The devices in the Model 731 Ventilator Series are indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in austere environments where they may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). When marked with an "MRI conditional" label, they are suitable for use in an MRI environment with appropriate precautions, as defined in the Operation Manual. The Model 731 Ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers. The EMV+® and Eagle II'" (with and without MRI label) have a full range of ventilation modes (AC, SIMV, CPAP with PS and NPPV-PPV). The AEV® (with and without MRI label) has a more limited range of ventilation modes for less sophisticated operators (AC, CPAP with PS and PPV).

Device Description

The Model 731 Ventilators are a small, extremely durable, full-featured portable mechanical ventilators designed to operate in hospitals or austere and under-resourced environments. The unit is a volume and pressure targeted, time or flow cycled ventilator designed to use either oxygen (O2) from a 55 psig source or fresh air using its internal compressor to deliver a positive pressure breath. The unit contains a pulse oximeter which is intended for continuous noninvasive monitoring of arterial hemoglobin (SpO2) and pulse rate (measured by the SpO2 sensor). The unit contains various controls and indicators that are placed to facilitate ease of use and visibility in all operating environments. A liquid crystal display (LCD) provides continuous display of control settings, operating conditions, power, and alarm status information. The unit uses a comprehensive suite of alarms to alert the operator and guide their actions to resolve the alarm condition and assure patient safety. At the onset of an alarm, the screen displays the alarm name and then a series of context-sensitive help messages. These messages serve to guide the operator by presenting suggestions as to the cause and resolution of a particular alarm. When multiple alarms occur they are prioritized and displayed based on the risk to the patient. The unit offers a range of modes using both pressure and volume targeting that can be selected to optimally manage the patient. Assist/Control (AC): patient receives either controlled or assisted breaths. When the patient triggers an assisted breath they receive a breath based on either the volume or pressure target. Synchronized Intermittent Mandatory Ventilation (SIMV): patient receives controlled breaths based on the set breathing rate. Spontaneous breaths can be either unsupported demand flow or supported using Pressure Support. (This mode is not available in the AEV® unit.) Continuous Positive Airway Pressure (CPAP): patient receives constant positive airway pressure while breathing spontaneously. Spontaneous breaths can be either demand flow or supported using Pressure Support. The unit contains a built-in back up ventilator mode that is designed to provide a limited degree of operation should certain types of failures occur to the primary operating system. The unit can be used in environments where chemical and/or biological toxins are present. To do this safely, all gas delivered to the patient comes from either a pressurized medical-grade O₂ source and/or filtered ambient air entrained through the FRESH GAS/EMERGENCY AIR INTAKE. Operators can chose between a bacterial/viral filter and a chemical/biological filter based on the direction of the Medical Control Officer. To prevent the patient from breathing contaminated ambient air in the event of a ventilator failure, the unit contains an internal anti-asphyxia valve that allows the patient to inspire gas through the external filter. The unit continuously monitors environmental conditions (temperature and ambient pressure) and when extreme environments are detected the operator is alerted by a low priority alarm which defines the operating condition and prompts the actions of the operator. The unit uses a rechargeable lithium-ion battery which offers a wide temperature operating range, does not exhibit "memory" characteristics (reduced capacity) or vent hydrogen gas. The unit can use O₂ from low flow sources, O₂ flow meters and O₂ concentrators, to provide supplemental O₂ to patients. To do this, O₂ is entrained through the Fresh Gas/Emergency Air Intake when the unit's internal compressor cycles to deliver a breath. The testing in MRI environment was done with a 3.0 T Siemens Trio scanner, which has a magnetic field of 0.2 T (500 gauss) at a distance of slightly more than 1 meter (~3.3 feet) from the bore entrance. There was no effect on either the ventilator functionality or the MRI performance at a distance of 2 meters.

