TRACH VOX

K013728 · Engineered Medical Systems · JOH · Jul 30, 2002 · Anesthesiology

Device Facts

• Record ID: K013728
• Device Name: TRACH VOX
• Applicant: Engineered Medical Systems
• Product Code: JOH · Anesthesiology
• Decision Date: Jul 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For patients breathing spontaneously via a tracheostomy tube, the TrachVox provides heat and humidity for entrained air and incorporates a cough relief and suction port valve. The unit may be closed by the patient's finger, which directs the air through the vocal cords to facilitate speech. For patients breathing spontaneously via an endotracheal tube (ET tube) the TrachVox provides heat and moisture for the inhaled air.

Device Story

TrachVox is a tracheal heat and moisture exchanger (HME) with an integrated speech valve and suction port. It connects to 15 mm tracheostomy or endotracheal tube connectors. Used in home, hospital, ICU, and sub-acute settings by spontaneously breathing patients. For tracheostomy patients, the device provides humidification and allows speech by manually covering the suction valve with a finger; this action compresses a foam spring, closing exhalation vents and diverting air through the vocal cords. Removing the finger allows the foam to expand, reopening vents for normal exhalation. It also provides a port for supplemental oxygen delivery. The device benefits patients by maintaining airway moisture, facilitating speech, and providing a safe, accessible suction port.

Clinical Evidence

Bench testing only. Performance data includes moisture output (20.1 mg H2O/l at 500 ml tidal volume; 14.9 mg H2O/l with supplemental oxygen), flow resistance (0.23 cm H2O at 30 Lpm; 0.9 cm H2O at 60 Lpm), and dead space (9.5 ml). Testing conducted per ISO 9360 and ISO 5356-1 standards.

Technological Characteristics

Polypropylene housing; foam HME media; silicone valve. Conforms to ISO 5356-1 (15/22 mm conical connectors) and ISO 9360 (moisture output). Mechanical operation via manual finger-actuated valve and foam spring-action. Single-patient use, 24-hour duration.

Indications for Use

Indicated for spontaneously breathing patients with a tracheostomy or endotracheal tube requiring heat and moisture exchange, suction access, and speech facilitation (tracheostomy only).

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

• In Health - Blom-Singer Tracheostoma with HumidiFilter Cap (K821568)
• Passy Muir Speaking Valves (K944451)
• Gibeck, Inc. - Trach-Vent (K952845)
• Vital Signs - Breathe Easy (K914336)
• B&B Technologies - Bodai Suction Safe (K811241)

Reference Devices

• Intersurgical - Hydro-Trach T

Submission Summary (Full Text)

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JUL 3 0 2002

K0137∂X

## Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 April 30, 2002

| Engineered Medical Systems<br>2055 Executive Dr.<br>Indianapolis, IN 46241 | Tel [phone]<br>Fax [phone] |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Bonnie Holly - Quality Manager |
| Proprietary or Trade Name: | TrachVox |
| Common/Usual Name: | Tracheal HME with speech valve and suction port |
| Classification Name: | Laryngeal (Taub) Prosthesis - Accessory |
| Predicate Devices: | In Health - Blom-Singer Tracheostoma with<br>HumidiFilter Cap - K821568<br>Passy Muir Speaking Valves - K944451<br>Gibeck, Inc. - Trach-Vent - K952845<br>Vital Signs - Breathe Easy - K914336<br>Intersurgical - Hydro-Trach T - exempt<br>B&B Technologies - Bodai Suction Safe -- K811241 |

## Device Description:

The TrachVox connects to a 15 mm tracheostomy or endotracheal tube connector of a spontaneously breathing patient. It incorporates four (4) key features:

- HME media for humidifying inhaled air �
- 0 Suction port
- Method for closing off exhalation to outside and divert the exhaled breathe around the 0 tracheostomy tube and through the vocal cords for speech
- Connector for delivery of supplemental oxygen 0

| Intended Use: | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indicated Use -- | For patients breathing spontaneously via a tracheostomy tube, the<br>TrachVox provides heat and humidity for entrained air and<br>incorporates a cough relief and suction port valve. The unit may be<br>closed by the patient's finger, which directs the air through the vocal<br>cords to facilitate speech. |
| | For patients breathing spontaneously via an endotracheal tube the<br>TrachVox provides heat and moisture for the inhaled air. For single<br>patient use. |
| Environment of Use -- | Home, Hospital, ICU, Sub-acute Institutions |

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## Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 April 30, 2002

## Comparison to Predicate Devices:

11

| Attribute | Proposed TrachVox device |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| For spontaneously breathing tracheostomy patients | Yes |
| Incorporated speech valve | Yes |
| Provides heat and humidity | Yes |
| Can provide supplemental oxygen | Yes |
| Intended to connect to tracheostomy tube of<br>spontaneously breathing patient | Yes |
| Can connect to an ET tube of spontaneously breathing<br>patient | Yes |
| Intended for single patient up to 24 hours | Yes |
| Prescription | Yes |
| Intended population | Any patient |
| Intended Environment of Use | Home, Hospital, sub-acute, ICU |
| Placement in various locations in circuit | Yes |
| Supplemental oxygen connection | Yes |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | 9.5 ml |
| Resistance to flow | 0.23 cm H₂O @ 30 Lpm or 0.9 cm H₂O @ 60 Lpm |
| Weight | 2.9 gm |
| Normally closed suction slit valve | Yes |
| Speech valve normally open for inhalation | Yes |
| Allows exhalation to atmosphere freely | Yes |
| Method for diverting exhaled air through vocal cord<br>for facilitating speech (Speech valve) | Cover suction valve with fingers, depress housing,<br>compressing foam and closes off exhalation to<br>atmosphere vents |
| Method for revert to normal exhalation after speaking | Remove finger, foam spring-action raises housing,<br>opening exhalation to atmosphere vents |
| Moisture output (mg H₂O/l) ISO 9360 | 20.1 mg H₂O /l @ 500 ml TV |
| Moisture output (mg H₂O/I) ISO 9360<br>with supplemental oxygen | 14.9 mg H₂O /l @ 10 Lpm |
| Housing components - polypropylene | Yes |
| HME media | Foam |
| Valve | Silicone |
| None under Section 514 | Yes |
| ISO 5356-1 Conical 15/22 | Yes |
| ISO 9360 - HME moisture output | Yes |

Differences between Other Legally Marketed Predicate Devices

The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.

Public Health Service

JUL 3 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Engineered Medical Systems C/O Mr. Paul Dryden Promedic. Incorporated 6329 W. Waterview Court McCordsville, Indiana 46055-9501

Re: K013728

Trade/Device Name: Trach Vox Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: April 30, 2002 Received: May 1, 2002

Dear Mr. Dryden:

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.

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.

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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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Ullatorst

Timo ry A. Ulatowski 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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| 2.3 Indications for Use | |
|-------------------------|--|
|-------------------------|--|

| | Page 1 of 1 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K013728 (To be assigned) |
| Device Name: | TrachVox |
| Intended Use: | For patients breathing spontaneously via a tracheostomy tube, the TrachVox provides heat and humidity for entrained air and incorporates a cough relief and suction port valve. The unit may be closed by the patient's finger, which directs the air through the vocal cords to facilitate speech.<br><br>For patients breathing spontaneously via an endotracheal tube (ET tube) the TrachVox provides heat and moisture for the inhaled air. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

le Aulutohn

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 11/01/3728

**Prescription Use**
(Per CFR 801.109)

or

Over-the-counter use__________________________________________________________________________________________________________________________________________________________