CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)

K081330 · O-Two Medical Technologies, Inc. · BTL · Mar 6, 2009 · Anesthesiology

Device Facts

• Record ID: K081330
• Device Name: CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
• Applicant: O-Two Medical Technologies, Inc.
• Product Code: BTL · Anesthesiology
• Decision Date: Mar 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CAREvent PAR (Public Access Resuscitator) is indicated for Cardio Pulmonary Resuscitation (CPR) and short -term ventilatory support. It incorporates voice instructions, compression beeps and automatic ventilations to assist CPR Trained personnel for both inter - and intrahospital transport and pre-hospital (EMS) settings for nonbreathing adult patients.

Device Story

CAREvent PAR is an electronically controlled, pneumatically powered resuscitator; 12V internal rechargeable battery powers electronics. Device provides automated ventilations, voice instructions, and compression beeps to assist CPR-trained personnel during resuscitation. Used in hospital transport and pre-hospital EMS settings. Output includes fixed tidal volume (0.7L) and respiratory rate (20 BPM) with 1:2 I:E ratio. Includes audible pressure relief alarm (60 cm H2O). Healthcare providers use voice prompts and audible cues to synchronize CPR efforts. Benefits include standardized ventilation and guidance for non-breathing adult patients.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Electronically controlled, pneumatically powered resuscitator. Powered by 12V internal rechargeable battery. Fixed performance parameters: 0.7L tidal volume, 20 BPM respiratory rate, 1:2 I:E ratio. Maximum pressure relief 60 cm H2O with audible alarm. Input gas pressure 45-70 psi. Connectivity: 9/16 DISS input, 22mm output. Components include controller, circuit, mask, and head strap.

Indications for Use

Indicated for CPR and short-term ventilatory support in non-breathing adult patients. Used by CPR-trained personnel in hospital (inter/intra-transport) and pre-hospital (EMS) settings. No contraindications.

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

• O-Two Medical - CAREvent BSL+ (K991195)
• Auralogic - CPR Coach voice prompter (K860555)

Submission Summary (Full Text)

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Premarket Notification 510(k) Section 5 - 510(k) Summary

Image /page/0/Picture/1 description: The image shows the words "CAREvent PAR" in a serif font. The words are stacked on top of each other. The text is black and the background is white.

# Non-Confidential Summary of Safety and Effectiveness

1081336

Page 1 of 3 8-May-08

6 2009 MAR

O-Two Medical Technologies 7575 Kimbel St. Mississauga, Ontario L5S1C8 Canada

Tel -- 905-677-9410

Ammar Al-Dojaily

Official Contact:

Proprietary or Trade Name: CAREvent PAR

Common/Usual Name:

Classification Name:

ventilator, emergency, powered (resuscitator) BTL - 868.5925

ventilator, emergency, powered (resuscitator)

| Predicate Devices: | O-Two Medical - CAREvent BSL+ - K991195 |
|--------------------|-----------------------------------------------|
| | Auralogic - CPR Coach voice prompter - K86055 |

#### Device Description:

The CAREvent PAR® is an electronically controlled, pneumatically powered resuscitator with a . 12V, internal, rechargeable battery is used to power the electronics. It incorporababliator instructions to assist the user during CPR.

#### Indications for Use;

: The CAREvent PAR (Public Access Resuscitator) is indicated for Cardio Pulmonary Resuscitation (CPR) and short -term ventilatory support. It incorporates voice instructions, compression beeps and automatic ventilations to assist CPR Trained personnel for both inter s and intra-hospital transport and pre-hospital (EMS) settings for non-breathing adult patients.

