(111 days)
The NaviAid™ BGC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization).
The NaviAid™ BGC Disposable is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to ensure positioning of a standard endoscope during endoscopy of the large or small intestine (standard endoscope - i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization). The NaviAid™ BGC system comprises a disposable balloon system and an Air Supply Unit for inflating and deflating the balloon system. The role of the BGC disposable is to facilitate advancement of a standard endoscope into the large and/or small intestine. The NaviAid™ BGC Disposable includes the BGC Balloon and the BGC inflation tube. The balloon is inflated by ambient air. The Air Supply Unit ("ASU") operates and controls the inflation and deflation of the balloon through a footpedal. The balloon is connected to a dedicated inflation tube that runs inside the instrument channel of the endoscope, and is connected at its proximal (user) end to the ASU. The BGC balloon can be advanced ahead of the endoscope tip or pulled back by pushing/pulling action on the BGC inflation tube at its proximal side, outside the patient's body. When the BGC balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the BGC inflation tube serves as a "guide wire" that leads the endoscope as it is pushed towards the anchoring BGC balloon.
The NaviAid™ BGC device is designed as an accessory to an endoscope to facilitate its positioning in the small and large intestine. The device's performance was evaluated through a series of non-clinical tests to demonstrate its conformance to design specifications and safety requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit from Test Type) | Reported Device Performance (as stated in the document) |
|---|---|---|
| BGC Handle and Instrument Channel Compatibility | Ensure proper fit and function within various endoscope instrument channels. | Device meets design and performance specifications, easy to use, does not cause damage to the endoscope. |
| BGC Air Leakage | Maintain integrity of the balloon system and prevent air leaks during inflation. | Device meets design and performance specifications. |
| BGC Bending Radius | Maintain flexibility and maneuverability of the device within the endoscope. | Device meets design and performance specifications, negligibly compromises endoscope's flexibility. |
| Endoscope Flexibility | Not significantly impede the endoscope's flexibility and maneuverability. | Device meets design and performance specifications, negligibly compromises endoscope's flexibility or tip maneuverability. |
| BGC Assembly Degradation Test | Demonstrate durability and integrity of the device components over its intended single use. | Device meets design and performance specifications. |
| BGC Inflation/Deflation Test | Ensure reliable and controlled inflation and deflation of the balloon. | Device meets design and performance specifications. |
| BGC In-Vitro Validation Test | Verify the anchoring and advancement mechanism of the balloon in a simulated environment. | Device meets design and performance specifications, easy to use, does not cause damage to the intestine. |
| Packaging Validation (ISO 111607) | Maintain sterility and integrity during storage and transport (for non-sterile components). | Device meets design and performance specifications. (Note: Device is supplied non-sterile.) |
| BGC Balloon (Material and Design) | Demonstrate suitability of balloon material and design for intended use. | Device meets design and performance specifications. |
| Component Bond Strength | Ensure robust attachment of device components. | Device meets design and performance specifications. |
| BGC Balloon Cover | Ensure proper function and protection of the balloon. | Device meets design and performance specifications. |
| Electrical & Mechanical Safety Testing (IEC 60601-1) | Compliance with international standards for electrical and mechanical safety. | Complies with voluntary recognized standards. |
| Electromagnetic Compatibility Testing (IEC 60601-1-2) | Compliance with international standards for electromagnetic compatibility. | Complies with voluntary recognized standards. |
| Software Validation (IEC 60601-1-4 & FDA Guidelines) | Ensure software functionality and safety (for the Air Supply Unit). | Complies with voluntary recognized standards. |
| Biocompatibility Testing (ISO 10993) | Ensure patient contact materials are biocompatible. | All patient contact materials comply with biocompatibility testing and voluntary recognized standards. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states "Clinical Performance Data: Not Applicable." Therefore, there was no test set involving human subjects. The performance evaluations were conducted through non-clinical, in-vitro testing. The data provenance is internal to Smart Medical Systems Ltd., Israel, as all listed test document numbers appear to be internal company documents (e.g., Doc. No. TP310001).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical test set with human subjects requiring expert ground truth establishment was conducted. The non-clinical tests would have been evaluated against engineering and design specifications by internal company engineers and quality assurance personnel.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. The document states "Clinical Performance Data: Not Applicable."
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Since this is a mechanical accessory device, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not directly apply in the typical AI context. The device itself is designed as an accessory to be used with a human-operated endoscope. Its performance was evaluated in terms of its mechanical, electrical, and material properties. The non-clinical tests listed serve as the "standalone" performance evaluation of the device's technical specifications and safety attributes independent of clinical human performance outcomes.
7. Type of Ground Truth Used
For the non-clinical tests, the ground truth was established by adherence to:
- Engineering and Design Specifications: Each test (e.g., BGC Air Leakage, Component Bond Strength) would have specific quantitative or qualitative criteria defined during the device's design phase.
- International Standards: Compliance with recognized standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, and ISO 10993 served as the ground truth for safety, electrical, mechanical, software, and biocompatibility aspects.
- Simulated Conditions: The "BGC In-Vitro Validation Test" implies testing in a simulated environment to assess the device's functional performance in a context mimicking its intended use.
8. Sample Size for the Training Set
Not applicable. The NaviAid™ BGC device is a mechanical accessory, not an AI or machine learning algorithm, and therefore does not have a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.