MODIFICATION TO IVENT 101

K092135 · Versamed Medical Systems , Ltd. · CBK · Nov 23, 2009 · Anesthesiology

Device Facts

• Record ID: K092135
• Device Name: MODIFICATION TO IVENT 101
• Applicant: Versamed Medical Systems , Ltd.
• Product Code: CBK · Anesthesiology
• Decision Date: Nov 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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. 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 Story

iVent101 is a compact, portable, microprocessor-controlled ventilator; provides continuous or intermittent ventilatory support. Inputs: internal flow and pressure sensors. Operation: turbine-powered air source; rechargeable internal battery; user-controlled via LCD touch-screen. Outputs: real-time clinical data (Tidal Volume, Rate, PIP, FiO2, Peak Flow, Inspiratory Time, I:E, Minute Volume); optional waveform/diagnostic displays (pressure/flow waveforms, loops, trends). Used in institutions, home, and portable settings by clinicians or patients. Supports single or dual limb patient circuits. Benefits: provides mechanical ventilation freedom from wall air/power; enables real-time monitoring and adjustable alarm settings for patient safety.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on device description and technological characteristics.

Technological Characteristics

Microprocessor-controlled, turbine-powered ventilator. Features internal flow and pressure sensors. LCD touch-screen interface. Supports single or dual limb patient circuits. Powered by AC/DC or integrated rechargeable battery. Software-based control of ventilation modalities (Assist/Control, SIMV, PRVC, CPAP, Adaptive Bi-Level).

Indications for Use

Indicated for infants (from 5 kg) through adult patients requiring invasive or non-invasive mechanical ventilatory support. Suitable for use in institutional, home, and portable settings.

Regulatory Classification

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.

Submission Summary (Full Text)

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K092135

NOV 2 3 2009

# Premarket Notification 510(k) Summary As required by section 807.92 The iVent101 Non-Confidential Summary of Safety and Effectiveness

Sales Mary of Safety and Effectiveness of Safety and Effectiveness of Sales

## Submitter's Name:

GE HealthCare C/O Datex-Ohmeda PO Box 7550 Madison, WI 53707 USA Tel: [phone] Fax: [phone]

# Contact Person:

Ms. Adrienne Lenz, RAC Mr. Jim Raskob

## Trade Name:

The iVent101

#### Classification:

| Name: | Continuous ventilator |
|-----------------------|-----------------------|
| Product code: | 73 CBK, 73 NOU |
| Classification panel: | 868-5895 |
| Class: | 2 |
| Panel: | Anesthesiology |

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#### 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, FiG2, 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, allowing 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 iVentiol 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.

#### Intended use:

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. 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.

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Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES * USA" around the top half of the circle. The right side of the seal contains a stylized image of an eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

VersaMed Medicatl Systems, Limited C/O Adrienne Lenz, RAC Director Datex-Ohmeda, Incorporated P.O. Box 7550 Madision, Wisconsin 53707-7550

Re: K092135

Trade/Device Name: The iVent101 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK, NOU Dated: October 28, 2009 Received: October 30, 2009

Dear Ms. Lenz:

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 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.

# NOV 2 3 2009

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Page 2- Ms. Lenz

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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

for

Susan Runner, D.D.S., M.A. 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): | K091335 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: The iVent101

## Indications for Use:

The iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of invividuals who require mechanical ventilation. 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.

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)

L. Schullther

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

510(k) Number: k092135

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