ACUTEVENTILATOR

K012271 · Impoex International, Ltd. · BTM · Oct 4, 2002 · Anesthesiology

Device Facts

• Record ID: K012271
• Device Name: ACUTEVENTILATOR
• Applicant: Impoex International, Ltd.
• Product Code: BTM · Anesthesiology
• Decision Date: Oct 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acuteventilator is a pumping apparatus of the bellows type, which is adapted for artificial respiration of a distressed person having temporarily no ability to breath by him/herself.

Device Story

Acuteventilator is a manual, bellows-type pumping apparatus designed for emergency artificial respiration. Device provides mechanical ventilation support to patients experiencing temporary respiratory failure. Operated by healthcare personnel in emergency or clinical settings to deliver air to the patient's lungs via manual compression of the bellows. Output is the delivery of tidal volume to the patient to maintain oxygenation and ventilation during respiratory distress. Benefits include immediate, portable life-support capability for patients unable to breathe independently.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual bellows-type pumping apparatus; mechanical operation; portable form factor; intended for emergency respiratory support.

Indications for Use

Indicated for artificial respiration of distressed persons temporarily unable to breathe independently.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 -

Ms. Rosina Robinson Senior Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

OCT 0 4 2002

Re: K012271 Trade/Device Name: Acuteventilator Regulation Number: 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: July 11, 2002 Received: July 12, 2002

Dear Ms. Robinson:

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.

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.

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Page 2 - Ms. Robinson

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

Timothy A. Ulatowski 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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K012271/,

Page 1 of 1

: :

510(K) Number (if known): K012271

Device Name: Acuteventilator _________________________________________________________________________________________________________________________________________________

Indications For Use:

The Acuteventilator is a pumping apparatus of the bellows type, which is adapted for artificial respiration of a distressed person having temporarily no ability to breath by him/herself.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use | <div> <span style="text-decoration: underline;">✓</span> </div> |
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| (Per 21 CFR 801 109) | |

OR

| Over-The-Counter Use | <span style="text-decoration: underline;"></span> |
|--------------------------|---------------------------------------------------|
| (Optional Format 1-2-96) | |

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

| 510(k) Number: | <span style="text-decoration: underline;">K012271</span> |
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|----------------|----------------------------------------------------------|

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