intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
to be used only by healthcare providers
to be used only in professional healthcare facilities and for transport within these facilities

For NAVA and Edi monitoring, it is in addition intended:

to provide monitoring of the patient's breathing drive
to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

The SERVO-n ventilator system is:

intended for respiratory support, monitoring and treatment of neonatal and pediatric patients
to be used only by healthcare providers
to be used only in professional healthcare facilities and for transport within these facilities

For NAVA and Edi monitoring, it is in addition intended:

to provide monitoring of the patient's breathing drive
to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

Device Description

The SERVO-U/n Ventilator System is available in two models, SERVO-U and SERVOn. The SERVO-U/n 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 SERVO-U/n Ventilator System is built on the same architecture as the cleared predicate device SERVO-i Ventilator System (K123149). The ventilation modes in the SERVO-U/n Ventilator System are identical to the ventilation modes in the cleared predicate device, even though the standard configurations of available modes and optional modes differ between the devices i.e. SERVO-U, SERVO-n and the cleared predicate device SERVO-i Ventilator System (K123149).

The ventilator delivers controlled or supported breaths to the patient, with constant flow. constant pressure or pressure proportional to the Edi signal (the electrical activity of the diaphragm) of the patient, using a set oxygen concentration.

NAVA (Neurally Adiusted Ventilatory Assist) is a supported mode for SERVO-U/n that uses the Edi signal as an addition to the flow/pressure trigger to synchronize the patient efforts with the onset and cycle off of supported breaths. NAVA is available in invasive and non-invasive modes. These ventilation modes are identical in the SERVO-U/n Ventilation system and the cleared predicate device SERVO-i Ventilator System (K123149). Furthermore, the included hardware parts Edi module and Edi catheters are also identical to the ones used for the cleared predicate device SERVO-i Ventilator System (K123149).

SERVO-U/n contains a dedicated controller circuit for the Aerogen Pro and Solo nebulizers (included as standard). In the cleared predicate device SERVO-i Ventilator System (K123149) the corresponding nebulizer function is available as an optional module.

Accessories for CO2 monitoring and flow and pressure measurements at the Y piece (Y sensor) are integrated as options. The CO2 monitoring option is updated with Capnostat 5 and the Y sensor is based on a new technology and measuring function compared to the corresponding options for the cleared predicate device SERVO-i Ventilator System (K123149).

The SERVO-U/n Ventilator System will produce visual and audible alarms if any parameter varies beyond preset or default limits and produce alarm recordings. The alarm handling is very similar to the one used in the cleared predicate device SERVO-i Ventilator System (K123149), except the possibility to set alarm off for leakage related alarms in Neonatal Patient category when leakage compensation is activated. Additionally, an Inspiratory tidal volume (VT) too high alarm has been added in the neonatal patient category and three alarms have been removed in the Non-invasive modes.

The system contains provisions for battery modules to supply the system in the case of mains power failure or during in-hospital transport. The batteries are identical to the one used for the cleared predicate device SERVO-i Ventilator System (K123149).

System parts:
The SERVO-U/n Ventilator System consists of the following parts:

User interface, where all user interactions are performed.
Patient unit with all connections to the patient, to power and gases.
Mobile cart, on wheels, for using the ventilator on either the left or the right side of the patient.

AI/ML Overview

This document describes the premarket notification (510(k)) for the SERVO-U and SERVO-n Ventilator System. It largely focuses on demonstrating substantial equivalence to a predicate device (SERVO-i Ventilator System, K123149) rather than presenting a study to prove acceptance criteria for novel device performance. Therefore, the information typically requested regarding acceptance criteria and a proving study for a new AI/ML device is not fully available in this document.

However, based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present a formal table of acceptance criteria with reported performance in the way one might expect for a new device claiming specific performance metrics. Instead, "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device and compliance with relevant standards. The "reported device performance" is mainly a statement that the device performs "within its specifications and within the limits of the applied product performance standards."

