SMARTVENT 201 PORTABLE VENTILATOR

K981668 · Versamed , Ltd. · CBK · Apr 7, 1999 · Anesthesiology

Device Facts

• Record ID: K981668
• Device Name: SMARTVENT 201 PORTABLE VENTILATOR
• Applicant: Versamed , Ltd.
• Product Code: CBK · Anesthesiology
• Decision Date: Apr 7, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The SmartVent™ 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 SmartVent™ 201 ventilator is suitable for intra-hospital use, home and alternate-site use, transport and energy use. The SmartVent™ 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

Portable, computer-controlled, electrically powered ventilator; provides continuous or intermittent ventilatory support. Inputs: oxygen-enriched air; power from AC, DC, or internal battery. Operation: software-controlled delivery of pressure- or volume-controlled ventilation; supports nebulized medication administration. Used in intra-hospital, home, transport, and emergency settings; operated by qualified, trained personnel under physician direction. Output: mechanical ventilation support; enables clinicians to manage respiratory status. Benefits: provides life-sustaining or supportive respiratory therapy in diverse clinical environments.

Clinical Evidence

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

Technological Characteristics

Electrically powered, computer-controlled ventilator. Power: AC, DC, or internal battery. Standards: ASTM F1100-90, ASTM F1246-91, MIL-STD-810E, ISO 10651-1, ISO 10651-2, ISO 10651-3, EN 60601-1-1, EN 60601-1-2. Modes: Assist/Control (Pressure/Volume), SIMV (Pressure/Volume), CPAP/PSV.

Indications for Use

Indicated for adult and pediatric patients weighing ≥10 kg requiring continuous or intermittent mechanical ventilation via Assist/Control, SIMV, or CPAP/PSV modes. Contraindicated for patients <10 kg.

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

• TBIRD VS & AVS Ventilators (K950484)
• Oxylog 2000 (K943531)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or other winged creature, composed of three curved lines that suggest feathers or wings.

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: K981668

Trade/Device Name: SmartVent™ 201 Portable Ventilator Regulatory Class: II (Two) Product Code: 73 CBK Dated: January 10, 1999 Received: January 14, 1999

Dear Jerome Korten:

This letter corrects our substantially equivalent letter of April 7, 1999. 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.

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

{1}------------------------------------------------

Page 2- Mr. Korten

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 toU free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

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

{2}------------------------------------------------

#### INDICATIONS FOR USE

## 510(k) Number (if known): K981668

Device Name: SmartVent™ 201 Portable Ventilator

#### Indications for Use:

The SmartVent™ 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 SmartVent™ 201 ventilator is suitable for intra-hospital use, home and alternate-site use, transport and energy use.

The SmartVent™ 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 K981668

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use

Signature

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

510(k) Numbe

{3}------------------------------------------------

4/7/99

510(k) Summary Ultramind International Ltd. SmartVent™ 201 Portable Ventilator 510(k) Number K 981668

# Submitter's Name:

A.M.E. Ltd. 14 Raul Wallenberg St. Ramat Hachayal, Tel-Aviv 69719, Israel

# Contact Person:

Shoshana Friedman 117 Ahuzah St. Ra'ananna 43373, Israel Tel: [phone] Fax: [phone]

# Trade Name:

SmartVent™ 201 Portable Ventilator (Temporary name)

## Classification Name:

Continuous Ventilator

## 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.

{4}------------------------------------------------

### Predicate Devices:

The SmartVent™ 201 Portable Ventilator is substantially equivalent to:

- · TBIRD VS & AVS Ventilators (Bird Product Co.), cleared under K950484
- · Oxylog 2000 (Dräger, Inc.), cleared under K943531.

### Performance Standards:

No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act. However, the SmartVent™ 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 60601-1-1, EN 60601-1-2.

## Indication for Use:

The SmartVent™ 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 SmartVent™ 201 ventilator is suitable for inter-hospital use, home and alternate-site use, transport and emergency use.

The SmartVent™ 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 Description:

The SmartVent™ 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

{5}------------------------------------------------

SmartVent™ 201 can use external AC or DC power supply and contains an internal battery. Its operation is controlled by the SmartVent™ 201 Software.

## Substantial Equivalence:

Based on a series of safety and performance testing including a comparative study and analysis of similarities and differences we believe that the SmartVent™ 201 is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues.