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

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.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for the Cook Incorporated VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula. It outlines the device's characteristics and compares it to a predicate device. However, the provided text does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (Portex® Blue Line Ultra® Tracheostomy Tube, K030381), rather than presenting a performance study against specific acceptance criteria for a novel device.

The "verification testing" mentioned is general and serves to confirm the design and performance for substantial equivalence, not to meet specific, quantified acceptance criteria for a clinical or performance study.

Therefore, I cannot answer the request directly as the information is not present in the provided text. To provide the requested information, the document would need to include:

Specific, quantified acceptance criteria for metrics like "cuff performance," "insertion force," etc.
Detailed results of primary studies demonstrating whether the device met those criteria, including sample sizes, ground truth establishment, and expert involvement.

Here's what I can extract based on the provided text, highlighting the absence of the requested details:

1. Table of Acceptance Criteria and Reported Device Performance:

Information Not Provided in the Text. The document lists types of verification testing but does not provide specific acceptance criteria (e.g., "Insertion force shall be less than X Newtons") or the quantitative results of those tests.

2. Sample Size Used for the Test Set and Data Provenance:

Information Not Provided in the Text. The text mentions "verification testing" but does not specify sample sizes for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective). These verification tests appear to be engineering/benchmark tests rather than clinical studies with test sets.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Information Not Provided in the Text. Since no clinical test set is described, there's no mention of experts establishing ground truth. The verification tests performed appear to be technical assessments of the device's physical properties.

4. Adjudication Method for the Test Set:

Information Not Provided in the Text. No adjudication method is described as there's no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No MRMC comparative effectiveness study was done or mentioned. The document is for a tracheostomy tube, which is a physical medical device, not an AI or imaging diagnostic tool where MRMC studies are typically performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not applicable. This device is a physical tracheostomy tube, not an algorithm or AI system.

7. The Type of Ground Truth Used:

Information Not Provided in the Text. For the "verification testing" mentioned (Strength of neck-plate, cuff performance, insertion force, etc.), the "ground truth" would implicitly be engineering standards, physical measurements, and biological compatibility test results. However, the exact methods and standards are not detailed.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set, this information is not relevant.

Summary of Study (Verification Testing) Mentioned:

The document briefly lists the following "verification testing" performed to demonstrate reliable design and performance:

Strength of neck-plate and 15 mm connector attachment to cannula
Cuff performance
Insertion force
Inner cannula extraction force
Sterilization testing
Biocompatibility testing

However, no specific study report, methodology, acceptance criteria, or quantitative results for these tests are provided or referenced in the given text. The focus of the 510(k) is to demonstrate substantial equivalence based on technological characteristics and intended use compared to a predicate device.

Summary

{0}------------------------------------------------

K100283
6

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

1. 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

(800) 468-1379

(812) 332-0281

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

{1}------------------------------------------------

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:

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 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.

{2}------------------------------------------------

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.

{3}------------------------------------------------

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.

{4}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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

{5}------------------------------------------------

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

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

Regulation Number and Section

§ 868.5800 Tracheostomy tube and tube cuff.

(a)
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.(b)
Classification. Class II.