PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000

K050309 · Viasys Medsystems · CAP · Mar 25, 2005 · Anesthesiology

Device Facts

• Record ID: K050309
• Device Name: PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
• Applicant: Viasys Medsystems
• Product Code: CAP · Anesthesiology
• Decision Date: Mar 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2600
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The PULMANEX® Disposable Manometer is designed to provide visual indication of a pediatric/infant/neonate's airway pressure during ventilation. It may be attached to the manometer port on manual ventilation devices such as resuscitation bags or hyperinflation bags.

Device Story

PULMANEX® Disposable Pressure Manometer; mechanical device for visual airway pressure monitoring. Input: pneumatic pressure from manual ventilation circuits (resuscitation/hyperinflation bags). Operation: connects to standard manometer port; provides real-time visual pressure indication to clinician. Usage: clinical settings (hospitals, emergency care); operated by physicians, nurses, or respiratory therapists. Benefit: enables monitoring of airway pressure during manual ventilation to assist in clinical decision-making and patient safety.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable mechanical pressure manometer; connects to standard manual ventilation bag ports; provides visual pressure readout; non-electronic; no software.

Indications for Use

Indicated for pediatric, infant, and neonate patients requiring airway pressure monitoring during manual ventilation via resuscitation or hyperinflation bags.

Regulatory Classification

Identification

An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.

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 eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

MAR 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stephanie Wasielewski VP. Regulatory Affairs/Quality Assurance Viasys Medsystems 100 Chaddick Drive Wheeling, Illinois 60090

Re: K050309

Trade/Device Name: PULMANEX® Disposable Pressure Manometer Regulation Number: 21 CFR 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: II Product Code: CAP Dated: February 7, 2005 Received: February 8, 205

Dear Ms. Wasielewski:

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 - Ms. Wasielewski

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 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/industry/support/index.html.

Sincerely vours.

Senite Michin Ems.

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

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## Indications for Use

510(k) Number (if known): K050309

Device Name: PULMANEX® Disposable Pressure Manometer

Indications For Use: The PULMANEX® Disposable Manometer is designed to provide visual indication of a pediatric/infant/neonate's airway pressure during ventilation. It may be attached to the manometer port on manual ventilation devices such as resuscitation bags or hyperinflation bags.

Prescription Use x (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)

Ques Suliom

tion of Anesthesiology, General Hospital, con Control, Dental Devices

Number K05030