AMSINO ENDOTRACHEAL TUBE

K050785 · Amsino International, Inc. · BTR · Jul 15, 2005 · Anesthesiology

Device Facts

• Record ID: K050785
• Device Name: AMSINO ENDOTRACHEAL TUBE
• Applicant: Amsino International, Inc.
• Product Code: BTR · Anesthesiology
• Decision Date: Jul 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMSINO® Endotracheal Tube is intended for use in airway management by oral/nasal intubation of the trachea. The cuff inflation system (where applicable) is used to establish a seal between the tube and the trachea.

Device Story

AMSINO Endotracheal Tube is a medical device used for airway management. It is inserted into the trachea via oral or nasal routes to maintain an open airway. For cuffed versions, an integrated inflation system creates a seal against the tracheal wall to facilitate mechanical ventilation and prevent aspiration. The device is intended for use by trained healthcare professionals in clinical settings such as hospitals or emergency care. It functions as a conduit for gas exchange between the ventilator/anesthesia machine and the patient's lungs.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Endotracheal tube with optional cuff inflation system. Materials are biocompatible medical-grade plastics. Device is designed for oral/nasal insertion. Sterilization is performed via standard medical methods.

Indications for Use

Indicated for airway management via oral or nasal intubation of the trachea 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.

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three stylized wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 5 2005

Mr. Ching Ching Seah, Ph.D Director of Regulatory Affairs · Amsino International, Incorporated 855 Towne Center Drive Pomona, California 91767

Re: K050785

Trade/Device Name: AMSINO™ Endotracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: May 25, 2005 Received: May 31, 2005

Dear Dr. Seah:

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 Amendinents, of to arrived Cosmetic Act (Act) that do not require approval of a premarket the Federal I vou, Drag, and , therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provided 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 (1 Writ), it hay of each 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 - Dr. Seah

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA s issualled on that your device complies with other requirements mean that FDA nas made a decommances and regulations administered by other Federal agencies. of the Act of ally receitar statutes and regarants, including, but not limited to: registration You must comply with and her her her brog (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), laooiiisg (21 CFR (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality brovisions (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 5 10(k) This letter will anow you to obgin mained of substantial equivalence of your device to a premarket notification. The PDF milians of sabssification 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), if you desire specific auvice for your de recolour and the regulation in the regulation prease contact the Other or Some 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 miormation on the mational and Consumer Assistance at its toll-free Division [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Senute y. Michael Omd.

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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AMSINO

a participating program (1998). sa juternali in 'n'i

| 510(k) Number: (if known) | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | <i>AMSINO</i> ^® Endotracheal Tube |
| Indications for Use: | The <i>AMSINO</i> ^® Endotracheal Tube is intended for use in airway management by oral/nasal intubation of the trachea. The cuff inflation system (where applicable) is used to establish a scal between the tube and the trachea. |

#### Indications for Use Statement

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription/ Use (Per 21 CFR 801. 109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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Aure Suliom

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

510(k) Number:_

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