(76 days)
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.
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.
The Bivona® Tracheostomy Tube’s acceptance criteria for MR-Conditional status were based on the ASTM F2503-05 standard. The study involved bench testing that confirmed the device's performance against these criteria.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ASTM F2503-05 for MR-Conditional) | Reported Device Performance |
|---|---|
| Static Magnetic Field | ≤ 3-Tesla |
| Spatial Gradient Magnetic Field | ≤ 720-Gauss/cm |
| Maximum MR System Reported Whole-Body Averaged Specific Absorption Rate (SAR) | ≤ 3-W/Kg for 15 minutes of scanning |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified as a distinct "sample size" in the document. The document states "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..." This implies testing was conducted on representative samples of each specified configuration of the Bivona® Tracheostomy Tube.
- Data Provenance: The study was a non-clinical bench test. There is no information regarding country of origin or whether it was retrospective or prospective in the context of patient data, as no patient data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth was established by adherence to the ASTM F2503-05 standard for MR-Conditional status through bench testing, not through expert consensus on patient data.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical bench test against a standardized technical specification (ASTM F2503-05), not a study involving human interpretation or adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This was not an AI device or a study involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This was not an algorithm or AI device.
7. The Type of Ground Truth Used
The ground truth used was the ASTM F2503-05 standard for determining MR-Conditional and MR-Safe status. The device's physical properties and behavior under specified MRI conditions were directly measured and compared against the limits defined by this standard.
8. The Sample Size for the Training Set
Not applicable. There was no "training set" as this was a non-clinical bench test, not a machine learning or AI study.
9. How the Ground Truth for the Training Set was Established
Not applicable. There was no training set.
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K083641
p. 1 of 2
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:
ાં
Timothy J. Talcott Director, Requlatory Affairs and Compliance Phone: (603)352-3812, ext. 2457 Fax: (603)355-8157
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 (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.
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: _
§ 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.