(150 days)
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 sately 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 TRACOES-FLEX model 302 and 304.
The TRACOE -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. The special feature of the TRACOE -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.
The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of typical AI/ML medical device submissions. Instead, it describes a traditional medical device (tracheostomy tubes) and its comparison to predicate devices for 510(K) clearance.
Therefore, I cannot fulfill your request for the following sections:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
- If a standalone performance (algorithm only) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
However, I can provide information based on the "Assessment of Substantial Equivalence based on non-clinical Performance Data" section:
Summary of Device Performance and Equivalence
The TRACOE®-FLEX tracheostomy tubes, including the "speaking valves," were tested in comparison to Shiley/Mallinckrodt tubes. The assessment aimed to demonstrate substantial equivalence, focusing on physical characteristics and performance rather than a clinical study with patients or AI-driven analysis.
Non-Clinical Performance Data Overview:
- Tests Conducted: Measurements of dimensions, resistance to airflow, kink resistance, and connection between cannula and neck plate.
- Results: All tested parameters were "at least as good as those of the predicate devices." Some features showed improvement, specifically:
- Resistance to airflow
- Softness of the wall
- Flexibility between cannula and neck plate
Key Technological Characteristics and Improvements (compared to predicate devices):
- Neck Plate Flexibility: TRACOE®-FLEX tubes have a neck plate that allows movement in both horizontal and vertical axes, enhancing cannula stability during patient head movements, unlike Shiley/Mallinckrodt tubes which only move horizontally, and other tubes with fixed neck plates.
- Thinner Cannulas: TRACOE®-FLEX tubes have thinner cannulas, which at a given tracheostoma size, provide comparatively higher airflow.
- Softer Material: Made from a softer plastic (polyurethane) than Shiley products, resulting in greater softness and flexibility.
- Integrated Speaking Valve: The Tracoe "speaking valves" are constructed as an integral part of the inner cannulas, making them less bulky than predicate devices from Shiley/Mallinckrodt and Passy-Muir.
Biocompatibility Assessment:
- All materials are medical grade with certificates of compliance.
- Elution tests according to USP23 on final sterilized products were negative.
This information describes the evidence provided for a traditional medical device's 510(k) submission, confirming its equivalence to existing devices based on non-clinical performance and material biocompatibility. It does not fit the structure of an AI/ML device study.
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Image /page/0/Picture/0 description: The image shows the date "SEP 13 1996" in bold, black font. The letters and numbers are evenly spaced and aligned horizontally. The date is likely part of a document or label.
Image /page/0/Picture/2 description: The image shows the logo for TRACOE, a company that specializes in medical supplies. The logo consists of the word "TRACOE" in bold, followed by the registered trademark symbol. Below the company name is the text "Gesellschaft für medizinische Bedarfsgegenstände mbH", which translates to "Company for medical supplies". To the right of the company name is a black square.
TRACOE GmbH, Reichsforststraße 32, D-60526 Frankfurt/Main
S M D A
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. 069/666 3274 Fax 069/666 4807
Franz Waldeck
(Franz Waldeck, M.D., Ph.D., Director Development and Production)
Date:
July 11, 1996
Image /page/0/Picture/13 description: The image shows a logo with a black vertical rectangle on the left side and a white background on the right side. There is a white circle in the upper part of the black rectangle. The word "TRACOE" is written in white letters on the black rectangle, with the letters slightly overlapping each other. There is a trademark symbol next to the letter E.
Reichsforststraße 32 Professorelondido de de de
D-60528 Franklink de
Tel. 069 / 666 32 14/84
Fax 069 / 666 48 07 Geschäftsführer:
Stephan Köhler
Hildegard Waldeck
AG Frankfurt HAB 32871
Deutsche Bank, Ffm
BLZ 500 700 10 Klo-Nr. 4 694 006
Postbank, Frm
BLZ 500 100 60
Kto-Nr. 370 364 602
Kto-Nr.
Summary Page 1
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1. Products:
Trade Name: Tracheostomy Tubes TRACOE®-FLEX
| 1. | Tracheostomy Tubes | |
|---|---|---|
| 1.1 | Low Pressure Cuffed Tracheostomy TubeTRACOER-FLEX | Model 301 |
| 1.2 | Fenestrated Low Pressure CuffedTracheostomy Tube TRACOER-FLEX | Model 302 |
| 1.3 | Cuffless Tracheostomy Tube TRACOER-FLEX | Model 303 |
| 1.4 | Fenestrated Cuffless TracheostomyTube 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).
- Accessories 2.1 Fenestrated Inner Canulas with "Speaking Valve" for Models 302 and 304 in all five sizes
Model 401
Replacement Parts 3.
- 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 ANESTESSOLOGY, 73JOH and 73BTO Class 11, 868.5800 and 874.4900
2. Description:
The TRACOE -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.
4 A 25, 10 100 100 1
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The special feature of the TRACOE -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 sately 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 TRACOES-FLEX model 302 and 304.
4. Predicate Devices:
| TRACOER-FLEX | Predicate devices | 510(K) Number | |
|---|---|---|---|
| Model 301 | - | Shiley Low Pressure Thin CuffedTracheostomy Tube, Non-Fenestrated | K811033 |
| - | Modified Shiley Low Pressure CuffedTracheostomy Tube | K880614 | |
| - | Bivona Aire Cuff SiliconeTracheostomy Tube | K885130 | |
| - | Fome-Cuf and Aire-Cuf TracheostomyTubes (Shapiro-Bivona) | K862267 | |
| - | Portex Tracheostomy Tubes withCuff | K903730 |
Summary Page 3
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| Model 302 | - Shiley Fenestrated Low PressureCuffed Tracheostomy Tube withImproved Cuff- Shiley Disposable CannulaFenestrated Low Pressure CuffedTracheostomy Tube | K812302K865061 |
|---|---|---|
| Model 303 | - Shiley Single Cannula TracheostomyTube- Shiley Disposable Cannula Tracheo-stomy Tube- Portex Tracheostomy Tubes withoutCuff- Tracoe Tracheostomy Tubes | K810106K811447K912124K781729 |
| Model 304 | - Shiley Cuffless FenestratedTracheostomy Tube | K880614 |
| Model 305 | - Shiley Laryngectomy Tube | K821993 |
| Model 401 | - Shiley Phonate Speaking Valve- Bivona Tracheostomy Valve- Tracoe Tracheostomy Tubes withSpeaking Valve | K945406K852272K781729 |
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.
- TRACOE8-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.
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- The thinner walls of the TRACOES-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 an are less bulkier than predicate devices of Shiley/Mallinckrodt and Passy-Muir.
6. Assessment of Substantial Equivalance based on non-clinical Performance Data
The performance of the TRACOES-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.
§ 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.