Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ventilation modes and adjuncts without mentioning any AI or ML capabilities. The performance studies reference existing standards and a predicate device, not AI/ML specific validation.

Therapeutic

Yes
Explanation: The device is 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," which directly describes a therapeutic application to treat a medical condition.

Diagnostic

No

The device is a ventilator used for providing continuous positive-pressure ventilation in patients with respiratory failure; its function is therapeutic, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components and modes of operation for a physical ventilator, not just software. It mentions pressure and volume targeting, modes like AC, SIMV, and CPAP, and adjuncts like Pressure Support and NPPV, all of which are functions of a physical medical device. The performance studies also reference standards for physical devices (ASTM, IEC, ISO, Mil-Std).

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Model 731EMV+ is a ventilator. Its function is to provide mechanical ventilation to patients with respiratory issues. It directly interacts with the patient's respiratory system, not with samples taken from the patient.
Intended Use: The intended use clearly states it's for "providing continuous positive-pressure ventilation" to patients. This is a therapeutic intervention, not a diagnostic test.
Device Description: The description details modes of operation related to delivering air and managing breathing, not analyzing biological samples.
Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or any other activities typically associated with IVD devices.

Therefore, the Model 731EMV+ is a therapeutic medical device, specifically a ventilator, and does not fall under the category of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Model 731EMV+ (EMV+) is 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. It is appropriate for use in hospitals, outside the hospital, during transport and in austere environments where it may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, it may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). It is not intended to operate in explosive environments. The EMV+ is 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.

Product codes (comma separated list FDA assigned to the subject device)

CBK, DQA

Device Description

MODES OF OPERATION
The EMV+ 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 or supported using Pressure Support. (The software implementation allows for devices to be configured with and without the SIMV mode feature.)

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.

ADDITIONAL ADJUNCTS OF OPERATION
In addition to Modes of Operation, the EMV+ also provides various adjuncts that can be used to manage the patient. Two adjuncts are Pressure Support (PS) and Noninvasive Positive Pressure (NPPV). The table below shows which adjuncts can be used with which modes. It is possible to use more than one adjunct, if the mode permits.

Mode Breath Target Pressure Support (PS) Noninvasive Positive Pressure Ventilation (NPPV) AC V & P No No SIMV V & P Yes No CPAP N/A Yes Yes

Pressure Support (PS): can be used to assist spontaneous breaths in both SIMV and CPAP modes.

Noninvasive Positive Pressure (NPPV): provides flow during the expiratory phase to maintain the baseline pressure (CPAP) in spontaneously breathing patients with a leaking airway or facemask. The amount of leak compensation depends on the leak flow rate during the expiratory period and ranges from 0 to 15 liters/min and is automatically adjusted by the ventilator in order to maintain the CPAP target.

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

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)

Non-Clinical Performance data: This device meets the same performance criteria as the Predicate (K091238), specified by ASTM F1100-90, IEC 60601-1, ISO 9919:2005, Mil-Std-461F, Mil-Std-810F.
Clinical Performance: N/A. No clinical performance data is being submitted.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K091238

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 a logo for IMPACT Instrumentation Inc. The logo features the word "IMPACT" in large, bold letters, superimposed over a world map. Above the logo, there is a handwritten number, "K103318". The logo is simple and clean, with a focus on the company name and a global image.

APR - 7 2011

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

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. It also includes the completed checklist with approval signature.

| 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., CQA/ CQE
Quality Engineer
Date this
Summary was
prepared	January 4, 2011
Trade name of
device	Uni-Vent® 731 Series Model EMV+® Portable Critical Care Ventilator
Common
name	ventilator
Classification
name	Continuous Ventilator (21 CFR 868.5895, Product Codes CBK, DQA)
Legally
marketed
device –
Equivalence
Claim	This device has updated software from the Predicate EMV+ ventilator (K091238). This update provides SIMV (Synchronized Intermittent Mandatory Ventilation) and CPAP (Continuous Positive Airway Pressure) modes with ventilator support options of Pressure Support and Leak Compensation.

,

ー

1

| Description of
Required

Information	Information
Description of
the device	MODES OF OPERATION
The EMV+ 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 or supported using Pressure Support. (The software implementation allows for devices to be configured with and without the SIMV mode feature.)

