TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT

K091761 · Teleflexmedical, Inc. · BTR · Oct 29, 2009 · Anesthesiology

Device Facts

• Record ID: K091761
• Device Name: TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT
• Applicant: Teleflexmedical, Inc.
• Product Code: BTR · Anesthesiology
• Decision Date: Oct 29, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is indicated for airway management by oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.

Device Story

Single-use, sterile polyvinyl chloride tracheal tube; features cuffed design, radiopaque line, and 15mm connector. Includes dorsal lumen with opening above cuff and male suction connector port for subglottic secretion aspiration. Used in clinical settings (OR/ICU) by healthcare professionals for airway management during mechanical ventilation or anesthesia. Suction accessory pack connects to port to facilitate secretion removal. Benefits include airway patency maintenance and potential reduction of subglottic secretion accumulation.

Clinical Evidence

Bench testing only. Testing verified compliance with ISO 5361, ISO 5356-1, ISO 10993, ISO 14971, and ISO 11135. Suction/aspiration performance was demonstrated to be equivalent to predicate devices.

Technological Characteristics

Polyvinyl chloride tube body; cuffed design with inflation line, pilot balloon, and one-way valve. Includes radiopaque line and 15mm connector. Features dorsal lumen for subglottic suction. Standards: ISO 5361, ISO 5356-1, ISO 10993, ISO 14971, ISO 11135. Sterile, single-use.

Indications for Use

Indicated for airway management via oral intubation in patients requiring mechanical ventilation or anesthesia; includes functionality for subglottic secretion removal.

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

• Sheridan HVT, Cuffed, Uncuffed Tracheal Tube (K822082)
• Hi-Lo Evac and Evac II Endotracheal Tubes (K965132)
• Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube (K081086)

Submission Summary (Full Text)

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091761

Abbreviated 510(k)

Teleflex ISISTM HVTTM Tracheal Tube, Cuffed with Subglottic Secretion Suction Port

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

# TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port

# A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: [phone] Fax:

Section 5 - Summary of Safety and Effectiveness

#### B. Contact Person

OCT 2 9 2009

William Heard Regulatory Affairs Specialist

#### C. Date Prepared

May 15, 2009

#### D. Device Name

Trade Name: TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port (ISIS Tube) Common Name: Tracheal Tube

Classification Name: Tracheal Tube (W/Wo Connector) (21 CFR 868.5730, Product Code BTR)

#### E. Device Description

The ISIS Tube is a single-use, sterile tracheal tube made of polyvinyl chloride tube body, cuff inflation line and a compatible pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the tracheal tube. Each tracheal tube is supplied with an appropriately sized 15mm connector. ISIS Tube will be sold in Murphy eye style. Each tube has a dorsal lumen with an opening above the cuff and a male suction connector port attached to the tube which is close to the machine end of the tube. Access to the suction lumen is accomplished via a connection of the suction accessory pack (P/N 5-23000) directly to the male suction connector.

Teleflex Medical, Inc.

CONFIDENTIAL

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#### F. Indications for Use

The ISIS Tube is indicated for airway management by oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.

#### G. Contraindications

There are no known contraindications.

# H. Substantial Equivalence

The proposed ISIS Tube is substantially equivalent to the predicate devices:

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|-----------------------------------------------------------------|-----------------------------|------------|--------------|
| Sheridan HVT, Cuffed,<br>Uncuffed Tracheal Tube | Teleflex Medical, Inc. | K822082 | 08/10/1982 |
| Hi-Lo Evac and Evac II<br>Endotracheal Tubes | Mallinckrodt Medical | K965132 | 03/20/1997 |
| Portex Blue Line Sacett Suction<br>Above the Cuff Tracheal Tube | Smiths Medical ASD,<br>Inc. | K081086 | 08/13/2008 |

# I. Summary of Testing

The proposed ISIS Tube device meets the following standards: ISO 5361, ISO 5356-1, ISO 10993, ISO 14971, and ISO 11135. Bench testing determined that the suction/aspiration capability of the ISIS Tube is equivalent to the predicate devices.

# J. Substantial Equivalence

The proposed ISIS Tube is substantially equivalent in intended use, design, performance and principles of operation to the identified predicate devices cleared under 510(k)s K822082, K965132 and K081086: The differences between the ISIS Tube and the predicated devices are minor and raise no new issues of safety and efficacy. The ISIS Tube is substantially equivalent to the currently marketed predicate devices.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three branches extending upwards.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. William Heard Regulatory Affairs Specialist Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, North Carolina 27709

OCT 2 9 2009

Re: K091761

Trade/Device Name: TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port

Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: October 15, 2009 Received: October 16, 2009

Dear Mr. Heard:

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 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. Heard

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Susan Peanes

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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### Indications for Use Statement

Page 1 of 1

510(k) Number:

Device Name:

TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port

Indications for Use:

The TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is indicated for airway management by oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.

Prescription Use XX (Part 21 CFR 801 Subpart D)

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis

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

510(k) Number: K091761