TALKING TRACH

K062104 · Engineered Medical Systems, Inc. · BTO · Apr 20, 2007 · Anesthesiology

Device Facts

• Record ID: K062104
• Device Name: TALKING TRACH
• Applicant: Engineered Medical Systems, Inc.
• Product Code: BTO · Anesthesiology
• Decision Date: Apr 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EMS Talking Trach tracheostomy tube, cuffed, is intended to provide tracheal access for airway management of tracheostomized patient. The device allows tracheostomy patients with a functional larynx and an unobstructed upper airway to vocalize / phonate. The Inner Speech cannula allows vocalization with the tracheostomy tube's cuff to remain inflated for ventilator dependent patients.

Device Story

EMS Talking Trach is a cuffed tracheostomy tube designed to facilitate speech/phonation in ventilator-dependent or spontaneously breathing patients. Device features outer tube (sizes 4.0-10.0 mm) and interchangeable inner cannulas: standard disposable or 'Speech' cannula. Speech cannula enables vocalization while maintaining cuff inflation for ventilator-dependent patients. Used in home, hospital, and sub-acute care settings by clinicians or patients. Device provides tracheal access; allows airflow to larynx for speech without requiring cuff deflation. Benefits include improved patient communication while maintaining airway management and ventilation support.

Clinical Evidence

Bench testing only. Performance evaluated via ventilator testing, comparing peak pressure and expiratory flow rates against predicate devices. No clinical data provided.

Technological Characteristics

Materials: PVC, Silicone. Sizes: 4.0-10.0 mm. Features: Cuffed outer tube, standard or speech inner cannula, optional fenestration. Standards: ISO 5366.1, 5366-3. Mechanical device; no software or electronic components.

Indications for Use

Indicated for adult patients > 30 kg requiring tracheal access for airway management. Allows vocalization/phonation in patients with functional larynx and unobstructed upper airway. Contraindicated for patients with abnormal upper airway anatomy or pathology.

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 (K962714)
• Portex - Trach Talk (K972385)
• Shiley - Trach tubes (K962173)

Submission Summary (Full Text)

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### 510(k) Summary

# Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 18-Apr-07

Engineered Medical System, Inc. 2055 Executive Dr. Indianapolis, IN 46241

Tel - [phone] Fax - [phone]

| Official Contact: | Jeff Quinn - President |
|----------------------------|-----------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Talking Trach |
| Common/Usual Name: | Tracheostomy tube |
| Classification Name: | Tube, tracheostomy and tube cuff |
| Device: | Traceostomy tube with inner cannula |
| Predicate Devices: | Passy Muir - K962714<br>Portex - Trach Talk – K972385<br>Shiley - Trach tubes - K962173 |

Device Description -- - The proposed EMS Talking Trach is a tracheostomy tube which allows patients who are ventilator dependent or spontaneously breathing to speak or phonate. It can be used with patients on ventilators while the cuff is "up" or inflated. It is offered in sizes from 4.0 to 10.0 mm with disposable standard and speaking inner cannula.

Indications for Use -- The EMS Talking Trach tracheostomy tube, cuffed, is intended to provide tracheal access for airway management of tracheostomized patient. The device allows tracheostomy patients with a functional larynx and an unobstructed upper airway to vocalize / phonate. The Inner Speech cannula allows vocalization with the tracheostomy tube's cuff to remain inflated for ventilator dependent patients.

Patient Population -- For adult patients > 30 kg.

Environment of Use -- Home, hospital, and sub-acute care settings

Contraindications --Do not use this tracheostomy tube with abnormal upper airway anatomy or pathology as this may result in partial or total airway obstruction.

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# Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 18-Apr-07

| Device Attributes: | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | EMS Talking Trach |
| Attributes | |
| Intended use<br>General | To provide tracheal access for airway management of<br>tracheostomized patient. |
| Intended use<br>Specific | Can allow a patient to phonate with cuff up while on a<br>ventilator as well be used with a standard inner cannula or as a<br>standard tracheostomy tube |
| Environments of use | Home, hospital, sub-acute care settings |
| Patient Population | For adult patients > 30 kg. |
| Contraindications | Not for abnormal airway anatomy |
| Prescription | Prescription |
| Design | |
| Outer tube | Sizes 4 to 10 with or without fenestration |
| Inner cannula | Standard disposable<br>Speech inner cannula |
| Materials | |
| Components in air pathway | PVC, Silicone |
| Performance | |
| Ventilator performance | Substantially equivalent to predicate when testing<br>Peak Pressure as measured by the ventilator at various flow rates Peak Pressure - intra-pulmonary at various flow rates Expiratory Flow (average) Expiratory Flow (Peak) |
| Standards | Comply with ISO 5366.1, 5366-3 |

## Differences between Other Legally Marketed Predicate Devices

The EMS Talking Trach is viewed as substantially equivalent to the following predicate devices – Passy Muir – K962714, Portex – Trach Talk – K972385, and Shiley – Trach tubes – K962173.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Engineered Medical Systems, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court #102 Bonita Springs, Florida 34134-2015

APR 2 0 2007

Re: K062104 Trade/Device Name: EMS Talking Trach Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: BTO Dated: March 23, 2007 Received: March 26, 2007

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.

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#### Page 2 - Mr. Dryden

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. 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 (QS) 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), please contact 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/industry/support/index.html.

Sincerely yours,

Sayete Y. Michael O m.D.

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 Statement

Page 1 of 1

510(k) Number: K062104

Device Name:

EMS Talking Trach

#### Indications for Use:

The EMS Talking Trach tracheostomy tube, cuffed, is intended to provide tracheal access for airway management of tracheostomized patient. The device allows tracheostomy patients with a functional larynx and an unobstructed upper airway to vocalize / phonate. The Inner Speech cannula allows vocalization with the tracheostomy tube's cuff to remain inflated for ventilator dependent patients. For adult patients > 30 kg.

Prescription Use XX (Part 21 CFR 801 Subpart D)

or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suette Y. Michie MD.

ion Control, Related Devices

K06 2104