(623 days)
No
The document describes software updates to existing algorithms for calculating respiratory rate, minute volume, and managing apnea alarms. While these involve data processing and logic, there is no mention of AI or ML techniques like training on data sets or using neural networks. The focus is on refining existing calculations and alarm behavior based on clinical evaluation.
Yes
The device is described as a "Ventilator System" intended for "treatment and monitoring of patients ... with respiratory failure or respiratory insufficiency." This directly aligns with the definition of a therapeutic device, as it provides a medical intervention (ventilation) to treat a patient's condition.
No
Explanation: The device is a ventilator system intended for treatment and monitoring of patients with respiratory failure or insufficiency, providing continuous ventilation and delivering controlled or supported breaths. While it monitors vital parameters and has features like NAVA that use physiological signals (electrical activity of the diaphragm), its primary function is therapeutic (providing ventilation) rather than diagnostic (identifying or characterizing a disease or condition). The "monitoring" aspect is for managing the ventilation, not for diagnosing an underlying condition.
No
The device description explicitly states that the SERVO-i and SERVO-s Ventilator Systems consist of both a Patient Unit (hardware for gas mixing and administration) and a User Interface, in addition to the software that controls the functionality. The submission also mentions modifications to both software and hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SERVO-i and SERVO-s Ventilator Systems are for the "treatment and monitoring of patients... with respiratory failure or respiratory insufficiency." This describes a device used directly on a patient for life support and monitoring, not for testing samples taken from the body.
- Device Description: The description details a system that mixes and administers gases, delivers breaths, and monitors vital parameters of the patient. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Providing information about a patient's health status based on laboratory tests.
- Using reagents or assays.
The device is a ventilator system, which is a type of medical device used to assist or control breathing in patients.
N/A
Intended Use / Indications for Use
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.
Product codes
CBK
Device Description
SERVO-i Ventilator System
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).
SERVO-s Ventilator System Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonate to adult patients, neonates, infants, and adults
Intended User / Care Setting
healthcare providers in hospitals or healthcare facilities and for in-hospital transport.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
SERVO-i Ventilator System
Design Verification and Validation
The design verification activities for the modified SERVO-1 Ventilator System version 7.0 consist of:
- Requirement verification of affected requirements
- Regression testing
- Code review and static code analysis
- Free User Testing (FUT)
- Verification of applicable product standards (IEC 60601-1 :2005, IEC 60601-1-2, IEC 60601-1-8, ISO 80601-2-12, ISO 80601-2-55, ISO 5356-1, CGA V-5)
The scope of the verification activities is dependent upon the scope and volume of changes made to the system software or hardware. All existing and new test cases at the system and subsystem level are listed and a discreet judgment is made regarding which tests must be performed. The test cases are based on system and subsystems functions and requirements specifications.
The Regression Tests are selected by a risk based analysis which evaluates the impact of the changes on the unchanged system and subsystems.
The verification testing performed on software changes include static code analysis, as well as code review and test before the code is integrated into the system.
In addition to the analyses and requirements verification, MAQUET performs "free user testing" on the full system software. Free user testing is conducted at the MAQUET test laboratory by software testers and clinicians to try and identify software issues that would not be identified during strict requirements testing.
Verification of applicable standard package for intensive care ventilators is performed by a third party test house according to the CB scheme.
The non-clinical performance data presented in this submission shows that MAQUET has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements. These results support that the modified SERVO-i Ventilation System 7.0 (K123149) is substantially equivalent to the predicate device, SERVO-i Ventilation System 4.0 (K073149).
Clinical Performance Data
The functionality added in the SERVO-i Ventilator System version 7.0 (K123149) does not add any new functions that need to be validated by clinical investigation.
Some Validation activities for the SERVO-i Ventilation system have been performed in clinical settings to show that the system meets the Market Requirement Specifications, its intended use, performance and user needs. A summary of Design Validation activities performed since the last 510(k) submission (K073149) in clinical settings are shown below.
Changes to reduce nuisance alarms in NAVA
Updates to the calculation of Respiratory Rate (RR) and Minute Volume (MV) in the NAVA option were performed to reduce nuisance visual and audible alarms. The new software was released in a post market evaluation to 6 sites where 22 patient treatments were recorded. The evaluation at MAQUET showed that the new algorithms did effectively calculate RR and MV while reducing the occurrence of nuisance RR and MV alarms.