AI/ML Overview

The provided text is a 510(k) summary for the Uni-Vent® Model 731 Series Portable Critical Care Ventilators. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared device (K103318), with the main difference being the addition of operation in an MRI environment.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

Acceptance Criteria (from FDA Draft Guidance "A Primer on Medical Device Interactions with Magnetic Resonance Imaging systems")	Reported Device Performance
Location of testing: Passed	Passed
Imaging sequence: Passed	Passed
Effect on Medical Device: Passed	No effect on ventilator functionality at 2 meters from a 3.0 T Siemens Trio scanner (0.2 T / 500 gauss at ~1 meter).
Generation of Artifact/Noise: Passed	No effect on MRI performance at 2 meters from a 3.0 T Siemens Trio scanner (0.2 T / 500 gauss at ~1 meter).
Longer breathing circuit for MRI operation requirements (ASTM F1100)	Passed testing to ASTM F1100 requirements.
Section 5.3 Waveform Performance	Passed
Section 5.4 Volume Performance	Passed

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of patient data. The evaluation appears to be entirely non-clinical performance testing focused on the device's interaction with an MRI environment and its functional performance. No human subjects were involved. As such, there is no sample size for a test set of patient data, nor is there information on data provenance (country of origin, retrospective/prospective).

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)

Not applicable. Since the performance evaluation was non-clinical testing of device functionality and MRI compatibility, there was no "ground truth" to be established by experts in the context of medical diagnoses or interpretations. The acceptance criteria were met through direct measurements and observations during testing.

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

Not applicable. As noted above, there was no "test set" involving human interpretation or diagnosis that would require an adjudication method.

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 submission is for a medical device (ventilator), not an AI-based diagnostic or assistive technology.

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

Not applicable. This device is not an algorithm or AI system. Its performance was evaluated as a standalone medical device in various operational conditions, including an MRI environment.

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

The "ground truth" for the non-clinical performance evaluation was based on predefined engineering specifications, regulatory standards (e.g., ASTM F1100), and the physical effects measured during MRI compatibility testing. For example, "no effect on ventilator functionality" or "no effect on MRI performance" measured against established baselines determined the passing criteria.

8. The sample size for the training set

Not applicable. This device is a ventilator, not an AI or machine learning system that requires a "training set."

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

Not applicable. As there is no training set for this device, there is no ground truth establishment method for it.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance tests.

MRI Compatibility Testing: The primary study mentioned is testing for MRI environment compatibility. This involved placing the ventilator near a 3.0 T Siemens Trio scanner which has a magnetic field of 0.2 T (500 gauss) at approximately 1 meter. The testing demonstrated "no effect on either the ventilator functionality or the MRI performance at a distance of 2 meters." This test was conducted in accordance with the acceptance criteria defined in the FDA Draft Guidance "A Primer on Medical Device Interactions with Magnetic Resonance Imaging systems," covering aspects like location of testing, imaging sequence, effect on medical device, and generation of artifact/noise, all of which "passed."
Breathing Circuit Performance: The longer breathing circuit required for MRI operation was tested and "passed testing to ASTM F1100 requirements."
Waveform and Volume Performance: Sections 5.3 and 5.4, related to "Waveform Performance" and "Volume Performance" respectively, also "passed." (Specific details of these tests are not provided in this summary but are indicated as having met their criteria).

In summary, the provided document details a non-clinical evaluation to demonstrate the safe and effective operation of the Uni-Vent® Model 731 Series Portable Critical Care Ventilators, particularly in an MRI environment, by meeting specific pre-defined performance and safety criteria through direct physical testing and measurement against established standards.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for IMPACT Instrumentation Inc. The logo features the company name in bold, uppercase letters above a world map. The word "IMPACT" is also written in large, bold letters across the center of the world map. The image is in black and white.

27 Fairfield Place, West Caldwell, NJ 07006. P.O Box 508, West Caldwell, NJ 07007-0508

FEB 1 6 2012

510(k) Summary

This 510(k) summary consists of a table with the information required in the 510(k) Summary Checklist from the FDA Guidance document.

