BIVONA TRACHEOSTOMY TUBES

K083641 · Smiths Medical Asd, Inc. · JOH · Feb 23, 2009 · Anesthesiology

Device Facts

• Record ID: K083641
• Device Name: BIVONA TRACHEOSTOMY TUBES
• Applicant: Smiths Medical Asd, Inc.
• Product Code: JOH · Anesthesiology
• Decision Date: Feb 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Bivona® Tracheostomy Tube is intended to provide direct airway access for a tracheostomized patient up to 29 days. It may be reprocessed for single-patient use up to 10 times for adults sizes and up to 5 times for pediatric sizes.

Device Story

Bivona® Tracheostomy Tubes are sterile, single-patient-use silicone tubes providing direct airway access. Configurations include cuffed (TTS®, Aire-Cuf®, or Fome-Cuf®) or cuffless, with or without wire reinforcement. Used in clinical settings for tracheostomized patients. This submission updates marketing claims to include MRI compatibility. Bench testing confirms MR-Conditional status (3-Tesla or less) for wire-reinforced and specific cuffed models per ASTM F2503-05; non-reinforced cuffless/Fome-Cuf® models are MR-Safe. No changes to device design or materials.

Clinical Evidence

No clinical data. Bench testing only, confirming MR-Conditional and MR-Safe status per ASTM F2503-05.

Technological Characteristics

Silicone tracheostomy tubes; cuffed (TTS, Aire-Cuf, Fome-Cuf) or cuffless; wire-reinforced or plain. MR-Conditional (3-Tesla, 720-Gauss/cm, 3-W/Kg SAR) for wire-reinforced and specific cuffed models; MR-Safe for non-reinforced cuffless/Fome-Cuf models per ASTM F2503-05. Sterile, single-patient use, reprocessable.

Indications for Use

Indicated for tracheostomized patients (adult, pediatric, neonatal) requiring direct airway access for up to 29 days.

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

• Bivona® Tracheostomy Tubes (K081440)

Submission Summary (Full Text)

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K083641
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FEB 2 3 2009

## SECTION 5: 510(k) Summary

#### 1. Company Information

Smiths Medical ASD, Inc. 5700 West 23rd Avenue Gary, IN 46406 USA

#### -11. Contact Person:

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Timothy J. Talcott Director, Requlatory Affairs and Compliance Phone: [phone], ext. 2457 Fax: [phone]

#### lll. Device Trade/Proprietary Name Bivona® Tracheostomy Tube Tracheostomy Trade/Propriety Name: Tubes

IV. Device Classification Name

> Classification Name: Classification Code/Regulation: JOH, 21 CFR 868.5800 Common/Usual Name:

Tracheostomy tube and tube cuff Tracheostomy Tubes

#### V. Identification of Predicate Device

The Bivona® Tracheostomy Tubes are identical to the Bivona® Tracheostomy Tubes currently marketed by Smiths Medical. This modification consists of changes to the marketing claims and not the devices. The Bivona® Fixed and Adjustable Neckflange Hyperflex™ Tracheostomy Tubes were found to be MR-Conditional under 510K K081440.

#### VI. Device Description

The Bivona® Tracheostomy Tubes are sterile, single patient use, silicone tracheostomy tubes. They come in a variety of configurations for adults, pediatric and neonatal patients. They come cuffed (TTS®, Aire-Cuf® or Fome-Cuf®) or cuffless. The tubes may be wire reinforced or plain silicone. Each tube is individually packaged in a peel-open tray with an obturator, decannulation cap, twill tape, and a disconnection wedge if appropriate. Additionally, a range of customizable options are offered allowing the clinician to create a tracheostomy tube to meet a specific patient's needs.

The purpose of this submission is to include the use of properly placed Bivona® Tracheostomy Tubes in the MRI environment. No changes have been made to the devices themselves.

#### VII. Indications for Use

The Bivona® Tracheostomy Tube is intended to provide direct airway access for a tracheostomized patient up to 29 days. It may be reprocessed for single-patient use up to 10 times for adults sizes and up to 5 times for pediatric sizes.

### VIII. Technological Characteristics

There are no changes to the Bivona® Tracheostomy Tubes. The intention of this submission is to modify the marketing claims to include the use of these products in an MRI environment.

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K083641
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#### IX. Non-Clinical Data

Bench testing confirms that the Bivona® cuffless and Fome-Cuf Tracheostomy Tubes with wire reinforcement and Bivona® cuffed Tracheostomy Tubes (Aire-Cuf® or TTS®) with or without wire reinforcement have been determined to be MR-Conditional according to ASTM F2503-05 under the following conditions: a static magnetic field of 3-Tesla or less with spatial gradient magnetic field of 720-Gaussicm or less and maximum MR system reported whole-body averaged specific absorption rate (SAR) of 3-W/Kg for 15 minutes of scanning.

The Bivona® cuffless or Fome-Cuf® Tracheostomy Tubes without wire reinforcement have been determined to be MR-Safe according to ASTM F2503-05 based on the nature of the materials of construction. They contain no metal.

#### X. Clinical Data

Not required.

#### XI. Conclusion

Bench testing confirms that the Bivona® cuffless and Fome-Cuf Tracheostomy Tubes with wire reinforcement and Bivona® cuffed Tracheostomy Tubes (Aire-Cuf® or TTS®) with or without wire reinforcement have been determined to be MR-Conditional according to ASTM F2503-05 and the Bivona® cuffless or Fome-Cuf® Tracheostomy Tubes without wire reinforcement have been determined to be MR-Safe according to ASTM F2503-05.

SMITHS MEDICAL ASD, INC.

Timothy Ralon

Timothy J. Talcott Director, Regulatory Affairs and Compliance

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 2 3 2009

Mr. Daniel Coates Senior, Design Engineer Smith's Medical ASD, Incorporated 5700 West 23td Avenue Gary, Indiana 46406

Re: K083641

Trade/Device Name: Bivona® Tracheostomy Tubes Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: February 16, 2009 Received: February 17, 2009

Dear Mr. Coates:

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 -- Mr. Coates

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours.

Sutte H. Michael Davis.

Ginette Y. Michaud, M.D. Acting 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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## SECTION 4: Indications for Use Statement

# Indications for Use

510(k) Number (if known): K083641 ·

Device Name: Bivona® Tracheostomy Tubes

Indications for Use:

The Bivona® Tracheostomy Tube is intended to provide direct airway access for a tracheostomIzed patient up to 29 days. It may be reprocessed for single-patient use up to 10 times for adults sizes and up to 5 times for pediatric sizes.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Lan M.Z.

(Division Sign-Off) Division of Anestnesiology, General Hospital Infection Control, Dental Devices

2083641 510(k) Number: _