Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a traditional mechanical ventilator with various modes, alarms, and monitoring capabilities. There is no mention of AI or ML in the intended use, device description, or performance studies. The "context-sensitive help messages" for alarms are rule-based, not indicative of AI/ML.

Therapeutic

Yes

The device is indicated for use in the management of infant through adult patients with acute or chronic respiratory failure, providing continuous positive-pressure ventilation, which directly addresses a medical condition.

Diagnostic

No

The device is a ventilator, designed to provide continuous positive-pressure ventilation for patients with respiratory failure. While it monitors SpO2 and pulse rate, its primary function is therapy (ventilation), not diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical ventilator with hardware components such as an internal compressor, pulse oximeter, LCD display, controls, indicators, and a rechargeable battery. It is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "providing continuous positive-pressure ventilation" to patients with respiratory failure. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
Device Description: The description details a mechanical ventilator that delivers air and oxygen to the patient. While it includes a pulse oximeter for monitoring SpO2 and pulse rate, these are physiological measurements taken directly from the patient, not diagnostic tests on in vitro samples.
Lack of IVD Characteristics: The text does not mention any components, processes, or intended uses related to analyzing biological samples (blood, urine, tissue, etc.) outside of the body to diagnose diseases or conditions.

Therefore, the Model 731 Ventilator Series is a therapeutic medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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).

Product codes

CBK, DQA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

infant through adult patients weighing ≥5 kg

Intended User / Care Setting

hospitals, outside the hospital, during transport and in austere environments. 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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

It was demonstrated that there was no effect on either the ventilator functionality or the MRI performance at a 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 distance of slightly more than 1 meter. This test meets the acceptance criteria defined in FDA Draft Guidance "A Primer on Medical Device Interactions with Magnetic Resonance Imaging systems" Location of testing: passed Imaging sequence: passed Effect on Medical Device: passed Generation of Artifact/Noise: passed The longer breathing circuit required for MRI operation passed testing to ASTM F1100 requirements. Section 5.3 Waveform Performance: passed Section 5.4 Volume Performance: passed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K103318

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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 Required

Information	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/CQA
Quality Engineer, Impact Instrumentation, Inc.
Date this Summary was
prepared	December 28, 2010
Trade name of device	Uni-Vent® Model 731 Series Portable Critical Care Ventilators
Versions:
EMV+®
EMV+®- MRI version
Eagle IITM
Eagle IITM - MRI version
AEV®
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, extremely
durable, full-featured portable mechanical ventilators
Description of Required
Information	Information
	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 |
| Description of Required
Information | Information |
| | 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. |
| Intended Use of Device | The Intended Use is taken from the Operation Manual:
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 |
| Description of Required
Information | Information |
| Comparison Technological
Characteristics to Predicate | 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. They are not intended to
operate in explosive environments. 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) provides specific
modes consistent with pre-hospital care provider’s operating
procedures (AC, CPAP with PS and PPV).

The only difference in this Intended Use from the Predicate is
the 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 and
Operation Manual. |

Section 5 – 510(k) Summary

1

2

r

.

3

4

| Description of Required

Information	Information
Non-Clinical Performance
data	It was demonstrated that there was no effect on
either the ventilator functionality or the MRI performance at
a 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 distance
of slightly more than 1 meter. This test meets the acceptance criteria defined in
FDA Draft Guidance "A Primer on Medical Device
Interactions with Magnetic Resonance Imaging
systems" Location of testing: passed Imaging sequence: passed Effect on Medical Device: passed Generation of Artifact/Noise: passed The longer breathing circuit required for MRI
operation 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 Predicate
device (K103318).
Other Information requested	Impact Instrumentation, Inc. will provide the FDA with any
by FDA	additional required information.

·

:

.

،

.

5

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.

6

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

7

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

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).

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