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.

Device Description

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.

AI/ML Overview

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):	<10% discrepancy when compared with an existing system used in published articles, which was within acceptance criteria.
Nuisance Alarm Reduction (RR and MV in NAVA) (SERVO-i only):	New algorithms effectively calculated RR and MV while reducing nuisance RR and MV alarms, as evaluated at MAQUET.
Apnea Ventilation and Alarm Behavior (NAVA) (SERVO-i only):	New algorithm for switching between NAVA and backup ventilation is acceptable and reduces nuisance alarms, meeting intended use and user needs.
SERVO-s specific changes (e.g., enclosure, power supply, weight/tidal volume ranges):	Adapted to new smaller enclosure, 2 internal rechargeable battery modules (vs. 2-6), 4 updated PC boards. Performance within specifications for its intended patient range (2-250 kg, 10-2000 mL tidal volume).
Substantial Equivalence:	Demonstrated through design verification, validation, and comparison to predicate devices, showing no new functions requiring clinical investigation for basic safety/efficacy.

Study Information

The document describes verification and validation activities rather than a single, formal "study" with a defined test set sample size for regulatory approval of this specific 510(k) submission's changes. The clinical activities mentioned are more akin to post-market evaluations or validation of specific features, built upon the foundation of the predicate devices.

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

Test Set (General Verification & Validation): Not explicitly stated as a uniform "test set" in terms of number of patients or specific data points for the entire device. The document refers to "existing and new test cases at the system and subsystem level" and "regression tests."
Data Provenance (General): Not specified. Likely a combination of lab simulations, engineering tests, and potentially previous datasets from predicate device development.
Specific Clinical Validation Activities (SERVO-i):
- Nuisance Alarm Reduction (NAVA RR/MV): 22 patient treatments recorded across 6 sites. Provenance: Post-market evaluation, specifics (e.g., country) not stated but likely within markets where MAQUET operates.
- Stress Index (SI): 10 adult patients with ALI or ARDS. Provenance: Not stated, likely clinical settings (hospitals).
- Apnea Ventilation/Alarm Behavior (NAVA): Patients in 3 sites during four weeks. 25 clinicians involved. Provenance: Post-market evaluation, likely clinical settings.

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

General V&V: "Software testers and clinicians" were involved in "Free User Testing (FUT)" in MAQUET's test laboratory. Specific number and qualifications not detailed.
Specific Clinical Validation Activities (SERVO-i):
- Nuisance Alarm Reduction (NAVA RR/MV): "Evaluation at MAQUET showed that the new algorithms did effectively calculate RR and MV while reducing the occurrence of nuisance RR and MV alarms." This implies internal experts at MAQUET (engineers, potentially medical staff) evaluated the data. Qualifications not specified.
- Stress Index (SI): Comparison against "an existing system used in multiple published articles." This "existing system" acts as the de facto ground truth reference. The evaluation of results was likely done by MAQUET's internal team.
- Apnea Ventilation/Alarm Behavior (NAVA): 25 clinicians filled in questionnaires. Their responses, evaluated by MAQUET, established the "ground truth" (or acceptance) that the new algorithm was acceptable and reduced nuisance alarms. Their specific qualifications (e.g., years of experience, specialty) are not detailed beyond "clinicians."

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

No formal adjudication method like "2+1" or "3+1" is described. Evaluations were made by MAQUET internally or based on comparison with existing systems/feedback from clinicians.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The device is a ventilator, not an AI diagnostic tool where human readers interpret output.
Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as it's not an AI-assisted diagnostic tool for human readers. The "AI" (software algorithms) are intrinsic to the device's function.

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

Yes, implicitly. The extensive "design verification and validation" for both SERVO-i and SERVO-s, including requirement verification, regression testing, code review, static code analysis, and compliance with product standards, represents standalone testing of the algorithm (software) and hardware. The "Free User Testing" involves human interaction, but the core functionality tests are against specifications.

