CAREVENT CA AND DRA

K051889 · O-Two Medical Technologies, Inc. · BTL · Aug 30, 2005 · Anesthesiology

Device Facts

• Record ID: K051889
• Device Name: CAREVENT CA AND DRA
• Applicant: O-Two Medical Technologies, Inc.
• Product Code: BTL · Anesthesiology
• Decision Date: Aug 30, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CAREvent CA and CAREvent DRA are pneumatically powered, time/volume cycled ventilators used to provide ventilatory support in confined space rescue in IDLH (Immediately Dangerous to Life and Health) environment. The ventilator is suitable for use in: - Pulmonary resuscitation during respiratory and/or cardiac arrest. - Short term ventilatory support in the confined space rescue in IDLH (Immediately Dangerous to Life and Health) environment, pre-hospital, Intra-hospital transport of non-breathing patients.

Device Story

CAREvent CA and CAREvent DRA are pneumatically powered, time/volume cycled ventilators; designed for use in confined space rescue, IDLH environments, and patient transport. Devices provide ventilatory support to non-breathing patients or those in respiratory/cardiac arrest. Operated by emergency responders or medical personnel; devices function via pneumatic power without requiring electrical input. Output consists of controlled mechanical ventilation cycles to assist patient breathing. Benefit includes life-sustaining respiratory support in hazardous or transport settings.

Clinical Evidence

No clinical data provided; device is a pneumatically powered ventilator for emergency use.

Technological Characteristics

Pneumatically powered, time/volume cycled ventilator. Operates without electrical power. Designed for use in IDLH environments. Class II device (Product Code: BTL).

Indications for Use

Indicated for patients requiring pulmonary resuscitation during respiratory or cardiac arrest, or short-term ventilatory support in IDLH (Immediately Dangerous to Life and Health) confined space environments, including pre-hospital and intra-hospital transport of non-breathing patients.

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.

Submission Summary (Full Text)

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AUG 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ammar Al-Dojaily Engineering Manager O-Two Medical Technologies, Incorporated 7575 Kimbel Street Mississauga, Ontario CANADA L5S 1C8

Re: K051889

K0J1869
Trade/Device Name: CAREvent CA and CAREvent DRA Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: August 10, 2005 Received: August 16, 2005

Dear Mr. Al-Dojaily:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 910(t) production is substantially equivalent (for the referenced above and have determined the device is and is a Madical Devices marketed in
indications for use stated in the enclosure) to legally marketed predice Medical Douic indications for use stated in the cholorors, to regionent date of the Medical Device interstate commerce prior to May 20, 1770, and enal many approvil of a provisions of
Amendments, or to devices that have been reclassified in accordance with of a premarket Amendments, of to devices that have been rockets that do not require approval of a premarket.
The Federal Food, Drug, and Cosmetic Act (Act) that do desice, systematic the Federal Food, Drug, and Cosment Pre (1996) and Chica, subject to the general
approval application (PMA). You may, therefore, market the Aet include approval application (1 Mrx). Fou may, most on the Act include controls provisions of the Act. The general connects good manufacturing practice, requirements for any requirements for annual reasonst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) of class III If your device is classified (see above) into controls. Existing major regulations affecting
(PMA), it may be subject to such additional controls. Existes Title 21, Ports (PMA), it may be subject to sach additional contreasons, Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21, In the Federal your device can be found in the Code of Peacharies concerning your device in the Federal Register.

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Page 2 - Mr. Al-Dojaily

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I Dri 3 issualled on that your device complies with other requirements Incan that IDA has made a determinations administered by other Federal agencies. 01 the Act of ally I ederal bate and survey with and limited to: registration You must comply with an the Piseling (21 CFR Part 801); good manufacturing practice in and listing (21 CFR Part 807), laceling (DS) 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) This letter will anow you to over mading of substantial equivalence of your device to a premits the motification. - The PDF mails 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), if you desire specific at no roo roo roo room at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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 vours,

Anjette Y. Michie m.D.

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): K051889

CAREvent CA and CAREvent DRA Device Name:

## Indications For Use:

Indications For Use.
The CAREvent CA and CAREvent DRA are pneumatically powered, time/volume The CAREVENT CA and OAREVERE BAS are Pro Pars and Submitted and sin confined cycled vehilators used to provide vonellately bapper.
space rescue in IDLH (Immediately Dangerous to Life and Health) environment.

The ventilator is suitable for use in:

- · Pulmonary resuscitation during respiratory and/or cardiac arrest.
- Short term ventilatory support in the confined space rescue in IDLH . Short term ventiatory Support in and Health) environment, pre-hospital, Intra-(Immediately Dangerous to Elle and Visal transport of non-breathing patients.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aury Sueliom

(Division Sign) Off (Division Signesh)
Division of Anesthesiology, General Hospital, Division of Anesthousists of Devices

051 0 510(k) Number.

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