(532 days)
The SmartPilot View is software which monitors and logs the dosage of intravenous and volatile drugs administered to a human being. Additionally, SmartPilot View displays pharmacokinetic, pharmacodynamic (PK/PD) and interactive PD modeling information. Smart Pilot provides the health care professional with theoretical information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient.
The SmartPilot View is software for use by health care professionals trained in the application of general anaesthesia.
The SmartPilot View is intended for use with data from adults only. The demographic ranges for these patient data are as follows:
Height 59 in to 79 in (150 cm to 200 cm) Weight 88 lb to 309 lb (40 kg to 140 kg) Age 18 to 90 years
The current version of the SmartPilot View is receiving data from a dedicated anesthesia workstation or combination of workstation and other devices.
The Software SmartPilot View runs on a dedicated patient vincinity workstation (Draeger C700 for IT) with the installed Infinity Explorer Software.
The data is taken from dedicated anesthesia workstation A (Draeger Primus US "Apollo") or combination of the workstation and other devices like IV Pumps (B.Braun Perfusor Space pump) and patient monitors M (Draeger Delta/Delta XL, Kappa, Omega S).
The software visualizes the drug effect based on pharmacokinetic models and the drug interaction based on pharmacodynamic models known from scientific literature.
The software visualizes the synergetic and additive drug effect on a screen in a specially developed 2D pharmacodynamic diagram. Furthermore a new pharmacodynamic parameter (NSRI) is calculated based on the synergetic drug effects.
The software monitors and calculates data for the use during the anesthesia case. The software also logs data during the anesthesia case for a retrospective analysis.
Supported drugs:
Intravenous hypnotics – Propofol
Volatile hypnotics
- Isoflurane
- Sevoflurane
- Desflurane
- Enflurane
Intravenous opioids
- Fentanyl
- Remifentanil
- Sufentanil
- Alfentanil
Intravenous muscle relaxants
- Pancuronium
- Rocuronium
Parameters provided by the basic device (monitor and anaesthesia machine)
- Heart rate HR in 1/min
- Mean non-invasive blood pressure NIBP M or mean arterial pressure ART M in mmHg or kPa.
- End-expiratory CO2 concentration etCO2 in mmHg, Vol.% or kPa.
- Bispectral index BIS
- BIS signal quality index SQI in %
The provided text K103035 Traditional 510(k) SmartPilot View describes a medical device, the SmartPilot View software, which monitors and logs drug dosages and displays pharmacokinetic/pharmacodynamic (PK/PD) modeling information.
However, the document does not contain information about acceptance criteria, specific performance metrics (like sensitivity, specificity, accuracy), or any studies designed to prove the device meets such criteria.
The "Assessment of non-clinical testing" section states that the device "has been tested according to its specifications, including software validation," and lists standards and guidelines adhered to (ISO 14971, IEC 62304, FDA CDRH Guidance for Software). This generally refers to verification and validation activities to ensure the software functions as intended and meets design requirements, but it does not provide specific performance acceptance criteria or study results in terms of device performance metrics typically associated with AI/CAD devices.
Furthermore:
- The section for "Clinical performance data" explicitly states "Not applicable."
- There is no mention of a test set, data provenance, ground truth establishment, sample sizes for test or training sets, expert involvement, or any multi-reader multi-case studies.
- The device is described as "software which monitors and logs the dosage of intravenous and volatile drugs administered to a human being" and "displays pharmacokinetic, pharmacodynamic (PK/PD) and interactive PD modeling information." It "provides the health care professional with theoretical information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient." This sounds more like a data visualization and information system based on established pharmacological models rather than an AI/CAD system that would generate a diagnostic or screening output requiring performance metrics like sensitivity and specificity.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about the studies, as that information is not present in the provided text.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).