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

General V&V: Primarily established by device specifications, regulatory requirements (standards), and comparison to predicate device performance.
Specific Clinical Validation Activities (SERVO-i):
- Nuisance Alarm Reduction: Reduced frequency of nuisance alarms (an objective metric) and effective calculation of RR/MV (comparison to expected values).
- Stress Index: Outputs from "an existing system used in multiple published articles."
- Apnea Ventilation/Alarm Behavior: Clinician feedback via questionnaires, representing user acceptance and perceived reduction in nuisance alarms.

7. The sample size for the training set:

Not applicable. This device is a medical ventilator (hardware and software) and not a machine learning model that undergoes a distinct "training phase." The "training" for the device's development involves engineering design, coding, and iterative testing, not data-driven machine learning in the conventional sense.

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

Not applicable, as there is no specific "training set" in the context of a machine learning model. The "ground truth" for the device's design and functionality is established through engineering principles, adherence to medical device standards, clinical requirements, and performance of existing predicate devices.

Summary

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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 ABRöntgenvägen 2SE-171 54 Solna, SwedenTel: (011) 46 8 730 7300Fax: (011) 46 8 730 7838
Contact Person for this submission:	Ms. Mirva BootheRegulatory Affairs ManagerPhone: direct: (011) 46 8 730 7864Email: mirva.boothe@maquet.com
Application Correspondent:	Ms. Whitney TörningDirector, Regulatory AffairsMaquet Medical Systems USA45 Barbour Pond DriveWayne, NJ 07470Phone: 973-709-7994Fax: 973-807-9210Email: 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	ClassificationNumber	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

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DEVICE DESCRIPTION:

SERVO-i Ventilator System

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.

SERVO-s Ventilator System Description

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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.

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

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).

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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.

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. 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

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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

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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 <10% discrepancy which was within the acceptance criteria.

Changes to improve Apnea ventilation and alarm behavior in NAVA

A pnea alarms due to common apnea episodes in neonatal patients causing nuisance apnea alarms in NAVA triggered an update to the algorithm for how the switching between NAVA and backup ventilation happens and how apnea alarms are activated. The updated software was released to 3 sites in a post market evaluation and during four weeks it was used on patients. 25 clinicians were using it and they filled in a questionnaire that was evaluated by MAQUET showing that the new algorithm for switching between NAVA and Backup is acceptable and reduces nuisance alarms. The conclusion of the evaluation is that the new Back Up option within the NAVA and NIV NAVA modes meets the intended use and user needs.

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SERVO-s Ventilator System

The functionality added in the SERVO-s Ventilator System version 7.0 (K123149) does not add any new functions that need to be validated by clinical investigation.

CONCLUSION FOR SUBSTANTIAL EQUIVALENCE:

MAQUET believes the modifications included since the last submission does not affect the indications for use nor alter the fundamental scientific technology of the device.

MAQUET has conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements.

MAQUET has concluded that the modified SERVO-i Ventilator System version 7.0 (K123149) is substantially equivalent to the predicate device, SERVO-i Ventilator System version 4.0 that includes the Heliox option (K073179) and the modified SERVO-s Ventilator System version 7.0 (K123149) is substantially equivalent to the predicate device, SERVO-i Ventilator System version 2.0 (K041223).

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Image /page/8/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 20, 2014

Maquet Critical Care AB c/o Whitney Torning Director Regulatory Affairs Maquet Medical Systems USA 45 Barbour Pond Drive Wayne, NJ 07470

Re: K123149

Trade/Device Name: SERVO-i and SERVO-s Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Ventilator, continuous, facility use Class: II Product Code: CBK Dated: March 31, 2014 Received: April 1, 2014

Dear Ms. Törning:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Töming

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director
DAGRID/ODE/CDRII FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K123149

Device Name SERVO-i Ventilator System

Indications for Use (Describe)

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).

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over - The-Counter Use (21 CFR 801 Subpart C)

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FOR FOR FDA USE ONLY . 444

Anva C. Harry -S

05:02:15 -04'00'

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Regulation Number and Section

§ 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).