Stress Index (SI)
The primary objective was to validate the market requirement "The calculation of SI value shall be based on relevant published articles in clinical journals for the Stress Index option". This was done by comparing values monitored on a total of ten (10) adult patients with ALL or ARDS with the SERVO-i Stress Index option and with an existing system used in multiple published articles about Stress Index. The results of the comparison with existing system was a
§ 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).
0
GETINGE GROUP K123149
SERVO-i and SERVO-s . 510(k) SUMMARY Prepared in accordance with 21 CFR Part 807.92
JUN 2 0 7014
GENERAL INFORMATION:
| Submitter's Name & Address: | Maquet Critical Care AB
Röntgenvägen 2
SE-171 54 Solna, Sweden
Tel: (011) 46 8 730 7300
Fax: (011) 46 8 730 7838 |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person for this submission: | Ms. Mirva Boothe
Regulatory Affairs Manager
Phone: direct: (011) 46 8 730 7864
Email: mirva.boothe@maquet.com |
| Application Correspondent: | Ms. Whitney Törning
Director, Regulatory Affairs
Maquet Medical Systems USA
45 Barbour Pond Drive
Wayne, NJ 07470
Phone: 973-709-7994
Fax: 973-807-9210
Email: whitney.torning@maquet.com |
Date prepared:
.
October 4, 2012
DEVICE INFORMATION:
This summary describes the changes performed for the SERVO-i Ventilator System and the SERVO-s Ventilator System.
| Trade Name : | Model: | Model no: |
|---|---|---|
| SERVO-i Ventilator System | SERVO-i | 64 87 800 |
| SERVO-s | 66 40 440 |
Device Classification
| Classification name | Classification
Number | Class | Regulation Number |
|--------------------------------------|--------------------------|-------|-------------------|
| Ventilator, continuous, facility use | CBK | II | 21CFR 868.5895 |
PREDICATE DEVICE INFORMATION:
| Legally marketed devices to which equivalence is being claimed | 510(k) # | Model of Subject device |
|---|---|---|
| SERVO-i Ventilator system | K073179 | SERVO-i |
| SERVO-i Ventilator system | K041223 | SERVO-s |
1
DEVICE DESCRIPTION:
SERVO-i Ventilator System
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).
SERVO-s Ventilator System Description
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
2
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.
DEVICE INDICATIONS FOR USE / INTENDED USE:
SERVO-i Ventilator System Indications For Use
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 healthcare providers in hospitals or healthcare facilities and for in-hospital transport.
The added indications for use of the NA VA option is when the electrical signal from the brain to the diaphragm is intact; NAVA 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 1.7, 1.5T and 3T MR scanners. This means that it is safe to use in the MR environment if the conditions in 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).
SERVO-s Ventilator System Indications For Use
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.
COMPARISON OF INDICATIONS FOR USE:
The Indications for Use for the modified SERVO-i Ventilator System version 7.0 (K123149) are identical to the predicate device, SERVO-i Ventilator System version 4.0.
Note: Version 4.0 is the general software included in the last submission (K073179). The focus of the previous submission was on the Heliox option, and it had therefore not the complete indications for use for the entire Ventilation system included.
The Indication for Use for the modified SERVO-s Ventilator System version 7.0 (K123149) is identical to the predicate device, SERVO-i Ventilator System version 2.0 (K041223).
3
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
SERVO-i Ventilator System
The technological characteristics for the subject device SERVO-i Ventilator System version 7.0 (K 123149) with respect to the control mechanism, operating principle, energy type, ergonomics of the patient interface, firmware, environmental specifications and performance specifications are similar to the predicate device, SERVO-i Ventilator System version 4.0 (K073179). The small differences are described below.
Changes according to mandatory requirements in the standards IEC 60601-1:2005. ISO 80601-2-12:2011 and ISO 80601-2-55:2011:
- . Update of all accuracy statements, the performance is the same is only the way to measure and present the data that is different.
- Update to Noise level measurement, the performance is the same is only the way to . measure and present the data that is different.
