ENDOTRACHEAL TUBE

K080105 · Chilecom Medical Devices Co., Ltd. · BTR · Feb 13, 2009 · Anesthesiology

Device Facts

• Record ID: K080105
• Device Name: ENDOTRACHEAL TUBE
• Applicant: Chilecom Medical Devices Co., Ltd.
• Product Code: BTR · Anesthesiology
• Decision Date: Feb 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Endotracheal tube is intented for oral or nasal intubation and for airway management.

Device Story

Endotracheal tube used for oral or nasal intubation to manage patient airways. Device consists of a body, connector, and optional cuff with inflating tube, pilot balloon, and valve. Features include a 38±10° curvature, radiopaque line, length markings, and Murphy eye. Connector attaches to anesthesia or respiratory equipment. Valve fitting uses 6% (Luer) taper. Single-use device, sterilized by EO gas. Used by clinicians in clinical settings to maintain airway patency and facilitate ventilation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Not specified. Design: Tracheal tube with/without cuff, 38±10° angle, radiopaque line, length markings, Murphy eye. Connector: Standard respiratory/anesthesia interface. Valve: 6% (Luer) taper. Sterilization: EO gas. Standards: ISO 5361:1999.

Indications for Use

Indicated for oral or nasal intubation and airway management in patients requiring mechanical ventilation or airway maintenance.

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

• Tracheal tube, Well lead endotracheal tube (K042683)

Submission Summary (Full Text)

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K080105
p. 1 of 2

# 510(K) SUMMARY

[as required by 807.92(c)]

- A. 510k Number:
#### B. Applicant:

Company name: Chilecom Medical Devices Co., Ltd. Address: 106 Boyi Road, Boluo County, Guangdong, China

Tel: [phone]

Fax: [phone]

Http://www.chilecom.cn

E-mail: [e-mail]

C. Proprietary and Established Names: Chilecom Medical Devices Co., Ltd.

- · D. Regulatory Information
- Classification: Class II Device 1.
- Common Name: Tracheal tube ﻨﺎ
- 3. Product Code: BTR (21 CFR 868.5730)
- Proprietary name: Endotracheal tube বা

#### E. Intended use

:

Endotracheal tube is intented for oral or nasal intubation and for airway management.

#### F. Device Description

Tracheal Tube uncuffed (chart 1) and with cuffed (chart uncuffed of Tracheal Tube only make up of body and connector. Tracheal Tube with cuffed make up of body and connector、cuff、inflating tube、Pilot balloon、Valve。Tracheat tube with a radius of curvature.。 a line for x-radial through the body.。 All tubes have an angle of 38±10° . Length marks in centimeters measured from the patient end. The murphy eye on the side of the tube opposite the bevel. The tube machine end have the connector .It can connect the anesthesia machine or respiratory equipment. The inflating pilot balloon includes a valve fitting with a 6% (Luer) taper.

Each tracheal tube was contained in an individual pack . Sterilized by EOT. Single use only

FEB 1 3 2009

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-
#### G. Substantial Equivalence Information

- 1. Predicate device name
Predicate Device 1 - K042683 / Tracheal tube, Well lead endotracheal tube

#### 2. Comparison with predicate

The Chilecom Tracheal tube device described in this 510K is very similar in terms of design, materials and indications for use to three predicate devices already approved and marketed. There are no new safety concerns when compared to the already available predicate devices. For these reasons, we feel the Chilecom Tracheal tube fulfills all criteria to be found substantially equivalent to the predicate devices and should be cleared for marketing.

- H. Standard / Guidance Document Referenced (if applicable) ISO 5361:1999 Anaesthetic and respiratory equipment—Tracheal tubes and connectors
- -Sterility

-Sterilized by EO gas

-Sterile method: refer to validation report

-Self-life: 3 years

-Single use only.

Performance Characteristics (If/when applicable) J.

1. See the Exhibits.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle with three legs.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Chilecom Medical Devices Company, Limited C/o Mr. Brandon Choi PATS Corporation 155 Flemington Court La Mirada, California 90638

FEB 1 3 2009

K080105 Re:

> Trade/Device Name: Endotracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: October 28, 2008 Received: January 21, 2009

Dear Mr. Choi:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Choi

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours.

Anthony D. Anant for CRM
Signature of Applicant, M.D.

Ginette Y. Michaud, M.D Acting 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):

Device Name: Endotracheal Tube

Indications for Use: Endotracheal tubes 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 (21 CFR 801 Subpart C) -

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-U) ز (Division Sign-Of.)
Division of Anesthasiningy General Hospitzl Division of Anton Contact, Dentes Dovides
Infection Control, Dental, Dental, Dentes

510(k) Number: _______________________________________________________________________________________________________________________________________________________________