(205 days)
Not Found
No
The summary describes a mechanical tracheostomy tube and its accessories, with no mention of AI or ML capabilities.
No
The device is a tracheostomy tube intended for intubation to provide a patent airway, which is a supportive function rather than a therapeutic treatment for a disease or condition.
No
The device is a tracheostomy tube with accessories, used to provide a patent airway, not to diagnose a condition.
No
The device description clearly outlines physical components like a tracheostomy tube, obturator, cough cap, inner cannulas, and neck band, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Rusch Ultra Tracheoflex Tracheostomy Set-Cuffed is a device used to create and maintain an airway within the body. It is a surgical implant/device, not a diagnostic test kit.
- Intended Use: The intended use clearly states it's for "intubation through a surgical incision into the trachea, for the purpose of providing a patent airway." This is a therapeutic/supportive function, not a diagnostic one.
The description and intended use align with a surgical device used for airway management, not an IVD.
N/A
Intended Use / Indications for Use
The Rusch Ultra Tracheoflex Tracheostomy Set-Cuffed is a tracheostomy tube with accessories, intended for intubation through a surgical incision into the trachea, for the purpose of providing a patent airway.
Product codes
Not Found
Device Description
The Ultra Tracheoflex Tracheostomy Set-Cuffed is a sterile, disposable, single use cuffed tracheostomy tube with a fixed flange. The set includes a radiopaque tube, a tube obturator, a cough cap, a 15 mm airway connector, exchangeable inner cannulas, and a neck band. The inner cannula will be also available as a separate item.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trachea
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)
No clinical testing was completed.
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
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
Image /page/0/Picture/0 description: The image shows the logo for RUSCH, with the word "RUSCH" in large, bold letters. Below the logo, the words "INTERNATIONAL Group Regulatory Affairs" are printed in a smaller font. At the bottom of the image, the text "A Subsidiary of Teleflex Incorporated (USA)" is displayed.
Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108
JUN 28 1996 K955564
510(K) SUMMARY
ULIBA TRACHEQFLEX TRACHEOSTOMY SET - CUFFED
Submitter Information:
Neil R. Armstrong Group Regulatory Affairs Manager Rüsch International Tall Pines Park Jaffrey, NH 03452 Phone Number: (603) 532-7706 Fax Number: (603) 532-8211
Date 510(k) Summary Prepared:
October 10, 1995
Name of the Device:
| Trade or Proprietary Name: | Rüsch Ultra Tracheoflex®
Tracheostomy Set - Cuffed |
|----------------------------|-------------------------------------------------------------------------|
| Common Name: | Tracheostomy Set-Cuffed, Fixed
length |
| Classification Name: | Tracheostomy tube and tube
cuff, and accessories: 21 CFR
868.5800 |
| | Airway Connector: 21 CFR
868.5810 |
1
Identification of Legally Marketed Device to which the Submitter Claim Equivalence:
The Ultra Tracheoflex Tracheostomy set cuffed is substantially equivalent to two products marketed by Rüsch prior to May 28, 1976: These are the Safetyflex Tracheotomy Set available since April, 1974, and the Tracheoflex Tracheotomy Set, available since April 1971. This device is also similar to the Portex Flexible D.I.C. Tracheostomy Tube found substantially equivalent under K934465.
The subject devices are similar or equivalent to the predicates in significant features, materials, dimensions, and intended use.
Description of the Subject Devices:
The Ultra Tracheoflex Tracheostomy Set-Cuffed is a sterile, disposable, single use cuffed tracheostomy tube with a fixed flange. The set includes a radiopaque tube, a tube obturator, a cough cap, a 15 mm airway connector, exchangeable inner cannulas, and a neck band. The inner cannula will be also available as a separate item.
These devices meet applicable portions of the following voluntary standards:
ASTM F1242-89, Standard Specification for Cuffed and Uncuffed Tracheal Tubes.
ISO 5366-1, Tracheostomy Tubes, Part 1, Connectors for Tubes for Adults
ISO 5366.2, Basic requirements for Tracheostomy Tubes for Adults.
ISO 5356: Anesthesia and Respiration Equipment, Conical Connectors, Cones and Sockets.
ISO 5361, Tracheal Tubes, Part 5: Requirements and Tests for Cuffs and Tubes.
Attachment 1
2
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
Intended Use of Subject Device
The Rusch Ultra Tracheoflex Tracheostomy Set-Cuffed is a tracheostomy tube with accessories, intended for intubation through a surgical incision into the trachea, for the purpose of providing a patent airway.
.. ..
Technological Characteristics of the Subject Devices
The subject device and the predicates have the same technological characteristics as the predicate devices except for:
-
- The subject device's tube cuff is filled via a pilot balloon tube that ends in a spring (Bespack) valve. The Rüsch predicate devices have a balloon that ended in a capped luer. This technological improvement was made to aid in the prevention of the loss of cuff pressure due to the improper placement of the cap after cuff inflation.
-
- The Rusch predicate devices had a 15 mm airway connector permanently attached to the tube flange. The subject device has a ISO standard screw-luer fitting permanently attached. This allows a locking connections to a 15 mm airway connector, a cough cap, or other connectors as needed.
No clinical testing was completed.
Attachment 1