- Improved Ingress Protection to IP2, improvements done to the chassi. , ●
- . Brakes on all four wheels, (previous only two wheels) to improved mechanical stability to meet new requirements for transport within hospitals.
- Changed Gas inlet pressure specification. Gas inlet max pressure is lowered to comply . with the required testing.
- . Added measurement of Patient circuit resistance to the Pre-Use Check. Compliance and resistance testing of the patient circuit mandatory in the new standard ISO 80601-2-12.
Other changes to the predicate device:
- Added ventilation mode NIV NAVA, combination of the two cleared ventilation modes .
- NIV (Non-invasive ventilation) and NAVA (Neurally Adjusted Ventilatory Assist). r
- . Added features:
.
- o A second RS232 port, identical with the first RS-232 port.
- Changed built-in nebulizer. The previous SUN nebulizer has been replaced with o an Aeroneb nebulizer that also works in battery mode. Nebulization performance is equal.
- o Stress Index, new monitoring parameter. No impact on ventilation performance.
SERVO-s Ventilator System
The technological characteristics for the subject device SERVO-s Ventilator System version 7.0 (K123149) with respect to the control mechanism, operating principle, energy type, ergonomics of the patient interface, firmware, environmental specifications and performance specifications is similar to the predicate device, SERVO-i Ventilator System version 2.0 (K041223). The small differences are described below.
Changes according to mandatory requirements in the standards IEC 60601-1:2005, ISO 80601-2-12:2011 and ISO 80601-2-55:2011:
- Update of all accuracy statements, the performance is the same is only the way to . measure and present the data that is different.
- . Update to Noise level measurement, the performance is the same is only the way to measure and present the data that is different.
- Improved Ingress Protection to IP21, improvements done to the chassi. .
- . Brakes on all four wheels, (previous only two wheels) to improve mechanical stability to meet new requirements for transport within hospitals.
4
- . Changed Gas inlet pressure specification. Gas inlet max pressure is lowered to comply with the required testing.
- . Added measurement of Patient circuit resistance to the Pre-Use Check. Compliance and resistance testing of the patient circuit mandatory in the new standard ISO 80601-2-12.
Other changes to the predicate device:
- Smaller enclosure and new carrier .
- Attachment of the graphic user interface, fixed attachment to the ventilator the predicate . device attaches to the mobile cart, a table, railing, or 15-30 mm diameter pipe.
- . Power Supply, 2 rechargeable internal battery modules, the predicate device has 2-6 rechargeable battery modules
- 4 PC boards in Servo-s are similar to the ones in the predicate device but adapted to the . change of the new smaller enclosure the other PC boards are identical.
- . Infant weight range 2 - 30 kg, the predicate has a lower weight limit of 0.5 kg.
- . Tidal volume range 10-2000 mL. the predicate has a range of 2-4000 mL.
- Fewer Ventilation modes and options available .
NON-CLINICAL PERFORMANCE DATA:
SERVO-i Ventilator Svstem
Design verification and validation has demonstrated that the SERVO-i performs within its specifications and within the limits of the applied performance standards.
The design verification activities for the modified SERVO-1 Ventilator System version 7.0 consist of:
- . Requirement verification of affected requirements
- . Regression testing
- Code review and static code analysis .
- Free User Testing (FUT) .
- . Verification of applicable product standards
- o IEC 60601-1 :2005
- IEC 60601-1-2
- o IEC 60601-1-8
- ISO 80601-2-12 O
- O ISO 80601-2-55
- o ISO 5356-1
- CGA V-5 o
- . The scope of the verification activities is dependent upon the scope and volume of changes made to the system software or hardware. All existing and new test cases at the system and subsystem level are listed and a discreet judgment is made regarding which tests must be performed. The test cases are based on system and subsystems functions and requirements specifications.
- The Regression Tests are selected by a risk based analysis which evaluates the impact of . the changes on the unchanged system and subsystems.
- . The verification testing performed on software changes include static code analysis, as well as code review and test before the code is integrated into the system.
