INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG

K981308 · International Respiratory Systems, Inc. · BTM · Jul 6, 1998 · Anesthesiology

Device Facts

• Record ID: K981308
• Device Name: INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG
• Applicant: International Respiratory Systems, Inc.
• Product Code: BTM · Anesthesiology
• Decision Date: Jul 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The International Respiratory Systems, Inc's Manual Resusciated to provide I he international Respuatory BystonEs, Ino of reasoned as a commonly associated with cardiopulmonary arrest.

Device Story

Manual resuscitator used to provide ventilation to patients experiencing cardiopulmonary arrest. Device operated by healthcare professionals in clinical settings to deliver manual breaths. Provides respiratory support during emergency resuscitation efforts; assists in maintaining patient oxygenation and ventilation.

Clinical Evidence

No clinical data provided; substantial equivalence based on device classification and regulatory review.

Technological Characteristics

Manual pulmonary resuscitator; Class II device; Product Code 73 BTM. Mechanical operation; no software or electronic components.

Indications for Use

Indicated for use in adult, child, and infant populations experiencing cardiopulmonary arrest.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 6 1898

Mr. E.J. Smith International Respiratory Systems, Inc. c/o Smith Associates P.O. Box 4341 Crofton, MD 21114

Re : K981308 Manual Pulmonary Resuscitator Requlatory Class: II (two) Product Code: 73 BTM Dated: April 7, 1998 Received: April 10, 1998

Dear Mr. Smith:

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, Drug, 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 additional controls. Existing major regulations affecting your device 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.

{1}------------------------------------------------

Page 2 - Mr. E.J. Smith

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,

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

{2}------------------------------------------------

## 510(k)m Number:K981308

Device Name: International Respiratory Systems, Inc.'s Manual Resuscitator

Classification Panel:

Indication for Use:

The International Respiratory Systems, Inc's Manual Resusciated to provide I he international Respuatory BystonEs, Ino of reasoned as a commonly associated with cardiopulmonary arrest.

Patient Population: Adult Child Infant

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over the Counter Use_ Prescription Use______________________________________________________________________________________________________________________________________________________________ or

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K981308