Description of RequiredInformation	Information
Owner's Name	Leslie H. Sherman (President)
Address	27 Fairfield Place, West Caldwell NJ 07006
Phone	973-882-1212
Fax	973-882-4993
Contact Person	Susan McNevin Ph.D., CQE/CQAQuality Engineer, Impact Instrumentation, Inc.
Date this Summary wasprepared	December 28, 2010
Trade name of device	Uni-Vent® Model 731 Series Portable Critical Care VentilatorsVersions:EMV+®EMV+®- MRI versionEagle IITMEagle IITM - MRI versionAEV®AEV®- MRI version
Common name	ventilator
Classification name	Continuous Ventilator (21 CFR 868.5895, Product Codes CBK,DQA)
Legally marketed device –Equivalence Claim	Uni-Vent® Model 731 Series Portable Critical Care Ventilators(K103318).
Description of the device	The below is taken from the Operation Manual:● The Model 731 Ventilators are a small, extremelydurable, full-featured portable mechanical ventilators
Description of RequiredInformation	Information
	designed to operate in hospitals or austere and under-resourced environments.
	The unit is a volume and pressure targeted, time orflow cycled ventilator designed to use either oxygen (O2)from a 55 psig source or fresh air using its internalcompressor to deliver a positive pressure breath. The unit contains a pulse oximeter which is intendedfor continuous noninvasive monitoring of arterialhemoglobin (SpO2) and pulse rate (measured by the SpO2sensor). The unit contains various controls and indicators thatare placed to facilitate ease of use and visibility in alloperating environments. A liquid crystal display (LCD)provides continuous display of control settings, operatingconditions, power, and alarm status information. The unit uses a comprehensive suite of alarms to alertthe operator and guide their actions to resolve the alarmcondition and assure patient safety. At the onset of an alarm,the screen displays the alarm name and then a series ofcontext-sensitive help messages. These messages serve toguide the operator by presenting suggestions as to the causeand resolution of a particular alarm. When multiple alarmsoccur they are prioritized and displayed based on the risk tothe patient. The unit offers a range of modes using both pressureand volume targeting that can be selected to optimallymanage the patient. Assist/Control (AC): patient receives either controlledor assisted breaths. When the patient triggers anassisted breath they receive a breath based on eitherthe volume or pressure target.Synchronized Intermittent Mandatory Ventilation(SIMV): patient receives controlled breaths based onthe set breathing rate. Spontaneous breaths can beeither unsupported demand flow or supported usingPressure Support. (This mode is not available in theAEV® unit.)Continuous Positive Airway Pressure (CPAP): patientreceives constant positive airway pressure whilebreathing spontaneously. Spontaneous breaths can
Description of RequiredInformation	Information
	be either demand flow or supported using PressureSupport.
	• The unit contains a built-in back up ventilator modethat is designed to provide a limited degree of operationshould certain types of failures occur to the primaryoperating system.
	• The unit can be used in environments where chemicaland/or biological toxins are present. To do this safely, all gasdelivered to the patient comes from either a pressurizedmedical-grade O₂ source and/or filtered ambient airentrained through the FRESH GAS/EMERGENCY AIR INTAKE.Operators can chose between a bacterial/viral filter and achemical/biological filter based on the direction of theMedical Control Officer. To prevent the patient frombreathing contaminated ambient air in the event of aventilator failure, the unit contains an internal anti-asphyxiavalve that allows the patient to inspire gas through theexternal filter.
	• The unit continuously monitors environmentalconditions (temperature and ambient pressure) and whenextreme environments are detected the operator is alertedby a low priority alarm which defines the operating conditionand prompts the actions of the operator.
	• The unit uses a rechargeable lithium-ion batterywhich offers a wide temperature operating range, does notexhibit "memory" characteristics (reduced capacity) or venthydrogen gas.
	• The unit can use O₂ from low flow sources, O₂ flowmeters and O₂ concentrators, to provide supplemental O₂ topatients. To do this, O₂ is entrained through the FreshGas/Emergency Air Intake when the unit's internalcompressor cycles to deliver a breath.
	• The testing in MRI environment was done with a 3.0 TSiemens Trio scanner, which has a magnetic field of 0.2 T(500 gauss) at a distance of slightly more than 1 meter (~3.3feet) from the bore entrance. There was no effect on eitherthe ventilator functionality or the MRI performance at adistance of 2 meters.
Intended Use of Device	The Intended Use is taken from the Operation Manual:The devices in the Model 731 Ventilator Series are indicatedfor use in the management of infant through adult patientsweighing ≥5 kg with acute or chronic respiratory failure or
Description of RequiredInformation	Information
Comparison TechnologicalCharacteristics to Predicate	during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use inhospitals, outside the hospital, during transport and inaustere environments where they may be exposed to rain,dust, rough handling and extremes in temperature andhumidity. With an appropriate third-party filter in place, theymay be operated in environments where chemical and/orbiological toxins are present (see External Filter Use). Whenmarked with an “MRI conditional” label, they are suitable foruse in an MRI environment with appropriate precautions, asdefined in the Operation Manual. They are not intended tooperate in explosive environments. The Model 731Ventilators are intended for use by skilled care providers withknowledge of mechanical ventilation, emergency medicalservices (EMS) personnel with a basic knowledge ofmechanical ventilation and by first responders under thedirection of skilled medical care providers. The EMV+® andEagle II™ (with and without MRI label) have a full range ofventilation modes (AC, SIMV, CPAP with PS and NPPV-PPV).The AEV® (with and without MRI label) provides specificmodes consistent with pre-hospital care provider’s operatingprocedures (AC, CPAP with PS and PPV).The only difference in this Intended Use from the Predicate isthe addition of operation in an MRI environment.There is no change in either the software or the hardware.The only difference is external conditional MRI label andOperation Manual.

