ENDOFLEX TRACHEAL TUBE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a handwritten string of alphanumeric characters, "K031794". The characters are written in a bold, slightly slanted font. The image has a white background. ## Section E - 510(k) Summary June 2, 2003 | Applicant: | Merlyn Associates Inc.<br>11 Bayleaf Lane<br>Irvine, CA 92620<br>Phone: 714 730-3976 Fax: 714 730-3899<br>Email: jkotin.merlyn@cox.net | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Application Preparer &<br>Correspondent | Thomas E. Ferari<br>Medical Device Consultant<br>181 Dixon Road<br>Queensbury, NY 12804<br>Phone - 518-792-2258 Fax: 518-792-2274<br>Email - tferari@aol.com | | Proprietary Device Name: | EndoFlex Tracheal Tube | | Common Device Name: | Endotracheal Tube | | Classification Name: | Tracheal Tube (Class II Device Ref 21CFR 868.5730) | | Predicate Devices: | Cuffed Tracheal Tube<br>Mallinckrodt Critical Care K871204 | Device Description: The EndoFlex Tracheal Tube is sterile, single use device for airway management during anesthesia and mechanical ventilation. The tube is made in fifteen sizes; 3.0mm through 10.0mm in 0.5 mm increments. The EndoFlex Tracheal tube is identical to the predicate devices in terms of material composition, biocompatibility, and sterilization. The EndoFlex Tracheal tube has a beveled tip, high volume/low pressure cuff, inflation system, and 15mm connector equivalent to the predicate devices. The EndoFlex Tracheal tube differs from the predicate device in the following ways: - The EndoFlex Tracheal tube has an articulating tip that can be flexed to facilitate . intubation. The flexing tip eliminates the need for intubation stylets. Intended Use: The EndoFlex Tracheal Tube is intended for airway management by oral/nasal intubation. Non-Clinical Performance Data: The EndoFlex Tracheal Tube was evaluated using the ASTM 1242-96 performance standard. The EndoFlex Tracheal Tube conforms to all of the performance standard criteria for materials, cuffs, inflation system, radius of curvature, marking {1}------------------------------------------------ materials, and packaging. The tube passes all performance tests for tube collapse, cuff materals, and paekaging - Netwees we/volume/diameter assessment, radiopaque markers, and leak test. Clinical Performance Data: To date, no clinical data has been collected. Substantial Equivalence Assessment: Based on the non-clinical testing of the EndoFlex Substantial Liqurulent to the predicate devices and both safe and effective for clinical usc. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 2 2004 Merlyn Associates Incorporated c/o Dr. Ching Ching Seah, Ph.D. Amsino International, Incorporated 4501 Brickell Privado Ontario, CA 91761 Re: K031794 Trade/Device Name: EndoFlex Tracheal Tube Regulation Number: 863.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: January 8, 2004 Received: January 12, 2004 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 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. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r hat 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 {3}------------------------------------------------ Page 2 - Dr. Ching Ching Seah, Ph.D. 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 (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. 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 Office of Compliance at (301) 594-4646. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Charles 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 {4}------------------------------------------------ ## Section D - Statement of Indications for Use | 510(k) Number: | K031794 | |----------------|--------------------------------------------------------------------------------------------------------| | Applicant: | Merlyn Associates Inc.<br>11 Bayleaf Lane<br>Irvine, CA 92620<br>Phone: 714 730-3976 Fax: 714 730-3899 | EndoFlex Tracheal Tube Proprietary Device Name: Intended Use: The EndoFlex Tracheal Tube is intended for airway management by oral/nasal intubation. Prescription USE 510(k) Number: fth (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices