(84 days)
The Low-Profile Optical Probe, as part of the Nvision VLE Imaging System, is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal and pancreatico-biliary system tissue microstructures, by providing two-dimensional, cross-sectional, real-time depth visualization.
The NvisionVLE Imaging System is intended to provide an image of tissue microstructure. The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.
The NinePoint Medical NvisionVLE® Imaging System subject to this 510(k) is a general imaging system comprised of the NvisionVLE® Console and NvisionVLE® Optical Probe.
The NinePoint Medical NvisionVLE® Imaging System is a high-resolution volumetric imaging system based on optical coherence tomography (OCT). In an analogous fashion to ultrasound imagery, OCT images are formed from the time delay and magnitude of the signal reflected from the tissue or organ of interest. The NvisionVLE® Imaging System employs an advanced form of OCT known as swept-source OCT (SS-OCT), or Optical Frequency Domain Imaging (OFDI), in combination with a scanning optical probe to acquire highresolution, cross-sectional, real-time imagery of tissue called Volumetric Laser Endomicroscopy (VLE).
The device consists of the following main components and accessories: (i) a mobile NvisionVLE® Console with an integrated computer and two touch-screen interfaces; (ii) proprietary NvisionVLE Software used to acquire, process, and visualize VLE images; (iii) a single-use, sterile NvisionVLE® Optical Probe that is inserted through the working channel of an endoscope: and (iv) a Probe Lock Accessory to prevent longitudinal motion of the Probe within the endoscope.
The provided document is a 510(k) Premarket Notification from the FDA for the NinePoint Medical NvisionVLE Low-profile Optical Probe. It concludes that the device is substantially equivalent to a legally marketed predicate device (NvisionVLE® Imaging System, K182261) and permits its marketing.
Important Note: The document explicitly states: "The NvisionVLE Imaging System is intended to provide an image of tissue microstructure. The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated." This means the device is cleared for imaging, not for diagnostic claims or AI-based diagnostic analysis. Therefore, the questions related to AI performance metrics (acceptance criteria for diagnostic accuracy, standalone algorithm performance, MRMC studies, ground truth for training/test sets for diagnostic purposes) are not applicable in this context. The provided information relates to the device's ability to image tissue microstructure and its safety/effectiveness for that purpose.
Based on the provided text, here's a description of the acceptance criteria and the study that proves the device meets them, focusing on the device's clearance for imaging and not diagnostic capabilities.
Acceptance Criteria and Study for NvisionVLE Low-profile Optical Probe (K191117)
The NvisionVLE Low-profile Optical Probe, as part of the NvisionVLE Imaging System, is cleared as an imaging tool to evaluate human tissue microstructure. The regulatory finding of substantial equivalence (K191117) is based on the device having the same intended use, principles of operation, and technological characteristics as its predicate device (NvisionVLE Imaging System, K182261). The current submission (K191117) specifically sought to add additional specific anatomical locations (pancreatico-biliary tract) to its cleared indications for use, specifically for the Low-profile Optical Probe.
The core "acceptance criteria" here is substantial equivalence to the predicate device for its defined imaging purpose, specifically demonstrating that the expanded anatomical locations do not introduce new questions of safety or effectiveness.
