(92 days)
The SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.
The Disposable Inner Cannulae are indicated for use in maintaining airway patency of the outer cannula in the presence of thick tenacious secretions or when it is desirable to minimize the cleaning materials and the nursing time required. The Disposable Inner Cannulae provide a means to protect against the risk of airway obstruction, contamination, and infection.
The Per-Fit™ Percutaneous Tracheostomy Tube is intended for use as a replacement tube for the percutaneous tracheostomy tube that is supplied in the Per-Fit™ Percutaneous Tracheostomy Kit. It is intended to be used for replacement during the initial procedure or as a change-out tube following the procedure.
The SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral l 5 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.
The Disposable Inner Cannula is made of polyethylene and is ethylene oxide sterilized. The cannula is designated as a single use disposable device for use only with the Portex Percutaneous Tracheostomy Tube.
The Portex® Percutaneous Tracheostomy Tube is designed for insertion via the percutaneous route utilizing the Per-Fit™ Percutaneous Tracheostomy Kit. The tracheostomy tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube features a flexible flange, an integral 15 mm connector, and a cuff that deflates to a low profile for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The tube is supplied with an obturator/dilator sized to match the outer tube and to facilitate insertion.
The provided text is a 510(K) summary for a medical device (SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula). It describes the device, its indications for use, and a conclusion about its safety and effectiveness based on testing and comparison to predicate devices.
However, this document does not describe a study that uses acceptance criteria to evaluate the performance of an AI/ML powered device. The document pertains to a traditional, non-computerized medical device. Therefore, it does not contain the specific information requested in the prompt regarding AI/ML study design, such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance of an algorithm.
The core of the document's "conclusion" is that the device is "substantially equivalent" to predicate devices, which is a regulatory pathway for non-AI/ML devices.
Therefore, I cannot extract the requested information from the provided text based on the nature of the device and the document type.
{0}------------------------------------------------
KG60429
Image /page/0/Picture/1 description: The image shows the logo for Smiths Industries Medical Systems. The logo consists of the acronym "SIMS" in bold, black letters on the left, with a black circle above the "I". To the right of "SIMS" is the text "SMITHS INDUSTRIES" in bold, black letters, with "Medical Systems" in a smaller, serif font below it. A thin black line separates "SMITHS INDUSTRIES" from "Medical Systems".
MAY - 2 1996
Internal Correspondence
K: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY:
COMPANY INFORMATION
Smiths Industries Medical Systems, Inc. 15 Kit Street Keene, NH 03431 (603) 352-3812 Contact: Timothy J. Talcott Manager of Regulatory Affairs
PREPARATION DATE OF SUMMARY
January 30, 1996
TRADE NAME
SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula
COMMON NAME
Tracheostomy Tube with Disposable Inner Cannula
PRODUCT CLASS/CLASSIFICATION
Class II, 73 JOH, 21 CFR 868.5800.
PREDICATE DEVICE
Our current Percutaneous Tracheostomy Kit, K936133 and our current Disposable Inner Cannula, K903730 and K912124. Also, comparison is being made to the Cook Critical Care Ciaglia Percutaneous Tracheostomy Introducer Set.
{1}------------------------------------------------
DESCRIPTION
SIMS PER-FITTM Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula
The SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral l 5 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.
Disposable Inner Cannula
The Disposable Inner Cannula is made of polyethylene and is ethylene oxide sterilized. The cannula is designated as a single use disposable device for use only with the Portex Percutaneous Tracheostomy Tube.
Per-Fit™ Portex® Percutaneous Tracheostomy Tube
The Portex® Percutaneous Tracheostomy Tube is designed for insertion via the percutaneous route utilizing the Per-Fit™ Percutaneous Tracheostomy Kit. The tracheostomy tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube features a flexible flange, an integral 15 mm connector, and a cuff that deflates to a low profile for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The tube is supplied with an obturator/dilator sized to match the outer tube and to facilitate insertion.
INDICATIONS FOR USE
SIMS PER-FITM Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula
The SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.
Disposable Inner Cannula
The Disposable Inner Cannulae are indicated for use in maintaining airway patency of the outer cannula in the presence of thick tenacious secretions or when it is desirable to minimize the cleaning materials and the nursing time required. The Disposable Inner
26
{2}------------------------------------------------
Cannulae provide a means to protect against the risk of airway obstruction, contamination, and infection.
Per-FitTM Portex® Percutaneous Tracheostomy Tube
The Per-Fit™ Percutaneous Tracheostomy Tube is intended for use as a replacement tube for the percutaneous tracheostomy tube that is supplied in the Per-Fit™ Percutaneous Tracheostomy Kit. It is intended to be used for replacement during the initial procedure or as a change-out tube following the procedure.
TECHNICAL CHARACTERISTICS
The SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula has the same technical characteristics as is currently marketed with our existing Percutaneous Tracheostomy Kit, K936133 and our current Disposable Inner Cannula, K903730 and K912124. The guidewire is equivalent to the guidewire supplied in our current device and the Cook Critical Care Ciaglia Percutaneous Tracheostomy Introducer Set.
CONCLUSION
The testing performed and comparison to the predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices.
Very truly yours,
Smiths Industries Medical Systems, Inc. dba Concord/Portex
Timothy J. Zalatoris
Timothy J. Palcott 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.