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

The Bivona® Adjustable Neckflange Hyperflex™ Tracheostomy Tube is not intended for long term use. It is intended to provide temporary airway access for a tracheostomized patient when determining the optimal tube length for a patient. It must be replaced with a fixed neck flange tracheostomy tube when the optimal length is determined.

The Bivona® Adjustable and Fixed Neckflange Hyperflex™ Tracheostomy Tubes with wire reinforcement have been determined to be MR-conditional. They may be used in a static magnetic field of 3-Testa or less with spatial gradient magnetic field of 720-Gauss/cm 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® Adjustable and Fixed Neckflange Hyperflex™ Tracheostomy Tubes are contraindicated for use with lasers or electrosurgical devices where their output may contact and damage the tube. The Bivona® Adjustable Neckflange Hyperflex™ Tracheostomy Tube is contraindicated for use in home care settings.

Device Description

The Bivona® Adjustable and Fixed Neckflange Tracheostomy Tubes are sterile, single patient use, silicone tracheostomy tubes. They come in a variety of configurations for adults and pediatrics. They come cuffed (TTS®, Aire-Cuf® or Fome-Cuf®) or cuffless. The tubes are wire reinforced. 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 modify the indications for use for these devices to include the use of a properly placed Bivona® Adiustable and Fixed Neckflange Hyperflex™ Tracheostomy Tubes in the MRI environment. No changes have been made to the devices themselves.

AI/ML Overview

The medical device described in the provided text is the Bivona® Adjustable and Fixed Neckflange Hyperflex™ Tracheostomy Tubes. The recent submission is a modification to the indications for use to include the use of these tubes in an MRI environment, as no changes were made to the devices themselves.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Condition for MR-Conditional)	Reported Device Performance
Static magnetic field of 3-Tesla or less	3-Tesla or less
Spatial gradient magnetic field of 720-Gauss/cm or less	720-Gauss/cm or less
Maximum MR system reported whole-body averaged specific absorption rate (SAR) of 3-W/Kg for 15 minutes of scanning	3-W/Kg for 15 minutes of scanning
Temperature rise of less than or equal to 0.4°C	0.4°C was noted (at stated SAR conditions)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the "sample size" in terms of how many tracheostomy tubes were tested. The testing was bench testing.
Data Provenance: The study was a non-clinical bench test. There is no information regarding the country of origin, but it can be inferred that the testing was conducted by or for Smiths Medical ASD, Inc., which is an American company. The testing is described as "bench testing," meaning it was conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this submission. The ground truth for proving MR-conditional status of a medical device is established through calibrated measurement instruments and adherence to standardized testing protocols (e.g., ASTM standards for MRI safety of medical devices), not through expert consensus on qualitative observations.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human readers or expert consensus, not in non-clinical bench testing for physical properties. The bench testing would have yielded quantitative results directly from instruments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for assessing the performance of AI algorithms in diagnostic imaging interpretation and their impact on human readers, which is not the subject of this 510(k) submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

No, a standalone algorithm performance study was not conducted. This submission concerns the MR-conditional status of a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used was based on objective physical measurements and established scientific principles related to MRI safety (e.g., electromagnetic interference, heating, and magnetic field interactions). The determination of MR-conditional status is based on adhering to predefined limits for temperature rise, artifact generation, and movement within a specified MRI environment.

8. Sample Size for the Training Set

This information is not applicable. This submission does not involve an AI algorithm or machine learning model that would require a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there was no training set for an AI algorithm.

Summary

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K081440

SEP 1 2 2008

SECTION 5: 510(k) Summary

l. Company Information Smiths Medical ASD, Inc. 5700 West 23rd Avenue Gary, IN 46406 USA
1. Contact Person: Barbara Law Regulatory Affairs Manager Phone: (614)791-5568 Fax: (866)226-7156 Date prepared: May 20, 2008

III. Device Trade/Proprietary Name Trade/Propriety Name:

Bivona® Adjustable and Fixed Neckflange Hyperflex™ Tracheostomy Tube Tracheostomy Tubes

IV. Device Classification Name

Classification Name: Classification Code/Regulation: Common/Usual Name:

Tracheostomy tube and tube cuff JOH, 21 CFR 868.5800 Tracheostomy Tubes

V. Identification of Predicate Device

The Bivona® Adjustable and Fixed Neckflange Hyperflex™ Tracheostomy Tubes are identical to the Bivona® Adjustable and Fixed Neckflange Hyperflex™ Tracheostomy Tubes currently marketed by Smiths Medical. This modification consists of changes to the marketing claims and not the devices. Substantial equivalence and predicate device information is not applicable.

VI. Device Description

VII. Indications for Use

The Bivona® Fixed Neckflange Hyperflex™ 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.

The Bivona® Adjustable Neckflange Hyperflex™ Tracheostomy Tube is not intended for long term use. It is intended to provide temporary airway access for a

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tracheostomized patient when determining the optimal tube length for a patient. It must be replaced with a fixed neck flange tracheostomy tube when the optimal length is determined.

The Bivona® Adjustable and Fixed Neckflange Hyperflex™ Tracheostomy Tubes with wire reinforcement have been determined to be MR-conditional. They may be used in a static magnetic field of 3-Tesla or less with spatial gradient magnetic field of 720-Gauss/cm or less and maximum MR system reported whole-body averaged specific absorption rate (SAR) of 3-W/Kg for 15 minutes of scanning. Special care should be taken as follows:

(1) Ensure that the tracheostomy tube is firmly secured using the tracheostomy tube holder supplied or equivalent commercially available fixation device in order to prevent movement in the MRI environment.
(2) Ensure that the inflation valve is securely taped down in order to prevent its movement in the MRI environment.
(3) MR image quality may be compromised if the area of interest is close to the position of the tube and/or inflation valve. The inflation valve should be secured away from the area of interest. Optimization of MR imaging parameters to compensate for the presence of this device may be necessary.
(4) A temperature rise of less than or equal to 0.4℃ was noted at a maximum MR system-reported whole body averaged specific absorption rate (SAR) of 3-W/kg for 15-minutes of MR scanning in a 3-Tesla MR system using a transmit/receive body coil.

VIII. Technological Characteristics

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

IX. Non-Clinical Data

Bench testing confirms that the Bivona® Adjustable and Fixed Neckflange Tracheostomy Tubes with wire reinforcement have been determined to be MRconditional under the following conditions: a static magnetic field of 3-Tesla or Jess with spatial gradient magnetic field of 720-Gauss/cm or less and maximum MR system reported whole-body averaged specific absorption rate (SAR) of 3-W/Kg for 15 minutes of scanning.

X. Clinical Data

Not required.

XI. Conclusion

Bench testing confirms that the Bivona® Adjustable and Fixed Neckflange Tracheostomy Tubes with wire reinforcement have been determined to be MRconditional.

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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 eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, using a black and white color scheme.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2008

Ms. Barbara Law Regulatory Affairs Manager Smiths Medical ASD, Incorporated 6250 Shier Rings Road Dublin, Ohio 43016

Re: K081440

Trade/Device Name: Bivona® Adjustable and Fixed Neckflange HyperflexTM Tracheostomy Tubes Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: August 22, 2008 Received: September 9, 2008

Dear Ms. Law:

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. Law

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hilamuelss-Kind mr
frei

Chiu S. Lin, Ph. D Division 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):

Device Name: Bivona® Adjustable and Fixed Neckflange Hyperflex™ Tracheostomy Tubes

Indications for Use:

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)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control. Dental Devices

510(k) Number:

Regulation Number and Section

§ 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.