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    K Number
    K143306
    Device Name
    ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe
    Manufacturer
    ERBE USA, INC.
    Date Cleared
    2015-10-27

    (343 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K072404,K092090,K083608,K060183
    Why did this record match?
    Device Name :

    ERBE WaterJet Model ERBEJET**®** 2 System with HybridAPC Probe

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

    ERBEJET® 2 System - The ERBEJET 2 is intended for lifting mucosal lesions by injection into the submucosa as well as the cutting and dissection of soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME) in open as well as endoscopic surgery.

    HybridAPC Probe - The HybridAPC probe is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope and for HF ablation of the mucosal lesions by Argon Plasma Coagulation (APC).

    Device Description

    The HybridAPC Probe is used with the ERBE Water Jet Model ERBEJET 2 and an ERBE Argon Plasma Coagulator (APC) Model APC 2/ElectroSurgical Unit (ESU) VIO Model System. The Water Jet delivers pressurized sterile normal saline through the Probe to provide a saline cushion beneath mucosal lesions. The induction of the saline into the submucosa is a routine practice and acts as a cushion which can reduce/limit unwanted tissue damage (penetration depth) when applying argon plasma coagulation. The APC/ESU System with the Probe supplies ionized (electrically charged) argon gas to create the HF argon plasma for the ablation of the lifted lesions. The HybridAPC Probe consists of tubing to the Water Jet, a cable with a filter integrated connector for the APC, and dual lumen tubing. The inside lumen delivers the pressurized sterile normal saline and the outer lumen delivers the electrically charged argon gas for the HF argon plasma. Clinicians would attach the Probe to the Water Jet and APC/ESU System. Then the Probe is positioned at the operative site under direct visualization endoscopically. If an operative endoscope is utilized, the working channel must be greater than 2.5 mm. Upon the setup of the Water Jet and APC/ESU System, the Probe is ready for use. The pedal of the ERBEJET 2 footswitch activates its water-jet capabilities. The tip of the Probe is placed against a lesion and the saline accumulates within the submucosal layer which cushions the lesion. Then the tip of the Probe is placed in close proximity of the raised lesion (not touching/non-contact modality). Finally, the footswitch for the APC/ESU System is depressed which delivers the ionized argon gas to create the HF argon plasma for the ablation of the lesion. The HybridAPC Probe's dimensional working parameters (tubing/tip interfacing with scope as applicable/tissue) are 2.3 mm Outer Diameter, 1.9 m Length. The device is manufactured with typical materials or agents used in the medical device industry such as tungsten, stainless steel, plastics, silicone, etc. The HybridAPC Probe is provided sterile and is single use.

    AI/ML Overview

    The document describes a 510(k) premarket notification for the ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe. The focus is on demonstrating substantial equivalence to predicate devices, particularly regarding the new HybridAPC Probe and the added functionality of lifting mucosal lesions to the ERBEJET 2 System.

    Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

    1. A table of Acceptance Criteria and the Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Macroscopic and histological data demonstrating that the proposed device (HybridAPC probe) is comparable or better than (substantially equivalent to) the predicate device (HybridKnife) in the mitigation of thermal tissue damage to the underlying tissue layers upon lifting the mucosa and coagulating/ablating tissue.When the tissues were analyzed macroscopically and histologically, the HybridAPC probe and HybridKnife produced comparable thermal effect when coagulating/abating tissue. The thermal damage profile and tissue effects were substantially equivalent in protecting the proper muscle layer upon the induction of 0.9% NaCl in the submucosa.
    Demonstrating that the lifting/cushioning for the HybridAPC probe was substantially equivalent to or better than the HybridKnife, in terms of height and area measurements of the created lift/cushion.The results of the test showed that height and area measurements of the created cushion upon the induction of 0.9% NaCI into the submucosa of the tissue types was comparable for the proposed and predicate devices.
    No detrimental damage to esophageal tissue (i.e., no perforation) when the ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe is used at higher pressures (Effect 70/1,015 psi) to lift the submucosa.Performance testing with the ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe at Effect 70 (1,015 psi, near the maximum setting) to lift the submucosa of esophageal tissue showed no detrimental damage to the tissue (i.e., no perforation).
    All changes with the proposed devices were verified or validated, and the changes did not raise safety or efficacy concerns nor adversely affect safety or effectiveness.The ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe has been verified or validated in design control. The document states, "As a result, the changes did not raise safety or efficacy concerns nor adversely affect safety or effectiveness. In conclusion, there are no issues with the ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe that would raise additional safety or efficacy issues, when compared to the predicate devices." (This is a general statement about overall design control and verification/validation, not a specific performance metric).

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

    • Sample Size: The study used three (3) different ex-vivo tissue types (esophagus, stomach, and rectum) from pigs.
      • For coagulation/ablation testing, each tissue type was tested with and without submucosa lifting, and then with coagulation. Testing was done with minimum, default, and maximum intensity settings in triplicate (3X) for both the proposed and predicate devices.
      • For submucosa lift testing, the ERBE WaterJet System settings were Effect 40, 70, and 80 to deliver 2 ml, 3 ml, and 5 ml of 0.9% NaCl at an application angle of 90° into each specified tissue type in triplicate (3X) for both the proposed and predicate devices.
    • Data Provenance: The data was generated from ex-vivo animal (pig) tissue. This indicates a lab-based, pre-clinical study. The data is prospective in the sense that the experiments were conducted specifically for this submission. The country of origin of the data is not explicitly stated, but the manufacturer is ERBE USA, Inc. with the parent company ERBE Elektromedizin GmbH, suggesting European or US-based research.

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

    This information is not provided in the document. The study involves macroscopic and histological examination, which implies expert assessment, but the number and qualifications of the individuals performing these assessments are not specified.

    4. Adjudication method for the test set:

    This information is not provided. Given the nature of macroscopic and histological examination, an adjudication method (such as independent expert review or consensus) would typically be employed, but it is not described.

    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:

    This was not an MRMC comparative effectiveness study, nor does it involve AI. The study is a bench and ex-vivo animal study comparing a new medical device to predicate devices for its physical and functional performance, not human diagnostic performance.

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

    This is not applicable. The device is an electrosurgical cutting and coagulation device with a waterjet and APC probe, not an algorithm, so a standalone algorithm performance study is irrelevant.

    7. The type of ground truth used:

    • For the coagulation/ablation and thermal damage assessment: Macroscopic and histological examination of the ex-vivo pig tissues. This is a form of expert assessment of tissue damage and morphology.
    • For the lifting/cushioning assessment: Macroscopic measurements for height and area of the created lift/cushion. This is an objective measurement based on the observed physical effect on the tissue.
    • For the non-perforation test: Observation of the absence of detrimental damage (perforation) to the tissue.

    8. The sample size for the training set:

    This is not applicable/not provided. This study describes a pre-market submission for a physical medical device, not an AI/ML algorithm that would typically have a training set. The term "training set" is generally used in the context of machine learning model development.

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

    This is not applicable/not provided for the same reasons as #8.

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