(247 days)
Not Found
No
The device description and intended use are for a physical tracheostomy tube and its accessories, with no mention of software, data processing, or AI/ML capabilities.
No.
The device provides tracheal access for airway management and an artificial airway to assist in the treatment of respiratory diseases, which are supportive functions rather than direct therapeutic actions to cure or treat a disease.
No
Explanation: The device is a tracheostomy tube designed for providing tracheal access and facilitating ventilation, which are therapeutic functions, not diagnostic ones.
No
The device description clearly describes a physical tracheostomy tube with disposable inner cannulas, which is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide tracheal access for airway management and facilitate ventilation. This is a direct intervention on the patient's airway.
- Device Description: The description details a physical device inserted into the trachea to create an artificial airway.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples like blood, urine, or tissue. This device is used in vivo (inside the body) for therapeutic and airway management purposes.
N/A
Intended Use / Indications for Use
The Shiley FlexTra Tracheostomy Tube with Disposable Inner Cannula is intended to provide tracheal access for airway management.
Cuffed Shiley FlexTra products sizes 7.0, 8.0, and 9.0 mm ID are also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.
Product codes
JOH
Device Description
The Shiley FlexTra disposable tracheostomy tubes are double cannula tracheostomy tubes with disposable inner cannula. The device is latex-free, sterile, and for single patient use only.
The device is intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The device is used to provide an artificial airway in order to assist in the treatment of a variety of respiratory diseases and airway management for adult patients. After insertion in place through a tracheotomy incision in the patient's neck and trachea, the device is then secured in place through the tracheostomy tube's swivel neck plate/flange with the use of a neck strap. Once in place, the device provides a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.
Selected cuffed Shiley FlexTra products are also intended for use in conjunction with Percutaneous Dilatational Tracheotomy. The device is inserted into the patient using the appropriate loading dilator provided in a separate percutaneous dilatational kit. The device is intended to be used as an artificial airway immediately post tracheotomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trachea, neck
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The technological characteristics of the Shiley FlexTra tracheostomy tube and the results of bench tests do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003315, K962173, K963732, K880247, K811447, K810106
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
Image /page/0/Picture/0 description: The image shows a handwritten text string that appears to be an identifier or code. The string is "K030787". The characters are written in a bold, somewhat stylized manner, with the numbers being distinct and legible. The text is slightly tilted, giving it a dynamic appearance.
tuco
Healthcare
Nellcor
NOV 1 4 2003
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: | Gina To
Senior Regulatory Affairs Project Manager
(925) 463-4427
(925) 463-4020 — FAX |
| Date Summary Prepared: | June 24, 2003 |
| Trade Name: | Shiley® FlexTra™ Tracheostomy Tube |
| Common/Usual Name: | Tracheostomy Tube |
| Classification Name: | Tube Tracheostomy and Tube Cuff
JOH per 21CFR §868.5800 |
Substantially Equivalent Devices:
-
- Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula, Mallinckrodt Inc., K003315
- Shiley Tracheostomy Tubes and Accessories, Mallinckrodt Medical, K962173 2.
-
- Shiley Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure / Lower Profile Cuff and Disposable Inner Cannula, Mallinckrodt Medical Inc., K963732
-
- Modified Shiley Low Pressure Cuffed Tracheostomy Tube, Shiley Inc., K880247
- న్. Shiley Disposable Cannula Tracheostomy Tube with Low Pressure Cuff and Disposable Inner Cannula, Shiley Inc., K811447
-
- Shiley Cuffed Single Cannula SCT Tracheostomy Tubes, Shiley Inc., K810106
DEVICE DESCRIPTION
The Shiley FlexTra disposable tracheostomy tubes are double cannula tracheostomy tubes with disposable inner cannula. The device is latex-free, sterile, and for single patient use only.
The device is intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The device is used to provide an artificial airway in order to assist in the treatment of a variety of respiratory diseases and airway management for adult patients. After insertion in place through a tracheotomy incision in the patient's neck and trachea, the device is then secured in place through the tracheostomy tube's swivel neck plate/flange with the use of a neck strap. Once in place, the device provides
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a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.
Selected cuffed Shiley FlexTra products are also intended for use in conjunction with Percutaneous Dilatational Tracheotomy. The device is inserted into the patient using the appropriate loading dilator provided in a separate percutaneous dilatational kit. The device is intended to be used as an artificial airway immediately post tracheotomy.
INDICATIONS FOR USE
The Shiley FlexTra Tracheostomy Tube with Disposable Inner Cannula is intended to provide tracheal access for airway management.
Cuffed Shiley FlexTra products sizes 7.0, 8.0, and 9.0 mm ID are also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES
The Shiley FlexTra tracheostomy tube incorporates features and materials from the referenced Shiley predicate devices. The features that differentiate the Shiley FlexTra tracheostomy tube from the predicate devices include lengths, material of the inner cannula, and rigid tip on selected sizes of tracheostomy tubes designed to facilitate percutaneous dilatational tracheotomy insertion.
CONCLUSIONS
The technological characteristics of the Shiley FlexTra tracheostomy tube and the results of bench tests do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
NOV 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nellcor Puritan Bennett, Incorporation Ms. Gina To Regulatory Affairs Manager 4280 Hacienda Drive Pleasanton, California 94588
Re: K030787
Trade/Device Name: Shiley Flextra Tracheostomy Tube Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: October 10, 2003 Received: October 14, 2003
Dear Ms. To:
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 your 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
Page 2 - Ms. To
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 (OS) 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 (301) 594- 4646 . 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/dsma/dsmamain.html
Sincerely yours,
Quls
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
Page of
510(k) Number (if known):
Device Name: Shiley® FlexTra™ Tracheostomy Tube
Indications For Use:
The Shiley FlexTra Tracheostomy Tube with Disposable Inner Cannula is intended to provide tracheal access for airway management.
Cuffed Shiley FlexTra products sizes 7.0, 8.0, and 9.0 mm ID are also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
vision Sian-Off n of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
Prescription Use ^
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Optional Format (1-2-96)
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