The iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for infants from 5 kg through adult patients who require invasive or non-invasive support via the following ventilatory modalities:

Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated . Volume Control (PRVC)
CPAP with Pressure Support .
Adaptive Bi-Level for either NIV or invasive ventilation. ●
The iVent101 ventilator is suitable for use in institution, home and portable settings.

Device Description

The iVent101 is a compact, portable, microprocessor-controlled ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation .A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets . Internal flow and pressure are read through flow/pressure sensors. Clinical data [Tidal Volume, Rate, PIP, FiO2, Peak Flow, Inspiratory Time, I:E Minute Volume] are presented on machine screen.
All the operator actions are performed on the LCD touch-screen on the front panel, allows, rapid control and continuous real-time monitoring of patient ventilation. · Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes.
The iVent101 can use external AC or DC power supply and contains an integrated battery.
The iVention is equipped with two configurations, which differs in the patient circuit type that connects to the machine. One configuration is to be used with a standard one limb patient circuit, and the second configuration is to be used with a standard dual limb patient circuit. The two configurations are incorporating the same infrastructure and can be easily replaced by the user.
The iVent101 is capable of providing the following types of ventilatory support:

Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated . Volume Control (PRVC)
CPAP with Pressure Support
Adaptive Bi-Level for either NIV or invasive ventilation. .

AI/ML Overview

The iVent101 is a continuous ventilator intended to provide continuous or intermittent ventilatory support for patients requiring mechanical ventilation, including infants (from 5 kg) through adults. It supports various ventilatory modalities and can be used in institutional, home, and portable settings.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act." Therefore, there are no specific, quantitative acceptance criteria provided in the document in terms of performance metrics (like accuracy, sensitivity, or specificity for a diagnostic device, or specific flow/pressure tolerances for a ventilator). Instead, the device's conformance to established voluntary standards is used as evidence of its safety and effectiveness.

Acceptance Criteria (Voluntary Standards met)	Reported Device Performance
ASTM F 1100-90 (Critical Care Ventilators)	Complies with standard
ASTM F 1246-91 (Home Care Ventilators)	Complies with standard
Draft Reviewer guidance for ventilators (July 1995)	Complies with standard
ISO 10651-2 (Home Care Ventilators)	Complies with standard
ISO 10651-6 (Usability of Medical Electrical Equipment)	Complies with standard
IEC 60601-1 (General Safety for Medical Electrical Equipment)	Complies with standard
IEC 60601-2-12 (Safety of Lung Ventilators)	Complies with standard
IEC 60601-1-2 (Electromagnetic Compatibility)	Complies with standard
IEC 60601-1-8 (Alarm Systems)	Complies with standard
UL 60601-1 (General Safety for Medical Electrical Equipment)	Complies with standard

The overall reported device performance conclusion is: "The iVent101 performs as intended according to its performance specification. The iVent101 is substantially equivalent to the predicate devices."

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

No human or animal test set data is described or used. The evaluation relies on compliance with engineering and safety standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth was established by experts for a test set in the context of clinical performance data.
Adjudication method for the test set:

Not applicable.
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:

Not applicable. This is a medical device (ventilator), not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device (ventilator), not an algorithm for diagnosis or interpretation.
The type of ground truth used:

Not applicable. Clinical ground truth (e.g., pathology, outcomes data) was not used as there were no clinical studies. The "ground truth" for the device's performance in this context is its adherence to the specified technical requirements and voluntary industry standards.
The sample size for the training set:

Not applicable. This is a medical device (ventilator), not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" demonstrating the device meets its "acceptance criteria" (which are defined by adherence to voluntary standards and substantial equivalence to predicate devices) is a series of non-clinical performance tests.

The document states: "Due to comprehensive scientific literatures, performance tests per ASTM 1246-91, ASTM 1100-90, IEC and ISO standards, VersaMed believes that clinical studies are not required to determine the safety and efficacy of the device."

Therefore, the proof consists of:

Engineering and Performance Testing: The device underwent internal performance tests to ensure it met its own engineering specifications and complied with the listed voluntary international and national standards (ASTM, ISO, IEC, UL). These tests would verify aspects like air delivery accuracy, pressure control, alarm functionality, electrical safety, electromagnetic compatibility, and usability, all as specified in those standards.
Substantial Equivalence Argument: The core of the submission relies on demonstrating substantial equivalence to four predicate devices (LTV1200, iVent201, PLV Continuum II, Legendair XL2). This argument posits that because the iVent101 has the same intended use, environment for use, patient population, and employs the same technology (internal compressor, software algorithms for breath delivery) as legally marketed, safe, and effective devices, it is also safe and effective. No specific data from the predicate devices is provided beyond their identification.

