WELL LEAD TRACHEOSTOMY TUBE

K042684 · Well Lead Medical Instruments · BTO · Feb 17, 2005 · Anesthesiology

Device Facts

• Record ID: K042684
• Device Name: WELL LEAD TRACHEOSTOMY TUBE
• Applicant: Well Lead Medical Instruments
• Product Code: BTO · Anesthesiology
• Decision Date: Feb 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.

Device Story

Well Lead Tracheostomy Tube; single-patient disposable device for airway management in tracheostomotized patients. Constructed from medical-grade PVC; features appropriate tube hardness, high-capacity low-pressure cuff, and smooth surface. Device provides airway access; used in clinical settings by healthcare professionals. Biocompatible design conforms to ISO 5366-1 and ISO 5366-3 standards.

Clinical Evidence

Bench testing only. Device performance, including dimensions, design, material, sterility, and packaging, was verified against ISO 5366-1 and ISO 5366-3 standards.

Technological Characteristics

Medical-grade PVC construction; high-capacity low-pressure cuff; dimensions and design conform to ISO 5366-1 and ISO 5366-3. Sterilization and packaging meet international standards.

Indications for Use

Indicated for airway management in tracheostomotized patients requiring a single-patient disposable tracheostomy tube.

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

• Rusch Tracheofix Set, Cuffed and Uncuffed (K021764)

Submission Summary (Full Text)

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K0512684

FEB 1 7 2005

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

| Submitter of 510(k): | Well Lead Medical Instruments Ltd<br>Jinhu Industrial Estate, Hualong, Panyu,<br>Guangzhou City, China 511434 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Huan Guang Yuan, [e-mail] |
| Date of Summary: | October 1, 2004 |
| Trade/Proprietary Name: | Well Lead Tracheostomy Tubes |
| Classification Name: | Tracheostomy Tube |
| Product Code: | BTO |
| Predicate Device: | Rusch Tracheofix Set, Cuffed and Uncuffed - K021764 |
| Intended Use: | The device is a single patient disposable tracheostomy<br>tube for airway management of tracheostomotized<br>patients. |

### Device Description:

The tracheostomy tubes are made from the raw material of PVC for medical use, with the The trachetoney wave. The tracheostomy tubes have such good performances as the tube with appropriate hardness, the cuff with big capacity and low pressure, smooth tube and excellent biocompatibility.

#### Device Performance:

The dimension, design, material, sterility and packaging of Well Lead tracheostomy tubes are conformed with ISO 5366-1 and ISO 5366-3.

Device Comparison: The device has the same dimensions and design as the predicate device (Section 9).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.

Public Health Service

FEB 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Well Lead Medical Instruments Limited C/O Mr. Arthur J. Ward Regulatory Consultant AJW Technology Consultants, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572

Re: K042684

Trade/Device Name: Well Lead Tracheostomy Tube Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: BTO Dated: January 3, 2005 Received: January 6, 2005

Dear Mr. Ward:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your secure mined 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 merslate commerce priors that have been reclassified in accordance with the provisions of Amendinents, or to actrices and motic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of an 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 If your device is classified (500 additional controls. Existing major regulations affecting (1 MA), it may of subject to tach of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in firsther 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 I least that FDA has made a determination that your device complies with other requirements Incall that I DX mas made a actessiand regulations administered by other Federal agencies. of the Act of ally I oderal title Act sequirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 607), laceling (21 CFR Pat 820) regulation (21 CFR Part 820); and if requirents as sectionic 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) I mis letter will anow Jourse of Journalial equivalence of your device to a premairer notification and 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), rryou desire specific and 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 maj obtain 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,

Solita H. Michio m.D.

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

K042684 510(k) Number (if known):

Device Name: Well Lead Tracheostomy Tubes

Indications for Use: The device is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.

Prescription Use (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 Device Evaluation (ODE)

liii Julion

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

510(k) Number: K042684