Search Results

The NaviAid™ ICVI device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine (i.e., an endoscope that is used for standard intestinal endoscopic visualization and has a compatible instrument channel as defined in the instructions for use)

The modified NaviAid™ ICVI is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to enable advancement and positioning of a standard endoscope in the small intestine. The modified NaviAid™ ICVI Device comprises a disposable balloon system and an air supply control unit for inflating and deflating the balloon system. The role of the ICVI disposable is to facilitate advancement of a standard endoscope into the small intestine. The modified NaviAid™ ICVI disposable includes the ICVI Balloon and the ICVI inflation tube. The balloon is inflated by ambient air. Either the Air Supply Unit ("ASU") or Single Balloon Air Supply Unit ("SB ASU") may operate and control the inflation and deflation of the balloon through a foot-pedal. 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 or SB ASU.

The ICVI balloon can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the ICVI inflation tube at its proximal side, outside the patient's body. When the ICVI balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the ICVI inflation tube serves as a rail that leads the endoscope as it is pushed towards the anchoring ICVI balloon.

The balloon and tube negligibly compromise the endoscope's flexibility, or its field of view. Additionally, the ICVI disposable negligibly compromise the maneuverability of the endoscope's tip and does not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc. The ICVI disposable can be pulled back at any time during the procedure in order to allow use of therapy tools.

The NaviAid™ ICVI disposable is intended for-single use, while the ASU and SB ASU are re-usable.

The provided text describes a 510(k) submission for the NaviAid™ ICVI device, focusing on its substantial equivalence to a predicate device and non-clinical performance data. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/ML performance evaluation. The document confirms that clinical performance data was "Not Applicable" for this submission.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a breakdown of what can be extracted or inferred based on the document's content:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or a table of reported device performance in the way a typical AI/ML study would. Instead, it refers to "design and performance specifications" being met through non-clinical tests.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample size for test set: Not applicable, as clinical performance data was "Not Applicable" and only non-clinical (in vitro, mechanical) tests were performed.
• Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Adjudication method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC study: No. The document explicitly states "Clinical Performance Data: Not Applicable." The device is an accessory to an endoscope, not an AI/ML diagnostic tool for human readers.
• Effect size: Not applicable.

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

• Standalone study: No. The device is a physical accessory to an endoscope, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of ground truth: Not applicable in the context of clinical studies. For non-clinical tests, the "ground truth" would be established engineering specifications and physical measurements (e.g., balloon inflation, material properties, compatibility with endoscope channels).

8. The sample size for the training set

• Sample size for training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• How ground truth for training set was established: Not applicable.

Summary of available information:

The document describes the NaviAid™ ICVI device's non-clinical performance testing. These tests focused on ensuring the device meets engineering specifications and functions as intended, rather than evaluating performance against a clinical ground truth or human reader performance.

• Acceptance Criteria & Device Performance: The document generally states that "The non-clinical tests demonstrated that the modified NaviAid™ ICVI device meets its design and performance specifications." Specific criteria are implied by the types of tests conducted:

  • ICVI-In Vitro Validation
  • PU Balloon (material properties/functionality)
  • AB Tip (material properties/functionality)
  • Irrigation Cap (functionality)
  • AB Compatibility with 3.2mm Working Channel using a Handle (fit and function)
  • ICVI Tube Length (dimensional accuracy)
  • Set Point Pressure Tolerance (for the SB ASU)
  • Inflation/Deflation Cycles (durability/functionality)
  • Electrical & Mechanical Safety, Electromagnetic Compatibility, Software Validation, Biocompatibility (compliance with recognized standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, FDA Guidelines, ISO 10993)

• Study Proving Acceptance Criteria: The study described is a series of non-clinical performance tests conducted on the modified NaviAid™ ICVI device. These tests focused on the device's physical and mechanical properties, compatibility, and safety.

  • The ASU and SB ASU (Air Supply Units) components' performance tests were referenced from previous 510(k) submissions (K060923 and K110291, respectively), indicating reliance on prior established performance data for shared components.
  • The ICVI disposable's performance tests were also referenced from K101191.
  • New tests for the modified device specifically addressed the ICVI-R model's rotation capability, new tip material, irrigation cap, and modified working length.

• Clinical Performance Data: Explicitly stated as "Not Applicable," meaning no human clinical trials were conducted to establish safety or effectiveness for this 510(k) submission. The FDA cleared the device based on substantial equivalence to a predicate device and satisfactory non-clinical testing.

Ask a specific question about this device