(208 days)
Our Flexible D.I.C. Tracheostomy Tube, Fenestrated Blue Line Tracheostomy Tube, Fenestrated D.I.C. Tracheostomy Tube, Shiley's fenestrated low pressure cuffed tracheostomy tube, Boston Medical Products' Tracoe fex® fenestrated tracheostomy tube.
Not Found
No
The description focuses on the physical characteristics and intended use of a tracheostomy tube, with no mention of AI or ML capabilities.
Yes
The device aids in weaning patients from mechanical ventilation, providing a means for phonation, which directly contributes to the patient's recovery and well-being.
No
Explanation: The device is a tracheostomy tube designed for airway management and weaning from mechanical ventilation. It provides a means for ventilation and phonation, but it does not diagnose any condition or disease.
No
The device description clearly states it is a physical tracheostomy tube made of polyvinyl chloride with a cuff, inflation line, and fenestrations. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for airway management in a tracheostomized patient. This is a direct intervention on the patient's body for therapeutic and supportive purposes.
- Device Description: The description details a physical tube designed to be inserted into the trachea. It mentions materials, a cuff, and fenestrations, all consistent with a medical device used for airway access and management.
- 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 outside the body to analyze biological samples. This device is used inside the body to manage the airway.
N/A
Intended Use / Indications for Use
The Fenestrated Flexible D.I.C. Tracheostomy Tube is indicated for airway management of the tracheostomized patient for providing tracheal access where the use of a fenestration is desirable in order to allow for safe and effective weaning from mechanical ventilation or adjunctive airway support. With the cuff deflated, primary ventilation is allowed to be spontaneous through the fenestrations and around the main tube. This provides a means for phonation when the patient breaths through his/her upper airway. A red decannulation cap can be used to occlude the proximal end of the tracheostomy tube.
Product codes (comma separated list FDA assigned to the subject device)
73 JOH
Device Description
The Fenestrated Flexible D.I.C. Tracheostomy Tube is made of implant tested, polyvinyl chloride with compatible profile, high volume, low pressure cuff. Radiopaque material is incorporated into the full length of the Fenestrated Flexible D.I.C. Tracheostomy Tube. The cuff inflation line has an inflation indicator and a self sealing luer one-way valve. The tracheostomy tube has three fenestrations on the radius of the tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea, upper airway
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 required.
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.
Our Flexible D.I.C. Tracheostomy Tube, Fenestrated Blue Line Tracheostomy Tube, Fenestrated D.I.C. Tracheostomy Tube, Shiley's fenestrated low pressure cuffed tracheostomy tube, Boston Medical Products' Tracoe fex® fenestrated 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
SMITHS INDUSTRIES
Image /page/0/Picture/1 description: The image shows the words "Medical Systems" in a serif font. The words are black and are underlined. To the left of the words is a black graphic that appears to be the letters "LS".
SIMS Inc.
JAN 20 1998
15 Kit Street Keene, NH 03431 Telephone: (603) 352-3812 Fax: (603) 352-3703
J: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY
COMPANY INFORMATION
Smiths Industries Medical Systems, Inc. 15 Kit Street Keene, NH FAX: 603-357-5038 Timothy J. Talcott Manager, Regulatory Affairs
PREPARATION DATE OF SUMMARY
June 24, 1997
TRADE NAME
Fenestrated Flexible D.I.C. Tracheostomy Tube
COMMON NAME
Tracheostomy Tube, with or without a cuff
CLASSIFICATION NAME
Class II, 73 JOH, 21 CFR 868.5800.
PREDICATE DEVICE
Our Flexible D.I.C. Tracheostomy Tube, Fenestrated Blue Line Tracheostomy Tube, and Fenestrated D.I.C. Tracheostomy Tube. Also, Shiley's fenestrated low pressure cuffed tracheostomy tube and Boston Medical Products' Tracoe fex® fenestrated tracheostomy tube.
DESCRIPTION
The Fenestrated Flexible D.I.C. Tracheostomy Tube is made of implant tested, polyvinyl chloride with compatible profile, high volume, low pressure cuff. Radiopaque material is incorporated into the full length of the Fenestrated Flexible D.I.C. Tracheostomy Tube. The cuff inflation line has an inflation
1
indicator and a self sealing luer one-way valve. The tracheostomy tube has three fenestrations on the radius of the tube.
INDICATIONS FOR USE
The Fenestrated Flexible D.I.C. Tracheostomy Tube is indicated for airway management of the tracheostomized patient for providing tracheal access where the use of a fenestration is desirable in order to allow for safe and effective weaning from mechanical ventilation or adjunctive airway support. With the cuff deflated, primary ventiation is allowed to be spontaneous through the fenestrations and around the main tube. This provides a means for phonation when the patient breaths through his/her upper airway. A red decannulation cap can be used to occlude the proximal end of the tracheostomy tube.
TECHNOLOGICAL CHARACTERISTICS
The location of the fenestrations are relocated to accomodate a greater percentage of the population. The location of the fenestrations has been determined based on a literature search taking into account the mean sagittal diameter and mean skin to trachea dimension.
SUMMARY OF PERFORMANCE DATA
Not required.
SUMMARY OF NONCLINICAL AND CLINICAL TESTS
Not required.
CONCLUSION OF NONCLINICAL AND CLINICAL TESTS
Not required.
ADDITIONAL INFORMATION
None
Very truly yours,
Smiths Industries Medical Systems, Inc.
Timothy J. Talcott
Manager of Regulatory Affairs
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 1998
Mr. Timothy J. Talcott Smiths Industries Medical Systems, Inc. 10 Bowman Drive P.O. Box 0724 Keene, NH 03431
K972385 Re : Fenestrated Flexible D.I.C. Tracheostomy Tube Regulatory Class: II (two) 73 JOH Product Code: November 26, 1997 Dated: December 2, 1997 Received:
Dear Mr. Talcott: .... ... ................................
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 assumptions. Failure to comply with the GMP regulation may result in 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
Page 2 - Mr. Timothy J. Talcott
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. Cal ahan, Ph. D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
B: INTENDED USE OF DEVICE
Page 1 of 1
510(k) Number (if known): Unknown
Device Name: Fenestrated Flexible D.I.C. Tracheostomy Tube
Indications For Use:
The Fenestrated Flexible D.I.C. Tracheostomy Tube is indicated for airway management of the tracheostomized patient for providing tracheal access where the use of a fenestration is desirable in order to allow for safe and effective weaning from mechanical ventilation or adjunctive airway support. With the cuff deflated, primary ventilation is allowed to be spontaneous through the fenestrations and around the main tube. This provides a means for phonation when the patient breaths through his/her upper airway. A red decannulation cap can be used to occlude the proximal end of the tracheostomy tube.
(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. Respiratory, and Neurological Devices | |
| 510(k) Number | K972385 |
| Prescription Use | |
|---|---|
| OR | |
| Over-The-Counter Use |