IVENT 2001 MRI CONDITIONAL

K073694 · Versamed Medical Systems, Inc. · CBK · May 30, 2008 · Anesthesiology

Device Facts

• Record ID: K073694
• Device Name: IVENT 2001 MRI CONDITIONAL
• Applicant: Versamed Medical Systems, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: May 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The iVent™ 201 MR Conditional is a portable, computer controlled, electrically powered intensive care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, who require invasive or non-invasive assistance via the following general modes of ventilatory support, as prescribed by an attending physician: - Assist/Control (Pressure Controlled or Volume Controlled) - SIMV (Pressure Controlled or Volume Controlled) - CPAP/PSV The iVent™ 201 MR Conditional ventilator is suitable for use in the ICU and all other hospital areas, including Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field, in all hospital-type facilities, alternate care sites, transport, emergency and in the home environment. The iVent™ 201 MR Conditional ventilator is MR Conditional. The optional non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate and is suitable for use in all above mentioned areas, excluding MR environments. The iVent™ 201 MR Conditional ventilator is a restricted medical device intended for use by qualified, trained personnel under the direct supervision of a physician.

Device Story

Portable, microprocessor-controlled ventilator; turbine-powered air source; rechargeable battery. Provides continuous/intermittent ventilatory support. Inputs: user-defined settings via control knob/push buttons. Outputs: real-time ventilation monitoring, pressure/flow waveforms, loops, trends. Used in ICU, hospital, transport, home; operated by trained personnel under physician supervision. MR Conditional (up to 3.0 Tesla). Optional non-invasive pulse oximeter for SpO2/pulse rate. Clinical benefit: provides mechanical ventilation in diverse settings, including MR environments, without reliance on wall air/power.

Clinical Evidence

Bench testing only. Device performance in 1.5 and 3.0 Tesla MR environments was validated according to ASTM F2052-06-e1 standards.

Technological Characteristics

Microprocessor-controlled, turbine-powered ventilator. Features internal rechargeable battery. MR Conditional design tested per ASTM F2052-06-e1. Includes optional non-invasive pulse oximeter. User interface via turn-and-click knob and push buttons. Supports pressure/volume controlled modes, SIMV, and CPAP/PSV.

Indications for Use

Indicated for adult and pediatric patients requiring invasive or non-invasive mechanical ventilatory support (Assist/Control, SIMV, CPAP/PSV). Suitable for ICU, hospital, transport, emergency, and home environments. MR Conditional up to 3.0 Tesla. Optional pulse oximeter for oxygen saturation/pulse rate monitoring (excluding MR environments). Restricted to use by trained personnel under physician supervision.

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.

Predicate Devices

• VersaMed iVent™ 201 (K061627)
• Maquet SERVO-I (K063404)

Submission Summary (Full Text)

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K073694
page 1 of 3

#### 510(k) Summary Non-Confidential Summary of Safety and Effectiveness Page 1 of 3 29-May-08

| Versalvied Medical Systems<br>2 Blue Hill Plaza, Bldg. 2<br>Pearl River, NY 10965 | Tel - 845-770-2840 x 101<br>Fax - 845-770-2850 | MAY 30 200 |
|-----------------------------------------------------------------------------------|------------------------------------------------|------------|
|-----------------------------------------------------------------------------------|------------------------------------------------|------------|

S. Deler - VP Quality Assurance and Regulatory Affairs

| Proprietary or Trade Name: | VersaMed iVent™ 201 MR Conditional |
|----------------------------|-----------------------------------------------------------|
| Common/Usual Name: | Ventilator, continuous, facility use |
| Classification Name: | Ventilator, continuous, facility use |
| Device: | iVent™ 201 MR Conditional |
| Predicate Devices: | VersaMed iVent™ 201 - K061627<br>Maquet SERVO-I - K063404 |

#### Device Description:

The iVent™ 201 MR Conditional is a compact, portable, fully featured, microprocessorcontrolled ventilator offering the versatility and capability of larger and costlier ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn and click control knob, quick choice push buttons, and a bright, well-organized, easy-to-read screen allow 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.

Optional equipment:

- Non-invasive pulse oximeter (not to be used in MR environments) .
- . Remote Alarm Adapter

Testing has been performed according to ASTM F2052-06-e1 in 1.5 and 3.0 Tesla environments.

# Indications for Use:

The iVen™ 201 MR Conditional is a portable, computer controlled, electrically powered intensive care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, who require invasive or non-invasive assistance via the following general modes of ventilatory support, as prescribed by an attending physician:

- Assist/Control (Pressure Controlled or Volume Controlled) .
- SIMV (Pressure Controlled or Volume Controlled) .
- CPAP/PSV .

