(247 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical characteristics and material biocompatibility of a standard endotracheal tube, with no mention of AI or ML capabilities.
No.
The device is used for airway management and gas transport, which are supportive functions rather than directly therapeutic in nature.
No
The device is described as an "endotracheal tube" for "airway management," and its function is to transport gas and connect to a ventilator. This is a therapeutic or supportive function, not a diagnostic one.
No
The device description clearly describes a physical, single-lumen tube with a cuff, inflation tube, and pilot balloon, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "airway management by oral/nasal intubation of the trachea for anesthesia." This describes a device used in vivo (within the body) to manage a physical function (breathing).
- Device Description: The description details a physical tube used for gas transport and connected to a ventilator. This is a mechanical device for supporting respiration.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a person's health. This device does not perform any such analysis.
Therefore, based on the provided information, the Bard Endotracheal Tube, Cuffed is a medical device used for airway management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bard Endotracheal Tube, Cuffed is indicated for airway management by oral/nasal intubation of the trachea for anesthesia.
Product codes
BTR
Device Description
The Bard® Endotracheal Tube, Cuffed is a single lumen tube with a cuff. The lumen is used for ainway management/gas transport and is connected to a ventilator via a connector. The two-way valve on the cuff inflation tube is assembled to a pilot inflation line/pilot balloon assembly that is bonded to the tube to lead into the inflation lumen. The Bard Endotracheal Tube is offered in the following sizes: 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, and 10.0mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea
Indicated Patient Age Range
Not Found
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
The Bard® Endotracheal Tube, Cuffed is constructed of biocompatible materials and has been tested using ASTM F 1242-96, "Standard Specification for Cuffed and Uncuffed Tracheal Tubes". Both the Bard device and the predicate device meet the ASTM standard with the exceptions of radius of curvature and device markings.
Key Metrics
Not Found
Predicate Device(s)
Mallinckrodt Hi-Lo®/Intermediate Hi-Lo Tracheal Tube, Cuffed
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K030792". The characters are written in a bold, somewhat messy style, with varying stroke thicknesses. The image has a white background.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
- A. Submitter's Information:
| Submitter's Name: | C. R. Bard, Inc., Medical Division |
|---|---|
| Address: | 8195 Industrial Blvd. |
| Covington, Georgia 30014 | |
| Contact Person: | Frances E. Harrison, RAC |
| Contact Person's Phone: | (770) 784-6257 |
| Contact Person's Fax: | (770) 784-6419 |
| Date of Preparation: | August 28, 2003 |
- B. Device Name:
| Trade Name: | Bard® Endotracheal Tube, Cuffed |
|---|---|
| Common / Usual Name: | ET Tube |
| Classification Name: | Tracheal Tube |
- C. Predicate Device Name:
Mallinckrodt Hi-Lo®/Intermediate Hi-Lo Tracheal Tube, Cuffed
Trade Name: Same as above.
- D. Device Description: The Bard® Endotracheal Tube, Cuffed is a single lumen tube with a cuff. The lumen is used for ainway management/gas transport and is connected to a ventilator via a connector. The two-way valve on the cuff inflation tube is assembled to a pilot inflation line/pilot balloon assembly that is bonded to the tube to lead into the inflation lumen. The Bard Endotracheal Tube is offered in the following sizes: 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, and 10.0mm.
- The Bard Endotracheal Tube, Cuffed is indicated for airway E. Intended Use: management by oral/nasal intubation of the trachea for anesthesia.
1
- F. Technological Characteristics Summary: The Bard® Endotracheal Tube, Cuffed is constructed of polyvinyl chloride. It has the same intended use and design and is manufactured from the same biocompatible materials and offered in the same sizes as the predicate device.
- G. Performance Data Summary: The Bard® Endotracheal Tube, Cuffed is constructed of biocompatible materials and has been tested using ASTM F 1242-96, "Standard Specification for Cuffed and Uncuffed Tracheal Tubes". Both the Bard device and the predicate device meet the ASTM standard with the exceptions of radius of curvature and device markings.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human figures.
NOV 1 4 2003
Food and Drug Administration
Public Health Service
9200 Corporate Boulevard Rockville MD 20850
Ms. Frances E. Harrison, RAC Director, Regulatory Affairs C.R. Bard, Inc. 8195 Industrial Boulevard Covington, GA 30014
Re K030792
Trade/Device Name: Bard Endotracheal Tube, Cuffed Regulation Number: 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: August 15, 2003 Received: August 20, 2003
Dear Ms. Harrison:
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.
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
3
Page 2 - Ms. Harrison
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K030792 |
|---|---|
| --------------------------- | --------- |
Device Name: Bard® Endotracheal Tube
Indications for Use:
The Bard Endotracheal Tube, Cuffed is indicated for airway management by oral/nasal intubation of the trachea for anesthesia
(PLEASE DO NOT WRITE BELOW THIS LINE - CC NTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
1 Prescription Use (Per 21 CFR 801.109)
OR , Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1/2/96)
Huthausen
510(k) Number: K030792