TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO

K043160 · Tracoe Medical GmbH · JOH · Feb 18, 2005 · Anesthesiology

Device Facts

• Record ID: K043160
• Device Name: TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO
• Applicant: Tracoe Medical GmbH
• Product Code: JOH · Anesthesiology
• Decision Date: Feb 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tracoe Phon Assist I (Ref Models 650-S/SO and 650-T/TO) are one way valves with oxygen port designed to allow tracheostomy patients with and without a supplemental oxygen port to vocalize without the need for finger occlusion. The single patient use valves are attached to the tracheostomy tube with a 15mm standard connector (Phon Assist I Ref 650-T/TO) or a Tracoe Stoma Button (Phon Assist I Ref 650-S/SO). Such valves consist of an identical cylindrical housing with a silicone membrane whereby the airflow is allowed to enter in a unidirectional fashion upon inspiration and close upon expiration which redirects the airflow up to the larynx and through the mouth.

Device Story

The Tracoe Phon Assist I is a one-way speaking valve designed for tracheostomy patients with an intact larynx. The device features a cylindrical housing with a silicone membrane that allows unidirectional airflow during inspiration and closes during expiration. This mechanism redirects exhaled air through the larynx and mouth, enabling vocalization without requiring manual finger occlusion of the tracheostomy tube. The device includes an optional supplemental oxygen port. It is intended for single-patient use and attaches to standard 15mm tracheostomy tube connectors or Tracoe Stoma Buttons. By restoring airflow through the upper airway, the device facilitates speech production in patients with various respiratory or neurological conditions.

Clinical Evidence

No clinical data provided; device is a mechanical speaking valve.

Technological Characteristics

Mechanical one-way valve; cylindrical housing with silicone membrane; 15mm standard connector; includes optional oxygen port; single-patient use; non-powered.

Indications for Use

Indicated for tracheostomy patients (with intact larynx) using uncuffed or deflated/fenestrated tracheostomy tubes and Tracoe Stoma Buttons. Conditions include mild tracheal stenosis, laryngeal tumors, bilateral vocal cord paralysis, tracheomalacia, head trauma, bronchopulmonary dysplasia, amyotrophic lateral sclerosis, and chronic obstructive pulmonary disease.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health. The caduceus is depicted with a staff and two snakes winding around it.

Public Health Service

FEB 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tracoe Medical GmbH C/O Mr. Michael A. Warren Boston Medical Products, Incorporated 117 Flanders Road Westborough, Massachusetts 01581

Re: K043160

Trade/Device Name: Tracoe Phon Assist I Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: January 24, 2005 Received: January 25, 2005

Dear Mr. Warren:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your becatermined 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 devises and Cosmetic Act (Act) that do not require approval of a premarket the Federal 1 000; Drag, and Coou may, therefore, market the device, subject to the general approval upplieation (she Act. The general controls provisions of the Act include controls provisions of an 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 (1 Wry, it may of bacyott is the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear oe roundsh further announcements concerning your device in the Federal Register

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Page 2 - Mr. Warren

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA 3 issualled of a basetainments with other requirements mean that FDA has made a decommans. In a ministered by other Federal agencies. of the Act of any receial statutes and regulations, but not limited to: registration You must comply with an the Fice brequility, which 801); good manufacturing practice and listing (21 CFR Part 607), labeling (21 cres (QS) regulation (21 CFR Part 820); and if requirements as sectionin the quality byocally (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 anow you to objacting of substantial equivalence of your device to a premarket notification. The PDF minating or 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), IT you desire specific advice for your de 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 may obtain other generalational 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 yours,

Sinette Michie O

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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## SECTION 4- Statement of Indications for Use

## INDICATIONS FOR USE

Not Issued 510(k) Number:

Tracoe Phon Assist I Device Name:

## Indications for Use:

The Tracoe Phon Assist I (Ref Models 650-S/SO and 650-T/TO) are one way valves with The Tracoc I hon I Loster (Tree Insees port designed to allow tracheostomy patients with and without a supplemental your portygen pered for finger occlusion. The single patient use all intact laryin' to voombo withiout to fa tracheostomy tube with a 15mm standard valves are attached to the Such 12650-T/TO) or a Tracoe Stoma Button (Phon Assist Icombelor (I hour Assist I "House cosist of an identical cylindrical housing with a silicone Model 050-67507. Bour var to enter in a unidirectional fashion upon inspiration and close menorano whereby the airflow is redirected up to the larynx and through the mouth. upon expiration whice of the a 650-T/TO) Speaking Valves are indicated for uncuffed I hon I hon I uses I (x 2 suffed tubes that have been fennestrated or deflated and Tracoe Stoma Buttons(Ref Model 650-S/SO) in the cases of:

- Mild Tracheal Stenosis u
- Laryngeal Tumors 1
- Bilateral Vocal Cord Paralysis .
- Trachealmalacia r
- . Head Trauma
- Broncheopulmonary Dysplasia .
- Amyotrophic Lateral Scierosis .
- Chronic Obstructive Pulmonary Disease .

X Prescription Use: (Part 21 CFR 801 Subpart D) Over-The-Counter-Use: (Part 21 CFR 807 Subpart C)

DO NOT WRITE BELOW THIS LINE

AND/OR

Concurrence of CDRH, Office of Device Evaluation

510(K) NOTIFICATION- TRACOE PHON ASSIST I TRACHEOSTOMY SPEAKING VALVF.S

Anne Sullivan

Genaral Hosnital .. Accord

Section 510(k) for Dental Devices

K043160