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# 510(k) Summary Non-Confidential Summary of Safety and Effectiveness Page 2 of 3 29-May-08

The iVent™ 201 MR Conditional ventilator is suitable for use in the ICU and all other hospital areas, including Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field, in all hospital-type facilities, alternate care sites, transport, emergency and in the home environment. The iVent™ 201 MR Conditional ventilator is MR Conditional.

The optional non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate and is suitable for use in all above mentioned areas, excluding MR environments.

The iVent™ 201 MR Conditional ventilator is a restricted medical device intended for use by qualified, trained personnel under the direct supervision of a physician.

| Patient Population: | Adult and pediatric | |
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| Environment of Use: | ICU and all other hospital areas, including Magnetic Resonance<br>(MR) environment, not to exceed a 3.0 Tesla static magnetic field, in<br>all hospital-type facilities, alternate care sites, transport,<br>emergency and in the home environment. | |
| Features | Predicates | Proposed Device<br>VersaMed iVentTM 201 MR<br>Conditional |
| Indications for use<br>Already cleared | The iVentTM 201 is a portable, computer controlled, electrically powered intensive care<br>ventilator intended to provide continuous or intermittent ventilatory support for the care of<br>individuals who require mechanical ventilation. Specifically, the ventilator is applicable for<br>use with adult through pediatric patients, who require invasive or non-invasive assistance<br>via the following general modes of ventilatory support, as prescribed by an attending<br>physician:<br>Assist/Control (Pressure Controlled or Volume Controlled) SIMV (Pressure Controlled or Volume Controlled) CPAP/PSV The iVentTM 201 ventilator (with or without the non-invasive Pulse Oximeter option) is<br>suitable for use in the ICU and all other hospital areas, in all hospital-type facilities,<br>alternate care sites, transport, emergency and in the home environment. The non-invasive<br>Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate<br>and is suitable for use in all above mentioned areas, excluding MR environments. | Same plus MR environment<br>(MR Conditional) |
| Expanded Indications<br>for Use | The iVentTM 201 ventilator is a restricted medical device intended for use by qualified,<br>trained personnel under the direct supervision of a physician.<br>VersaMed - K061627<br>Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.<br>Maquet - K063404 | Magnetic Resonance (MR)<br>environment, not to exceed a 3.0<br>Tesla static magnetic field. MR<br>Conditional |
| Environment of Use | MR environments - Not to exceed 3.0 Tesla<br>K063404 - Maquet SERVO-i | Same<br>Not to exceed 3.0 Tesla |
| Patient Population | Adult and pediatrics - K061627 | Same |
| Contraindications | None | Same |
| MR Testing | ASTM F2502 not known (K063404) | ASTM F2502-06-el |

# Differences Between Other Legally Marketed Predicate Devices

The VersaMed iVent™ 201 MR Conditional ventilator system is viewed as substantially equivalent to the following predicate devices – VersaMed iVent™ 201 - K061627 and Maquet SERVO-i - K063404.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is black and white, and the text is in a simple sans-serif font. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 3 0 2008

VersaMed Medical Systems, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, FL 34134-2958

Re: K073694

Trade/Device Name: iVent™ 201 MR Conditional Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 15, 2008 Received: May 19, 2008

Dear Mr. Dryden:

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. Dryden

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely vours.

Clues

Chiu Lin, Ph.D. 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 Statement

Page 1 of 1

| 510(k) Number: | K073694 (To be assigned) |
|----------------|---------------------------|
| Device Name: | iVent™ 201 MR Conditional |

#### Indications for Use:

The iVent™ 201 MR Conditional is a portable, computer controlled, electrically powered intensive care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, who require invasive or non-invasive assistance via the following general modes of ventilatory support, as prescribed by an attending physician:

- Assist/Control (Pressure Controlled or Volume Controlled) O
- SIMV (Pressure Controlled or Volume Controlled) o
- CPAP/PSV o

The iVent™ 201 MR Conditional ventilator is suitable for use in the ICU and all other hospital areas, including Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field, in all hospital-type facilities, alternate care sites, transport, emergency and in the home environment. The iVent™ 201 MR Conditional ventilator is MR Conditional.

The optional non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate and is suitable for use in all above mentioned areas, excluding MR environments.

The iVent™ 201 MR Conditional ventilator is a restricted medical device intended for use by qualified, trained personnel under the direct supervision of a physician.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mi Thul

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

510(k) Number: Ko73694