FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED

K972385 · Smiths Industries Medical Systems, Inc. · JOH · Jan 20, 1998 · Anesthesiology

Device Facts

• Record ID: K972385
• Device Name: FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
• Applicant: Smiths Industries Medical Systems, Inc.
• Product Code: JOH · Anesthesiology
• Decision Date: Jan 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The Fenestrated Flexible D.I.C. Tracheostomy Tube is a medical device designed for airway management in tracheostomized patients. It consists of a polyvinyl chloride tube featuring three fenestrations, a high-volume, low-pressure cuff, an inflation line with an indicator, and a self-sealing luer one-way valve. Radiopaque material is integrated throughout the tube length. The device is used by clinicians to provide tracheal access and facilitate weaning from mechanical ventilation. By deflating the cuff, the fenestrations allow for spontaneous breathing through the upper airway, enabling patient phonation. A red decannulation cap may be used to occlude the proximal end. The fenestration locations are optimized based on anatomical data to accommodate a broader patient population.

Clinical Evidence

No clinical or nonclinical testing data required.

Technological Characteristics

Constructed of implant-tested polyvinyl chloride. Features three fenestrations, high-volume/low-pressure cuff, inflation indicator, and self-sealing luer one-way valve. Radiopaque material incorporated throughout. Design optimized for anatomical fit based on literature-derived mean sagittal diameter and skin-to-trachea dimensions.

Indications for Use

Indicated for airway management of tracheostomized patients requiring tracheal access, specifically those needing fenestration to facilitate weaning from mechanical ventilation or adjunctive airway support and to enable phonation.

Regulatory Classification

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.

Predicate Devices

• 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

Submission Summary (Full Text)

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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".

K972385

#### SIMS Inc.

JAN 20 1998

15 Kit Street Keene, NH 03431 Telephone: [phone] Fax: [phone]

# J: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

# 510(K) SUMMARY

#### COMPANY INFORMATION

Smiths Industries Medical Systems, Inc. 15 Kit Street Keene, NH FAX: [phone] 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

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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

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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.

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#### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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## 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) | <img alt="sign" src="file:///C:/Users/rauna/Downloads/image.png" width="100"/> |
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| (Division Sign-Off) Division of Cardiovascular. Respiratory, and Neurological Devices | |
| 510(k) Number | K972385 |

| Prescription Use | <img alt="check" src="file:///C:/Users/rauna/Downloads/image.png" width="20"/> |
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| Over-The-Counter Use | |