SMART BAG MO

K021328 · O-Two Systems International, Inc. · BTM · Jun 26, 2003 · Anesthesiology

Device Facts

• Record ID: K021328
• Device Name: SMART BAG MO
• Applicant: O-Two Systems International, Inc.
• Product Code: BTM · Anesthesiology
• Decision Date: Jun 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The SMART BAG" Mo is intended for manual ventilation of patients using ambient air or supplemental oxygen supplied from an oxygen source. The SMART BAG®MD is available in a child and an adult size. The SMART BAG®MO is available with components that can be autoclaved, or can be chemically disinfected. A single use disposable version is also available. The SMART BAG®MO includes a flow limiting valve that limits the inspiratory flow to approximately 40 litres per minute, for the adult version and 30 litres per minute for the child version. The flow limiting valve is intended to minimize gastric inflation during manual ventilation. The flow limiting valve can be disabled to permit conventional operation of the resuscitator.

Device Story

Manual resuscitator (bag-valve-mask) for non-breathing patients; consists of self-inflating bag, one-way valve, and facemask. Operator compresses bag to deliver ventilation. Includes flow-limiting valve to restrict inspiratory flow (40 L/min adult; 30 L/min child) to minimize gastric inflation. Manual Override Control allows disabling flow-limiting valve for conventional BVM operation. Used in emergency settings by clinicians/rescuers. Benefits patient by providing ventilation while reducing risk of gastric insufflation.

Clinical Evidence

Bench testing only. Performance verified against domestic and international standards, specifically ISO 8382-1988, confirming device operates within specifications.

Technological Characteristics

Manual resuscitator; self-inflating bag, one-way valve, facemask, flow-limiting valve. Available in adult/child sizes. Reusable (autoclavable/chemically disinfectable) or single-use disposable versions. Mechanical operation; no software or electronics.

Indications for Use

Indicated for manual ventilation of adult and child patients requiring respiratory support using ambient air or supplemental oxygen.

Regulatory Classification

Identification

A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Predicate Devices

• DMR Plus Disposable Manual Resuscitator (K973419)

Submission Summary (Full Text)

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# SAFETY AND EFFECTIVNESS STATEMENT.

SMART BAG® MO TRADE NAME:

COMMON NAME: BAG-VALVE-MASK RESUSCITATOR

REGULATORY CLASS: Il

510K # :

## LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED:

DMR Plus Disposable Manual Resuscitator - 510K #: K973419

#### DESCRIPTION OF THE DEVICE:

The SMART BAG® MO is a manual resuscitator comprising a self inflating bag, a one way valve and a facemask designed to supply ventilations to a non-breathing patient by the compression of the bag portion of the device by the operator.

## SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

Similar in all respects to the predicate device, 510(k) #: K973419, this product has the addition of a flow-limiting valve that is responsive to the squeeze of the balloon applied by the rescuer. In cases where high flowrates are required to overcome mask leakage or adverse patient conditions, the Manual Override Control is provided to disable the flow controlling mechanism and allow the SMART BAG ®MO to act like a standard BVM.

#### 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.

## CONCLUSIONS BASED ON PERFORMANCE DATA

The testing undertaken verified that the SMART BAG® MO device, 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

Doc. #: SBMO/SES/Apr.02

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Public Health Service

JUN 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kevin Bowdon Director of Product Technology O-Two Systems International Incorporated 7575 Kimbel Street Mississauga, Ontario CANADA L5S 1C8

Re: K021328

Trade/Device Name: SMART BAG® MO Regulation Number: 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: May 14, 2003 Received: May 16, 2003

Dear Mr. Bowden:

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. Bowden

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 (OS) 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 Office of Compliance 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 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/dsma/dsmamain.html

Sincerely vours.

Susan Runpo

Susan Runner, DDS, MA Interim 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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Page 1

510K Number (if known): K021328

Device Name: SMART BAG®MO

Indications for Use:

"The SMART BAG" Mo is intended for manual ventilation of patients using ambient air or supplemental oxygen supplied from an oxygen source. The SMART BAG®MD is available in a child and an adult size. The SMART BAG®MO is available with components that can be autoclaved, or can be chemically disinfected. A single use disposable version is also available. The SMART BAG®MO includes a flow limiting valve that limits the inspiratory flow to approximately 40 litres per minute, for the adult version and 30 litres per minute for the child version. The flow limiting valve is intended to minimize gastric inflation during manual ventilation. The flow limiting valve can be disabled to permit conventional operation of the resuscitator".

Kevin Bowden. Director of Product Technology O-Two Systems International Inc.

January 20th 2003

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use ાર (Per 21 CPR 801.109)

(Optional Format 1-2-96)

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

510(k) Number: