(448 days)
The Saneso Colonoscope 360-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and cecum) and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A, Saneso Processor-A and other ancillary equipment.
The Saneso Gastroscope 360-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consistroscope 360-A/Saneso Single Camera Gastroscope-A, Saneso Processor-A and other ancillary equipment.
The Saneso Single Camera Colonoscope-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and ileocecal valve). The system also provides access for therventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A/Saneso Single Camera Colonoscope-A, Saneso Processor-A and other ancillary equipment.
The Saneso Single Camera Gastroscope-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Gastroscope 360-A/Saneso Single Camera Gastroscope-A. Saneso Processor-A and other ancillary equipment.
The Saneso Colonoscope 360-A is an endoscopic platform for diagnostic visualization and therapeutic access to the lower gastrointestinal tract (including the anus, rectum, sigmoid colon, colon and cecum) and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system enables physicians to view a high resolution wide field of view of up to 360°. The system consists of Saneso camera heads, colonoscope, video system, light source and other ancillary equipment. The Saneso Colonoscope 360-A is a full circular view video colonoscope and features multiple viewing options: 5 camera 360-degree raw images, 5 camera-stitched 360-degree images, and forward only view modes. The selection is made through the video interface.
The Saneso Colonoscope 360-A must be used in conjunction with the Saneso Processor-A. The Saneso Processor-A system serves as a control platform for the Saneso Colonoscope 360-A. The processor box consists of the electronics and mechanics required to operate the endoscope. It is responsible for image processing, transferring video signals from the colonoscope, pneumatic control of various external accessories that interface with the system. The accessories include the foot pedal, which is used to control the tissue wash water, the mouse, and the keyboard which are used for interfacing with the software and changing settings as needed. There are two monitors which can be connected, i.e. the master monitor and the slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.
The device is equipped with five cameras in order to provide a maximum 360° field of view (FOV) with high resolution video using external monitors connected through display ports. Each camera has LED light sources enabling the user to visualize in white light and other user selectable spectrum with Select Band Imaging or Dual Band Imaging modes (applicable only with SBI/DBI). The system is configured to transfer data to an external HL7 compliant electronic health record system. The system can be controlled using a mouse and keyboard.
The Saneso Gastroscope 360-A is an endoscopic platform for diagnostic visualization and therapeutic access to the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system enables physicians to view a high resolution wide field of view of up to 360°. The system consists of Saneso camera heads, gastroscope, video system, light source and other ancillary equipment. The Saneso Gastroscope 360-A is a full circular view video gastroscope and features multiple viewing options: 5 camera 360-degree raw images, 5 camera-stitched 360-degree images and forward only view modes. The selection is made through the video interface.
The Saneso Gastroscope 360-A must be used in conjunction with the Saneso Processor-A. The Saneso Processor-A system serves as a control platform for the Saneso Gastroscope 360-A. The processor box consists of the electronics and mechanics required to operate the endoscope. It is responsible for image processing, transferring video signals from the gastroscope, pneumatic control, and control of various external accessories that interface with the system. The accessories include the foot pedal, which is used to control the tissue wash water, the mouse and the keyboard which are used for interfacing with the software and changing settings as needed. There are two monitors which can be connected, i.e. the master monitor and the slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.
The device is equipped with five cameras in order to provide a maximum 360° field of view (FOV) with high resolution video using external monitors connected through display ports. Each camera has LED light sources enabling the user to visualize in white light and other user selectable spectrum with select either single band imaging or dual band imaging modes (applicable only with SBI/DBI). The system is configured to transfer data to an external HL7 compliant electronic health record system. The data is transferred using Wi-Fi or Ethernet. The system can be controlled using a mouse and keyboard.
The Saneso Single Camera Colonoscope-A is an endoscopic platform that provides diagnostic visualization and therapeutic access to the lower gastrointestinal tract including the rectum, colon and ileocecal valve. The system employs Select Band Imaging mode. The Saneso Single Camera Colonoscope-A features a single camera at the distal end that offers a 140° Field of View. The distal end features the front camera. LED light assembly, instrument channel outlet, nozzle, tissue wash outlet.
The Saneso Single Camera Colonoscope-A comprises programmable control buttons, insertion tube, suction valve, air/water valve, instrument channel port, umbilical cord, connector, angulation knobs and the bending section.
The Saneso Single Camera Colonoscope-A must be used in conjunction with Saneso Processor-A. The Saneso Processor-A is preinstalled with the Saneso Image Processing software and serves as a control platform for the Saneso Single Camera Colonoscope-A. The Saneso Processor processes the image and relays the video signals from the colonoscope to external display monitors. The Saneso Processor also offers pneumatic/water controls and interfaces for insufflation, tissue irrigation and camera lens wash. The Saneso processor also controls various external accessories that interface with the system. The software is operated via a mouse and keyboard. Two monitors are connected to the system i.e a master monitor and slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.
