AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)

K080170 · C.R. Bard, Inc. · BTR · Mar 25, 2008 · Anesthesiology

Device Facts

• Record ID: K080170
• Device Name: AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)
• Applicant: C.R. Bard, Inc.
• Product Code: BTR · Anesthesiology
• Decision Date: Mar 25, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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.

Device Story

Sterile, bifurcated polyvinyl chloride (PVC) endotracheal tube; features Magill curve, radiopaque line, and intermediate high-volume, low-pressure cuff. Coated with proprietary hydrophilic silver on outer surface, cuff surface, and interior airway lumen to reduce incidence of ventilator-associated pneumonia (VAP). Used by clinicians in hospital settings for airway management. Device provides mechanical airway access; silver coating acts as antimicrobial barrier to reduce bacterial colonization. Output is physical airway maintenance; clinical benefit includes 36% reduction in microbiologically confirmed VAP incidence and delayed onset of VAP in adult patients intubated for 24+ hours.

Clinical Evidence

Clinical evidence cited for the Agento™ I.C.® technology demonstrates a reduction in microbiologically confirmed Ventilator Associated Pneumonia (VAP) incidence from 7.5% (uncoated) to 4.8% (silver-coated), representing a 36% reduction. Evidence also indicates a delay in time to onset of VAP. Data applies to adult patients intubated for 24 hours or longer.

Technological Characteristics

Sterile, bifurcated PVC tube with PVC cuff; Magill curve; radiopaque line; intermediate high-volume, low-pressure cuff; self-sealing valve with pilot balloon. Sizes: 6.0-10.0 mm ID. Proprietary hydrophilic silver coating on outer surface, cuff, and interior lumen. Tested per ISO 5361.

Indications for Use

Indicated for airway management via oral or nasal tracheal intubation in adults requiring anesthesia or intubation expected to last 24 hours or longer. Contraindicated for pediatric use.

Regulatory Classification

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.

Predicate Devices

• Agento™ I.C.® Silver-Coated Endotracheal Tube (K071365)

Submission Summary (Full Text)

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C.R. Bard, Inc. Special 510(k): Device Modification

## Attachment 4

MAR 2 5 2008

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# 510(k) Summary

| Product | Agento™ I.C.® Silver-Coated Endotracheal Tube (Intermediate High<br>Volume Low Pressure) |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's<br>Information | Skip Rimer<br>Regulatory Affairs Specialist II<br>Bard Medical Division<br>C.R. Bard Inc.<br>8195 Industrial Blvd.<br>Covington, Georgia 30014 USA<br>Phone [phone], Fax [phone]<br>E-mail [e-mail] |
| Date Prepared | January 21, 2008 |
| Name of Device | Agento™ I.C.® Silver-Coated Endotracheal Tube (Intermediate High<br>Volume Low Pressure) |
| Name/Address of<br>Sponsor | C.R. Bard Inc.<br>Bard Medical Division<br>8195 Industrial Blvd.<br>Covington, Georgia 30014 USA<br>Phone [phone], Fax [phone] |
| Common or usual<br>names | Endotracheal tube |
| Classification name | Tube, Tracheal (W/Wo Connector) |
| Predicate devices | K071365, Agento™ I.C.® Silver-Coated Endotracheal Tube |
| Intended use and<br>indications for use | Intended Use<br>The Agento™ I.C.® Silver-Coated Endotracheal Tube intended use is for<br>airway management by oral or nasal intubation of the trachea for<br>anesthesia and in cases where duration of intubation is expected to be 24<br>hours or longer, or may be unpredictable.<br>Agento™ I.C.® Silver-Coated Endotracheal Tube has been shown to<br>reduce the incidence of microbiologically confirmed Ventilator<br>Associated Pneumonia (VAP) in patients intubated for 24 hours or longer<br>from an incidence of 7.5% in patients intubated with uncoated ET tubes<br>to 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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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 [phone]. 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 [phone] or [phone] 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Minh Nhan

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: 3/24/04