(59 days)
The Marpac Messenger™ attaches to standard 15mm tracheostomy tubes and assists tracheostomy patients with speech by managing airflow.
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.
The provided text describes a 510(k) submission for the Marpac Messenger™ speaking valve. This is not a study of an AI/ML powered device, but rather a submission for a mechanical medical device, demonstrating substantial equivalence to a predicate device. Therefore, many of the requested criteria regarding AI/ML studies are not applicable.
Here's an attempt to answer the relevant questions based on the provided text:
Acceptance Criteria and Reported Device Performance
1. Table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a mechanical device, the "acceptance criteria" are not framed in terms of AI performance metrics (like sensitivity, specificity, AUC). Instead, the acceptance criterion is demonstrating that the device is substantially equivalent to a predicate device, specifically regarding its operating principle and performance. The primary performance metric mentioned is 'inhalation flow resistance'.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Passy-Muir PMV 2001) in Operating Principle, Intended Use, and Basic Design. | Stated to have the same indicated use, operating principle, and basic speaking valve design. |
| Comparable Inhalation Flow Resistance to Predicate Device | "The chart demonstrates substantial equivalence to the predicate device with respect to inhalation flow resistance." (Chart itself is not provided in the text). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text refers to "Non-clinical test data" for "Inhalation Flow Resistance Chart." It does not specify a sample size for this testing, nor does it provide details on the data provenance (country of origin, retrospective/prospective). This would typically be found in the "Attachment B (Inhalation Flow Resistance Chart)" which is referenced but not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a mechanical device, and "ground truth" as it relates to expert consensus for diagnostic or prognostic AI models is not relevant here. Performance is measured against physical properties (flow resistance).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for expert interpretation in clinical studies, not for non-clinical engineering tests of a mechanical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context would be the measured physical properties (e.g., flow resistance) of both the Marpac Messenger™ and the predicate device, likely obtained through direct testing in a controlled environment.
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML powered device that requires a training set and associated ground truth.
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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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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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§ 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.