(113 days)
Not applicable.
No Reference Device(s) K/DEN numbers were found in the text.
No
The document describes a physical medical device (tracheostomy tube) and its intended use, contraindications, and MR compatibility. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The submission focuses on modifying the indications for use related to the MRI environment, not on adding new technological capabilities.
Yes
The device is intended to provide direct airway access for tracheostomized patients, which is a therapeutic intervention to manage their breathing.
No
The device is a tracheostomy tube that provides airway access and is not used for diagnosing medical conditions.
No
The device description clearly states it is a physical tracheostomy tube made of silicone, which is a hardware component. The submission is for a modification to the indications for use related to MRI compatibility, not for a software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Bivona® Tracheostomy Tube is a medical device intended to provide direct airway access for a patient. It is a physical device inserted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes providing airway access and being used in an MRI environment. It does not mention any diagnostic testing of biological samples.
Therefore, the Bivona® Tracheostomy Tube falls under the category of a medical device, specifically a respiratory support device, rather than an in vitro diagnostic.
N/A
Intended Use / 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 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.
Product codes
JOH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
airway
Indicated Patient Age Range
adults, pediatric
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® 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Predicate Device(s)
Not applicable.
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.
0
SEP 1 2 2008
SECTION 5: 510(k) Summary
- l. Company Information Smiths Medical ASD, Inc. 5700 West 23rd Avenue Gary, IN 46406 USA
-
- 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
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.
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
1
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.
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.
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.
2
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.
3
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
4
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:
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.
| 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: