IVENT 201 PORTABLE VENTILATOR

K021981 · Versamed , Ltd. · NOU · Aug 13, 2003 · Anesthesiology

Device Facts

• Record ID: K021981
• Device Name: IVENT 201 PORTABLE VENTILATOR
• Applicant: Versamed , Ltd.
• Product Code: NOU · Anesthesiology
• Decision Date: Aug 13, 2003
• Decision: SESE
• Submission Type: Abbreviated
• 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 Portable Oximeter is suitable for intrahospital use, home and alternate-site use, transport and energy use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate. The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical speqification, limits.

Device Story

iVent™ 201 is a portable, computer-controlled, electrically powered ventilator with integrated pulse oximetry; provides ventilatory support (A/C, SIMV, CPAP/PSV) and monitors SpO2/pulse rate. Input: patient respiratory signals and pulse oximetry sensor data. Operation: computer-controlled ventilation; MS-5 pulse oximeter board processes sensor inputs to output oxygen saturation, pulse rate, and waveforms via serial digital interface. Used in hospitals, home, alternate-site, and transport settings; operated by qualified, trained personnel under physician direction. Output: visual/audible monitoring data and ventilation parameters; assists clinicians in managing patient respiratory status and oxygenation. Benefits: provides life-sustaining ventilatory support and continuous physiological monitoring in diverse clinical environments.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including software validation procedures, EMC interference testing (ventilator-to-oximeter and unit-to-external-devices), and compliance with voluntary safety standards (ISO 9919, IEC 60601-1, EN 865).

Technological Characteristics

Portable, computer-controlled ventilator with integrated MS-5 pulse oximeter board. Connectivity: serial digital interface. Power: DC power with isolation from mains. Standards: ISO 9919, UL 544, IEC 60601-1, EN 865. Software: programmable electrical medical system. Sterilization: not specified.

Indications for Use

Indicated for adult and pediatric patients weighing at least 10 kg (22 lb.) requiring continuous or intermittent mechanical ventilatory support (Assist/Control, SIMV, CPAP/PSV) and non-invasive monitoring of oxygen saturation and pulse rate.

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

• Masimo SET 2000 (K990966)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2004 APR 1

Jerome Korten President and CEO Versamed Corporation 2 Blue Hill Plaza Pearl River, NY 10965

Re: K021981

Trade/Device Name: iVent™ 201 Portable Ventilator with Pulse Oximeter Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II (Two) Product Code: CBK, NOU, DQA Dated: May 12, 2003 Received: May 15, 2003

Dear Jerome Korten:

This letter corrects our substantially equivalent letter of August 13, 2003. 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 (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. Ilsting 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.

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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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

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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#### INDICATIONS FOR USE

## 510(k) Number (if known): K021981

#### Device Name: iVent™ 201 Portable Ventilator

#### 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 Portable Oximeter is suitable for intrahospital use, home and alternate-site use, transport and energy use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate.

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

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

Concurrence of CDRH, Office of Device Evaluation (Q

(ODE)

nesthesiology, General Ho ction Control, Denta

(Division Sign-Off)

510(k) Number: K021981

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K021981

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use

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## AUG 1 3 2003

## 510(k) Summary

# iVent™ 201 Portable Ventilator with Non-invasive Pulse Oximeter 510(k) Number KOZ |98 |

## Submitter's Name:

VersaMed Ltd. Hasharon I ndustrial Park, Ornat Bkdg, P.O.B. 5011, Kadima 60920, Israel

## Contact Person:

Ken Raichman VersaMed Ltd. Hasharon Industrial Park, Ornat Bkdg, P.O.B. 5011, Kadima 60920, Israel

Tel: [phone] Fax: [phone]

## Trade Name:

## iVent™ 201 Pulse Oximeter

## Classification Name:

Non-invasive Pulse Oximeter

## Classification:

The FDA has classified these devices as a class II device (product code 74 DQA) and are reviewed by the Anesthesiology, Respiratory, and Defibrillator Devices Group.

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## Predicate Devices:

The Non-invasive Pulse Oximeter for the itVent™ 201 Portable Ventilator is substantially equivalent to:

- · MASIMO CSD-1050, 510(k) Masimo Set 2000, cleared under K990966
#### Performance Standards:

No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act. However, to the best of our knowledge, the Non-invasive Pulse Oximeter, complies with the following voluntary standards:

- ISO 9919 Pulse Oximeters for Medical Use Specifications; -
- UL 544 Standard for Medical and Dental Equipment; Council Directive -93/42/EEC:
- IEC 601-1-4 Medical Electrical Equipment Programmable electrical medical systems:
- EN 865 Pulse Oximeters Particular Specifications. -

Versamed's iVent 201 with integrated Pulse Oximetry is designed to meet the FDA recognized Medical Safety standard IEC 60601-1 and the voluntary Pulse Oximetry standards ISO 9919 and EN 865.

## Acceptance Criteria and Risk Analysis:

Acceptance criteria for compliance with the standards is detailed in Section 3, part E (Compliance).

Risk Analysis is addressed in Section 5 for hardware and Section 7 for Software.

The hardware risks addressed are leakage current. SpO2 power source failure, SpO2 Alarms and EMC interference. EMC interference is considered from three points: interference of the Ventilator on the Pulse Oximeter, which is checked by Masimo; interference of the Pulse Oximeter on the Ventilator which is checked Versamed's software validation procedure; and interference of the integrated unit on external devices and vise versa, which is checked by an independent accredited testing agent.

The software risks addressed are loss of communication and out of range inputs. These are checked as part of Versamed's Software Test Procedure for validation of the software.

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## Indication for Use:

The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate of adult and pediatric patients.

## Device Description:

The Non-invasive Pulse Oximeter board, MS-5, connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interface. The iVent201 provides DC power and isolates the board from the mains power and ground.

## Substantial Equivalence:

The MASIMO MS-5 Board is considered to be substantially equivalent to its predicate device (Masimo SET 2000, cleared under K990966) and cited above without raising new safety and/or effectiveness issues.