(231 days)
Not Found
Not Found
No
The device description and intended use clearly describe a mechanical tracheostomy tube and its components. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device description indicates it is a tracheostomy tube for airway management, acting as a physical conduit. While it helps patients breathe, it does not directly treat a disease or condition in a therapeutic manner beyond providing an airway.
No
Explanation: The device is described as a tracheostomy tube for airway management, which is a therapeutic device, not a diagnostic one. Its function is to facilitate breathing, not to diagnose a condition.
No
The device description clearly lists multiple physical components (outer tube, inner tube, introducer, neck band, etc.), indicating it is a hardware medical device.
Based on the provided information, the Rusch TracheoFix-Set (TFS) 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 intervention on a patient's body for a physiological purpose (maintaining an airway).
- Device Description: The description details a physical tube and accessories used to facilitate breathing through a tracheostomy. There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Rusch TracheoFix-Set does not perform this function.
Therefore, the Rusch TracheoFix-Set is a medical device used for airway management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Rusch TracheoFix-Set (TFS) is a single patient disposable tracheostomy Tube for airway management of tracheostomized patients.
Product codes (comma separated list FDA assigned to the subject device)
JOH
Device Description
The TracheoFix-Set consists of the following:
- . outer tube with low pressure cuff and pilot balloon, flexible fixation flange and turn lock fastener (the flange is not adjustable).
- luer activated valve for cuff inflation/deflation .
- luer activated valve for carr inituseem.
Inner tube with standard taper and a replacement inner . tube - introducer .
- standard connector .
- neck band .
· neck band
The Rusch TracheoFix-Set is a sterile, single patient, The Rusch fracheorin , pressure tracheostomy tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
The Rusch TracheoFix-Set is substantially equivalent in design, use, and materials to the Mallinckrodt (Shiley) Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, the Smiths Industries Medical Systems (Concord/Portex) D.I.C. Tracheostomy Tubes, Cuffed and the Bivona Medical Technologies AIRE-CUF® Tracheostomy Tube .
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
Image /page/0/Picture/1 description: The image shows the logo for RÜSCH International, Group Regulatory Affairs, a subsidiary of Teleflex Incorporated (USA). Above the logo is the number K972423. The text is black and the background is white. The logo is bold and easy to read.
Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108
510 K Summary
[As required by 21 CFR 807.92]
- Submitter Name, Address, and Date of Submission. 1.
Mr. James R. Whitney Group Requlatory Affairs Associate Willy Rüsch AG Group Tall Pines Park Jaffrey, New Hampshire 03452
Telephone: (603) 532-7706
Contact: Same as above
-
- Name of the Device, Common, Proprietary (if Known), and Classification.
Classification Name: Tracheostomy Tube
- Name of the Device, Common, Proprietary (if Known), and Classification.
Common Name: Tracheostomy Tube
Proprietary Name: TracheoFix-Set
3. Identification of the legally marketed device to which the submitter claims equivalence.
The Rusch TracheoFix-Set is substantially equivalent in design, use, and materials to the Mallinckrodt (Shiley) Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, the Smiths Industries Medical Systems (Concord/Portex) D.I.C. Tracheostomy Tubes, Cuffed and the Bivona Medical Technologies AIRE-CUF® Tracheostomy Tube .
4 . Description of the Product:
The TracheoFix-Set consists of the following:
- . outer tube with low pressure cuff and pilot balloon, flexible fixation flange and turn lock fastener (the flange is not adjustable).
1
- luer activated valve for cuff inflation/deflation .
- luer activated valve for carr inituseem.
Inner tube with standard taper and a replacement inner . tube - introducer .
- standard connector .
- neck band .
· neck band
The Rusch TracheoFix-Set is a sterile, single patient, The Rusch fracheorin , pressure tracheostomy tube.
Intended Use of the Device. 5.
The Rusch TracheoFix-Set (TFS) is a single patient The Rusch Tracheorin Sol Tube for airway management of tracheostomized patients.
Summary of Technological Characteristics. 6.
The following technological characteristics are the same as or equivalent to predicate devices:
The TracheoFix-Set Cuffed tracheostomy tube is equivalent to predicate devices in materials, design characteristics, function and intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 1998
Mr. James R. Whitney Group Regulatory Affairs Associate Rüsch International Tall Pines Park Jaffrey, NH 03452
Re : K972423 Rüsch TracheoFix-Set Requlatory Class: II (two) 73 JOH Product Code: November 14, 1997 Dated: Received: November 17, 1997
Dear Mr. Whitney:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known):
TracheoFix-Set Device Name:
Indications for Use:
. . .
The Rusch TracheoFix-Set (TFS) is a single patient disposable tracheostomy Tube for airway management of tracheostomized patients.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Re- and Neurological Devices | |
| 510(k) Number | K972423 |
OR Over-The-Counter Use
Prescription Use
(Per 21 CFR 801.109)