1. Table of Acceptance Criteria (for Imaging Device) and Reported Device Performance
| Acceptance Criteria (related to Substantial Equivalence for Imaging) | Reported Device Performance/Conclusion in 510(k) Submission |
|---|---|
| Similar Intended Use: The device (Low-profile Optical Probe) should maintain its intended use of evaluating human tissue microstructure, including for the newly proposed pancreatico-biliary system. | The device's intended use remains consistent with the predicate: "The Low-Profile Optical Probe, as part of the NvisionVLE Imaging System, is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal and pancreatico-biliary system tissue microstructures, by providing two-dimensional, cross-sectional, real-time depth visualization." The 510(k) successfully expanded this to include pancreatico-biliary. |
| Similar Technological Characteristics: The device should employ the same fundamental technology (SS-OCT/OFDI) as the predicate, or any changes should not raise new safety/effectiveness concerns. | The technological characteristics are unchanged from the predicate device (K182261). The subject of this 510(k) is an additional specific anatomical location, not a physical change to the device. |
| Safety: Use in expanded anatomical locations should be demonstrated as safe, with no new risks not normally associated with the device's general use. | **"No new risks are introduced not normally associated with the general use of the device."**Clinical literature review highlighted two studies: Corral (2018) and Tyberg (2018). The Tyberg (2018) in vivo study involving 10 patients reported "no complications" and "no OCT-related complications" during ERCP procedures within the pancreatico-biliary system, supporting safety. |
| Effectiveness (for Imaging Capability): The device should effectively provide imaging of tissue microstructure in the additional anatomical locations. | The clinical literature review of two studies (Corral 2018, Tyberg 2018) indicated "OCT imaging is feasible within the pancreatico-biliary system and may be used as a tool to help clinicians evaluate the tissue micro-structure." Image features correlating to tissue microstructure were identified in both studies. |
| Performance Standard Compliance: The device should continue to comply with relevant voluntary standards. | The NvisionVLE® Imaging System Low-profile Optical Probe continues to comply with: - ANSI/AAMI/ISO 10993-7 (Biological evaluation of medical devices: Part 7: Ethylene oxide sterilization residuals)- ANSI/AAMI/ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing)- ANSI/AAMI/ISO 11135:2014 (Sterilization of Health Care Products – Ethylene Oxide- Requirements for Development, Validation and Routine Control of Ethylene Oxide Sterilization Process for Medical Devices) |
2. Sample Sizes and Data Provenance for the Clinical Literature Review (Test Set)
-
Corral (2018) Study (Ex vivo):
- Sample Size: 25 surgical specimens (biliary and pancreatic ducts).
- Data Provenance: Not explicitly stated, but typically ex vivo studies are done in a controlled environment, likely retrospectively collected surgical samples from a local institution. The country of origin is not specified.
- Retrospective/Prospective: Ex vivo studies on surgical specimens are inherently retrospective for the tissue acquisition, though the imaging and analysis are prospective.
-
Tyberg (2018) Study (In vivo):
- Sample Size: 10 patients (biliary and pancreatic ducts).
- Data Provenance: Not explicitly stated. The country of origin is not specified.
- Retrospective/Prospective: This was an "in vivo" feasibility study, which implies a prospective collection of patient data during ERCP procedures.
3. Number of Experts and Qualifications to Establish Ground Truth for the Test Set
- The document describes studies that evaluated the feasibility of OCT imaging and the correlation of OCT images with tissue microstructure. The "ground truth" here refers to the actual tissue microstructure.
- Corral (2018): "Histology correlation to image: Yes." This indicates that a pathologist or similar expert was involved in interpreting the tissue histology to correlate with the OCT images. The specific number and qualifications of experts are not provided.
- Tyberg (2018): "Histology correlation to image: No." For this in vivo study, the focus was on the feasibility of obtaining images and identifying image features, not on a direct histological correlation. Therefore, no pathology-based ground truth establishment is mentioned for this study.
4. Adjudication Method for the Test Set
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the interpretation of images or establishment of ground truth within these summarized studies. The studies appear to be descriptive and feasibility-focused rather than comparative diagnostic performance studies requiring such methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done to evaluate how human readers improve with AI vs. without AI assistance.
- The device is cleared as an imaging tool, and its safety and effectiveness for diagnostic analysis or differentiating normal vs. abnormal tissue "has not been evaluated." Therefore, there is no AI component or diagnostic claim in this submission that would necessitate an MRMC study comparing human performance with and without AI assistance.
6. Standalone (Algorithm-Only) Performance Study
- No, a standalone (algorithm-only) performance study was not done.
- As explained above, no AI algorithm for diagnostic analysis is part of this device's regulatory submission or its stated claims. The device provides images, and interpretation is left to the clinician.
7. Type of Ground Truth Used
- For the Corral (2018) study, the ground truth for tissue microstructure was based on histology/pathology correlation from surgical specimens.
- For the Tyberg (2018) study, the "ground truth" was the successful acquisition of in vivo images and the ability to identify image features, without direct histological correlation at the time of the study. The study focused on feasibility and safety.
8. Sample Size for the Training Set
- This device is an imaging system, not an AI/ML algorithm that requires a "training set" in the computational sense.
- The 510(k) submission describes the device itself and its performance based on traditional medical device evaluation principles (same intended use, same technology, existing performance data, clinical literature review for expanded use). Therefore, the concept of a "training set" for an AI model is not applicable here.
9. How the Ground Truth for the Training Set Was Established
- As there is no AI/ML algorithm requiring a training set mentioned in this submission, this question is not applicable.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.