(76 days)
Not Found
No
The summary describes a physical medical device (tracheostomy tube) and its MR compatibility testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device provides airway access and is not intended for the treatment or prevention of a disease or condition itself.
No
Explanation: The device is a tracheostomy tube designed to provide direct airway access. Its intended use is to facilitate breathing and manage a patient's airway, not to diagnose a medical condition.
No
The device description clearly states it is a physical tracheostomy tube made of silicone, including various configurations and accessories. The submission is for adding MRI compatibility, not for a software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide direct airway access for a tracheostomized patient." This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description details a physical tube inserted into the airway. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples in vitro (outside the body).
- Detecting or measuring specific substances or markers.
- Providing information for diagnosis, monitoring, or screening.
The device is a medical device used for airway management, and the submission focuses on its compatibility with MRI.
N/A
Intended Use / 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.
Product codes
JOH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
adults, pediatric and neonatal patients.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
2
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.
3
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
4
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: _