The Saneso Single Camera Gastroscope-A is an endoscopic platform that provides diagnostic visualization and therapeutic access to the upper Gastrointestinal (G.I) tract including the esophagus, stomach and duodenum. The system employs Select Band Imaging mode. The Saneso Single Camera Gastroscope-A consists of the Saneso Single Camera Gastroscope-A which is used in conjunction with the Saneso Processor-A and other ancillary equipment. The gastroscope features a single camera at the distal end that offers a 140° Field of View. The distal end features the front camera, LED light assembly, instrument channel outlet, nozzle, tissue wash outlet.
The Saneso Single Camera Gastroscope-A comprises programmable control buttons, insertion tube, suction valve, air/water valve, instrument channel port, umbilical cord, connector, angulation knobs and the bending section.
The Saneso Single Camera Gastroscope-A must be used in conjunction with Saneso Processor-A. The Saneso Processor-A is preinstalled with the Saneso Image Processing Software and serves as a control platform for the Saneso Single Camera Gastroscope-A. The Saneso Processor processes the image and relays the video signals from the colonoscope to external display monitors. The Saneso Processor also offers pneumatic/water controls and interfaces for insufflation, tissue irrigation and camera lens wash. The Saneso processor also controls various external accessories that interface with the system. The software is operated via a mouse and keyboard. Two monitors are connected to the system i.e a master monitor and slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.
Here's a breakdown of the acceptance criteria and study details for the Saneso-A Series devices, based on the provided text:
1. Table of Acceptance Criteria & Reported Device Performance
The FDA clearance letter refers to "acceptance criteria" through various performance tests, but it doesn't explicitly list numerical thresholds that were accepted. Instead, it states that the devices "met all acceptance criteria" for the respective tests. The reported device performance is generally described in terms of equivalence to predicate devices and successful completion of procedures.
| Acceptance Criteria Category | Specific Test / Characteristic | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | General Performance | "Performs as intended" and "safe and effective as the predicate device" |
| Electrical Safety & EMC | IEC 60601-1-2, ANSI AAMI ES60601-1 | Met all acceptance criteria in accordance with these standards. |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation | Biocompatible. Testing performed on Saneso Endoscope 360-A (same components/manufacturing as Saneso Single Camera Endoscope-A). Reprocessing steps met worst-case scenario for assessment. |
| Reprocessing Effectiveness | Cleaning Validation | Met all acceptance criteria; demonstrated cleaning process does not impact functionality. |
| High Level Disinfection Report | Met all acceptance criteria; demonstrated high-level disinfection does not impact functionality. | |
| Performance (Bench) | Design Verification & Validation, Performance Test Requirements | Met all design verification & validation, performance test requirements. |
| Software Performance | Software Verification and Validation Testing | Conducted and documented as recommended by FDA guidance; software considered 'moderate' level of concern. |
| Clinical Performance (Gastroscope) | Primary Outcome: Successful intubation of the third portion of the duodenum | 100% successful procedure rate (achieved with both Saneso and Olympus gastroscopes). |
| Secondary Outcome: Qualitative rating by endoscopists | Saneso gastroscope rated superior to Olympus gastroscope in terms of field of view. Rated substantially equivalent in other visualization and mechanical characteristics. | |
| Secondary Outcome: Mucosal injury | No complications or evidence of mucosal injury reported/observed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 22 subjects
- Data Provenance: Prospective, multi-center clinical study. The document does not specify the country of origin for the sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The text mentions "endoscopists who performed the procedure" but does not specify the exact number of experts or their specific qualifications (e.g., years of experience). They were responsible for qualitative ratings and assessing mucosal injury.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "qualitative rating by the endoscopists" suggests individual assessments, and it doesn't mention a process for resolving discrepancies if multiple endoscopists were evaluating the same case.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
While a comparative study was done using the Saneso gastroscope and a traditional gastroscope (Olympus GIF-H180), it was not a traditional MRMC study with AI assistance. It was a comparison of two different endoscopy devices.
- Comparison: Saneso gastroscope vs. traditional gastroscope (Olympus GIF-H180).
- Effect Size (Human Readers with/without AI assistance): Not applicable, as this study compared devices, not the effect of AI assistance on human readers. The Saneso device itself does not appear to incorporate AI for assisted reading, but rather offers a wider field of view.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable. The described device is an endoscopic visualization system, not an AI algorithm for standalone image interpretation. The "software" mentioned is for control and image processing, not for AI analysis.
7. The Type of Ground Truth Used
- Clinical Ground Truth: For the clinical study, the primary outcome of "successful intubation of the third portion of the duodenum" served as a procedural success ground truth. This would have been determined by the performing endoscopist.
- Expert Opinion: Qualitative ratings by endoscopists on aspects like field of view and mucosal injury assessment were also part of the evaluation, relying on expert observation and judgment.
8. The Sample Size for the Training Set
The document does not mention any training set size. This is consistent with the device being a visualization tool rather than an AI-driven diagnostic algorithm that typically requires a large training dataset.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As no AI training set is mentioned for this device, a method for establishing its ground truth is also not described.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.