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510(k) Data Aggregation

    K Number
    K022132
    Device Name
    SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Cleared
    2002-09-19

    (80 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K003550,K963380,K003068,K010925,K001646,K980642,K001686,K984407,K003075
    Why did this record match?
    Device Name :

    SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E

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

    The Servo' Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.

    Device Description

    The ventilator is the same as described in the notification K010925. This application if for the following options to the Servo-i ventilator family.

    The Bi-Vent mode is a Pressure controlled mode with added possibility to allow unrestricted spontaneous breathing, also at high level pressure.

    The CO2 analyzer displays continuous CO2 curves of mainstream expired air and etCO2 figures. The aim is to measure the concentration of carbon dioxide to aid in determining the patient's ventilatory, circulatory, and metabolic status.

    AI/ML Overview

    This document is a 510(k) summary for a Special 510(k) submission for the Siemens Servo Ventilator System, seeking clearance for two new options: Bi-Vent ventilation mode and a CO2 analyzer. The submission claims substantial equivalence to previously cleared devices.

    Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text does not explicitly state specific numerical acceptance criteria (e.g., accuracy percentages, error margins) for the CO2 analyzer or performance metrics for the Bi-Vent mode. Instead, it relies on claiming technological and clinical equivalence to predicate devices, implying that if the new options perform similarly to cleared devices, they meet implicit acceptance criteria.

    The "reported device performance" is described through the lens of this equivalence:

    Acceptance Criterion (Implicit)Reported Device Performance
    CO2 Analyzer Functional Equivalence: Measures CO2 concentration to aid in determining ventilatory, circulatory, and metabolic status; continuous CO2 curves, EtCO2, and VCO2 display."The CO2 functionality for the Servo-i CO2 module is equivalent to the CO2 analyzer in Siemens Infinity CO2 pod (file number K003550)... which also is technologically based and componentry sourced as Sensor and input electronics card from Novametrix (file number K963380)." This implies the Servo-i CO2 analyzer performs these functions with similar accuracy and reliability as the predicate device.
    Bi-Vent Mode Functional Equivalence: Pressure-controlled ventilation with unrestricted spontaneous breathing; periodic switching between two levels of continuous positive airway pressure; allowing spontaneous breathing in any phase."Bi-Vent is a Biphasic positive airway pressure (BIPAP™) which is equivalent to airway pressure release ventilation (APRV)... These modalities operate by periodic switching between two levels of continuous positive airway pressure while allowing spontaneous breathing in any phase of the ventilatory cycle."
    "The Bi Vent mode is substantially equivalent to Puritan Bennet 840 ventilator with NeoMode option (K001646), Dräger Evita 4 – (K980642)... Savina (Dräger – K003068), Galileo (Hamilton - K001686), and Harmony S/T Respironics - K984407 and KnightStar 330 (Nellcor - K003075)." This implies the Bi-Vent mode provides the intended ventilation support with equivalent clinical performance to these predicate devices.
    Clinical Performance Equivalence: Safe and effective for intended patient populations (neonates, infants, adults) and use environments (hospitals, in-hospital transport)."The technology used is assessed, verification and design validation on animals show that the Servo Ventilator System has the equivalent clinical performance with the above options." This statement broadly confirms the clinical performance of the entire system with the new options.

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

    • Sample Size: The document does not specify a numerical sample size for "test sets" in the typical sense of a clinical trial with a defined number of patients or samples.
    • Data Provenance: The document mentions "verification and design validation on animals." This indicates that some form of pre-clinical testing data was used.
      • Country of Origin: Not specified for the animal studies.
      • Retrospective/Prospective: Animal studies are typically prospective by design.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    • This information is not provided. The submission relies on technological and clinical equivalence to predicate devices. It doesn't describe a process of establishing ground truth on a new dataset by experts.

    4. Adjudication Method

    • Not applicable as the submission does not detail a study involving expert review or adjudication of a test set.

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

    • No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or implied in this submission. The focus is on device function and equivalence, not on human reader performance with or without AI assistance (as this is a ventilator, not an AI-assisted diagnostic tool).

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

    • Yes, for a ventilator and CO2 analyzer, the performance is inherently "standalone" in the sense that the device performs its functions and measurements independently. The clinical use involves a human operator (healthcare provider), but the performance metrics of the device itself (e.g., CO2 measurement accuracy, pressure delivery) are evaluated for the device alone. The "verification and design validation on animals" would assess this standalone performance.

    7. Type of Ground Truth Used

    • The ground truth is not explicitly defined as pathology, expert consensus, or outcomes data in the context of a new study on the Servo-i. Instead, the "ground truth" for the new options is essentially the performance of the legally marketed predicate devices. The new options are deemed to meet acceptance criteria if they exhibit "equivalent clinical performance" and "technological basis" to these established devices. For the animal study, the "ground truth" would be physiological measurements and observations in the animal model.

    8. Sample Size for the Training Set

    • This document does not refer to a "training set" as it would for a machine learning or AI algorithm. A ventilator's design and engineering are based on medical, physiological, and engineering principles rather than a data-driven training set in the AI sense.

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

    • Not applicable, as there is no "training set" in the context of this device and submission type. The design and validation are based on established engineering principles, regulatory standards, and comparative performance to predicates.
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