CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV

K991195 · O-Two Systems Intl., Inc. · BTL · Apr 22, 1999 · Anesthesiology

Device Facts

• Record ID: K991195
• Device Name: CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
• Applicant: O-Two Systems Intl., Inc.
• Product Code: BTL · Anesthesiology
• Decision Date: Apr 22, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

CAREvent series (BLS, BLS*, ALS, ALS*, ATV) are pneumatically powered, time-cycled resuscitators/ventilators. Inputs: compressed air or oxygen (50-90 psi). Operation: manual or automatic ventilation modes; some models include demand breathing (ATV, ALS*). Mechanism: rotary controls adjust tidal volume and frequency; manual override allows operator-controlled flowrates. Outputs: respiratory support delivered via patient valve. Used in emergency respiratory care settings by trained personnel. Benefits: provides respiratory support for patients in arrest or distress; protects airway via over-pressure alarm (venting excess volume to atmosphere).

Clinical Evidence

Bench testing only. Performance verified against ISO 8382-1988 standards for automatic resuscitators. Testing confirmed devices perform within specifications compared to predicate devices.

Technological Characteristics

Pneumatically powered; no batteries/electrical power required. Operates on compressed air/oxygen (50-90 psi). Time-cycled ventilation. Features rotary controls for tidal volume/frequency/minute volume. Includes over-pressure relief (20-60 cmH2O) and audible alarms. Modular design with control module, hose, and patient valve.

Indications for Use

Indicated for patients in respiratory or cardiac arrest requiring pulmonary resuscitation or 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® BLS (K983643)
• GENESIS® II A/C (K932170)
• Autovent 1000 (K983785)
• Autovent 1500 (K983857)

Submission Summary (Full Text)

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4/22/99

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TRADE NAME: CAREvent BLS Resuscitator

COMMON NAME: AUTOMATIC RESUSCITATOR

REGULATORY CLASS: II

510K # : TO BE SUPPLIED

LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED:

GENESIS® BLS -510K #: K983643

#### DESCRIPTION OF THE DEVICE:

The CAREvent BLS automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress.

The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® II BLS device. The device is totally pneumatic in its function therefore 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.

## SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

This device is designed to meet the ever-changing needs of the emergency respiratory care market. This device is similar in terms of features to the GENESIS® BLS - 510K #: K983643 except in the addition of an extra automatic setting and the change of the manual ventilation mode to manual override of the automatic cycling, allowing the selection of a range of flowrates for manual ventilation in line with the size of patient being resuscitated.

#### ASSESSMENT OF PERFORMANCE DATA

The 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 both the current domestic and international standards for these devices.

In particular, references were made to ISO 8382-1988.

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### CONCLUSIONS BASED ON PERFORMANCE DATA

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

#### CONTACT PERSON: KEVIN BOWDEN, GENERAL MANAGER O-TWO SYSTEMS INTERNATIONAL INC. 7575 KIMBEL STREET MISSISSAUGA ONTARIO CANADA 155 1C8

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

> Doc. #: SER/BLS/Mar 99

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TRADE NAME: CAREvent ALS Resuscitator

COMMON NAME: AUTOMATIC RESUSCITATOR

REGULATORY CLASS: II

510K # : TO BE SUPPLIED

LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED:

GENESIS® II A/C - - - -510K #: K932170

#### DESCRIPTION OF THE DEVICE:

The CAREvent ALS automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress.

The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® " Adult/Child device. The device is totally pneumatic in its function therefore 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.

#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

This device is designed to meet the ever-changing needs of the emergency respiratory care market. This device is similar in terms of features to the Genesis® II product -510K # K932170 except in the addition of an extra automatic setting and the change of the manual ventilation mode to manual override of the automatic cycling, allowing the selection of a range of flowrates for manual ventilation in line with the size of patient being resuscitated.

## ASSESSMENT OF PERFORMANCE DATA

The 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 both the current domestic and international standards for these devices.

In particular, references were made to ISO 8382-1988.

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## CONCLUSIONS BASED ON PERFORMANCE DATA

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

#### CONTACT PERSON: KEVIN BOWDEN, GENERAL MANAGER O-TWO SYSTEMS INTERNATIONAL INC. 7575 KIMBEL STREET MISSISSAUGA ONTARIO CANADA L5S 1C8

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

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CAREvent BLS* TRADE NAME:

COMMON NAME: AUTOMATIC RESUSCITATOR

REGULATORY CLASS: II

TO BE SUPPLIED 510K # :

LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED:

510K #: K983785 Autovent 1000

## DESCRIPTION OF THE DEVICE:

The CAREvent BLS* is an automatic time cvcled 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 Autovent 1000 - 510K #: K983785 with the addition of the ability to select the manual flowrate equivalent to that selected on the tidal volume/frequency control.

## 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. A manual button is provided to enable the operator to control the patient's breathing parameters with a flowrate equivalent to that selected on the tidal volume/frequency control.

