SHILEY FLEXTRA TRACHEOSTOMY TUBE

K030787 · Nellcor Puritan Bennett, Inc. · JOH · Nov 14, 2003 · Anesthesiology

Device Facts

• Record ID: K030787
• Device Name: SHILEY FLEXTRA TRACHEOSTOMY TUBE
• Applicant: Nellcor Puritan Bennett, Inc.
• Product Code: JOH · Anesthesiology
• Decision Date: Nov 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Double cannula tracheostomy tube with disposable inner cannula; latex-free; sterile; single-patient use. Inserted into surgical tracheal opening to provide artificial airway for spontaneous breathing or connection to ventilation/anesthesia equipment. Secured via swivel neck plate/flange and neck strap. Selected cuffed models (7.0, 8.0, 9.0 mm ID) include rigid tip for use with percutaneous dilatational tracheotomy (PDT) kits. Used in clinical settings for airway management in adult patients. Healthcare providers insert device to facilitate ventilation; output is a secure airway path. Benefits include reliable airway access and compatibility with PDT procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Double cannula tracheostomy tube; latex-free; sterile. Features include disposable inner cannula, swivel neck plate/flange, and rigid tip on specific cuffed sizes (7.0, 8.0, 9.0 mm ID) for PDT insertion. Materials and design derived from existing Shiley product lines.

Indications for Use

Indicated for adult patients requiring tracheal access for airway management, including respiratory disease treatment and ventilation support. Cuffed versions (7.0, 8.0, 9.0 mm ID) indicated for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.

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

• Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula (K003315)
• Shiley Tracheostomy Tubes and Accessories (K962173)
• Shiley Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure / Lower Profile Cuff and Disposable Inner Cannula (K963732)
• Modified Shiley Low Pressure Cuffed Tracheostomy Tube (K880247)
• Shiley Disposable Cannula Tracheostomy Tube with Low Pressure Cuff and Disposable Inner Cannula (K811447)
• Shiley Cuffed Single Cannula SCT Tracheostomy Tubes (K810106)

Submission Summary (Full Text)

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# tuco

Healthcare

Nellcor

NOV 1 4 2003

4280 Hacienda Drive Pleasanton, CA 94588

Tele: 925 463-4000 Fax: [phone]

## 510(k) Summary

| Submitted by: | Nellcor Puritan Bennett, Inc.<br>4280 Hacienda Drive<br>Pleasanton, CA 94588 |
|------------------------|------------------------------------------------------------------------------------------------|
| Company Contact: | Gina To<br>Senior Regulatory Affairs Project Manager<br>[phone]<br>[phone] — 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<br>JOH per 21CFR §868.5800 |

### Substantially Equivalent Devices:

- 1. Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula, Mallinckrodt Inc., K003315
- Shiley Tracheostomy Tubes and Accessories, Mallinckrodt Medical, K962173 2.
- 3. Shiley Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure / Lower Profile Cuff and Disposable Inner Cannula, Mallinckrodt Medical Inc., K963732
- 4. 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
- 6. 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.

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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.

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#### 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 [phone] or [phone] 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

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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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