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. | | | | | | | | | | | | | | | | |
| | ADDITIONAL ADJUNCTS OF OPERATION
In addition to Modes of Operation, the EMV+ also provides various adjuncts that can be used to manage the patient. Two adjuncts are Pressure Support (PS) and Noninvasive Positive Pressure (NPPV). The table below shows which adjuncts can be used with which modes. It is possible to use more than one adjunct, if the mode permits. | | | | | | | | | | | | | | | | |
| Mode Breath
Target Pressure Support
(PS) Noninvasive Positive Pressure
Ventilation (NPPV) AC V & P No No SIMV V & P Yes No CPAP N/A Yes Yes | | | | | | | | | | | | | | | | | |
| | Pressure Support (PS): can be used to assist spontaneous breaths in both SIMV and CPAP modes.

Noninvasive Positive Pressure (NPPV): provides flow during the expiratory phase to maintain the baseline pressure (CPAP) in spontaneously breathing patients with a leaking airway or facemask. The amount of leak compensation depends on the leak flow rate during the expiratory period and ranges from 0 to 15 liters/min and is automatically adjusted by the ventilator in order to maintain the CPAP target. | | | | | | | | | | | | | | | | |

·

.

·

.

2

| Description of
Required

Information	Information
Intended Use
of Device	The Intended Use is the same as the Predicate device (K091238):
"The Model 731EMV+ (EMV+) is 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. It is appropriate for use in hospitals, outside the hospital, during
transport and in austere environments where it may be exposed to rain, dust,
rough handling and extremes in temperature and humidity. With an
appropriate third-party filter in place, it may be operated in environments
where chemical and/or biological toxins are present (see External Filter Use).
It is not intended to operate in explosive environments. The EMV+ is
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. "
Comparison
Technological
Characteristics
to Predicate	The changes modify the specification of the device in the following manner:
EMV+ (K091238) Modified EMV+ Operating Mode: AC Operating Mode: AC, SIMV, CPAP with
and without Pressure support and
with and without Noninvasive Positive
Pressure Ventilation (NPPV) PEEP: 0 to 25 cm H2O PEEP: 0 to 25 cm H2O (The minimum
PEEP in CPAP-NPPV is 3 cm H20) There is no change to the product materials or biocompatibility. There is no change to the power input or battery usage. There is no change to Impact®'s intended use statement. There is no change to the devices' fundamental scientific technology. The operating principals remain the same. The modified EMV+ provides the
operator methods consistent with the standard of care for managing patients
with acute or chronic respiratory failure.

:

.

3

| Description of
Required

Information	Information
Non-Clinical
Performance
data	This device meets the same performance criteria as the Predicate (K091238).
These criteria are specified by:
	Standard Standard Title ASTM F1100-90 Ventilators Intended for use in Critical Care IEC 60601-1 Medical Electrical Equipment - Part 1, General
Requirements for Safety ISO 9919:2005 Medical electrical equipment- particular requirements
for the basic safety and essential performance of pulse
oximeter equipment for medical use Additional Environmental Standards: Mil-Std-461F Requirements for the Control of Electromagnetic
Interference Characteristics of Subsystems and
Equipment Mil-Std-810F Environmental Engineering Considerations and
Laboratory Tests
Clinical
Performance	N/A. No clinical performance data is being submitted.
Safe and
Effective as
Predicate	The device design and development process is the same as the Predicate
(K091238). It was in accordance with:
	ISO 13485 Quality Systems - Medical Devices ISO 14971 Medical Devices - Application of Risk Management to
Medical Devices
	The resulting device being submitted is as safe and effective as the Predicate
(K091238).
Other
Information
requested by
FDA	Impact Instrumentation, Inc. will provide the FDA with any additional required
information.

.

:

4

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.

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

Susan McNevin. Ph.D Quality Engineer Impact Instrumentation, Incorporated 27 Fairfield Place West Caldwell, New Jersey 07006

APR - 7 2011

Re: K103318

Trade/Device Name: Uni-Vent®) 731 Series Model EMV4® Portable Critical Care Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK and DQA Dated: March 30, 2011 Received: March 31, 2011

Dear Dr. 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 Federal Register.

5

Page 2 - Dr. 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 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 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Wh for

Anthony 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

Enclosure

6

Indications for Use

510(k) Number (if known):

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

Indications For Use:

The Model 731EMV+ (EMV+) is 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. It is appropriate for use in hospitals, outside the hospital, during transport and in austere environments where it may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, it may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). It is not intended to operate in explosive environments. The EMV+ is 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.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
$10(k) Number: 103318