MARPAC MESSENGER MODEL #501

K041485 · Marpac, Inc. · JOH · Aug 2, 2004 · Anesthesiology

Device Facts

• Record ID: K041485
• Device Name: MARPAC MESSENGER MODEL #501
• Applicant: Marpac, Inc.
• Product Code: JOH · Anesthesiology
• Decision Date: Aug 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Marpac Messenger™ attaches to standard 15mm tracheostomy tubes and assists tracheostomy patients with speech by managing airflow.

Device Story

Marpac Messenger™ is a speaking valve for tracheostomy patients; attaches to standard 15mm tracheostomy tube hub. Device consists of plastic outer body and flexible medical-grade silicone diaphragm. One-way valve design allows airflow into valve during inhalation; maintains closed position during expiration to redirect airflow through larynx, mouth, and nose to enable speech. Used in clinical or home settings by tracheostomy patients. Output is mechanical redirection of airflow; enables patient vocalization. Benefits include restoration of speech capability for tracheostomy patients.

Clinical Evidence

Bench testing only. Inhalation flow resistance was measured and compared to the predicate device to demonstrate substantial equivalence.

Technological Characteristics

Plastic outer body; medical-grade silicone flexible diaphragm. One-way valve mechanism. Attaches to standard 15mm tracheostomy tube hubs. Mechanical operation; no energy source required.

Indications for Use

Indicated for tracheostomy patients requiring assistance with speech via airflow management. Attaches to standard 15mm tracheostomy tubes.

Regulatory Classification

Identification

A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

Predicate Devices

• Passy-Muir Tracheostomy Speaking Valve PMV 2001 (K903699)

Submission Summary (Full Text)

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

K041485

## MARPAC TRADITIONAL 510(k) SUMMARY MARPAC MESSENGER™

Marpac 8436 Washington Place NE Albuquerque, NM 87113 Phone: [phone] Fax:

Contact: Evelyn Trujillo mfg(@marpac.biz

Establishment Registration Number: 1722095

Date of Summary: May 20, 2004

Device Trade Name: Marpac Messenger™ Common Name: Speaking Valve Classification: Tracheostomy tube and tube cuff. 21 CFR 868.5800

Predicate Device: Passy-Muir Tracheostomy Speaking Valve PMV 2001 by Passy & Passy, Inc. (K903699), 9-4-1990.

Description of Device: The Marpac Messenger™ consists of a plastic outer body with an inner flexible diaphragm made of medical grade silicone. The Marpac Messenger™ attaches to the hub of a standard 15mm tracheostomy tube. The one-way valve design of the Marpac Messenger™ allows airflow into the valve when the tracheostomy patient inhales and maintains a closed position during expiration thereby directing airflow up through the larynx, mouth, and nose enabling speech.

Intended Use: The Marpac Messenger™ attaches to standard 15mm tracheostomy tubes and assists tracheostomy patients with speech by managing airflow. The Marpac Messenger™ has the same intended use as the previously cleared Passy-Muir PMV 2001 Tracheostomy Speaking Valve.

Substantial Equivalence: The Marpac Messenger™ has the same indicated use, uses the same operating principle, and incorporates the same basic speaking valve design as the Passy-Muir PMV 2001 Tracheostomy Speaking Valve which previously received a 510(k) concurrence. Non-clinical test data can be found in Attachment B (Inhalation Flow Resistance Chart). The chart demonstrates substantial equivalence to the predicate device with respect to inhalation flow resistance.

## MARPAC, INC.

[phone] • 1-800-334-6413 • Fax [phone] Washington Place NE • Albuquerque, New Mexico 87113-1671 www.marpac.biz

5

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

Image /page/1/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol consists of three stylized lines that resemble a bird in flight or a human figure in motion. The text is arranged around the perimeter of the circle, with the symbol positioned in the center.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 2 2004

Ms. Evelyn Trujillo Manufacturing Manager Marpac, Incorporated 8436 Washington Place, N.E. Albuquerque, New Mexico 87113-1671

Re: K041485

Trade/Device Name: Marpac Messenger™ Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: May 20, 2004 Received: June 7, 2004

Dear Ms. Trujillo:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reveal 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to act 1000 and Cosmetic Act (Act) that do not require approval of a premarket the I cueral I vou, Drag, and Soou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions or 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 (1 MA), it may of subject to base of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in facer announcements concerning your device in the Federal Register.

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

Page 2 -- Ms. Trujillo

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 mount that I Drima many Federal statutes and regulations administered by other Federal agencies. of the For of ally - outh all the Act's requirements, including, but not limited to: registration r od inting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 es result in the quality systems (QS) regulation (21 CFR Part 820); and if applicable as 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 and in Jourse of Substantial equivalence of your device to a premiaries notification - 11 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), 11 you don't 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 yours,

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

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known): K041485

Device Name: Marpac Messenger™

Indications for Use: The Marpac Messenger™ attaches to standard 15mm
Indications for Use: The Marpac westients with ansoch by manu indications for Use. The Marpac Messengor - "attaches with speech by managing airflow.

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)

| | <div style="text-align:center;"></div> |
|------------------------------------------------------------------------------------|----------------------------------------|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices | |
| 510(k) Number: | K041485 |

Page 1 of 1