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K Number
K100217
Device Name
LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30
Manufacturer
MEDIANA CO., LTD.
Date Cleared
2010-06-08

(134 days)

Product Code
MHX
Regulation Number
870.1025
Type
Traditional
Panel
CV
Reference & Predicate Devices
K042601,K053174,K082812,K080495,K012451,K062095
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Lucon M-series (M20, M30) is intended to be used to monitor for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician. The device is capable of monitoring:

  • Electrocardiography (ECG)
  • Heart rate (HR)
  • Noninvasive blood pressure (NIBP)
  • Functional arterial oxygen saturation (SpO2)
  • Pulse rate (PR)
  • Respiration rate (RR)
  • Temperature (Temp)
  • Arrhythmia/ST segment (M30 only)
  • Capnography (M30 only)
    Note: Hospital use typically includes such areas as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgical centers, and sub acute care centers.
    Note: The medically skilled and trained user can be clinicians like doctors and nurses who know to take and interpret a patient's vital signs. These clinicians must take direct responsibility for the patient's life. This can include care-givers or medically trained interpreters who are authorized under the appropriate clinical facility procedures to support patient care. Any inappropriate setting, especially the alarm limit or alarm notification settings, can lead to a hazardous situation that injures the patient, harms the patient, or threatens the patient's life. This equipment should only be operated by trained users who can adjust the settings of the patient monitor.
Device Description

The Mediana Lucon M-series (M20, M30) patient monitor is a lightweight and compact device (250 × 210 × 170 (mm) and 3.2 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on TFT-LCD displays.

  • Electrocardiography (ECG)
  • Heart rate (HR)
  • Noninvasive blood pressure (NIBP)
  • Functional arterial oxygen saturation (SpO2)
  • Pulse rate (PR)
  • Respiration rate (RR)
  • Temperature (Temp)
  • Arrhythmia/ST segment (M30 only)
  • Capnography (M30 only)
AI/ML Overview

The provided text does not contain specific acceptance criteria with numerical performance targets or a detailed study demonstrating that the device meets these criteria. Instead, it focuses on establishing substantial equivalence to predicate devices for a patient monitor (Mediana Lucon M-series M20, M30).

However, based on the information provided, we can infer the approach used to demonstrate performance and substantial equivalence:

Inferred Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to the performance specifications of the predicate devices. The document repeatedly states that the Mediana Lucon M-series has "identical" or "similar" specifications and uses "identical technology" or "same technology" as the predicate devices. It also mentions compliance with relevant performance standards.

Acceptance Criteria CategoryReported Device Performance (as inferred from predicate device comparison)
Electrocardiography (ECG)- ECG module (MDE-1) is identical to that in Omron HBP-2070.
  • ECG and heart rate specifications are identical to Omron HBP-2070.
  • ECG measurement performance is similar to Philips SureSigns VM6.
  • Uses identical technology as predicate devices. |
    | Noninvasive Blood Pressure (NIBP) | - NIBP module (M3200) is identical to that in Omron HBP-2070.
  • NIBP specifications are identical to Omron HBP-2070.
  • Complies with AAMI performance standard SP-10 & IEC60601-2-30.
  • Uses same technology as predicate devices (Omron HBP-2070 and Philips SureSigns VM6). |
    | Functional Arterial Oxygen Saturation (SpO2) | - SpO2 module (NELL-3) is used in Spacelabs mCARE 300, 91220 and Omron HBP-2070.
  • SpO2 specifications are identical to Omron HBP-2070 and Spacelabs 91220.
  • Complies with performance standard ISO9919. |
    | Respiration Rate (RR) | - Algorithm of Impedance measurement is identical to Omron HBP-2070.
  • Respiration specification is identical to Omron HBP-2070.
  • Respiration measurement (Thoracic Impedance) for Lucon M-series and Spacelabs 91220 are from the same ECG module (designed and manufactured by Mediana). |
    | Capnography (EtCO2) | - Algorithm of Airway Measurement has identical performance to Spacelabs 91220.
  • Airway Measurement is from Capnography module (Philips Respironics Inc.).
  • Operation theory of Airway Measurement in Welch Allyn Propaq Encore 200 series is same as Lucon M-series (M30 only) and Spacelabs 91220.
  • Uses Capnostat 5 and Lo Flo C5 modules (already FDA registered: K042601, K053174) which are identical to modules used in Spacelabs 91220.
  • Minor differences in Capnography specification between Lucon M-series (M30 only) and identified predicate devices; all three devices have identical technology and operation theory for Capnography. |
    | Temperature (Temp) | - Thermometry MDT-1 module is identical to that in Omron HBP-2070 and Spacelabs 91220.
  • Temperature measurement technology is equivalent to Omron HBP-2070 and Spacelab 91220.
  • Uses YSI 400 and 700 probes/probe covers, identical to predicate devices. |
    | Pulse Rate (PR) | - Derived from NIBP channel (M3200 module), identical to Omron HBP-2070.
  • Derived from SpO2 channel (NELL-3 module), identical to Omron HBP-2070 and Spacelabs 91220. |
    | General Device Functionality | - Internal power source (rechargeable lead acid battery and AC power) is similar to predicate devices.
  • Overall safety and effectiveness, and compliance with appropriate medical device standards, stated to be substantially equivalent to predicate devices. |

Study Details:

The submission highlights a "Summary of Performance Testing" but provides very limited details about the actual studies conducted to prove the device meets acceptance criteria.

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

    • The document states that the device "substantially have been tested... with the system V & V plan (#MDR-YW071202-02) and summary included with the submission using production equivalent units prior to release to market."
    • No specific sample size for a test set is mentioned.
    • No information on data provenance (e.g., country of origin, retrospective or prospective) is provided. The testing seems to be internal verification and validation (V&V) against design specifications and predicate device performance.

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

    • Not applicable/Not mentioned. The testing described involves technical performance characteristics, not clinical interpretation that would require expert ground truth.

  3. Adjudication method for the test set:

    • Not applicable/Not mentioned. Given the nature of the technical performance testing described, an adjudication method like 2+1 or 3+1 would not be relevant.

  4. 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 study was done. This device is a patient monitor, not an AI-assisted diagnostic tool.

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

    • Yes, implicitly. The "Performance Testing" refers to the device's technical specifications and how it performs in measuring various physiological parameters. This would be standalone performance of the device's modules and algorithms. The core argument for substantial equivalence relies on the identical/similar technology and specifications to the predicate devices, which suggests an evaluation of the device's intrinsic measurement capabilities.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • The ground truth for this type of device would typically be reference standards or highly accurate measurement equipment used to validate the accuracy and precision of each physiological parameter (ECG, NIBP, SpO2, Temp, RR, EtCO2). For example, NIBP accuracy might be validated against an invasive arterial line or a calibrated simulator. The document also mentions compliance with specific performance standards (e.g., AAMI SP-10, IEC60601-2-30, ISO9919), which define test methods and acceptance criteria.

  7. The sample size for the training set:

    • Not applicable/Not mentioned. This device does not appear to use a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its functionality is based on established physiological measurement technologies, often implemented as modules from reputable manufacturers (Omron, Nellcor, Philips Respironics).

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

    • Not applicable/Not mentioned. As there's no mention of a traditional training set for an AI algorithm, this question is not relevant. The performance is validated against established medical device standards and the performance of predicate devices.

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.