(92 days)
Not Found
No
The description focuses on the physical components and mechanical function of a tracheostomy kit and tube, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is designed for providing temporary tracheal access and maintaining airway patency, which are surgical and supportive functions, not therapeutic in the sense of actively treating or curing a disease.
No
The device is a tracheostomy kit, tube, and inner cannulae, used for providing and maintaining tracheal access for airway management. Its purpose is therapeutic and facilitative for ongoing care, not to diagnose a condition.
No
The device description clearly details physical components made of materials like polyvinylchloride and polyethylene, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing percutaneous temporary tracheal access for airway management. This is a surgical/procedural device used directly on the patient's body for a therapeutic purpose (airway management).
- Device Description: The description details the physical components of a tracheostomy kit and tube, designed for insertion into the trachea.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a medical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
73 JOH
Device Description
SIMS PER-FIT™ 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tracheal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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