IVENT 201 PORTABLE VENTILATOR

K011957 · Versamed , Ltd. · CBK · Jul 18, 2001 · Anesthesiology

Device Facts

• Record ID: K011957
• Device Name: IVENT 201 PORTABLE VENTILATOR
• Applicant: Versamed , Ltd.
• Product Code: CBK · Anesthesiology
• Decision Date: Jul 18, 2001
• 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 is suitable for intra-hospital use, home and alternate-site use, transport and energy use. 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 specification limits.

Device Story

iVent™ 201 is a portable, computer-controlled, electrically powered ventilator providing continuous or intermittent ventilatory support; treats various clinical conditions; delivers oxygen-enriched air; supports nebulized medication administration. Operates via internal battery or external AC/DC power. Used in intra-hospital, home, transport, and emergency settings by qualified personnel. Includes a Remote Alarm adapter connecting to hospital central alarm systems via relay circuit to signal major/medium priority alarm events. Healthcare providers monitor ventilator output and alarms to adjust therapy; device provides mechanical respiratory support to patients.

Clinical Evidence

Bench testing only. Compliance with voluntary standards including ASTM F1100-90, ASTM F1246-91, MIL-STD-810E, ISO 10651-1, ISO 10651-2, ISO 10651-3, EN 60601-1, and EN 60601-1-2.

Technological Characteristics

Portable, computer-controlled, electrically powered ventilator. Power: Internal battery, external AC/DC. Connectivity: Remote alarm relay interface. Standards: ASTM F1100-90, ASTM F1246-91, MIL-STD-810E, ISO 10651-1/2/3, EN 60601-1, EN 60601-1-2. Software-controlled operation.

Indications for Use

Indicated for adult and pediatric patients weighing ≥10 kg requiring continuous or intermittent mechanical ventilatory support via Assist/Control, SIMV, or CPAP/PSV modes. 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™ 201 Portable Ventilator (K981668)

Reference Devices

• LIFECARE Remote Alarm Unit

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: K011957

Trade/Device Name: iVent™ 201 Portable Ventilator Regulation Number: 868.5895 Regulatory Class: II (Two) Product Code: 73 CBK Dated: June 19, 2001 Received: June 22, 2001

Dear Jerome Korten:

This letter corrects our substantially equivalent letter of July 18, 2001. 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, 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.

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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 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 yours.

Clus

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): K011957

Device Name: iVent™ 201 Portable Ventilator (formally SmartVent 201)

#### 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 is suitable for intra-hospital use, home and alternate-site use, transport and energy use.

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 specification limits.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K011957

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use

fth

510(k) Number

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K011957

# JUL 1 8 2001

510(k) Summary iVent™ 201 Portable Ventilator with Remote Alarm Adapter 510(k) Number K011957

# 510(K) SUMMARY

A 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990. This 510(k) Summary meets the requirements identified in 21 C.F.R. §807.92.

#### Submitter's Name:

VersaMed Ltd .. Atidim Industrial Park, Bldg.2 P.O.B. 58135 Tel-Aviv 61580, Israel

Contact Person:

Ken Raichman VersaMed Ltd .. Atidim Industrial Park, Bldg.2 P.O.B. 58135 Tel-Aviv 61580, Israel Tel: [phone] Fax: [phone] E-mail: [e-mail]

Trade Name:

iVent™ 201 Portable Ventilator

Classification Name:

Continuous Ventilator

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## Classification:

The FDA has classified these devices as a class II device (product code 73 CBK) and are reviewed by the Anesthesiology, Respiratory, and Defibrillator Devices Group.

#### Predicate Devices:

The iVentil 201 Portable Ventilator with Remote Alarm adapter is substantially equivalent to the iVett™ 201 Portable Ventilator K981668

#### Performance Standards:

No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act. However, the Went™ 201 Portable Ventilator complies with the following voluntary standards: ASTM F1100-90, ASTM F1246-91, MIL-STD-810E, ISO 10651-1, ISO 10651-2, ISO 10651-3, EN 60601-1, EN 60601-1-2.

#### Indication for Use:

The iVentM 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 is suitable for inter-hospital use, home and alternatesite use, transport and emergency use.

The iVentilator 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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Intended Use of the Alarm Adapter: The Remote Alarm adapter is a device designed to connect the iVent 201 to a Central or Remote Alarm unit, such as a LIFECARE Remote Alarm Unit or similar device, for registration of the iVent 201 alarm output by a Central or Remote Alarm System.

## Device Description:

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. The ventilator is designed to treat a variety of clinical conditions. It can deliver oxygen-enriched air and may be used to administer nebulized medications by inhalation. The iVent™ 201 can use external AC or DC power supply and contains an internal battery. Its operation is controlled by the iVent™ 201 Software.

Description of Remote Alarm Adapter: The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central or Remote Alarm unit of the Hospital. The Adapter consists of a relay circuit, which meets the activating requirements of the Central or Remote Alarm unit. The iVent 201 with Remote Alarm Adapter will activate the Central or Remote Alarm unit for any major or medium priority alarm event that occurs on the iVent201.

#### Substantial Equivalence:

Based on a series of safety and performance testing we believe that the iVent™ 201 with Remote Alarm Adapter is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues.