(61 days)
Not Found
No
The description focuses on the physical characteristics and silver coating of the endotracheal tube, with no mention of AI or ML technology. The performance data relates to the reduction of VAP incidence, not the output of an AI/ML algorithm.
Yes
The device is intended to reduce the incidence of Ventilator Associated Pneumonia (VAP), which is a therapeutic effect.
No
The device is an endotracheal tube designed for airway management and to reduce the incidence of ventilator-associated pneumonia, not to diagnose a condition.
No
The device description clearly details a physical, bifurcated polyvinyl chloride tube with a cuff, radiopaque line, and a silver coating. This is a hardware device, not software.
Based on the provided information, the Agento™ I.C.® Silver-Coated Endotracheal Tube is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Agento™ I.C.® Silver-Coated Endotracheal Tube is a medical device used for airway management by being inserted into the trachea. Its primary function is to maintain an open airway and facilitate ventilation. The silver coating is intended to reduce the incidence of VAP, which is a clinical outcome related to the device's use in the body, not an analysis of a specimen.
- Intended Use: The intended use clearly describes a procedure performed directly on the patient (intubation) for airway management and reducing VAP. It does not involve the analysis of any in vitro specimens.
Therefore, the device is a therapeutic and airway management device, not an IVD.
N/A
Intended Use / Indications for Use
Intended Use: The Agento™ I.C.® Silver-Coated Endotracheal Tube intended use is for airway management by oral or nasal intubation of the trachea for anesthesia and in cases where duration of intubation is expected to be 24 hours or longer, or may be unpredictable. Agento™ I.C.® Silver-Coated Endotracheal Tube has been shown to reduce the incidence of microbiologically confirmed Ventilator Associated Pneumonia (VAP) in patients intubated for 24 hours or longer from an incidence of 7.5% in patients intubated with uncoated ET tubes to an incidence of 4.8% in patients intubated with the Bard Silver-Coated ET tubes (reduction of 36%) and to delay the time to onset of microbiologically confirmed VAP.
Indications for Use: The Agento™ I.C. silver-coated intermediate high volume low pressure endotracheal (ET) tube is indicated for airway management by oral or nasal intubation of the trachea for anesthesia and in cases where duration of intubation is expected to be 24 hours or longer, or may be unpredictable. The Agento™ I.C. silver-coated intermediate high volume low pressure endotracheal (ET) tube has been shown to reduce the incidence of microbiologically confirmed Ventilator Associated Pneumonia (VAP) in patients intubated for 24 hours or longer from an incidence of 7.5% in patients intubated with uncoated ET tubes to an incidence of 4.8% in patients intubated with the Bard Silver-Coated ET tubes (reduction of 36%) and to delay the time to onset of microbiologically confirmed VAP.
Product codes (comma separated list FDA assigned to the subject device)
BTR
Device Description
The Bard Silver-Coated Endotracheal Tube is a sterile bifurcated (two-lumen) polyvinyl chloride tube with a polyvinyl chloride cuff. The tube design incorporates a Magill curve and features a radiopaque line to assist radiographic visualization. An indicator (ORAL: NASAL) is provided on standard length tubes to mark the tracheal tube length in centimeters. This indicator and all other device features listed above were tested in accordance with the International Organization for Standardization (ISO) 5361, Anesthetic and Respiratory Equipment -Tracheal Tubes and Connectors. The Bard Silver-coated Endotracheal Tube is available with a hooded Murphy tip, an intermediate high volume, low pressure cuff and self-sealing valve with attached pilot balloon. The Bard Silver-coated Endotracheal Tube is available in sizes of 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, and 10.0 mm ID. The Bard Silver-coated Endotracheal Tube is coated on the outer endotracheal tube surface, including the cuff surface, and on the interior surface of the airway lumen with a proprietary hydrophilic silver coating. Neither the inside of the cuff nor the inside of the inflation lumen is coated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trachea
Indicated Patient Age Range
For Adults Only
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)
Functional, biocompatibility and predicate device comparative testing Performance data have demonstrated that the subject device is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reduction of 36% in the incidence of microbiologically confirmed Ventilator Associated Pneumonia (VAP).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 sequence of handwritten digits and letters. The sequence appears to be "K080170". The characters are written in a bold, somewhat uneven style, giving them a distinct, hand-drawn appearance. The contrast between the characters and the background is high, making them easily readable.