Summary

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K081845
page 1 of 4

VersaMed Medical Systems Inc. 2 Blue Hill Plaza Bldg. 2 Pearl River, NY 10965 USA

MAR 1 6 2019

Non-Confidential Summary of Safety and Effectiveness

The Summary of Safety and Effectiveness

Submitter's Name:

VersaMed Medical System Inc.

Contact Person:

Mr. Jerry Korten Tel: 845 770 8240 Fax: 845 770 8250

Owner / Operator:

General Electric Co. 3135 Easton Turnpike Fairfield, CT 06828

Owner / Operator Number:

9912004

Trade Name:

The iVent101

Classification:

Name: Product code: Classification panel: Class: 2 Panel:

Continuous ventilator 73 CBK, 73 NOU 868-5895 Anesthesiology

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Device Description:

All the operator actions are performed on the LCD touch-screen on the front panel, allows, rapid control and continuous real-time monitoring of patient ventilation. · Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes.

The iVent101 can use external AC or DC power supply and contains an integrated battery.

The iVention is equipped with two configurations, which differs in the patient circuit type that connects to the machine. One configuration is to be used with a standard one limb patient circuit, and the second configuration is to be used with a standard dual limb patient circuit. The two configurations are incorporating the same infrastructure and can be easily replaced by the user.

The iVent101 is capable of providing the following types of ventilatory support:

Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated . Volume Control (PRVC)
� CPAP with Pressure Support
Adaptive Bi-Level for either NIV or invasive ventilation. .

Intended use:

The intended use of the iVent101 ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes infants from 5 kg through adult patients.

The iVent101ventilator is suitable for use in institution, home and portable settings

{2}------------------------------------------------

Predicate Devices:

The iVent101 is substantially equivalent to:

· LTV1200 cleared under K060647 ·
· iVent201 cleared under K061627
· PLV Continuum II cleared under K034032
· Legendair XL2 cleared under K070899

Substantial Equivalence and Technological Characteristics:

The iVent101 is viewed as substantially equivalent to the following predicate devices;

· LTV1200 cleared under K060647
· iVent201 cleared under K061627
· PLV Continuum II cleared under K034032
· Legendair XL2 cleared under K070899

The iVent101 is viewed as substantially equivalent to the predicate device since them:

Have the same intended use:
Have the same environment for use:
Have the same patient populution :
Employ a same technology [utilized an internal compressor to generate compressed air and breathe delivery is controlled by software algorithms as the predicates]

Performance Standards:

No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act. However, the iVent101 complies with the following voluntary standards:

ASTM F 1100-90, "Standard specification for ventilators intended for use in critical care ventilators".

ASTM F 1246-91," Standard specification for ventilators intended for use in home care ventilators".

Draft Reviewer guidance for ventilators , July 1995

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ISO 10651-2," Lung Ventilators for medical use - Particular requirements for Home Care Ventilators", Second Edition (2004)

ISO 10651-6," Medical Electrical Equipment" part 1-6: General requirements for safety-collateral standard: Usability, First Edition (2004)

IEC 60601-1," Medical Electrical Equipment - General requirements for safety", Second edition (1990), #2 (1995), 13(1996)

IEC 60601-2-12," Medical electrical equipment. Part 2: Particular requirements for the safety of lung ventilators for medical use", Second Edition(2001).

IEC 60601-1-2, "Electromagnetic Compatibility (EMC)", 2005

IEC 60601-1-8, "General requirements for safety - collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems", First Edition (2003).

UL 60601-1," Medical Electrical Equipment, Part1: General Requirements for safety " , first edition (2003) .

Summary of clinical performance:

The safety and efficacy of mechanical ventilation is well established in scientific research and literature. Due to comprehensive scientific literatures, performance tests per ASTM 1246-91, ASTM 1100-90, IEC and ISO standards, VersaMed believes that clinical studies are not required to determine the safety and efficacy of the device.

Conclusions from Non-clinical Tests:

The iVent101 performs as intended according to its performance specification. The iVent101 is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized symbol that resembles an abstract representation of a human figure.

MAR 1 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jerry Korten CEO VersaMed Medical Systems, Incorporated 2 Blue Hill Plaza Building 2, 300 Floor Pearl River. New York 10965

Re: K081845

Trade/Device Name: The iVent101 Regulation Number: 21 CFR 868,5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK , NOU Dated: March 9, 2009 Received: March 12, 2009

Dear Mr. Korten:

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.

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

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Page 2 - Mr. Korten

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Saiste y. Michien Dnis

Ginette Y. Michaud. M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

The iVent101

1681843

Indications for Use:

Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated . Volume Control (PRVC)
CPAP with Pressure Support .
Adaptive Bi-Level for either NIV or invasive ventilation. ●

The iVent101 ventilator is suitable for use in institution, home and portable settings.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruma

(Division Sign-Off)___ Division of Anesthesiology, General Hospital, Infection Control, Dental Devices-

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Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).