(226 days)
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.
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.
This document does not describe acceptance criteria for a device, nor a study performed to prove a device meets acceptance criteria. Instead, it is a 510(k) summary for the PORTEX® Adjustable Flange Tracheostomy Tube, a medical device.
The section titled "SUMMARY OF PERFORMANCE DATA" explicitly states: "Performance assessment was not required to demonstrate substantial equivalence of the proposed device to the predicate devices."
Therefore, I cannot provide the requested information. The document indicates that no formal performance acceptance criteria or a study designed to prove the device met such criteria were necessary for this 510(k) submission, as the device was deemed substantially equivalent to predicate devices.
{0}------------------------------------------------
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
§ 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.