C.R. Bard, Inc. Special 510(k): Device Modification
Attachment 4
MAR 2 5 2008
510(k) Summary
| Product | Agento™ I.C.® Silver-Coated Endotracheal Tube (Intermediate High
Volume Low Pressure) |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's
Information | Skip Rimer
Regulatory Affairs Specialist II
Bard Medical Division
C.R. Bard Inc.
8195 Industrial Blvd.
Covington, Georgia 30014 USA
Phone (770) 784-6160, Fax (770) 784-6419
E-mail skip.rimer@crbard.com |
| Date Prepared | January 21, 2008 |
| Name of Device | Agento™ I.C.® Silver-Coated Endotracheal Tube (Intermediate High
Volume Low Pressure) |
| Name/Address of
Sponsor | C.R. Bard Inc.
Bard Medical Division
8195 Industrial Blvd.
Covington, Georgia 30014 USA
Phone (770) 784-6722, Fax (770) 385-4768 |
| Common or usual
names | Endotracheal tube |
| Classification name | Tube, Tracheal (W/Wo Connector) |
| Predicate devices | K071365, Agento™ I.C.® Silver-Coated Endotracheal Tube |
| Intended use and
indications for use | Intended Use
The Agento™ I.C.® Silver-Coated Endotracheal Tube intended use is for
airway management by oral or nasal intubation of the trachea for
anesthesia and in cases where duration of intubation is expected to be 24
hours or longer, or may be unpredictable.
Agento™ I.C.® Silver-Coated Endotracheal Tube has been shown to
reduce the incidence of microbiologically confirmed Ventilator
Associated Pneumonia (VAP) in patients intubated for 24 hours or longer
from an incidence of 7.5% in patients intubated with uncoated ET tubes
to an incidence of 4.8% in patients intubated with the Bard Silver-Coated |
1
ET tubes (reduction of 36%) and to delay the time to onset of microbiologically confirmed VAP.
For Adults Only
Technological The Bard Silver-Coated Endotracheal Tube is a sterile bifurcated (twocharacteristics lumen) polyvinyl chloride tube with a polyvinyl chloride cuff. The tube design incorporates a Magill curve and features a radiopaque line to assist radiographic visualization. An indicator (ORAL: NASAL) is provided on standard length tubes to mark the tracheal tube length in centimeters. This indicator and all other device features listed above were tested in accordance with the International Organization for Standardization (ISO) 5361, Anesthetic and Respiratory Equipment -Tracheal Tubes and Connectors. The Bard Silver-coated Endotracheal Tube is available with a hooded Murphy tip, a intermediate high volume, low pressure cuff and self-sealing valve with attached pilot balloon. The Bard Silver-coated Endotracheal Tube is available in sizes of 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, and 10.0 mm ID. The Bard Silver-coated Endotracheal Tube is coated on the outer endotracheal tube surface, including the cuff surface, and on the interior surface of the airway lumen with a proprietary hydrophilic silver coating. Neither the inside of the cuff nor the inside of the inflation lumen is coated.
Functional, biocompatibility and predicate device comparative testing Performance data have demonstrated that the subject device is as safe and effective as the predicate device.
2
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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2008
Mr. Skip Rimer Regulatory Affairs Specialist II C.R. Bard, Incorporated 8195 Industrial Boulevard Covington, Georgia 30014
Re: K080170
Trade/Device Name: Agento™ I.C. ® Silver-Coated Intermediate High Volume Low Pressure Endotracheal (ET)Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: March 6, 2008 Received: March 10, 2008
Dear Mr. Rimer:
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. Rimer
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clues
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): K080170
Agento™ I.C. 8 silver-coated intermediate high volume low pressure Device Name: endotracheal (ET) tube
Indications for Use:
The Agento™ I.C. silver-coated intermediate high volume low pressure endotracheal (ET) tube is indicated for airway management by oral or nasal intubation of the trachea for anesthesia and in cases where duration of intubation is expected to be 24 hours or longer, or may be unpredictable.
The Agento™ I.C. silver-coated intermediate high volume low pressure endotracheal (ET) tube has been shown to reduce the incidence of microbiologically confirmed Ventilator Associated Pneumonia (VAP) in patients intubated for 24 hours or longer from an incidence of 7.5% in patients intubated with uncoated ET tubes to an incidence of 4.8% in patients intubated with the Bard Silver-Coated ET tubes (reduction of 36%) and to delay the time to onset of microbiologically confirmed VAP.
For Adults Only
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Minh Nhan
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: 3/24/04