WELL LEAD ENDOTRACHEAL TUBE

K042683 · Well Lead Medical Instruments · BTR · Feb 18, 2005 · Anesthesiology

Device Facts

• Record ID: K042683
• Device Name: WELL LEAD ENDOTRACHEAL TUBE
• Applicant: Well Lead Medical Instruments
• Product Code: BTR · Anesthesiology
• Decision Date: Feb 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for oral or nasal intubation and for airway management.

Device Story

Well Lead Endotracheal Tube is a medical device used for airway management via oral or nasal intubation. The device consists of a medical-grade PVC tube, a connector, and a valve; it is available in cuffed or uncuffed configurations. It is intended for use by healthcare professionals in clinical settings to maintain a patent airway. The device functions as a conduit for gas exchange between the ventilator/anesthesia machine and the patient's lungs. It does not incorporate electronic components, software, or algorithms.

Clinical Evidence

Bench testing only. The device conforms to ISO 5361:1999(E) for dimension, design, material, sterility, and packaging.

Technological Characteristics

Medical-grade PVC construction; cuffed or uncuffed configurations; includes connector and valve; oral or nasal form factor. Conforms to ISO 5361:1999(E).

Indications for Use

Indicated for patients requiring oral or nasal intubation for airway management.

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

• Kendall (Pre-Amendment)
• RÜSCHELIT (K961837, K993786, K961840, K931163, K93786)

Submission Summary (Full Text)

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## FEB 1 8 2005

K042683

## 510K SUMMARY FOR ENDOTRACHEAL TUBE

SUBMITTER NAME: Well Lead Medical Instruments Ltd

SUBMITTER ADDESS: Jinhu Industrial Estate, Hualong, Panyu, Guangzhou City, China

CONTACT PERSON: Huan Guang Yuan (vice general manager)

PHONE NUMBER: [phone]

FAX NUMBER: [phone]

EMAIL: [e-mail]

DATE PREPARED: July 16, 2004

TRADE NAME: well lead Endotracheal tube

COMMON NAME: ET-tube

CLASSIFICATION NAME: Tracheal tube

CLASSIFICATION: BTR

PREDICATE DEVICE: Well Lead is claiming substantial equivalence to the following medical device(s) -

- . Kendall - Pre-Amendment
- RÜSCHELIT K961837, K993786, K961840, K931163, K93786 .

DEVICE DESCRIPTION: The tracheal tubes are made from medical grade PVC, with a connector and valve. The tracheal tubes may be cuffed or uncuffed and are for oral or nasal use.

INTENDED USE: The device is intended for oral or nasal intubation and for airway management.

DEVICE PERFORMANCE: the dimension, design, material, sterility and packaging of well lead endotracheal tube are conformed with ISO 5361:1999(E)

DEVICES COMPARE: the device has the same dimensions and design as the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or lines extending upwards, representing growth and vitality. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2005

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: K042683

Trade/Device Name: Well Lead Endotracheal Tube Regulation Number: 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: January 3, 2005 Reccived: January 6, 2005

Dear Mr. Ward:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined the device is substantially equivalent (for the inclications 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 commonel proces that have been reclassified in accordance with the provisions of Amendina, or to do roug, 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 approvisions of the Act. The general controls provisions of the Act include controls providents of a 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 olabilional controls. Existing major regulations affecting (1 Mrt), It may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be nouncements 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 r lease of advisor that 1 27 is issuaines on that your device complies with other requirements Incall that I DX mas made a statutes and regulations administered by other Federal agencies. of the Act of ally i ederal bate reguirements, including, but not limited to: registration 1 ou intist comply with and any, labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF R Part 007), as ality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in als quadion 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) IThis letter will anow you to begin mailing of substantial equivalence of your device to a premaired predicate 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 advise to your and (240) 276-__. 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 may obtain other general 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,

Syitte Michain D.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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## Indication for Use

K042683 510(k) Number (if known): 510(R) Name: Endotracheal Tube Indication For Use:

、

。 …

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The device is intended for oral or nasal intubation and for airway management.

| Prescription Use | X |
|-----------------------------|--------|
| (Part 21 CFR 801 Subpart D) | |
| | AND/OR |
| Over-The-Counter use | |
| (Part 21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------------------------------------------------------------------|---------|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K042683 |