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510(k) Data Aggregation

    K Number
    K240159
    Device Name
    InnoVoyce VYLO
    Manufacturer
    InnoVoyce
    Date Cleared
    2024-05-29

    (131 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K092735
    Why did this record match?
    Device Name :

    InnoVoyce VYLO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The InnoVoyce VYLO is intended for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Suggested applications include:

    General Surgery: Vaporizing, coagulating, incising, debulking, and ablating of soft tissue as well as in endoscopic (e.g., laparoscopic) or open surgeries.

    Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; gastrointestinal hemostasis (including varices, espohagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastrointestinal tissue ablation (benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorrhoids).

    Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: endometriosis; cervical, vulvar, and vaginal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions; submucosal fibroids.

    Head and Neck/ Otorhinolaryngology (ENT): Tissue incision, ablation, and vessel hemostasis.

    Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type.

    Ophthalmology: Post-vitrectomy endophotocoagulation of the retina.

    Plastic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue in endoscopic and open procedures.

    Spinal Surgery: Percutaneous lumbar diskectomy.

    Thoracic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures.

    Urology: Cutting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (ablation, vaporization, excision and coagulation of soft tissue) including treatment of: bladder, urethral & ureteral tumors; condylomas; lesions of external genitalia; urethral & penile; hemangioma; urethral strictures; bladder neck obstructions; and vaporization of prostate tissue for men suffering from benign prostate hyperplasia (BPH).

    Device Description

    InnoVoyce VYLO is a solid-state laser device with laser energy generated by internal diodes. The laser output energy of the device is in the blue spectrum at wavelength of 445-465nm.

    The system is intended to be used by professional practitioners (specialized physician/ authorized technical personnel) in the medical field. The system is intended for use in professional healthcare facility environments.

    The VYLO's base unit is a console with a graphical touch screen user interface and a footswitch, and single-use, disposable LOFs. The system has four laser emission modes: Continuous Wave (CW), Pulsed Wave (PW), Quasi Pulsed Wave (QPW), and Quasi Continuous Wave (QCW).

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification from the FDA, asserting the substantial equivalence of the InnoVoyce VYLO laser surgical instrument to a legally marketed predicate device (Greenlight XPS Laser System). It discusses indications for use, device description, electrical safety, electromagnetic compatibility, software, and performance testing.

    However, the document does not describe a study that involves human readers, AI assistance, ground truth established by medical experts (other than potentially for the histology review, which is not explicitly detailed), or acceptance criteria related to diagnostic performance metrics for an AI/software device. The performance testing described is a bench test comparing the VYLO device's tissue interaction to the predicate device, not an AI or software performance study.

    Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable in this context, as they relate to the evaluation of an AI/software diagnostic device, which the InnoVoyce VYLO is not.

    Based on the information provided, here's what can be extracted and what cannot:

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

    The document describes "Performance Testing" which is a comparison of tissue effects (Coagulation and Ablation Zones - CAZs) between the subject device (InnoVoyce VYLO) and the predicate device (Greenlight XPS). The acceptance criterion implicitly seems to be "comparable performance" in terms of tissue effects, with a note that smaller CAZs at max power for the subject device indicate a "safer and more controlled way."

    Acceptance Criteria (Implicit)Reported Device Performance
    Production of clearly detectable Coagulation and Ablation Zones (CAZs) in treated tissues.The study demonstrated that the treatments produced clearly detectable Coagulation and Ablation Zones (CAZs) in all three treated tissues (liver, kidney, and muscle) at all dose levels for both devices.
    Consistency of thermal damage profiles across test specimens and parameters.The obtained data allows one to conclude the VYLO's thermal damage profiles were consistent across all three test specimens for all tested parameters.
    Comparability of CAZs to the predicate device at similar power levels.The dimensions of the CAZs produced by the Predicate Device at 30 W were in close proximity to the CAZs produced by the VYLO Device at 30 W.
    "Worst-case" performance (max power level) of VYLO should be acceptable (implicitly safer).The dimensions of the CAZs produced by the Predicate Device at its maximum power level (180 W) were larger (deeper and wider) than damage produced by the VYLO Device at its maximum power level (30 W). "Thus, it can be concluded that treatment by the VYLO device at the maximum dose settings will provide a similar clinical effect to the Predicate Device in a safer and more controlled way, because the lesions profiles at worst cases (at max power levels 30 W at CW vs. 180 W at Q-CW) for the VYLO Device is smaller compared to Predicate device." "It can be concluded that treatment by such a device at the appropriate testing settings will possess a desirable clinical treatment effect."

    2. Sample size used for the test set and the data provenance:

    • Sample Size: For the histology testing, the document states: "All settings mentioned above were triplicated in all three types of tissues (liver, kidney, and muscle)." This means for VYLO, 3 power/mode settings (30W CW for 300 & 600 µm, 20W CW for 600 µm, 20W Q-CW for 600 µm) x 3 tissues x 3 repetitions = 27 tissue samples. For the Predicate, 2 power levels (30W, 180W) x 3 tissues x 3 repetitions = 18 tissue samples. The total number of tissue samples is 45.
    • Data Provenance: The tissues used were liver, kidney, and muscle. The document does not specify the origin (e.g., animal, human, specific country) or whether the study was retrospective or prospective, but it's clearly a bench/pre-clinical study.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • The document mentions "Histology testing was conducted." While histology implicitly involves expert review (pathologist), the number of experts, their qualifications, or their role in establishing "ground truth" (e.g., measurement of CAZs) is not specified.

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

    • Not applicable or Not specified. Adjudication methods are typically for human reader studies with multiple interpretations. For histology, it's usually either a single expert or a consensus process which is not detailed here.

    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. An MRMC study was not done. This device is a laser surgical instrument, not an AI or software diagnostic tool intended to assist human readers. The clinical evidence section explicitly states: "Clinical Evidence – N/A. No clinical studies were conducted as part of this submission."

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

    • Not applicable. This is not an AI algorithm. Its performance is evaluated through its interaction with tissue, not as a standalone diagnostic algorithm.

    7. The type of ground truth used:

    • The ground truth for evaluating the device's performance was the dimensions of the Coagulation and Ablation Zones (CAZs) in ex vivo tissue samples, as determined by histology. This is primarily a pathology/histology-based ground truth for physical tissue effects.

    8. The sample size for the training set:

    • Not applicable. This device does not involve a training set as it is not an AI/machine learning model.

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

    • Not applicable. This device does not involve a training set.
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