PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE

K100546 · Parkermedicalinc · BTR · Jun 3, 2010 · Anesthesiology

Device Facts

• Record ID: K100546
• Device Name: PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE
• Applicant: Parkermedicalinc
• Product Code: BTR · Anesthesiology
• Decision Date: Jun 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Tracheal tube designed for oral and nasal intubation and indicated for airway management.

Device Story

Parker Flex-Tip Tracheal Tube is a sterile, single-use device for airway management during anesthesia, respiratory care, or emergency procedures. Features a center-beveled, flexible, curved, and tapered distal tip with two Murphy eyes to facilitate passage through the airway. Designed to minimize nasal trauma and bleeding during intubation. Used by clinicians in clinical or emergency settings. The device is inserted into the trachea to maintain an open airway; the tapered tip design assists in navigating anatomical structures, reducing potential for tissue injury compared to standard tracheal tubes.

Clinical Evidence

Independent clinical testing demonstrated that the Parker Flex-Tip Tracheal Tube significantly minimizes and prevents nasal trauma and bleeding during nasal intubations compared to commercially available tracheal tubes.

Technological Characteristics

Sterile, single-use, polyvinyl chloride (PVC) tracheal tube. Features a center-beveled, flexible, curved, slightly rounded, tapered distal tip. Includes two Murphy eyes flanking the bevel. Contains a barium sulfate-filled stripe for radiopacity. Available in curved and preformed configurations.

Indications for Use

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

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

• Parker Flex-Tip Tracheal Tube (K984528)

Submission Summary (Full Text)

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## 510(k) Summary

Responsive

## JUN 님 3 2010

| Submitted by: | Parker Medical, Inc. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 9457 S. University Blvd., #331 |
| | Highlands Ranch, CO 80126 |
| Contact Person | Lewis Ward |
| | L.W. Ward and Associates, Inc. |
| | 4655 Kirkwood Court |
| | Boulder, CO 80301 |
| Date Prepared: | February 8, 2010 |
| Product: | Parker Flex-Tip Tracheal Tube |
| Trade Name: | |
| Common Name: | Tracheal Tube (also, Endotracheal Tube) |
| Classification Name: | Tube, Tracheal (w/wo connector) |
| Intended Use: | Tracheal tube designed for oral and nasal intubation and indicated for airway management |
| Technological Characteristics: | Sterile, single-use device for use in anesthesia and emergent and respiratory care. Center-beveled, flexible, curved, slightly rounded, tapered distal tip. Curved and preformed (shaped) tube configurations. Two facing Murphy eyes flanking the bevel. Polyvinyl chloride material with a barium sulfate filled stripe along the length of the device. |
| Substantial Equivalence: | The Parker Flex-Tip Nasal Tracheal Tube is an expanded Indication for Use to the Parker Flex-Tip Tracheal Tube cleared under K984528 for oral intubations. |
| Test Data: | Independent clinical testing of the Parker Flex-Tip Tracheal Tube demonstrates that it significantly minimizes and prevents the nasal trauma and bleeding which commonly occur in nasal intubations performed with comparable, commercially available tracheal tubes. |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle-like symbol with three overlapping lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 2 1 2012

Parker Medical, Incorporated C/O Mr. Lewis Ward Consultant to Parker Medical, Incorporated L.W. Ward and Associates, Incorporated 4655 Kirkwood Court Boulder, Colorado 80301

Re: K100546

Trade/Device Name: Parker Medical Nasal/Oral Flex-Tip Tracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: May 13, 2010 Received: May 17, 2010

Dear Mr. Ward:

This letter corrects our substantially equivalent letter of June 3, 2010.

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 (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 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. Ward

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm] 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and · Radiological Health

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## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Parker Medical Nasal/Oral Flex-Tip Tracheal Tube

Indications for Use:

Tracheal tube designed for oral and nasal intubation and indicated for airway management.

Prescription Use >< AND/OR (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (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)

L. Schultze

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

510(k) Number: K100546