(623 days)
The SERVO i 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-i is a ventilator system to be used only by healtheare providers in hospitals or healthcare facilities and for in-hospital transport.
The added indications for use of the NAVA option is when the electrical signal from the diaphragm is intact; NA VA will improve synchrony between the ventilator and patients with no contraindication for insertion/exchange of a Naso-Gastric tube.
The SERVO-i Ventilator is classified as MR Conditional for 1.T. 1.5T and 3T MR scanners. This means that it is safe to use in the MR environment if the MR Environment Declaration for SERVO-i are met.
The SERVO-i Ventilator System with Heliox option is indicated for use with the delivery of Air, Oxygen, or Heliox (a mixture of Helium and Oxygen).
The SERVO-s 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-s is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.
The SERVO-i Ventilator System (here after called SERVO-i) is intended to provide continuous ventilation for neonate to adult patients in the weight range 0.5-250 kg and with tidal volumes from 2 mL to 4000 mL. SERVO-i consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The ventilator delivers controlled or supported breaths to the patient, with either constant flow or constant pressure, using a set oxygen concentration. SERVO-i will produce visual and audible alarms if vital parameters vary beyond pre-set, or default, limits. The system contains provisions for at least two battery modules to supply the system in the case of mains power failure or during in-hospital transport. The ventilator functionality is controlled by software. The SERVO-i Ventilator System is available in three software versions. Infant. Adult and Universal.
The NAVA (Neurally Adjusted Ventilatory Assist) option is a supported mode for SERVO-i that uses the Edi signal (the electrical activity of the diaphragm) as an addition to the flow/pressure trigger to synchronize the patient efforts with the onset and cycle off. The NAVA option is available in invasive and non-invasive mode.
SERVO-i is MR conditional. The SERVO-i ventilator with MR option have been tested with 1.0, 1.5, 3.0 T scanners without impairing its performance or the image quality of the scanner. Each scanner and its environment form an individual device. The MR Environment Declaration describes how a SERVO-i with MR option can be qualified to be used with an MR scanner forming a safe Medical System. All vital parts of the ventilator have been tested for performance in excessive magnetic fields.
The SERVO-i with Heliox option requires a different mechanical adaptor on the air supply inlet to allow a mixture of Helium and Oxygen to be connected. Furthermore is the software updated to allow safe delivery and monitoring of the Heliox gas mixture.
Accessories for CO2-monitoring, nebulization and flow monitoring at the Y -piece (Y-sensor) are integrated as options in the SERVO-i and the drivers are controlled by the software in the ventilator.
This 510(k) submission for the SERVO-i include changes to receive a new baseline based on compatibility to the third edition standard package of AAMVANSI 60601-1 :2005 and its collateral and particular standards for intensive care ventilators. The submission does also include modifications of the software and hardware to update existing functionalities since the last submission (K073149).
The SERVO-s ventilator system (here after called SERVO-s) is based on the SERVO-i ventilator family platform. SERVO-s ventilation system is a downscaled version based on the SERVO-i ventilator system notified in K041223.
The SERVO-s Ventilator System is intended to provide continuous ventilation for neonate to adult patients in the weight range 2-250 kg and with tidal volumes from 10 mL to 2000 mL. The SERVO-s Ventilator System consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The ventilator delivers controlled or supported breaths to the patient, with either constant flow or constant pressure, using a set oxygen concentration. SERVO-s Ventilator System will produce visual and audible alarms if vital parameters vary beyond preset, or default, limits. The system contains two internal batteries to supply the system with power in the case of mains power failure or during inhospital transport. The ventilator functionality is controlled by software. The SERVO-s Ventilator System is available in two software versions, Infant and Adult.
This 510(k) submission for the SERVO-s include changes to receive a new baseline based on compatibility to the third edition standard package of IEC 60601-1 :2005 and its collateral and particular standards for intensive care ventilators. The submission does also include addition of the Infant option, patient weight range 2-10 kg, with tidal volumes from 10 mL to 350 mL and modifications of the software and hardware to update existing functionalities.
Here's a breakdown of the acceptance criteria and the studies mentioned in the provided 510(k) summary for the GETINGE GROUP SERVO-i and SERVO-s Ventilator Systems, organized according to your requested format.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "studies" described are primarily verification and validation activities rather than formal clinical trials designed to prove efficacy from scratch. The acceptance criteria are largely implied by compliance with standards and successful performance in these verification and validation tests.
Acceptance Criteria and Device Performance
This section synthesizes the implicit acceptance criteria from the various verification and validation activities described and attempts to align them with the reported "performance" based on the conclusions drawn in the document.
| Acceptance Criteria (Implicit from V&V and predicate equivalence) | Reported Device Performance (as stated or implied) |
|---|---|
| General Device Functionality: | |
| Compliance with IEC 60601-1 (2005) and collateral/particular standards (e.g., ISO 80601-2-12, ISO 80601-2-55, ISO 5356-1, CGA V-5) | Design verification and validation demonstrated performance within specifications and applied standards for both SERVO-i and SERVO-s. |
| Software functionality | Code review, static code analysis, and regression testing performed on software changes. Free User Testing (FUT) conducted. |
| Hardware functionality | Design verification and validation performed. |
| Proper functioning of User Interface | Tested as part of overall system and FUT. |
| Accuracy Statements (Ventilation Parameters): | Performance is the same as predicate, with updated measurement and presentation methods to comply with new standards. |
| Noise Level: | Performance is the same as predicate, with updated measurement and presentation methods to comply with new standards. |
| Ingress Protection (IP21): | Improved Ingress Protection to IP21 by chassis improvements. |
| Mechanical Stability (Transport): | Brakes on all four wheels (vs. previous two) to improve stability and meet new transport requirements. |
| Gas Inlet Pressure Specification: | Max pressure lowered to comply with required testing. |
| Pre-Use Check (Patient Circuit Resistance & Compliance): | Added measurement of patient circuit resistance to Pre-Use Check to comply with ISO 80601-2-12. |
| NIV NAVA functionality (SERVO-i only): | Added ventilation mode, leveraging existing cleared NIV and NAVA modes. Implied successful integration and functionality. |
| Second RS232 port functionality (SERVO-i only): | Added, identical in function to the first port. Implied proper functionality. |
| Built-in Nebulizer (Aeroneb) functionality (SERVO-i only): | Nebulization performance is equal to the predicate's SUN nebulizer. |
| Stress Index (SI) Calculation Accuracy (SERVO-i only): |
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).