Section 5 – 510(k) Summary

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Description of RequiredInformation	Information
Non-Clinical Performancedata	It was demonstrated that there was no effect oneither the ventilator functionality or the MRI performance ata distance of 2 meters from a 3.0 T Siemens Trio scanner,which has a magnetic field of 0.2 T (500 gauss) at a distanceof slightly more than 1 meter. This test meets the acceptance criteria defined inFDA Draft Guidance "A Primer on Medical DeviceInteractions with Magnetic Resonance Imagingsystems" Location of testing: passed Imaging sequence: passed Effect on Medical Device: passed Generation of Artifact/Noise: passed The longer breathing circuit required for MRIoperation passed testing to ASTM F1100 requirements. Section 5.3 Waveform Performance: passed Section 5.4 Volume Performance: passed
Clinical Performance	N/A. No clinical performance data is being submitted.
Safe and Effective as	The testing demonstrates that these devices are as safe and
Predicate	effective and performs as well as or better than the Predicatedevice (K103318).
Other Information requested	Impact Instrumentation, Inc. will provide the FDA with any
by FDA	additional required information.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

Ms. Susan McNiven Quality Engineer Impact Instrumentation, Inc. 27 Fairfield Place West Caldwell, New Jersey 07006

FEB 1 6 2012

Re: K111473

Trade/Device Name: Uni-Vent® 731 Series Model Portable Critical Care Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 2, 2011 Received: February 1, 2012

Dear Ms. McNevin:

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 Eederal Register.

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Page 2 - Ms. McNevin

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 (reporting of measur 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Somplikation" (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/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 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,

hh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): | | | | | 7 2

Device Name: Uni-Vent®) 731 Series Model Portable Critical Care Ventilator

Indications For Use: (the text in red shows Additions to Predicate device)

INTENDED USE

AND/OR Over-The-Counter Use × Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schullte

Division Sign-Off) ivision of Anesthesiology, General Hospital fection Control, Dental Devices

10(k) Number: K111473-

Section 4 -- Statements of Indications for Use

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).