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. For Adults Only.

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, 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.

AI/ML Overview

The provided text describes a Special 510(k) for a device modification of the Agento™ I.C.® Silver-Coated Endotracheal Tube. It primarily focuses on the regulatory submission and does not detail specific acceptance criteria or an analytical study with performance metrics in the format requested.

However, it does mention a key claim regarding the device's effectiveness. I will synthesize the available information to address as many of your points as possible, noting where information is not present in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Reduce incidence of microbiologically confirmed Ventilator Associated Pneumonia (VAP)	Reduced incidence of VAP from 7.5% (uncoated ET tubes) to 4.8% (Bard Silver-Coated ET tubes), representing a 36% reduction. Also delayed the time to onset of microbiologically confirmed VAP.
Maintain safety and effectiveness as predicate device	"Performance data have demonstrated that the subject device is as safe and effective as the predicate device." (No specific metrics provided in this document, but implied to meet an equivalence standard.)
Adherence to International Organization for Standardization (ISO) 5361	Device features were tested in accordance with ISO 5361, Anesthetic and Respiratory Equipment - Tracheal Tubes and Connectors. (Implied compliance as part of safety and effectiveness.)

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample size of a specific "test set" for the VAP reduction claim. It refers to a clinical finding: "incidences 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." This suggests a clinical study was performed, but the number of patients involved in that study is not provided here.

The data provenance (e.g., country of origin, retrospective or prospective) is not specified in this document.

3. Number of Experts and Their Qualifications for Ground Truth

This information is not provided in the document. The claim regarding VAP reduction would likely have been based on clinical diagnoses and microbiological confirmation, but the details of who made these determinations and their qualifications are not included.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human readers/AI assistance is present in this document. The device in question is a medical device (endotracheal tube), not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a medical device, not a software algorithm.

7. Type of Ground Truth Used

Based on the description:

For the VAP reduction claim: "microbiologically confirmed Ventilator Associated Pneumonia (VAP)". This indicates a ground truth established by clinical diagnosis and laboratory confirmation (microbiology).
For safety and effectiveness compared to the predicate: Likely a combination of functional, biocompatibility, and possibly clinical endpoint data, but the specific "ground truth" definition for these comparisons is not detailed beyond demonstrating equivalence.

8. Sample Size for the Training Set

Not applicable in the context of an endotracheal tube's primary functional claims. There might be internal data from device development and testing, but it's not described as a "training set" in the sense of machine learning.

9. How Ground Truth for Training Set Was Established

Not applicable.

Summary

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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 HighVolume Low Pressure)
Submitter'sInformation	Skip RimerRegulatory Affairs Specialist IIBard Medical DivisionC.R. Bard Inc.8195 Industrial Blvd.Covington, Georgia 30014 USAPhone (770) 784-6160, Fax (770) 784-6419E-mail skip.rimer@crbard.com
Date Prepared	January 21, 2008
Name of Device	Agento™ I.C.® Silver-Coated Endotracheal Tube (Intermediate HighVolume Low Pressure)
Name/Address ofSponsor	C.R. Bard Inc.Bard Medical Division8195 Industrial Blvd.Covington, Georgia 30014 USAPhone (770) 784-6722, Fax (770) 385-4768
Common or usualnames	Endotracheal tube
Classification name	Tube, Tracheal (W/Wo Connector)
Predicate devices	K071365, Agento™ I.C.® Silver-Coated Endotracheal Tube
Intended use andindications for use	Intended UseThe Agento™ I.C.® Silver-Coated Endotracheal Tube intended use is forairway management by oral or nasal intubation of the trachea foranesthesia and in cases where duration of intubation is expected to be 24hours or longer, or may be unpredictable.Agento™ I.C.® Silver-Coated Endotracheal Tube has been shown toreduce the incidence of microbiologically confirmed VentilatorAssociated Pneumonia (VAP) in patients intubated for 24 hours or longerfrom an incidence of 7.5% in patients intubated with uncoated ET tubesto an incidence of 4.8% in patients intubated with the Bard Silver-Coated

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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.

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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.

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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

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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

Regulation Number and Section

§ 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).