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

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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 CAREvent BLS* resuscitator, when compared with the performance of the device to which substantial equivalence is claimed, performed within specification.

### CONTACT PERSON: KEVIN BOWDEN. GENERAL MANAGER O-TWO SYSTEMS INTERNATIONAL INC. 7575 KIMBEL STREET MISSISSAUGA ONTARIO CANADA L5S 1C8

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

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CAREvent ATV TRADE NAME:

COMMON NAME: AUTOMATIC TRANSPORT VENTILATOR

REGULATORY CLASS:

510K # : TO BE SUPPLIED

## LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED:

Autovent 1500 -

## DESCRIPTION OF THE DEVICE:

The CAREvent ATV is an automatic time cycled ventilator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress.

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

This device is identical in terms of features to the Autovent 1500 product - 510K # K983857 with the addition of independent minute volume and frequency controls. adjustable pressure relief, 60/100% air/oxygen mix and the ability to select the manual flowrate with a flowrate equivalent to that selected on the minute volume control. An additional alarm feature has also been added to warn of low input pressure.

### 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, automatic frequency settings and 12 minute volume settings which are both adjusted by the rotation of a vertically mounted rotary control. A manual button is provided to enable the operator to control the patient's breathing parameters with a flowrate equivalent to that selected on the minute volume control.

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Should the patient commence spontaneous breathing while being ventilated, their inspiratory effort will cause the device to provide breathing on demand while simultaneously causing the automatic cycling to cease. Should the patient cease to breathe spontaneously the automatic cycling will recommence without intervention by the operator being necessary.

The patient's airway is protected by an over pressure alarm (adjustable from 20 to 60 cmH20), 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 CAREvent ATV, when compared with the performance of the device to which substantial equivalence is claimed, performed within specification.

## CONTACT PERSON: KEVIN BOWDEN, GENERAL MANAGER O-TWO SYSTEMS INTERNATIONAL INC. 7575 KIMBEL STREET MISSISSAUGA ONTARIO CANADA L5S 1C8 TEL: [phone]

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

Doc. #:SER/ATV/Mar 99

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TRADE NAME: CAREvent ALS*

COMMON NAME: AUTOMATIC RESUSCITATOR

REGULATORY CLASS: II

510K # : TO BE SUPPLIED

## LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED:

Autovent 1500 -

#### DESCRIPTION OF THE DEVICE:

The CAREvent ALS 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 Ventilation, Manual Ventilation, and Demand Breathing into a control module with separate hose and patient valve.

This device is identical in terms of features to the Autovent 1500 product - 510K # K983857 with the addition of the ability to select the manual flowrate with a flowrate equivalent to that selected on the tidal volume/frequency control.

#### 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. A manual button is provided to enable the operator to control the patient's breathing parameters with a flowrate equivalent to that selected on the tidal volume/frequency control.

Should the patient commence spontaneous breathing while being ventilated, their inspiratory effort will cause the device to provide breathing on demand while

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simultaneously causing the automatic cycling to cease. Should the patient cease to breathe spontaneously the automatic cycling will recommence without intervention by the operator being necessary.

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 CAREvent ALS*, when compared with the performance of the device to which substantial equivalence is claimed, performed within specification.

#### CONTACT PERSON: KEVIN BOWDEN, GENERAL MANAGER O-TWO SYSTEMS INTERNATIONAL INC. 7575 KIMBEL STREET MISSISSAUGA ONTARIO CANADA 155 1C8

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

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Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles or a caduceus-like design with three intertwined lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 1999

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

Re: K991195 CAREvent BLS, CAREvent BLS, CAREvent ALS, CAREvent ALS, and CAREvent ATV Regulatory Class: II (two) Product Code: 73 BTL Dated: April 6, 1999 Received: April 8, 1999

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, Druq, 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 Existing major regulations affecting your device additional controls. 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 Regulation (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 regulatory 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 regulation (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,

Thomas J. Callahan

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: CAREvent BLS 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)

Atl. A. Garchurst.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Nijm over-The-Counter Use

Prescription Use v (Per 21 CFR 801.109)

OR

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

## Device Name: CAREvent BLS* 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) (Division Sign-Off) Division of Cardiovascular, Respiratory, - -- - Purological Devices to and Number . Prescription Use OR Over-The-Counter Use __ (Per 21 CFR 801.109) (Optional Format 1-2-96)

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Page__1__of__1__

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

## Device Name: CAREvent ALS 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)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use ------------

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Page__________________________________________________________________________________________________________________________________________________________________________

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

## Device Name: CAREvent ALS* 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)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _

Prescription Use_/ (Per 21 CFR 801.109) OR

Over-The-Counter Use_

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Page__1__of__1__

510K Number (if known):

Device Name: CAREvent ATV

#### 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)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices ి 1 3(k) Number _____________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Prescription Use را (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________