AUTOVENT 1000

K983785 · O-Two Systems Intl., Inc. · BTL · Oct 29, 1998 · Anesthesiology

Device Facts

• Record ID: K983785
• Device Name: AUTOVENT 1000
• Applicant: O-Two Systems Intl., Inc.
• Product Code: BTL · Anesthesiology
• Decision Date: Oct 29, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.

Device Story

Autovent 1000 is a pneumatically powered, time-cycled automatic resuscitator providing respiratory support to patients in respiratory arrest or distress. Device operates via compressed air or oxygen (50-90 psi); requires no batteries. Features include 12 pre-set automatic settings for tidal volume and frequency, adjusted via a rotary control; a manual ventilation button; and an over-pressure alarm (pre-set to 60 cmH2O) that vents excess volume to the atmosphere. Used by clinicians for resuscitation and transport. Output consists of controlled mechanical breaths. Device design is based on the Genesis II Adult/Child resuscitator, with modified automatic settings and a separate on/off control.

Clinical Evidence

Bench testing only. Performance was evaluated against international standard ISO 8382-1988. Testing verified that the device performed within specifications compared to the predicate device.

Technological Characteristics

Pneumatically powered (compressed air or oxygen, 50-90 psi); no batteries. Time-cycled ventilator. 12 pre-set automatic settings for tidal volume and frequency. Vertically mounted rotary control. Over-pressure alarm (60 cmH2O).

Indications for Use

Indicated for patients in respiratory or cardiac arrest requiring pulmonary resuscitation and non-breathing patients requiring short-term ventilatory support during inter- or intra-hospital transport.

Regulatory Classification

Identification

A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Predicate Devices

• Genesis® II Adult/Child (K932170)

Submission Summary (Full Text)

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# 983785

## SAFETY AND EFFECTIVNESS STATEMENT.

TRADE NAME: Autovent 1000

COMMON NAME: AUTOMATIC RESUSCITATOR

REGULATORY CLASS: II

510K # : TO BE SUPPLIED

#### LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED:

GENESIS® II Adult/Child -

#### DESCRIPTION OF THE DEVICE:

The Autovent 1000 is an automatic time cycled resuscitator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress.

The device incorporates the features of Automatic and Manual Ventilation into a control module with separate hose and patient valve

This device is identical in terms of features to the Genesis® II Adult/Child resuscitator -510K #: K932170. The range of automatic settings of the device have been extended and chosen to provide the output requirements of the latest AHA recommendations and in the removal of the demand breathing function. An automatic/manual on/off control has been added which is separate from the frequency/volume control as in the predicate device.

#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The device is a pneumatically powered, requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi.

The device is a time-cycled ventilator with a range of 12, pre-set, automatic settings in which both the tidal volume and frequency of ventilation are adjusted simultaneously by the rotation of a vertically mounted rotary control.

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A manual button is provided to enable the operator to control the patient's breathing parameters.

The patient's airway is protected by an over pressure alarm, pre-set to 60 cmHzO, which gives an audible signal of over pressure and vents the remaining tidal volume delivery for that breath to atmosphere.

#### ASSESSMENT OF PERFORMANCE DATA

The predicate device submission incorporated a significant amount of non-clinical test data to support the claim of substantial equivalence. This test data reviewed the performance of the device against international standard for these devices - ISO 8382-1988.

#### CONCLUSIONS BASED ON PERFORMANCE DATA

The testing undertaken verified that the Autovent 1000 resuscitator, when compared with the performance of the device to which substantial equivalence is claimed, performed within specification.

CONTACT PERSON: KEVIN BOWDEN, DIRECTOR OF PRODUCT TECHNOLOGY O-TWO SYSTEMS INTERNATIONAL INC. 7575 KIMBEL STREET MISSISSAUGA ONTARIO CANADA 158 1C8 TEL: [phone]

FAX: [phone] E-MAIL: [e-mail]

Doc. #:SER/ATV1000/OCT 98

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three heads, representing the three branches of government. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 1998

Mr. Kevin Bowden O-Two Systems International Inc. 7575 Kimbel Street Mississauga, Ontario Canada L5S 1C8

Re : K983785 Autovent 1000 Regulatory Class: II (two) Product Code: BTL Dated: October 19, 1998 Received: October 27, 1998

Dear Mr. Bowden:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Kevin Bowden

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1_

#### 510K Number (if known):

### Device Name: AUTOVENT 1000 RESUSCITATOR

#### Indications for Use:

- Pulmonary resuscitation during respiratory and/or cardiac arrest. []
- Short term ventilatory support for both inter and intra-hospital transport of [] non-breathing patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ V (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Mark Kramis (Optional Format 1-2-96)

(Division Sign-Off) (Division of Cardiovascular, Respiratory and Neurological Pevices 482-186 510(k) Number