- In addition to the analyses and requirements verification, MAQUET performs "free user . testing" on the full system software. Free user testing is conducted at the MAQUET test
5
Image /page/5/Picture/0 description: The image shows the logo for MAQUET GETINGE GROUP. The word "MAQUET" is in large, bold, sans-serif font on the top line. Below that, "GETINGE GROUP" is in a smaller, bold, sans-serif font. The letters are black on a white background.
laboratory by software testers and clinicians to try and identify software issues that would not be identified during strict requirements testing.
- Verification of applicable standard package for intensive care ventilators is performed by . a third party test house according to the CB scheme.
The non-clinical performance data presented in this submission shows that MAQUET has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements. These results support that the modified SERVO-i Ventilation System 7.0 (K123149) is substantially equivalent to the predicate device, SERVO-i Ventilation System 4.0 (K073149).
SERVO-s Ventilator System
Design verification and validation has demonstrated that the SERVO-s performs within its specifications and within the limits of the applied performance standards.
The design verification activities for the modified SERVO-s Ventilator System version 7.0 consist of:
- . Requirement verification of affected requirements
- . Regression testing
- . Code review and static code analysis
- . Free User Testing (FUT)
- Verification of applicable product standards .
- o IEC 60601-1
- o IEC 60601-1-2
- IEC 60601-1-8 o
- ISO 80601-2-12 o
- ISO 80601-2-55 o
- o ISO 5356-1
- o CGA V-5
- . The scope of the verification activities is dependent upon the scope and volume of changes made to the system software or hardware. All existing and new test cases at the system and subsystem level are listed and a discreet judgment is made . regarding which tests must be performed. The test cases are based on system and subsystems functions and requirements specifications. Since the differences between the products SERVO-s Ventilator System and SERVO-i Ventilator System are small, tests performed on a SERVO-i ventilation system are also applicable for the SERVO-s ventilator system. Tests on the SERVO-s Ventilator System can be limited to Free User Tests and SERVO-s Ventilator System specific test cases. .
- . The Regression Tests are selected by a risk based analysis which evaluates the impact of the changes on the unchanged system and subsystems.
- . The verification testing performed on software changes include static code analysis, as well as code review and test before the code is integrated into the system.
- In addition to the analyses and requirements verification, MAQUET performs . "free user testing" on the full system software. Free user testing is conducted at
6
Image /page/6/Picture/0 description: The image shows the logo for MAQUET GETINGE GROUP. The word "MAQUET" is in large, bold, sans-serif font on the top line. The words "GETINGE GROUP" are in a smaller, sans-serif font on the second line, directly below the first word.
the MAQUET test laboratory by software testers and clinicians to try and identify software issues that would not be identified during strict requirements testing.
- . Verification of applicable standard package for intensive care ventilators is performed by a third party test house according to the CB scheme.
The non-clinical performance data presented in this submission shows that MAQUET has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input reauirements. These results support that the modified SERVO-s Ventilation System 7.0 (K123149) is substantially equivalent to the predicate device, SERVO-i Ventilation System 4.0 (K041223).
CLINICAL PERFORMANCE DATA:
SERVO-i Ventilator System
The functionality added in the SERVO-i Ventilator System version 7.0 (K123149) does not add any new functions that need to be validated by clinical investigation.
Some Validation activities for the SERVO-i Ventilation system have been performed in clinical settings to show that the system meets the Market Requirement Specifications, its intended use, performance and user needs. A summary of Design Validation activities performed since the last 510(k) submission (K073149) in clinical settings are shown below.
Changes to reduce nuisance alarms in NAVA
Updates to the calculation of Respiratory Rate (RR) and Minute Volume (MV) in the NAVA option were performed to reduce nuisance visual and audible alarms. The new software was released in a post market evaluation to 6 sites where 22 patient treatments were recorded. The evaluation at MAQUET showed that the new algorithms did effectively calculate RR and MV while reducing the occurrence of nuisance RR and MV alarms.
Stress Index (SI)
The primary objective was to validate the market requirement "The calculation of SI value shall be based on relevant published articles in clinical journals for the Stress Index option". This was done by comparing values monitored on a total of ten (10) adult patients with ALL or ARDS with the SERVO-i Stress Index option and with an existing system used in multiple published articles about Stress Index. The results of the comparison with existing system was a Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.