(59 days)
No
The device description and performance studies focus on mechanical airflow management and do not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is intended to assist tracheostomy patients with speech by managing airflow, which is a therapeutic purpose to improve a physiological function.
No
Explanation: The device's purpose is to assist tracheostomy patients with speech by managing airflow, which is a therapeutic function, not a diagnostic one. It helps the patient speak rather than detect or identify a medical condition.
No
The device description clearly states it consists of a "plastic outer body with an inner flexible diaphragm made of medical grade silicone," indicating it is a physical hardware device.
Based on the provided information, the Marpac Messenger™ is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Marpac Messenger™ Function: The Marpac Messenger™ is a mechanical device that attaches to a tracheostomy tube to manage airflow and facilitate speech. It does not perform any tests on biological samples.
Therefore, the Marpac Messenger™ falls under the category of a medical device, specifically a respiratory aid or speech aid, rather than an in vitro diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
JOH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
larynx, mouth, and nose
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Non-clinical test data can be found in Attachment B (Inhalation Flow Resistance Chart).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The chart demonstrates substantial equivalence to the predicate device with respect to inhalation flow resistance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
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.(b)
Classification. Class II.
0
MARPAC TRADITIONAL 510(k) SUMMARY MARPAC MESSENGER™
Marpac 8436 Washington Place NE Albuquerque, NM 87113 Phone: 505-344-4740 505-344-4169 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.
(505) 344-4740 • 1-800-334-6413 • Fax (505) 344-4169 8436 Washington Place NE • Albuquerque, New Mexico 87113-1671 www.marpac.biz
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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.
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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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
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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)
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K041485 |
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