TRACHEOSTOMY TUBES TRACOE-FLEX

K961449 · Tracoe Medical GmbH · JOH · Sep 13, 1996 · Anesthesiology

Device Facts

• Record ID: K961449
• Device Name: TRACHEOSTOMY TUBES TRACOE-FLEX
• Applicant: Tracoe Medical GmbH
• Product Code: JOH · Anesthesiology
• Decision Date: Sep 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Model 301: device is intended for providing tracheal access for airway management including artificial ventilation. Model 302: device is intended for providing tracheal access for airway management, in which a fenestration is needed in order to safely wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with "speaking valve". Model 303: device is intended for providing tracheal access for airway management. Model 304: device is intended for providing tracheal access for airway management where a fenestration is needed in order to safely wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with a "speaking valve". Model 305: device is intended for providing tracheal access for airway management in patients after laryngectomy. Model 401: device is intended for use in patients with the larynx intact in combination with TRACOER-FLEX model 302 and 304.

Device Story

TRACOE-FLEX tracheostomy tubes provide tracheal access for airway management; models include cuffed, cuffless, fenestrated, and laryngectomy-specific versions. Device consists of neck plate, outer cannula, and inner cannula; constructed from soft, body-temperature-responsive polyurethane. Unique feature: neck flange moves in horizontal and vertical axes, allowing cannula to remain stationary during patient head movement. Some models include inflatable low-pressure high-volume cuffs or fenestrations. Accessories include inner cannulas with integrated speaking valves. Used in clinical settings for airway maintenance and weaning; operated by healthcare professionals. Output is a patent airway; speaking valve enables phonation. Benefits include improved patient comfort due to flexibility, reduced tracheal movement, and increased airflow via thinner cannula walls.

Clinical Evidence

Bench testing only. Performance compared to Shiley/Mallinckrodt predicates via measurements of dimensions, resistance to airflow, kink resistance, and connection integrity. Results demonstrated performance equal to or better than predicates. Biocompatibility assessed via USP23 elution tests on sterilized products, which were negative.

Technological Characteristics

Materials: medical-grade polyurethane. Design: multi-axis movable neck plate (horizontal/vertical), thin-walled cannulas. Features: inflatable low-pressure high-volume cuff, fenestrations, integrated speaking valves. Connectivity: none. Sterilization: sterile, single-patient use.

Indications for Use

Indicated for patients requiring tracheal access for airway management, including artificial ventilation, weaning from mechanical ventilation, or post-laryngectomy care. Models 302, 304, and 401 are indicated for patients with intact larynx for phonation.

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

• Shiley Low Pressure Thin Cuffed Tracheostomy Tube, Non-Fenestrated (K811033)
• Modified Shiley Low Pressure Cuffed Tracheostomy Tube (K880614)
• Bivona Aire Cuff Silicone Tracheostomy Tube (K885130)
• Fome-Cuf and Aire-Cuf Tracheostomy Tubes (Shapiro-Bivona) (K862267)
• Portex Tracheostomy Tubes with Cuff (K903730)
• Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Improved Cuff (K812302)
• Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube (K865061)
• Shiley Single Cannula Tracheostomy Tube (K810106)
• Shiley Disposable Cannula Tracheostomy Tube (K811447)
• Portex Tracheostomy Tubes without Cuff (K912124)
• Tracoe Tracheostomy Tubes (K781729)
• Shiley Cuffless Fenestrated Tracheostomy Tube (K880614)
• Shiley Laryngectomy Tube (K821993)
• Shiley Phonate Speaking Valve (K945406)
• Bivona Tracheostomy Valve (K852272)
• Tracoe Tracheostomy Tubes with Speaking Valve (K781729)

Submission Summary (Full Text)

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SEP 13 1996
K961449
TRACOE
Gesellschaft für medizinische
Bedarfsgegenstände mbH

TRACOE GmbH, Reichsforststraße 32, D-60528 Frankfurt/Main

# SMDA

## Summary

This summary of 510 (K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitted by:

Tracoe GmbH
Reichsforststr. 32
D - 60528 Frankfurt
Tel. [phone]
Fax [phone]

Franz Waldeck
(Franz Waldeck, M.D., Ph.D.,
Director Development and Production)

Date: July 11, 1996


Summary Page 1

Reichsforststraße 32
D-60528 Frankfurt/Main
Tel. [phone]
Fax [phone]

Geschäftsführer:
Stephan Köhler
Hildegard Waldeck

AG Frankfurt HRB 32871

Deutsche Bank, Ffm
BLZ 500 700 10
Kto-Nr. 4 694 006

Postbank, Ffm
BLZ 500 100 60
Kto-Nr. 370 364 602

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Summary Page 2

# 1. Products:

**Trade Name:** Tracheostomy Tubes TRACOER-FLEX

1. Tracheostomy Tubes
1.1 Low Pressure Cuffed Tracheostomy Tube TRACOER-FLEX Model 301
1.2 Fenestrated Low Pressure Cuffed Tracheostomy Tube TRACOER-FLEX Model 302
1.3 Cuffless Tracheostomy Tube TRACOER-FLEX Model 303
1.4 Fenestrated Cuffless Tracheostomy Tube TRACOER-FLEX Model 304
1.5 Laryngectomy Tube TRACOER-FLEX Model 305

Models 301 to 304 come in five sizes (04, 06, 08, 10, 12); model 304 comes in three sizes (06, 08, 10).

