(175 days)
Mallinckrodt Hi-Lo® / Intermediate Hi-Lo Cuffed Tracheal Tubes
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.
Yes
The device is described as reducing the incidence of Ventilator Associated Pneumonia (VAP), which is a treatment or modification of a disease state.
No
Explanation: The device is an endotracheal tube used for airway management and to reduce the incidence of Ventilator Associated Pneumonia (VAP). It is a therapeutic and management device, not one designed to diagnose a condition.
No
The device description clearly describes a physical endotracheal tube made of polyvinyl chloride with a silver coating, indicating it is a hardware device.
Based on the provided information, the Agento™ I.C.® silver-coated endotracheal tube is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is for airway management by intubation of the trachea. It is a medical device used directly on a patient, not for testing samples taken from a patient.
- The device description and intended use clearly describe a device for direct patient care. It's a tube inserted into the trachea for breathing support.
- The performance studies focus on clinical outcomes in patients (reduction of VAP), not on the accuracy of a diagnostic test.
Therefore, this device falls under the category of a medical device for patient treatment and support, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Agento™ I.C.® silver-coated endotracheal 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.
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.
For Adults Only
Product codes
BTR
Device Description
Agento™ I.C.® silver-coated endotracheal tube is a sterile bifurcated (twolumen) 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 American Society for Testing and Materials ("ASTM") designation F 1242-96, Standard Specification for Cuffed and Uncuffed Tracheal Tubes. The Bard Silver-coated Endotracheal Tube is available with a hooded Murphy tip, a 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.
Agento™ I.C.® 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
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)
In vitro microbial assays, functional performance testing, biocompatibility testing, and animal studies have demonstrated the safety and effectiveness of the Agento™ I.C.® silver-coated endotracheal tube. Clinical studies of the Agento™ I.C.® silver-coated endotracheal tube demonstrated a reduction in the incidence and time to onset of VAP compared to the predicate uncoated endotracheal tube.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
reduction of 36% in incidence of microbiologically confirmed Ventilator Associated Pneumonia (VAP)
Predicate Device(s)
Mallinckrodt Hi-Lo® / Intermediate Hi-Lo Cuffed Tracheal Tubes
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
510(k) SUMMARY
Bard Medical Division, C.R. Bard, Inc.'s Agento™ I.C.® Silver-coated Endotracheal Tube
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Bard Medical Division, C.R. Bard, Inc. 8195 Industrial Boulevard Covington, GA 30014
770-784-6722 Phone: Facsimile: 770-784-6419
Contact Person: Michelle R. Gudith, Director, Regulatory Affairs
Date Prepared: March 30, 2007
Name of Device and Name/Address of Sponsor
Agento™ I.C.® silver-coated endotracheal tube
Bard Medical Division, C.R. Bard, Inc. 8195 Industrial Boulevard Covington, GA 30014
Common or Usual Name
Endotracheal tube
Classification Name
Tube, Tracheal (W/WO Connector)
Predicate Devices
Mallinckrodt Hi-Lo® / Intermediate Hi-Lo Cuffed Tracheal Tubes
Intended Use / Indications for Use
Agento™ I.C.® silver-coated endotracheal 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.
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.
For Adults Only
NOV 0 6 2007
1
Technological Characteristics
Agento™ I.C.® silver-coated endotracheal tube is a sterile bifurcated (twolumen) 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 American Society for Testing and Materials ("ASTM") designation F 1242-96, Standard Specification for Cuffed and Uncuffed Tracheal Tubes. The Bard Silver-coated Endotracheal Tube is available with a hooded Murphy tip, a 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.
Agento™ I.C.® 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.
Performance Data
In vitro microbial assays, functional performance testing, biocompatibility testing, and animal studies have demonstrated the safety and effectiveness of the Agento™ I.C.® silver-coated endotracheal tube. Clinical studies of the Agento™ I.C.® silver-coated endotracheal tube demonstrated a reduction in the incidence and time to onset of VAP compared to the predicate uncoated endotracheal tube.
Substantial Equivalence
Agento™ I.C.® silver-coated endotracheal tube is as safe and effective as the Mallinckrodt Hi-Lo® / Intermediate Hi-Lo Cuffed Tracheal Tubes. The Agento™!.C.® silver-coated endotracheal tube has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The technological differences between the Agento™I.C.® silver-coated endotracheal tube and its predicate device raise no new issues of safety or effectiveness. In vitro, bench, animal and clinical data demonstrate that the Agento™ I.C.® silver-coated endotracheal tube is as safe and effective as the Mallinckrodt Hi-Lo® / Intermediate Hi-Lo Cuffed Tracheal Tubes. Thus, the Agento™ I.C.® silver-coated endotracheal tube is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a stylized symbol. The symbol is a graphic representation of an eagle, with three lines forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 6 2007
Ms. Michelle R. Gudith Director of Regulatory Affairs C.R. Bard, Incorporated Bard Medical Division 8195 Industrial Boulevard Covington, Georgia 30014
Re: K071365
Trade/Device Name: Agento" I.C. ® Silver-Coated Endotracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: September 28, 2007 Received: October 1, 2007
Dear Ms. Gudith:
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 cither 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. Gudith
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): K 071365
Device Name: Agento™ I.C.® Silver-coated Endotracheal Tube
Indications for Use:
The Agento™I.C.® silver-coated endotracheal 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 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.
For Adults Only
Prescription Use X Use (Part 21 C.F.R. 801 Subpart D) Subpart C)
Over-The-Counter
(21 C.F.R. 807
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Min Thorf
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K071365
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