MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR

K052554 · Versamed Medical Systems, Inc. · CBK · Sep 23, 2005 · Anesthesiology

Device Facts

• Record ID: K052554
• Device Name: MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR
• Applicant: Versamed Medical Systems, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Sep 23, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require 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 ventilator with Non-invasive Pulse Oximeter is suitable for interahospital use, home and alternate-site use, transport and emergency use. The Noninvasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate. The i™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.

Device Story

iVent 201 is a portable, microprocessor-controlled ventilator; turbine-powered air source; rechargeable battery. Inputs: patient respiratory signals; pulse oximetry data via internal board. Operation: turn-and-click control knob; pushbuttons; real-time screen monitoring. Outputs: ventilatory support; pressure/flow waveforms; loops; trends; logged totals; pulse rate; oxygen saturation. Used in intra-hospital, home, transport, and emergency settings by trained personnel. Output informs clinical decision-making regarding ventilatory support adjustments. Benefits: provides portable, full-featured ventilation comparable to larger units; enables continuous monitoring.

Clinical Evidence

Bench testing only. Device complies with ASTM F 1100-90, ASTM F 1246-91, MIL-STD-810E, ISO 10651-1/2/3, IEC 60601-1, IEC 60601-2-12, IEC 60601-1-2, CAN/CSA-C22.2 No.601.1, and EN 865. Testing confirms device meets specifications.

Technological Characteristics

Microprocessor-controlled ventilator; turbine-powered; rechargeable internal battery. Connectivity: serial digital interface for pulse oximeter; remote alarm adapter relay circuit. Standards: ASTM F 1100-90, ASTM F 1246-91, MIL-STD-810E, ISO 10651-1/2/3, IEC 60601-1/2-12/1-2, CAN/CSA-C22.2 No.601.1, EN 865. Features: turn-and-click control, waveform/diagnostic software package.

Indications for Use

Indicated for adult and pediatric patients weighing ≥10 kg requiring mechanical ventilation (Assist/Control, SIMV, CPAP/PSV). Includes non-invasive pulse oximetry monitoring. Restricted to use by qualified personnel under physician direction.

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

• iVent™ (K042468)
• TBIRD VELA (K032451)

Submission Summary (Full Text)

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Premarket Notification 510(k) Section 3 -- Administrative requirements

SEP 2 3 2005

i Vent 201

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

K052554

Non-Confidential Summary of Safety and Effectiveness

# Summary of Safety and Effectiveness

Submitter's Name:

VersaMed Medical System Inc.

#### Contact Person:

Mr. Jerry Korten Tel: [phone] Fax: [phone]

Trade Name:

iVent™ 201 Portable Ventilator

# Classification Name:

Anesthesiology

#### Classification:

CBK, DQA, NOU.

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# Predicate Devices:

The iVent™ 201 Portable Ventilator is substantially equivalent to:

- · iVent™ cleared under K042468
- · TBIRD VELA cleared under K032451

### Performance Standards:

No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act. However, the iVent™ 201 portable ventilator complies with the following voluntary standards: ASTM F 1100-90 ASTM F 1246-91 MIL-STD-810E ISO 10651-1/2/3 IEC 60601-1 IEC 60601-2-12 IEC 60601-1-2 CAN/CSA-C22.2 No.601.1 180 EN 865 (section 6)

The non clinical testing results provides assurance that the device meets it's specifications and is safe and effective for its intended use.

# Device Description:

The iVent201 is a compact, portable, fully featured, microprocessor-controlled 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 pushbuttons, 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.

Description of Non- invasive Pulse Oximeter: The Non-invasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and

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other output information via a serial digital interface. The iVent 201 systems provide isolated DC power.

The Non-invasive Pulse Oximeter board is mounted internal to the iVent 201 unit and is part of the electronic configuration of the unit. Connection of the Pulse Oximeter accessories is via a connector on the back panel of the unit.

Description of remote Alarm Adaptor: The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central Remote Alarm unit of the Hospital. The adapter consists of a relay circuit, which meets activating requirements of the Central Remote Alarm unit.The iVent 201 Ventilator with Remote Alarm Adapter will activate the Central Remote Alarm unit for any major or medium priority alarm event that occurs on the unit.

# Intended use:

The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require 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 ventilator with Non-invasive Pulse Oximeter is suitable for interahospital use, home and alternate-site use, transport and emergency use. The Noninvasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate.

The i™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.

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# Substantial Equivalence:

The iVent™ 201 portable ventilator is viewed as substantially equivalent to the following predicate devices:

- · iVent™ cleared under K042468
- TBIRD VELA cleared under K032451

The iVent 201 -portable ventilator in this submittal is the same device as the cleared device under K042468 except for the modifications associated with this submittal:

- The new low tidal volume setting is 50ml while it was 100ml on the cleared device.

- The new maximum respiratory rate setting is 80BPM while 50BPM is the highest limit on the cleared device.

- The new maximum Inspiratory pressure range is 80cmH2O, while 60 cmH2O is the highest limit on the cleared device.

- The new maximum PEEP setting is 40 cmH2O, while 20 cmH2O is the highest setting on the cleared device.

-The new maximum setting for Pressure Support Ventilation (PSV) is 60 cmH2O, while 30 cmH2O is the highest setting on the cleared device.

-The new I:E ratio of 1:4 to 2:1 now covers a inspiratory time range of 0.2-3 seconds, while the previous I:E ratio of 1:4 to 2:1 covered an inspiratory time range of 0.3-3 seconds on the cleared device.

-The new trigger sensitivity is 1-20 lpm or 0.5 to 20 cmH2O, while a trigger sensitivity of 2-9 lpm or -1 to -8 cmH2O was on the predicate device.

There are no significant differences between the iVent™ 201 portable ventilator in this submittal and the predicate device under K042468 that affect the safety or effectiveness of the intended device as compared to the predicate devices. The iVent 201 portable ventilator is viewed as substantially equivalent to the predicate device since they:

#### 1. Have the same intended use:

1.1 The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

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- 2. Have the same environment for use:
2.1 intra-hospital use, home and alternate-site use. transport and emergency use.

- 3. Have the same patient populution :
3.1 this system can be used with adult and pediatric patients weighing at least 10 kg (22 lb.).

- 4. Are similar in design
- 5. Employ the same technology
- 6. Are made of identical materials

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle symbol.

#### Public Health Service

SEP 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jerry Korten CEO and President VersaMed Medical Systems, Inc. 2 Blue Hill Plaza Bldg. 2, 300 Floor Pearl River, New York 10965

Re: K052554

Trade/Device Name: iVENT 201 PORTABLE VENTILATOR Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: II Product Code: CBK Dated: September 12, 2005 Received: September 16, 2005

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 approvisions 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 (1 mr ), it e 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.

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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 and insuits (s 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 yours,

Chiu Lin, Ph.D.

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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Premarket Notification 510(k) Section 3 - Administrative requirements

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

iVent™ 201 Portable Ventilator

K052554

#### Indications for Use:

The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require 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 ventilator with Non-invasive Pulse Oximeter is suitable for intra-hospital use, home and alternate-site use, transport and emergency use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate.

The iVeur™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.

Prescription Use × (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)

Ona Sefion

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

K052554

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

510(k) Number ..