Acceptance Criteria (Implied by Substantial Equivalence and Standards)	Reported Device Performance (as stated in document)
Intended Use Equivalence: Similar therapeutic and monitoring use as predicate device, with minor differences not affecting safety/effectiveness.	The SERVO-U/n Ventilator System's intended use/indication for use is "very similar" to the predicate, with minor rephrasing and differences (SERVO-n for neonatal/pediatric only, no MR/Heliox options for SERVO-U/n) that are believed "will not affect the therapeutic or monitoring use."
Technology Equivalence: Built on the same architecture, re-uses software algorithms for ventilation and alarms, identical ventilation modes. Updates made (GUI, software platform, microprocessors, Y sensor, CO2 analyzer, leakage compensation, alarm changes) are described as improvements or adaptations.	"SERVO-U/n Ventilator System is built on the same architecture as the cleared predicate device SERVO-i Ventilator System (K123149). Software algorithms for ventilation and alarms are re-used... ventilation modes... are identical."
Performance within Specifications: Device performs as intended and meets design input requirements.	Design verification and validation have demonstrated that the SERVO-U/n Ventilator System "performs within its specifications."
Compliance with Product Standards: Adherence to recognized national and international standards.	"performs... within the limits of the applied product performance standards." Specific standards listed include ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 80601-2-12, ISO 80601-2-55, ISO 5356-1, CGA V-5.
Biocompatibility: New materials in gas pathway are biocompatible.	Biocompatibility evaluation performed in accordance with AAMI/ANSI/ISO 10993-1:2009 for components with new materials contacting the gas pathway. Cytotoxicity and sensitization testing performed.
Usability/Risk Management: Identification and mitigation of potential use errors; device meets user needs.	Usability activities performed, including formative tests and summative usability validation. Potential use errors identified and estimated during usability risk analysis, informing human factors testing.
Safety and Effectiveness Equivalence: As safe and effective as the predicate device.	"MAQUET has concluded that the performance data for the SERVO-U/n Ventilator System show that it is as safe and as effective as the already cleared predicate device SERVO-i Ventilator System (K123149)."

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not explicitly stated as a single "test set" in the context of typical AI/ML evaluation. The design verification and validation activities involved various types of testing (code review, unit tests, integration tests, system tests, Free User Testing, regression testing, biocompatibility testing, usability testing, and an animal study). The number of test cases or "samples" for each of these activities is not quantified.
Data provenance: Not directly applicable in the sense of a clinical dataset. The testing conducted was primarily non-clinical (engineering verification, lab testing, animal study).
- Animal study: Done to evaluate the performance of the Y sensor algorithm at different degrees of humidity and leakage and its effect on tidal volume measurements. Provenance (e.g., country) is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided. The ground truth for the verification and validation activities would largely be established by engineering specifications, regulatory standards, and expert review within the company. For "Free User Testing" and "usability validation," the "experts" would be representative users (healthcare providers), but their number and specific qualifications are not detailed.

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

Not applicable in the context of this 510(k) submission. Adjudication methods are typically relevant for human review of clinical data, especially in studies involving subjective assessments of images or patient outcomes. The testing described here is primarily technical and performance-based.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. This device is a ventilator, not an AI-powered diagnostic or assistive tool for human readers.

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

The device itself is a standalone medical device (a ventilator). The "performance" described is of the device's various functions and components, rather than the performance of an isolated algorithm. The document emphasizes the integration of hardware and software.

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

The "ground truth" for the various verification and validation activities would primarily consist of:

Engineering specifications and design input requirements: For system tests, unit tests, integration tests, and code reviews.
Applicable product standards: For compliance testing.
Predefined performance ranges and accuracy limits: For sensor evaluations (e.g., Y sensor in animal study, CO2 analyzer).
Simulated physiological conditions: Used in lab testing.
User expectations and safety requirements: For usability and risk analysis.

8. The sample size for the training set:

Not applicable. This document describes a medical device (ventilator), not an AI/ML system that undergoes "training" in the conventional sense.

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

Not applicable, as no training set for an AI/ML algorithm is described.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three faces layered on top of each other.

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

December 21, 2015

Maquet Critical Care Ab % Ms. Lia Gonzalez Regulatory Affairs Specialist Maquet Medical Systems USA 45 Barbour Pond Drive Wayne, New Jersey 07470

Re: K151814

Trade/Device Name: Servo-U and Servo-n Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: November 17, 2015 Received: November 18, 2015

Dear Ms. Lia Gonzalez:

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.

