(15 days)
Not Found
No
The description focuses on the mechanical components and function of a tracheostomy tube, with no mention of AI or ML capabilities.
No
The device facilitates airway management by providing access to the trachea, but it does not directly treat a disease or condition. It acts as a component of a life-sustaining device.
No
The device is described as providing "tracheal access for airway management" and an "artificial airway," which are therapeutic or supportive functions, not diagnostic ones.
No
The device description clearly lists physical components such as an outer cannula, inner cannula, tube holder, neck strap, and obturator, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "placement into a surgical opening of the trachea to provide tracheal access for airway management." This is a direct intervention on the patient's body for therapeutic or supportive purposes.
- Device Description: The description details a physical tube and associated components used to create and maintain an artificial airway. This is a medical device used for physiological support.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens for diagnostic purposes.
Therefore, the Mallinckrodt Inc. Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula is a medical device used for airway management, not an IVD.
N/A
Intended Use / Indications for Use
The Mallinckrodt Inc. Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and The Mallinektodt inc. Shiley Tractico son Aced into a surgical opening of the traches to Disposable Inner Cannula are michued to be placed into a search of eachers of a between the trachean wall and the tracheostomy tube. This device is intended to be a component of a life-sustaining device to be used with adult patients.
Product codes
JOH
Device Description
The Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula includes an extended length outer cannula, extended length disposable inner cannula, tracheostomy tube holder, neck strap, and obturator. The device is used to provide an artificial airway, in order to provide access to the patient's airway for airway management. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The tracheostomy tube is secured by means of the swivel neck plate/flange that is connected to a tracheostomy tube holder or neck strap. When appropriately connected to a tracheostomy tube holder or neck strap, the device provides a secure artificial airway for spontaneous or mechanical ventilation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
traches
Indicated Patient Age Range
adult patients.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
tyco Healthcare
Nellcor
JUN 16 2005
K 0514/16
4280 Hacienda Drive Pleasanton, CA 94588
Tele: 925 463-4000 Fax: 925 463-4020
510(k) Summary
| Submitted by: | Nellcor Puritan Bennett, Inc.
4280 Hacienda Drive
Pleasanton, CA 94588 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | James Patrick Garvey II, RRT, RAC
Regulatory Affairs Manager
(925) 463-4479 - Phone
(925) 463-4020 - FAX |
| Date Summary Prepared: | April 11, 2005 |
| Product Name: | Shiley TracheoSoft XLT Extended Length
Tracheostomy Tube and Disposable Inner Cannula |
| Common Name: | Tracheostomy Tube |
| Classification: | Class II; Tracheostomy tube and cuff 21 CFR
§868.5800 |
| Legally Marketed
(Unmodified) Device: | • Mallinckrodt, Inc, K003315,
Shiley TracheoSoft XLT Extended Length
Tracheostomy Tube and Disposable Inner Cannula |
DEVICE DESCRIPTION
The Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula includes an extended length outer cannula, extended length disposable inner cannula, tracheostomy tube holder, neck strap, and obturator. The device is used to provide an artificial airway, in order to provide access to the patient's airway for airway management. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The tracheostomy tube is secured by means of the swivel neck plate/flange that is connected to a tracheostomy tube holder or neck strap. When appropriately connected to a tracheostomy tube holder or neck strap, the device provides a secure artificial airway for spontaneous or mechanical ventilation.
INTENDED USE
- Purpose of The Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and . Disposable Inner Cannula is to provide tracheal access for airway management.
- . The device is intended for use on adult patients.
INTENDED ENVIRONMENT OF USE:
- . The device is intended for use in hospitals and hospital-type facilities, surgery centers, and home care environments.
1
- . The device is contraindicated in procedures which will involve the use of LASER or an electrosurgical active electrode in the immediate area of the device. Contact of the beam or electrode with tracheostomy tube and inner cannula, especially in the present of oxygenenriched or nitrous oxide containing mixtures could result in the rapid combustion of the tube with harmful thermal effects and with emission of corrosive and toxic combustion products including hydrochloric acid (HCl).
- . The device is intended for sale by or on the order of a physician only.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The intended use of the modified Shiley TracheoSoft Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula is the same as that for previously marketed Shiley TracheoSoft Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula. The materials and design of this device are similar to those of the predicate device. The technical characteristics of the device modification do not introduce new questions regarding safety or effectiveness of critical care ventilators. Furthermore, the labeling associated with The Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula provides similar information as the predicate devices.
Information provided in this Special 510(k) submission provides comparative, predicate device information and describes development procedures that support the determination of substantial equivalence and assertion that the modified device is safe and effective for its intended use. Product design and development, (including verification testing, test and quality procedures) were conducted using internal company requirements, referencing external standards.
In summary, Nellcor Puritan Bennett has provided information that indicates the Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula to be safe and effective. This device is considered to be substantially equivalent to currently marketed devices, incorporating designs that have been previously cleared by FDA.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health and Human Services (HHS). The logo features the department's seal, which includes an emblem of an eagle with three stylized lines representing its wings. The seal is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
JUN 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mallinckrodt Medical C/O Mr. Patrick Garvey Nellcor Puritan Bennett Incorporated 4280 Hacienda Drive Pleasanton, California 94588
Re: K051416
Trade/Device Name: Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: May 31, 2005 Received: June 1, 2005
Dear Mr. Garvey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Senyite G. Michael Ond.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 510(k) Number (if known): | |
|---|---|
| --------------------------- | -- |
Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Device Name: Disposable Inner Cannula
Indications For Use:
The Mallinckrodt Inc. Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and The Mallinektodt inc. Shiley Tractico son Aced into a surgical opening of the traches to Disposable Inner Cannula are michued to be placed into a search of eachers of a between the trachean wall and the tracheostomy tube. This device is intended to be a component of a life-sustaining device to be used with adult patients.
(per 21 CFR 801.109) Yes Prescription Use:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Senette Michie Dm.D.
(Division Sign-Off) (Childon Gigh-Olf)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K051416