2. Accessories
2.1 Fenestrated Inner Canulas with "Speaking Valve" for Models 302 and 304 in all five sizes Model 401

3. Replacement Parts
3.1 Replacement parts are available for all inner cannulas of all models and sizes as well as for all plugs.

**Classification Name:** Tracheostomy Tubes
ANESTESIOLOGY, 73JOH and 77BTO
Class II, 868.5800 and 874.4900

# 2. Description:

The TRACOER-FLEX tracheostomy tubes, the accessories as well as the replacement parts (inner cannulas and plugs) are sterile products for single patient use only. They essentially consist of a neck plate, an outer and an inner cannula. Outer and inner cannulas consists of thin walled relatively soft plastic material, which gets even softer at body temperature.

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The special feature of the TRACOER-FLEX tracheostomy tubes is, that the neck flange is movable in a horizontal as well as in a vertical axis, so that the cannula inside the trachea does not move, when the patient either bends or turns his head. The outer cannula can carry an inflatable low pressure high volume cuff (models 301 and 302) and/or can be perforated (models 302 and 304).

Inner cannulas with a twist-lock 15 mm adapter are non fenestrated (models 301, 302, 303 and 304); additional inner cannulas with a short blue twist-lock adapter (models 302 and 304) are fenestrated.

Fenestrated inner cannulas with an integrated "speaking valve" for models 302 and 304 are available as accessories (model 401) for all sizes.

## 3. Indications for use:

- Model 301: device is intended for providing tracheal access for airway management including artificial ventilation.
- Model 302: device is intended for providing tracheal access for airway management, in which a fenestration is needed in order to safely wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with "speaking valve".
- Model 303: device is intended for providing tracheal access for airway management.
- Model 304: device is intended for providing tracheal access for airway management where a fenestration is needed in order to safely wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with a "speaking valve".
- Model 305: device is intended for providing tracheal access for airway management in patients after laryngectomy.
- Model 401: device is intended for use in patients with the larynx intact in combination with TRACOER-FLEX model 302 and 304.

## 4. Predicate Devices:

| TRACOER-FLEX | Predicate devices | 510(K) Number |
| --- | --- | --- |
| Model 301 | - Shiley Low Pressure Thin Cuffed Tracheostomy Tube, Non-Fenestrated | K811033 |
| | - Modified Shiley Low Pressure Cuffed Tracheostomy Tube | K880614 |
| | - Bivona Aire Cuff Silicone Tracheostomy Tube | K885130 |
| | - Fome-Cuf and Aire-Cuf Tracheostomy Tubes (Shapiro-Bivona) | K862267 |
| | - Portex Tracheostomy Tubes with Cuff | K903730 |

Summary Page 3

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| Model 302 | - | Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Improved Cuff | K812302 |
| --- | --- | --- | --- |
| | - | Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube | K865061 |
| Model 303 | - | Shiley Single Cannula Tracheostomy Tube | K810106 |
| | - | Shiley Disposable Cannula Tracheostomy Tube | K811447 |
| | - | Portex Tracheostomy Tubes without Cuff | K912124 |
| | - | Tracoe Tracheostomy Tubes | K781729 |
| Model 304 | - | Shiley Cuffless Fenestrated Tracheostomy Tube | K880614 |
| Model 305 | - | Shiley Laryngectomy Tube | K821993 |
| Model 401 | - | Shiley Phonate Speaking Valve | K945406 |
| | - | Bivona Tracheostomy Valve | K852272 |
| | - | Tracoe Tracheostomy Tubes with Speaking Valve | K781729 |

## 5. Technological Characteristics of TRACOE®-FLEX tubes compared to the Shiley/Mallinckrodt products

The TRACOE®-FLEX tube models 301 to 305 correspond closely to the traditional Shiley/Mallinckrodt products LPC, FEN, CFS, CFN and LGT. For both these products series the labelling, the indications for use as well as the safety characteristics are essentially identical. The TRACOE®-FLEX tubes show however some improvements compared to the predicate devices such as

- the TRACOE®-FLEX tubes have a neck plate, which is connected to the outer cannula in a way, that outer and inner cannulas can move in a horizontal as well as in a vertical axis at the same time. The Shiley/Mallinckrodt tubes can only move around a horizontal axis; all other tubes on the market have fixed neck plates.
- TRACOE®-FLEX tubes have thinner cannulas than the Shiley products.
- The material used for TRACOE®-FLEX tubes is a much softer plastic material (polyurethane) than the material used for the Shiley products. The TRACOE®-FLEX tubes are therefore softer and have a higher flexibility than the predicate devices.

Summary Page 4

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- The thinner walls of the TRACOE®-FLEX tubes yield at a given size of a tracheostoma a comparatively higher airflow for the patient than the predicate devices.
- The Tracoe „speaking valve“ are constructed as integral part of inner cannulas and are less bulkier than predicate devices of Shiley/Mallinckrodt and Passy-Muir.

## 6. Assessment of Substantial Equivalence based on non-clinical Performance Data

The performance of the TRACOE®-FLEX tracheostomy tubes as well as of the „speaking valves“ was tested in comparison to the Shiley/Mallinckrodt tubes based on measurements of the dimensions, resistance to airflow, kink resistance and connection between cannula and neck plate. The results of all these tests showed, that all these parameters are at least as good as those of the predicate devices and in certain features like resistance to airflow of the tubes, softness of the wall and flexibility between cannula and neck plate even better.

## 7. Biocompatibility Assessment

All materials used are medical grade, and come with a certificate of compliance.

Elution tests of the final sterilized products according to USP23 were negative.

Summary Page 5