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

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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 devicerelated 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)	K151814
--------------------------	---------

Device Name

SERVO-U and SERVO-n Ventilator System

Indications for Use (Describe)

The SERVO-U ventilator system is:

intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
to be used only by healthcare providers
to be used only in professional healthcare facilities and for transport within these facilities

For NAVA and Edi monitoring, it is in addition intended:

to provide monitoring of the patient's breathing drive
to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

The SERVO-n ventilator system is:

intended for respiratory support, monitoring and treatment of neonatal and pediatric patients
to be used only by healthcare providers
to be used only in professional healthcare facilities and for transport within these facilities

For NAVA and Edi monitoring, it is in addition intended:

to provide monitoring of the patient's breathing drive
to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

FORM FDA 3881 (8/14)

Page 1 of 2

PSC Publishing Services (301) 443-6740

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510(k) SUMMARY

as required by section 21 CFR 807.92

Submitter 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 Persons for this submission:

Maria von Bahr Regulatory Affairs Manager Phone: + 46 70 7827934 Email: maria.vonbahr@maquet.com

Application Correspondent:

Ms. Lia Gonzalez Regulatory Affairs Specialist Maquet Medical Systems USA 45 Barbour Pond Drive Wayne, NJ 07470 Email:mailto: lia.gonzalez@maquet.com Phone: 973-709-7340 Fax: 973-709-7016

Date prepared: November 11, 2015

Trade Name:	Model:	Model no:
SERVO-U/n Ventilator System	SERVO-U	66 94 800
	SERVO-n	66 88 600

Device Classification

Common Name	ClassificationProduct Code	Class	Regulation Number
Ventilator, continuous, facility use	CBK	II	21 CFR 868.5895

Predicate Device Identification

Legally marketed devices to which equivalence is being claimed	510(k) #
SERVO-i Ventilator System version 7.0	K123149

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Indications for Use of the Device

The SERVO-U ventilator system is:

intended for respiratory support, monitoring and treatment of neonatal, pediatric ● and adult patients
to be used only by healthcare providers
to be used only in professional healthcare facilities and for transport within these . facilities

For NAVA and Edi monitoring, it is in addition intended:

to provide monitoring of the patient's breathing drive .
. to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
. for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

The SERVO-n ventilator system is:

intended for respiratory support, monitoring and treatment of neonatal and ● pediatric patients
to be used only by healthcare providers ●
to be used only in professional healthcare facilities and for transport within these . facilities

For NAVA and Edi monitoring, it is in addition intended:

to provide monitoring of the patient's breathing drive ●
. to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
. for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

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The second part of the indications for use is related to the NAVA (Neurally Adjusted Ventilatory Assist) ventilation mode which is a supported mode for SERVO-U/n 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 of supported breaths. NAVA is available in invasive and non-invasive modes. These ventilation modes are identical in the SERVO-U/n Ventilation system to the already cleared predicate device SERVO-i Ventilator System (K123149). Furthermore, the included hardware parts Edi module and Edi catheters are also identical to the cleared predicate device SERVO-i Ventilator System (K123149).

	SUBJECT DEVICE	SUBJECT DEVICE	Predicate Device	Conclusion/Comparison
Device	SERVO-U Ventilator	SERVO-n Ventilator	SERVO-i Ventilator
510(k) Number	Pending	Pending	K123149
Indications for Use	The SERVO-U ventilator system is:intended for respiratory support,monitoring and treatment ofneonatal, pediatric andadult patientsto be used only by healthcareprovidersto be used only in professionalhealthcare facilities and fortransport within thesefacilitiesFor NAVA and Edi monitoring, itis in addition intended:to provide monitoring of thepatient's breathing driveto improve synchrony between theventilator system and patient whenthe electrical signal from the brainto the diaphragm is activefor use on all patients with nocontraindication forinsertion/exchange ofa nasogastric tube	The SERVO-n ventilator systemis:intended for respiratory support,monitoring and treatment ofneonatal and pediatric patientsto be used only by healthcareprovidersto be used only in professionalhealthcare facilities and fortransport within thesefacilitiesFor NAVA and Edi monitoring, itis in addition intended:to provide monitoring of thepatient's breathing driveto improve synchrony betweenthe ventilator system and patientwhen the electrical signal from thebrain to the diaphragm is activefor use on all patients with nocontraindication forinsertion/exchange ofa nasogastric tube	The SERVO-i Ventilator System isintended for treatment andmonitoring of patients in the rangeof neonates, infants, and adultswith respiratory failure orrespiratory insufficiency.SERVO-i is a ventilator system tobe used only by healthcareproviders in hospitals or healthcarefacilities and for in-hospitaltransport.The added indications for use ofthe NAVA option is when theelectrical signal from the brain tothe diaphragm is intact; NAVAwill improve synchrony betweenthe ventilator and patients with nocontraindication for insertion/exchange of a Naso-Gastrictube. The SERVO-i Ventilator isclassified as MR Conditional for1.T, 1.5T and 3T MR scanners.This means that it is safe to use inthe MR environment if theconditions in the MR EnvironmentDeclaration for SERVO-i are met.The SERVO-i Ventilator Systemwith Heliox option is indicated foruse with the delivery of Air,Oxygen, or Heliox (a mixture ofHelium and Oxygen).	Similar- the indications for use arerephrased compared to the clearedpredicate device.Difference- SERVO-n is intendedfor neonatal and pediatric patientsonly.Difference- SERVO-U andSERVO-n are not equipped withMR or Heliox options.
Approved

