(163 days)
The Endoscope Module of the VS3-IR-MMS System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures. The Iridium Module of the VS3-IR-MMS System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.
The VS3-IR-MMS System consists of the cleared base system and the Iridium Module that is the subject of this submission. The currently marketed VS3 system with endoscope functionality was cleared under the following product codes: GCJ (General Surgery Endoscope), GWG (Neurological Endoscope), and HRX (Orthopedic Arthroscope). The cleared base system consists of the following components and accessories: High Definition 3D Endoscope, High Definition 3D Camera with 3 control buttons and a focus adjustment knob, 2D Coupler, CCU, Light Source, and Display Monitor. The VS3-IR-MMS System that is the subject of this submission contains the previously cleared components of the cleared base system listed above, as well as a High Definition IR Fluorescence Scope (MMS), a Laser Light Source (LLS), associated software and VS, Iridium IR Fluorescence Kit. The new Iridium Module, which uses the newly added High Definition IR Fluorescence Scope (MMS) and a Laser Light Source (LLS), as well as the cleared High Definition 3D Camera, Camera Control Unit (CCU), and Display Monitor, is used to generate florescence excitation illumination for external use in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.
The document describes the VS3-IR-MMS System and its Iridium Module, which is intended for capturing and viewing fluorescent images for the visual assessment of blood flow as an adjunctive method. The submission focuses on demonstrating substantial equivalence to a predicate device, the Novadaq Technologies SPY Imaging System (K063345), rather than setting specific performance acceptance criteria for the new module.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the Iridium Module's performance in terms of metrics like sensitivity, specificity, or accuracy. Instead, it relies on demonstrating that the device "functions as intended" and "met all performance acceptance criteria" based on bench testing and limited human subject evaluations. The primary "acceptance criteria" presented are related to regulatory standards compliance and functional equivalence to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1-2 EMC Standard | Conforms to standard |
| Compliance with IEC 60601-1 Basic Safety Standard | Conforms to standard |
| Compliance with IEC 60601-1-4 Programmable Medical Systems | Conforms to standard |
| Compliance with IEC 60825-1 Laser Safety Standard | Conforms to standard |
| System software performs as intended | Software validated and performs as intended |
| Detect and visualize anatomy and blood flow (Iridium Module) | Bench testing (ICG in water, ICG through chicken skin) showed "good quality imaging." "Functions as intended" in human hand simulation and free flaps. |
| Functions as intended with human subjects (no adverse events) | Demonstrated in human subjects with "no adverse events reported" |
| Substantially equivalent to predicate device (K063345) | Concluded as substantially equivalent based on technological characteristics and performance data. |
| Imaging device has no direct or indirect patient contact | No direct or indirect patient contact |
| Light source is Infrared Laser | Infrared Laser |
| Excitation Wavelength is 805nm | 805nm |
| Emission Band is 825nm to 850nm | 825nm to 850nm |
| Emission Capture using IR camera | IR camera |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing:
- ICG in sterile water: A single sample of 10mg ICG diluted to 2 ug/ml.
- ICG through chicken skin: A single sample of ICG in sterile water covered with chicken skin.
- Human Simulation: A human hand was used. (Sample size: 1)
- Human Subjects: "Several human subjects" were evaluated in free flaps. (Exact sample size not specified, but implied to be small).
- Data Provenance: The human hand simulation and human subject evaluations were conducted "outside of the United States." The context suggests these were prospective evaluations, albeit limited.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth for the test sets. The interpretations of "good quality imaging" during bench testing and "functions as intended" or "no adverse events" during human evaluations were likely made by the researchers or clinical personnel involved in the studies, but their specific expert qualifications are not detailed.
4. Adjudication Method for the Test Set
The document does not mention any formal adjudication method (e.g., 2+1, 3+1) for evaluating the test results. The assessment appears to be based on direct observation and qualitative judgment by the study personnel.
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
No MRMC comparative effectiveness study was done. This device is not described as an AI-powered diagnostic or assistive tool for human readers in the traditional sense. It's an imaging system for visualizing blood flow.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an imaging system; it captures and displays images for human interpretation. The concept of "standalone algorithm only" performance, as it applies to AI/ML diagnostic tools, is not relevant here. The system's function is to provide the visual information.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Bench Testing: The ground truth was the known presence and concentration of ICG and the physical setup (ICG solution, ICG under chicken skin). Visual assessment of "good quality imaging" was the outcome.
- Human Simulation (Hand): The ground truth was the expected blood flow in a human hand after ICG administration. Visual assessment of corresponding dye fluorescence was the outcome.
- Human Subjects (Free Flaps): The ground truth was the actual tissue perfusion and related tissue-transfer circulation in free flaps. The assessment was that the device visualized blood flow and "functions as intended with no adverse events reported." This implies clinical observation of actual perfusion.
8. The Sample Size for the Training Set
No information is provided about a "training set" for the Iridium Module. The document describes a system with specific optical and imaging characteristics, not a machine learning model that requires a training set. The software modifications mentioned are likely for instrument control and image processing, not for AI model training.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of machine learning, this question is not applicable.
§ 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.