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510(k) Data Aggregation

    K Number
    K101606
    Device Name
    MICROMED PD-8K INSULATION DEFECT DETECTOR
    Manufacturer
    MCGAN TECHNOLOGY, LLC
    Date Cleared
    2010-10-01

    (115 days)

    Product Code
    HFG
    Regulation Number
    884.4160
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K952889,K991424
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MicroMed PD-8K system is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation integrity of electrosurgical instruments.

    Device Description

    The MicroMed PD-8K system (MMPD-8K) is comprised of a reusable hand-held instrument probe, a detector or control/base unit, a ground wire and a high voltage wire in which the appropriate electrode (instrument probe) is control with and a fight vone in a mich in appropriate electrode housed at the end of the detector (control/base) unit The battery adaptor (recharger) is provided with the system for recharging the battery. The MicroMed PD-8K electrodes are reusable.

    MicroMed PD-8K System includes:

    • Detector (base unit)
    • Battery with Charging adaptor
    • Probe handle with 2m (6ft) lead-Red HV Wire
    • 2m (6ft) lead ground wire with clamp-Green Wire
    • Brush electrode 8mm (0.31inch) wide brass wires
    • Ring Electrode with brass wires
    • Carrying case
    • Standard Operating Instruction manuals. CD With additional information.
    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroMed PD-8K device:

    Based on the provided 510(k) summary, the device is an insulation tester, and the documentation focuses on its substantial equivalence to predicate devices rather than reporting a detailed clinical study with specific acceptance criteria in the traditional sense of diagnostic or therapeutic devices.

    The "acceptance criteria" here are met through demonstrating that the device has the same indications for use, similar design, and comparable performance to legally marketed predicate devices. The study proving this is primarily a comparison to predicate devices and an internal assessment of the device's technical specifications.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied by 510(k) Equivalence)Reported Device Performance of MicroMed PD-8K
    Indications for Use: Insulation / Continuity testing for electrosurgical instruments.Indications for Use: Insulation / Continuity testing for electrosurgical instruments. Matches predicate devices.
    Design: Tester and accessories, battery-operated, rechargeable.Design: Tester and accessories (Detector, Battery, Probe handle, Wires, Electrodes, Carrying case), battery operated and rechargeable. Similar to predicate devices.
    Materials: Housing materials acceptable for intended use.Materials: Plastic housing (different from predicate's aluminum casing, but implicitly acceptable).
    Performance (Voltage Insulation Tester): Capable of high voltage insulation testing comparable to predicate devices.Performance (Voltage Insulation Tester): Voltage: 0 to 8kV adjustable; Current Output: < 0.1mA at probe; Resolution: 10V; Test current 0.1mA max. Comparable in function to predicate devices.
    Usage: Pre-operating room use.Usage: Pre-operating room. Matches predicate devices.
    Biocompatibility: Not required (non-patient contact).Biocompatibility: Not required - Non patient contact. Matches predicate devices.
    Target Population: Pre-operation nurses or central sterile personnel.Target Population: Pre-operation nurses or central sterile personnel. Matches predicate devices.
    Mechanical Safety: Accessory to a device.Mechanical Safety: Accessory to a device. Matches predicate devices.

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

    • Test Set Sample Size: Not applicable in the context of this 510(k) submission. The document describes a comparison to predicate devices, not a test on a specific dataset of electrosurgical instruments for performance evaluation against a gold standard. The performance claims are based on engineering specifications and comparison to predicate devices.
    • Data Provenance: Not applicable in the context of this 510(k) submission. The submission relies on technical specifications and functional equivalence to predicate devices. No external data (e.g., from specific countries, retrospective/prospective) is cited for performance validation in the provided text.

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

    • Not applicable. There is no mention of human experts being used to establish a ground truth for a test set in the provided document. The device itself is an insulation tester, and its 'ground truth' would be determined by its ability to accurately detect insulation failures based on its technical specifications.

    4. Adjudication Method for the Test Set

    • Not applicable. No adjudication method is described because there wasn't a "test set" in the traditional sense involving interpretation or assessment that would require adjudication.

    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

    • Not applicable. This device is an insulation tester, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant to this device's function as described.

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

    • Yes, in a conceptual sense. The MicroMed PD-8K is a hardware device designed to perform insulation testing standalone. Its performance is based on its electronic and mechanical specifications (voltage output, current, resolution, alarm systems). There is no "algorithm" in the AI sense, but the device provides a direct measurement/assessment of insulation integrity without human interpretation being the primary determinant of the test result. The user operates the device, but the device itself identifies the insulation issue.

    7. The Type of Ground Truth Used

    • The "ground truth" for this device is effectively engineering specifications and the physical principles of electrical insulation testing. The device is designed to measure electrical integrity against defined thresholds. While not explicitly stated as "ground truth," its performance is evaluated against its ability to meet these technical specifications and function equivalently to established insulation testers already on the market. There's no mention of pathology, expert consensus, or outcomes data as "ground truth" for this type of device.

    8. The Sample Size for the Training Set

    • Not applicable. This device is not an AI/machine learning device that requires a training set. Its functionality is based on direct electrical measurement and comparison to established engineering principles.

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

    • Not applicable, as there is no training set for this device.
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