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Device Description

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neonatal patient category and three alarms have been removed in the Non-invasive modes.

System parts:

The SERVO-U/n Ventilator System consists of the following parts:

· User interface, where all user interactions are performed.
Patient unit with all connections to the patient, to power and gases.
Mobile cart, on wheels, for using the ventilator on either the left or the right side of the patient.

Image /page/7/Picture/7 description: The image shows a medical ventilator on a white stand with wheels. The ventilator has a screen at the top and a boxy unit in the middle. The stand has four legs with wheels, making it easy to move the ventilator around.

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Comparison and substantial equivalence statement

Comparison of Indication for Use

The intended use/indication for use for the proposed device. SERVO-U/n Ventilator System, is very similar since the general purpose of the device and the functions are unchanged compared to the intended use of the cleared predicate device SERVO-i Ventilator System (K123149). The intended use/indication for use is rephrased and there are only two minor differences compared to the cleared predicate device SERVO-i Ventilator System (K123149). The first one is that SERVO-n is intended for neonatal and pediatric patients only. The second one is that SERVO-U and SERVO-n cannot be equipped with MR or Heliox options available for SERVO-i. Note that not all SERVO-i devices are possible to use in MR environment (i.e. it requires a specially adapted SERVO-i). MAOUET believes that these two differences will not change the intended therapeutic or monitoring use of the SERVO-U/n compared to the cleared predicate device SERVO-i Ventilator System (K123149).

Comparison of Technology Used

The SERVO-U/n Ventilator System is built on the same architecture as the cleared predicate device SERVO-i Ventilator System (K123149). Software algorithms for ventilation and alarms are re-used. Furthermore, the ventilation modes in the SERVO-U/n Ventilator System are identical to the ventilation modes in the cleared predicate device, even though the standard configurations of available modes and optional modes differ between the devices, SERVO-U, SERVO-n and the cleared predicate device SERVO-i Ventilator System (K123149).

The following changes have been made compared to the cleared predicate device SERVO-i Ventilator System (K123149):

. Software and the Graphical User Interface (GUI) have been updated to improve the interaction between the user and the Ventilation System. The updated GUI includes context-based guidance and intuitive user interaction for all functions. The user interface panel is new compared to the one used for the cleared predicate device SERVO-i Ventilator System (K123149).
Software platform and microprocessors are upgraded to more modern versions to . enable functional growth in the future.
The lower limit for patient weight in neonatal patient category has been decreased from 0.5 kg to 0.3 kg.

