WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

K101721 · Regulatory and Marketing Services, Inc. · BTO · Mar 24, 2011 · Anesthesiology

Device Facts

• Record ID: K101721
• Device Name: WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
• Applicant: Regulatory and Marketing Services, Inc.
• Product Code: BTO · Anesthesiology
• Decision Date: Mar 24, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Well lead Tracheostomy Tubes and Disposable Inner Cannula is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.

Device Story

Tracheostomy tube system for airway management; provides access to trachea via tracheotomy incision. Components include outer cannula, disposable inner cannula, introducer, neck strap, and obturator. Disposable inner cannula acts as removable liner for outer tube; facilitates cleaning of phlegm/secretions; prolongs device use. Secured via swivel neck plate/flange. Used in clinical settings for patients requiring spontaneous or mechanical ventilation. Operated by healthcare professionals. Benefits include simplified airway maintenance and secure artificial airway access.

Clinical Evidence

Bench testing only. Device performance, including dimensions, design, material, sterility, and packaging, was validated against ISO 5366-1 and 5366-2 standards. No clinical data provided.

Technological Characteristics

Tracheostomy tube system; includes outer cannula, disposable inner cannula, introducer, neck strap, and obturator. Features cuffed and uncuffed versions. Includes locking mechanism for inner cannula. Materials and design conform to ISO 5366-1 and 5366-2. Non-electronic, mechanical device.

Indications for Use

Indicated for airway management of tracheostomotized patients requiring an artificial airway for spontaneous or mechanical ventilation.

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

• Well Lead Tracheostomy Tubes (K042684)

Submission Summary (Full Text)

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# 510(k) SUMMARY (as required by 807.92(c))

| Regulatory Correspondent: | AJW Technology Consultants Inc<br>962 Allegro Lane<br>Apollo Beach, FL 33572<br>Arthur Ward<br>[e-mail]<br>813-645-2855<br>813-677-4787 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Well LEAD Medical Device Instruments Ltd.<br>A4-1# Jinhu Industrial Estate<br>Hualong, Panyu<br>Guangzhou City, China 511434<br>Han Guang Yuan<br>[e-mail] |
| Date of Summary: | November 29, 2010 |
| Trade/Proprietary Name: | Well Lead Tracheostomy Tubes and Disposable<br>Inner Cannula |
| Classification Name: | Tracheostomy Tube and Tube Cuff |
| Product Code: | BTO |

#### Intended Use:

The Well lead Tracheostomy Tubes and Disposable Inner Cannula is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.

#### Device Description:

The Well lead Tracheostomy Tubes and Disposable Inner Cannula includes an outer cannula, disposable inner cannula, introducer, neck strap and obturator. The disposable inner cannula acts as a removable liner for the outer tube; it can be withdrawn and changed after the airway has been cleaned, such as phlegm suction. The disposable inner cannula facilitates the airway management to make it easy to clean and prolong the use of the device. The device is used to provide an artificial airway in order to provide access to the patient's airway for airway management. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The tracheostomy tube is

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secured by the means of the swivel neck plate/flange. When appropriately connected the device provides a secure artificial airway for spontaneous or mechanical ventilation.

K042684 – Well Lead Tracheostomy Tubes Predicate Device:

## Substantial Equivalence:

The proposed device is substantial equivalent to the Well Lead Tracheostomy Tubes, which has been cleared under K042684. The proposed device has the same intended use and similar technological characteristics as compared to the predicate device.

## Device Performance:

The dimension, design, material, sterility and packaging of Well Lead Tracheostomy Tubes and Disposable Inner Cannula conform to ISO 5366-1 and 5366-2.

### Comparison of Technological Characteristics

The intended use of the modified device remains unchanged as does its risk classification. The modified device will continue to be indicated for the same patient population and will continue to be a prescription device. Both devices are intended to be a component of life sustaining devices which are to be used for airway management.

Both Well Lead Tracheostomy Tubes and Disposable Inner Cannula and Well Lead Tracheostomy Tube have the same intended use, there is no new indications or contraindications.

Both the modified and unmodified device include an outer cannula, introducer, neck strap. A disposable inner cannula and obturator are being added to the modified device, both devices continue to have cuffed and uncuffed versions.

For fixing the inner cannula to the outer cannula a locking mechanism has been designed. As part of this design the component material has not changed.

#### Conclusions:

In summary, Well Lead Medical Instruments Ltd has demonstrated that Well Lead Tracheostomy Tubes and Disposable Cannula is safe and effective. The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use.

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Image /page/2/Picture/0 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" and is arranged in a circular fashion around the edge of the logo. The symbol in the center consists of three curved lines that resemble a stylized bird or abstract design. The logo appears to be a government or organizational emblem.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Mr. Arthur Ward Regulatory Correspondent AJW Technology Consultants, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572

# MAR 2 4 2011

Re: K101721

Trade/Device Name: Well Lead Tracheostomy Tubes and Disposable Inner Cannula Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: BTO Dated: March 3, 2011 Received: March 15, 2011

Dear Mr. Ward:

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- Mr. Ward

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 D. 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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Indications for Use

510(k) Number (if known): K101721

Device Name: Well Lead Tracheostomy Tubes and Disposable Inner Cannula

Indication for Use:

The Well Lead Tracheostomy Tubes and Disposable Inner Cannula is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Defice Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

| 510(k) Number: | K101721 |
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