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510(k) Data Aggregation

    K Number
    K101711
    Device Name
    CERULEAU ELECTROSURGICAL PROBE
    Manufacturer
    NUORTHO SURGICAL, INC
    Date Cleared
    2010-07-01

    (13 days)

    Product Code
    GEI,HRX
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K011083,K991960,K002422,K993885,K012018
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NuOrtho CERULEAU™ Probes are indicated for resection, coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. These procedures include the following indications: Resection and Excision (Acetabular Labrum, Articular Labrum, Capsule, Capsular Release, Cartilage Flaps, Cysts, Discoid Meniscus, Frozen Shoulder Release, Glenoid Labrum, Labral Tear, Lateral Release, Ligament, Loose Bodies, Meniscal Cystectomy, Meniscectomy, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon, Triangular Fibrocartilage (TFCC), Villusectomy), Debridement (ACL/PCL, Acromioplasty, Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Notchplasty, Scar Tissue, Soft Tissue, Subacromial Decompression, Synovectomy, Tendon), Coagulation (ACL/PCL, Articular Cartilage, Carpal Ligaments, Glenohumeral Capsule, Ligament, Medial Retinaculum, Rotator Cuff, Tendon, Wrist Tendons).

    Device Description

    The CERULEAU™ Electrosurgical Probe is a bipolar device designed to direct radiofrequency energy from an electrosurgical generator into target tissue during arthroscopic and orthopedic surgical procedures. Ceruleau delivers non-ablation, low-level amounts of radiofrequency energy to the treatment site. The radiofrequency energy is delivered via a protected electrode geometry which inhibits direct electrode-to-tissue contact. Design of the electrode's protective housing can function as a mechanical implement for use adjunct to energy delivery.

    AI/ML Overview

    The NuOrtho Surgical, Inc. CERULEAU™ Electrosurgical Probe is a bipolar device intended for resection, coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

    Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

    1. Acceptance Criteria and Reported Device Performance

    The document does not explicitly state quantitative acceptance criteria for the CERULEAU™ Electrosurgical Probe. Instead, the performance testing focuses on demonstrating "substantial equivalence" to predicate devices and proving that its design "consistently and significantly reduces incidence of damage to collateral and subject tissues."

    Acceptance Criteria (Implicit)Reported Device Performance
    Substantial equivalence to currently marketed predicate devices for intended use."Performance testing... provides support that the CERULEAU™ Electrosurgical Probe is substantially equivalent to currently marketed predicate devices." This is a general claim and not specific performance metrics.
    Compliance with relevant standards for design, labeling, packaging, and sterilization.The device is compliant with ANSI/AAMI ISO 11137-1, ISO 11607-1, ISO 11607-2, ASTM F1980-07, ASTM D4169, ISO 10993-5, ISO 10993-10, ISO 10993-11, IEC 60601-1, and IEC 60601-2-2.
    Effectiveness of probe performance compared to predicate devices in arthroscopic/orthopedic surgery.A comparison study (REP-100-1210) was conducted to evaluate the effectiveness. The summary indicates that it provides support for substantial equivalence, but specific quantitative results of the comparison are not detailed in this summary. The full report is in Appendix 12.
    Clinical efficacy and extent of collateral damage, particularly for chondroplasty.A comparative evaluation (REP-100-1220) "provides clear histological evidence to substantiate that, as compared to predicates, the design and use of the CERULEAU™ Probe consistently and significantly reduces incidence of damage to collateral and subject tissues." It "proves that, due to its design, the CERULEAU™ Probe consistently performs to reduce incidence of damage to collateral and subject tissues." The predicate devices are described as "inherently prone to cause damage to collateral and subject tissues."

    2. Sample Size Used for the Test Set and Data Provenance

    • Test Set Sample Size: The document does not specify the sample size for the test set used in studies REP-100-1210 and REP-100-1220.
    • Data Provenance:
      • REP-100-1210 is described as including "bench and in vitro human data."
      • REP-100-1220 was "conducted in-vitro on excised human tissue."
      • The country of origin for the human tissue or the studies is not specified. Both studies are retrospective in the sense that they are laboratory/bench studies, not prospective clinical trials.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

    The document does not specify the number of experts used or their qualifications to establish ground truth for the test set. For histological evidence (REP-100-1220), it would be expected that a qualified pathologist would be involved, but this is not explicitly stated.

    4. Adjudication Method for the Test Set

    The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted or human readers being involved with or without AI assistance. The studies described are focused on the device's direct performance.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    The device is an electrosurgical probe, which is a physical surgical tool, not an algorithm. Therefore, the concept of an "algorithm only without human-in-the-loop performance" study does not apply to this device. The studies described evaluate the physical performance of the probe (e.g., tissue effects).

    7. Type of Ground Truth Used

    • For study REP-100-1220, the ground truth for evaluating "incidence of damage to collateral and subject tissues" was histological evidence derived from excised human tissue.
    • For REP-100-1210, which evaluated "effectiveness of the CERULEAU™ Probe performance," the specific ground truth is not detailed but would likely involve measurements of resection, coagulation, or hemostasis efficacy in a bench/in vitro setting, compared to predicate devices.

    8. Sample Size for the Training Set

    The document does not mention a training set in the context of device development or performance evaluation. This is not an AI/machine learning device.

    9. How the Ground Truth for the Training Set Was Established

    As there is no mention of a training set, the method for establishing its ground truth is not applicable to this submission.

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