Patient Population: Non-breathing adult patients

. Environment of Use: Hospitals (inter - and intra- transport), pre-hospital (EMS) settings

Contraindications: None

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## Premarket Notification 510(k) Section 5 – 510(k) Summary

# Non-Confidential Summary of Safety and Effectiveness
Page 2 of 3 8-May-08

## Comparative table:

| Features | Predicates | Proposed Device |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K991195 - CAREvent BLS+<br>K860555 - CPR Coach voice<br>prompter | CAREvent PAR |
| | | |
| | | |
| | | |
| Indications for use | Pulmonary resuscitation during<br>respiratory and / or cardiac arrest.<br>Short-term ventilatory support for both<br>inter- and intra-hospital transport of<br>non-breathing patients (K991195)<br><br>No indications for use statement but<br>states voice prompts for CPR<br>(K860555) | The CAREvent PAR (Public Access<br>Resuscitator) is indicated for Cardio<br>Pulmonary Resuscitation (CPR) and short -<br>term ventilatory support. It incorporates<br>voice instructions, compression beeps and<br>automatic ventilations to assist CPR<br>Trained personnel for both inter - and intra-<br>hospital transport and pre-hospital (EMS)<br>settings for non-breathing adult patients. |
| Environment of Use | inter- and intra-hospital transport<br>(K991195) | Same added pre-hospital as this is covered<br>under inter-hospital transport |
| Patient Population | Non-breathing adult and child<br>(K991195) | Non-breathing adults |
| Contraindications | None<br>(K991195) | None |
| Software driven | No<br>(K991195)<br>Yes<br>K860555 | Yes, some features --<br>Respiratory rate (BPM), Pressure relief<br>audible alarm, voice prompts |
| Components uses | Controller - multi-patient, multi-use<br>Circuit and mask - single patient use<br>disposable (K991195) | Same |
| Components | Ventilator / controller<br>Circuit<br>Mask<br>Head strap<br>(K991195) | Ventilator / controller<br>Circuit<br>Mask<br>Head strap |
| Instructional voice<br>prompts | Yes<br>(K860555) | Yes |
| Performance and design features | | |
| Can deliver 100%<br>oxygen during<br>resuscitation | Yes<br>(K991195) | Yes |
| Tidal volume (I) | 12 settings (L)<br>1.35, 1.1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4,<br>0.35, 0.3, 0.25, 0.2<br>(K991195) | Fixed - 0.7 |
| Respiratory Rate<br>(BPM) | 12 settings<br>10, 12, 15, 18, 20<br>(K991195) | Fixed - 20 |
| I:E ratio | Fixed 1:2<br>(K991195) | Fixed 1:2 |
| Features | Predicates<br>K991195 - CAREvent BLS+<br>K860555 - CPR Coach voice<br>prompter | Proposed Device<br>CAREvent PAR |
| Maximum Pressure<br>relief (cm H2O) | 60<br>(K991195) | 60 |
| Pressure relief audible<br>alarm | Yes<br>(K991195) | Yes |
| Manual ventilation<br>option | Yes<br>(K991195) | No |
| Demand breathing<br>feature | No<br>(K991195) | No |
| Circuit pressure | 40 psi<br>(K991195) | Same |
| Input gas pressure | 45-70 psi<br>(K991195) | Same |
| Input fitting/<br>Output fitting | 9/16 DISS<br>22mm | Same |

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## Non-Confidential Summary of Safety and Effectiveness Page 2 of 3 8-May-08

# Differences Between Other Legally Marketed Predicate Devices:

The proposed device is viewed as substantially equivalent to the predicate devices, K991195 and K860555.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/3/Picture/0 description: The image shows a partial logo and the word "DEPARTMENT". The logo is a circular emblem with text around the perimeter, but only "OF HEALTH & HUMAN SERVICES - USA" is visible. To the left of the word "DEPARTMENT" is a stylized graphic consisting of three curved lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

O-Two Medical Technologies, Incorporated C/0 Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

6 2009 MAR

Re: K081330

> Trade/Device Name: CAREvent PAR Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: February 23, 2009 Received: February 24, 2009

Dear Mr. Dryden:

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 application (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 such 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. Dryden

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 begin 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Cinthony D. Watson for
S. Michael Lamb

Ginette Y. Michaud, M.D Acting 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 Statement

Page 1 of 1

Number:

(To be assigned)

e Name:

CAREvent PAR

ations for Use:

The CAREvent PAR (Public Access Resuscitator) is indicated for Cardio Pulmonary Resuscitation (CPR) and short -term ventilatory support. It incorporates voice instructions, compression beeps and automatic ventilations to assist CPR Trained personnel for both inter - and intrahospital transport and pre-hospital (EMS) settings for nonbreathing adult patients.

scription Use XX 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

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

510(k) Number: K051330