VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC

K100283 · Cook, Inc. · BTO · Apr 23, 2010 · Anesthesiology

Device Facts

• Record ID: K100283
• Device Name: VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
• Applicant: Cook, Inc.
• Product Code: BTO · Anesthesiology
• Decision Date: Apr 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VersaTube Tapered Tracheostomy Tube is intended to provide an artificial airway to establish airway patency and to provide maintenance of the airway.

Device Story

VersaTube is a sterile, single-use cuffed tracheostomy tube with a disposable inner cannula. It features a polyvinyl chloride outer cannula tapered at the distal end for insertion and a low-pressure, high-volume balloon cuff for airway sealing. Available in 7, 8, or 9 mm ID sizes with color-coded components to ensure proper fit between the tube and inner cannula. Used in clinical settings to establish and maintain an artificial airway for up to 29 days. The device is operated by healthcare professionals. It functions as a mechanical conduit for ventilation; the cuff seals the airway to facilitate effective gas exchange. Benefits include airway patency and maintenance for patients requiring respiratory support.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included strength of neck-plate and 15 mm connector attachment, cuff performance, insertion force, inner cannula extraction force, sterilization testing, and biocompatibility testing.

Technological Characteristics

Polyvinyl chloride outer cannula; low-pressure, high-volume balloon cuff; 15 mm airway connector; color-coded components. Sizes: 7, 8, 9 mm ID. Curvature: 96-97°. Sterile, single-use. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring an artificial airway to establish and maintain airway patency.

Regulatory Classification

Identification

A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

Predicate Devices

• Portex® Blue Line Ultra® Tracheostomy Tube (K030381)

Submission Summary (Full Text)

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K100283
6

Cook Incorporated VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula 29 January 2010

- 5. 510(k) Summary
APR 2 8 2010

# Cook Incorporated VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula 510(k) Summary 21 CFR 807.92

## 1. Submitter Information:

Applicant:

Cook Incorporated

[phone]

[phone]

Address:

750 Daniels Way P.O. Box 489 Bloomington, IN 47402

Phone Number: Fax Number:

Contact: Contact Address:

Susanne Galin, RAC Cook Incorporated 750 Daniels Way Bloomington, IN 47404

Contact Phone Number: 812-339-2235 x2296 812-332-0281 Contact Fax Number:

### 2. Device Information:

Trade name:

Common name: Classification:

Regulation:

Product Code:

VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula Tube Tracheostomy and Tube Cuff Class II

21 CFR § 868.5800 Tracheostomy tube and tube cuff

BTO

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#### Cook Incorporated

VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula 29 January 2010

# 3. Predicate Devices:

Cook Incorporated's VersaTube™ Tapered Tracheostomy Tube with Disposable Cannula (hereafter referred to as the VersaTube) is substantially equivalent to the Portex® Blue Line Ultra® Tracheostomy Tube originally manufactured by Portex Ltd. under 510(k) clearance K030381.

# 4. Device Description:

The VersaTube is a sterile, single use cuffed tracheostomy tube with a disposable inner cannula, and will be manufactured as a 7, 8, or 9 mm ID device (with the inner cannula being either 6, 7, or 8 mm ID). The angle of curvature of the VersaTube is 96° (7, 8 mm ID) or 97 ° (9 mm ID) and ranges from 78 to 98 mm. The neck-plate, 15 mm airway connector, and inner cannula are color coded to marry together the tracheostomy tube with the correctly sized inner cannula. The device is not intended to be used for more than 29 days.

#### 5. Intended Use:

The VersaTube Tapered Tracheostomy Tube is intended to provide an artificial airway to establish airway patency and to provide maintenance of the airway.

#### 6. Technological Characteristics:

The VersaTube consists of a polyviny1 chloride outer cannula which is tapered at the distal end for smooth insertion. The device also incorporates a low pressure, high volume balloon cuff at the distal end of the device for the purpose of sealing the airway for proper ventilation. Included with the VersaTube are two inner cannulae. Each inner cannula is designed for a close fit to the corresponding size VersaTube.

The technological characteristics of the VersaTube and the predicate device, the Portex Blue Line Ultra Tracheostomy Tube, are substantially equivalent in that both devices have the same main trachestomy tube materials, components, basic design, and function. No new technological aspects are being introduced with the proposed device.

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To demonstrate reliable design and performance of the VersaTube, the following verification testing was performed:

- Strength of neck-plate and 15 mm connector attachment to cannula, .
- Cuff performance, .
- Insertion force, .

.

- Inner cannula extraction force, .
- Sterilization testing, .
- . Biocompatibility testing.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem of an eagle, with its wings spread and head turned to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Susanne Galin Regulatory Affairs Specialist Cook, Incorporated 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402

# APR 2 3 2010

Re: K100283

Trade/Device Name: VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: BTO Dated: January 29, 2010 Received: February 1, 2010

Dear Ms. Galin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 - Ms. Galin

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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony Watson, B.S., M.S., M.B.A. 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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Cook Incorporated VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula 29 January 2010

4. Indications for Use Statement

510(k) Number (if known):

Device Name: VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula

## Indications for Use:

The VersaTube™ Tapered Tracheostomy Tube is intended to provide an artificial airway to establish airway patency and to provide maintenance of the airway.

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis

· Division Sign-Off) )ivision of Anesthesiology, General Hospital nection Control, Dental Devices

10(k) Number: K 10 02.83