Standard) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | N/A (implied by "meet design" and comparison to cleared devices for stiffness/force-to-tip deflection as a surrogate for biopsy sampling quality) | Found to meet design after testing for bending, pulling, torque, and presence of leaks. Also tested for stiffness/force-to-tip deflection in comparison to other cleared endometrial sampling devices (met this, serving as a surrogate for biopsy sampling quality assessment). |
| Temperature Testing | IEC 60601-2-18 | Found to meet requirements specified in IEC 60601-2-18 (surface temperatures at various points over time). |
| Field of View Testing | ISO 8600-3 | Found to meet requirements specified in ISO 8600-3 (accuracy of field of view). |
| Direction of Viewing Testing | ISO 8600-3 | Found to meet requirements specified in ISO 8600-3 (accuracy of directions of view). |
| Image Quality Testing | ISO 8600-5 | Found to meet requirements of ISO 8600-5. |
| Electrical Safety | IEC 60601-1, IEC 60601-1-2:2007 (EMC), IEC 61000-4-2:2008 (EMC), IEC 60601-2-18:2009 (thermal safety) | Met compliance requirements for electrical safety as specified in IEC 60601-1, including provisions for EMC safety in IEC 60601-1-2:2007 and IEC 61000-4-2:2008, as well as testing to IEC 60601-2-18:2009. Thermal safety included in IEC 60601-2-18. |
| Biocompatibility | ISO 10993 (implied, for tissue contact materials) | Demonstrates biocompatibility through cytotoxicity, sensitization, irritation, and acute systemic toxicity testing for device components in contact with the patient. |
| Sterilization Validation | ISO 11135-1:2007 | Found in compliance with ISO 11135-1:2007 (requirements for development, validation and routine control of a sterilization process for medical devices using Ethylene oxide). |
| Packaging (Sterile Devices) | ISO 11607-1:2006 | Found in compliance with ISO 11607-1:2006 (packaging for terminally sterilized medical devices). |
| Reprocessing (Reusable) | AAMI TIR12:2010, AAMI TIR 30:2011 | Found in compliance with AAMI TIR12:2010 (designing, testing, and labeling reusable medical devices for reprocessing) and AAMI TIR 30:2011 (compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices), likely referring to the HandTower which is reusable. |
| Shelf Life | N/A (validation for claimed shelf life) | Sterilization validation and shelf life testing confirmed the label shelf life. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not specify sample sizes for the test set for any of the performance tests (mechanical, temperature, field of view, image quality, electrical safety, biocompatibility, sterilization, or shelf life).
The data provenance is also not explicitly stated (e.g., country of origin, retrospective/prospective). These appear to be laboratory and bench testing rather than clinical study data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided as the document describes technical performance testing rather than studies involving human interpretation or clinical outcomes that would require ground truth established by experts.
4. Adjudication Method
This information is not applicable as the tests described are technical performance tests that do not involve expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study was not conducted or reported in this summary. The summary focuses on the technical performance and safety of the device itself, not its impact on human reader performance.
6. Standalone (Algorithm Only) Performance Study
No. This device is a hysteroscope with an endometrial biopsy cannula, a physical medical device. It is not an algorithm or AI-driven system, so a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
The "ground truth" for the performance tests described can be considered the established requirements and specifications of the referenced standards (ISO, IEC, AAMI). For example, for temperature testing, the ground truth is the allowable temperature range in IEC 60601-2-18. For image quality, it's the criteria specified in ISO 8600-5. For biocompatibility, it's the pass/fail criteria for the specific tests based on ISO 10993.
8. Sample Size for the Training Set
This information is not applicable. The U-Scope 8000 HSC+EMB Cannula is a physical device, not an AI or machine learning model that requires a training set.
9. How Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.