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. The flow measuring device in the Y sensor is a hot wire anemometer (HWA) type sensor. In the Y sensor of the cleared predicate device the flow measuring technology is based on fixed orifice, differential pressure. The pressure measurement uses the same technology for both devices. The Y sensor monitors flow and pressure and increases the accuracy of the delivered gas at small tidal volumes. The functionality to increase the accuracy of the delivered gas is new compared to the cleared predicate device SERVO-i Ventilator System (K123149).
. The materials included in the breathing circuit that indirectly will be exposed to the patient through the breathing gas are very similar to the materials used in the breathing circuit of the cleared predicate device SERVO-i Ventilator System (K123149). The differences are:
- two new gray color complexes are used in the polymeric material in the O inspiratory channel. However, the polymeric material is identical to the one used for the inspiratory channel in the cleared predicate device.
- new Y sensor which includes new materials o
The CO2 analyzer option has been updated to Capnostat 5. Capnostat 5 is an . OEM product and it is manufactured by Respironics Novametrix, Inc. (510(k) clearance number K042601).
In the neonatal patient category, there is a leakage compensation function ● available in all invasive modes except Bi-Vent/APRV. A leakage compensation function is available in the Non-invasive modes of the cleared predicate device SERVO-i Ventilator System (K123149).
A new function has been implemented to set alarm off for leakage related alarms ● in Neonatal Patient category when leakage compensation is activated.
. An Inspiratory tidal volume (VT) too high alarm has been added in the neonatal patient category.
In NIV modes, the following alarms have been removed in comparison to the ● cleared predicate device SERVO-i Ventilator System (K123149): "VT inspiratory overrange", "Inspiratory flow overrange" and "Unreliable Edi signal".
SERVO-U and SERVO-n cannot be equipped with MR or Heliox options. ●

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Conclusion

MAQUET believes that the rephrasing and the two minor differences in intended use/indication for use will not affect the therapeutic or monitoring use of the SERVO-U/n compared to the cleared predicate device SERVO-i Ventilator System (K123149). It is concluded that there are no new type questions of safety and effectiveness for the SERVO-U/n Ventilator System as compared to the cleared predicate device SERVO-i Ventilator System (K123149). MAQUET has conducted the risk analysis and performed the necessary verification and validation activities to demonstrate that the design outputs meet the design input requirements and the appropriate product standards. MAQUET has concluded that the performance data for the SERVO-U/n Ventilator System show that it is as safe and as effective as the already cleared predicate device SERVO-i Ventilator System (K123149).

Non-clinical Testing and Performance

Support for the substantial equivalence of the SERVO-U/n Ventilator system to the cleared predicate device SERVO-i Ventilator System (K123149) was provided as a result of risk management and testing.

The design verification activities consist of:

Code review and static code analysis
Unit tests
. Integration tests
System tests (including safety related functions from risk analysis) ●
Free User Testing (FUT) .
. Regression testing
. Verification of applicable product standards

The following product standards are included in the verification:

ANSI/AAMI ES 60601-1:2005, Recognition Number 19-5. ●
IEC 60601-1-2:2007, Recognition Number 19-1. ●
IEC 60601-1-8:2006, Recognition Number 5-86. ●
ISO 80601-2-12:2011, Recognition Number 1-98. ●
ISO 80601-2-55:2011, Recognition Number 1-96. ●
ISO 5356-1:2004, Recognition Number 1-62. ●
CGA V-5:2008, Recognition Number 1-81. ●
EN13544-1:2007, this standard is not recognized by FDA. ●

Biocompatibility evaluation of the SERVO-U/n Ventilator System is in accordance with AAMI / ANSI / ISO 10993-1:2009, recognition number 2-156 included the extent of recognition. The biocompatibility testing of new materials is based on Annex A in Blue

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book memorandum #G95-1, "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices'-Part 1: Evaluation and Testing"

Biocompatibility testing (i.e. cytotoxicity and sensitization) and evaluation has been performed regarding exposure to volatile organic compounds, particulate matter, introduced colorants and leachable (in case of condensate) for all components with new materials, or composition in materials, that contact the gas pathway to the patient. The patient contact is considered to be prolonged, less than 30 days, external communicating device with tissue contact.

Design validation has been performed in order to ensure that the product meets both its intended use and user needs, including usability. The validation activities included an animal study to evaluate the performance of the Y sensor algorithm at different degrees of humidity and leakage and to evaluate the effect of these two variables on tidal volume measurements. Usability activities, including a large number of formative tests as well as a summative usability validation, have been performed. Potential use errors were identified and estimated in the usability risk analysis process and the obtained information served as basic input to the performed human factors testing.

Design verification and validation have demonstrated that the SERVO-U/n Ventilator System performs within its specifications and within the limits of the applied product performance standards.

Clinical Investigation

No clinical investigation has been performed since it has been concluded based on literature data, state of the art knowledge and applicable product standards that SERVO-U/n has no new clinical aspects or risks which are not already discussed and evaluated in the 510(k) submission for the cleared predicate device SERVO-i Ventilator System (K123149).

K151814 (Premarket Notification [510(k)] Number)

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).