(226 days)
PORTEX® Blue Line Tracheostomy Tube and BIVONA Hyperflex "Tracheostomy Tube Adjustable Neckflange
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No
The document describes a physical medical device (tracheostomy tube) and its materials, design features, and clinical evaluation. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
No.
The device is a tracheostomy tube for airway management, not a therapeutic device designed to cure, treat, or prevent disease.
No
Explanation: The device, a tracheostomy tube, is indicated for airway management and does not collect or analyze any data to diagnose a condition. Its function is to facilitate breathing, not to identify or characterize diseases.
No
The device description clearly indicates it is a physical tracheostomy tube made of polyvinyl chloride with a cuff, flange, and connector. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "airway management of tracheostomized patients." This is a direct medical intervention on a patient's body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description details a physical tube inserted into the trachea, made of materials suitable for implantation. This aligns with a medical device used for treatment or support, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PORTEX® Adjustable Flange Tracheostomy Tube is indicated for airway management of tracheostomized patients where the ability to adjust the depth of insertion may be advantageous.
Product codes (comma separated list FDA assigned to the subject device)
73 JOH
Device Description
The PORTEX® Adjustable Flange Tracheostomy Tubes are made of implant tested, polyvinyl chloride with compatible profile, high volume, low pressure cuff. Radiopaque material is incorporated into the full length of the Adjustable Flange Tracheostomy Tube. The trachesstomy tube has an adjustable neck flange and a bonded 15 mm connector. The cuff inflation line has an inflation indicator and a self sealing luer one-way valve.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance assessment was not required to demonstrate substantial equivalence of the proposed device to the predicate devices.
A clinical evaluation was performed in Europe.
Inclusion criteria - patients requiring a trachessomy for airway management, age of at lease 6 years, a minimum weight of 20Kg, and either male or female.
Exclusion criteria - Tubes not to be used in patients during radiotherapy.
81 PORTEX® Adjustable Flange Tracheostomy Tubes were trialed, of which 58% were of the proposed device design.
There were very few negative comments, which seemed to be related closely to the investigators experience with competitive tubes. One comment which has been fully addressed before the commercial availability of the Adjustable Flange Tracheostomy Tube is the 15mm connector security. Every confidence should be gained in the security of the connector when fully inserted. In order to ensure customer confidence the 15mm connector is bonded into the tube.
The PORTEX® Adjustable Flange Tracheostomy Tube is a safe and effective product to use in cases of routine and special tracheostomy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
PORTEX® Blue Line Tracheostomy Tube and BIVONA Hyperflex "Tracheostomy Tube Adjustable Neckflange
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image displays the text "SMITHS INDUSTRIES" in a bold, sans-serif font. A thick, black line underlines the text, emphasizing the name. To the right of the company name, there is a handwritten signature or marking in black ink, adding a personal or identifying element to the image.
JAN 1 7 1997
SIMS Inc.
15 Kit Street Keene, NH 03431 Telephone: (603) 352-3812 Fax: (603) 352-3703
H: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY
COMPANY INFORMATION
Smiths Industries Medical Systems, Inc. 15 Kit Street Keene, NH FAX: 603-357-5038 Timothy J. Talcott Manager of Regulatory Affairs
Medical Systems
PREPARATION DATE OF SUMMARY
June 3, 1996
TRADE NAME
PORTEX® Adjustable Flange Tracheostomy Tube
COMMON NAME
Tracheostomy Tube, with or without a cuff
CLASSIFICATION NAME
Class II, 73 JOH, 21 CFR 868.5800.
PREDICATE DEVICE
PORTEX® Blue Line Tracheostomy Tube and BIVONA Hyperflex "Tracheostomy Tube Adjustable Neckflange
DESCRIPTION
The PORTEX® Adjustable Flange Tracheostomy Tubes are made of implant tested, polyvinyl chloride with compatible profile, high volume, low pressure cuff. Radiopaque material is incorporated into the full length of the Adjustable Flange Tracheostomy Tube. The trachesstomy tube has an adjustable neck flange and a bonded 15 mm connector. The cuff inflation line has an inflation indicator and a self sealing luer one-way valve.
1
INDICATIONS FOR USE
The PORTEX® Adjustable Flange Tracheostomy Tube is indicated for airway management of tracheostomized patients where the ability to adjust the depth of insertion may be advantageous.
TECHNOLOGICAL CHARACTERISTICS
Portex Blue Line Tracheostomy Tube -- The device is similar in construction and materials as the predicate device, Portex Blue Line Tracheostomy Tube (PVC extrusion), except for the adjustable flange, This flange is designed to be adjustable to accommodate patients with various distances from the skin to the trachea. The flange is made from Ethylene Vinyl Acetate Copolymer, rather than PVC. The materials of the other predicate device, BIVONA Hyperflex "Tracheostomy Tube Adjustable Neckflange, are made of silicone with a stainless steel imbedded wire. This tube is designed to accommodate patients with various distances from the skin to the trachea, as is the proposed device.
SUMMARY OF PERFORMANCE DATA
Performance assessment was not required to demonstrate substantial equivalence of the proposed device to the predicate devices.
SUMMARY OF NONCLINICAL AND CLINICAL TESTS
A clinical evaluation was performed in Europe. The subjects were selected based on the following requirements: Inclusion criteria - patients requiring a trachessomy for airway management, age of at lease 6 years, a minimum weight of 20Kg, and either male or female. Exclusion criteria - Tubes not to be used in patients during radiotherapy.
81 PORTEX® Adjustable Flange Tracheostomy Tubes were trialed, of which 58% were of the proposed device design.
There were very few negative comments, which seemed to be related closely to the investigators experience with competitive tubes. One comment which has been fully addressed before the commercial availability of the Adjustable Flange Tracheostomy Tube is the 15mm connector security. Every confidence should be gained in the security of the connector when fully inserted. In order to ensure customer confidence the 15mm connector is bonded into the tube.
CONCLUSION OF NONCLINICAL AND CLINICAL TESTS
The PORTEX® Adjustable Flange Tracheostomy Tube is a safe and effective product to use in cases of routine and special tracheostomy.
ADDITIONAL INFORMATION
None
Very truly yours,
Smiths Industries Medical Systems, Inc.
imothy J/D7 Manager of Regulatory Affairs