TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470

K051587 · Tracoe Medical GmbH · BTO · Oct 25, 2005 · Anesthesiology

Device Facts

• Record ID: K051587
• Device Name: TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
• Applicant: Tracoe Medical GmbH
• Product Code: BTO · Anesthesiology
• Decision Date: Oct 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TRACOE Vario Tracheostomy Tubes are indicated for providing tracheal access for airway management in patients with unusual anatomy or thick neck patients.

Device Story

Tracheostomy tube designed for patients with unusual anatomy or thick necks; provides tracheal access for airway management. Device features adjustable neck flange to accommodate varying patient anatomy. Used in clinical settings by healthcare professionals. Benefits include improved fit and airway access for patients where standard tracheostomy tubes may be unsuitable.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Tracheostomy tube with adjustable neck flange. Class II device (21 CFR 868.5800).

Indications for Use

Indicated for patients with unusual anatomy or thick necks requiring tracheal access for airway management.

Regulatory Classification

Identification

A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

Predicate Devices

• Bivona TTS Adjustable Neck Flange Tracheostomy Tube (K922665)

Submission Summary (Full Text)

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms or lines extending upwards, representing health and well-being.

OCT 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael A. Warren Boston Medical Products, Incorporated 117 Flanders Road Westborough, Massachusetts 01581

Re: K051587

N031507
Trade/Device Name: TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy tube and tube cuff Regulatory Class: II Product Code: BTO Dated: October 14, 2005 Received: October 17, 2005

Dear Mr. Warren:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Jor use stated in the encrosale) to regary the Medical Device Amendments, or to comments from to May 20, 1978 tire classified in accordance with the provisions of the Federal Food. Drug. devices that have been receive approval of a premarket approval application (PMA). and Cosmetic Ace (11ct) that the device, subject to the general controls provisions of the Act. The r ou may, therefore, manel the as Act include requirements for annual registration, listing of general control.. provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it n your device is classified (500 abs. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and may be subject to suer additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the exace of reasts concerning your device in the Federal Register.

{1}------------------------------------------------

## Page 2 -- Mr. Warren

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least oc advised that I Dry blassantes syour device complies with other requirements of the Act that I DT has made a and regulations administered by other Federal agencies. You must of any I call 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 CFA art 607), adomig (21 CFR x aroun), (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product faction control pro regin marketing your device as described in your Section 510(k) This letter with anow you'ls cogm tinding of substantial equivalence of your device to a legally premarket notineation: "The states 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 If you deall o specific and Compliance at [phone]. Also, please note the regulation entitled, Contact the Office of Connerset notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices ()ffice of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

SECTION 4- Statement of Indications for Use

## INDICATIONS FOR USE

TRACOE Vario Tracheostomy Tubes are indicated for providing tracheal access for airway TRACOL Vario - Fracticesvelless with unusual anatomy or thick neck patients.

(Ref Predicate 510(k)-K922665- Bivona TTS Adjustable Neck Flange Tracheostomy Tube)

Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR

Over -The-Counter-Use: (Part 21 CFR 807 Subpart C)

DO NOT WRITE BELOW THIS LINE

Concurrence of CDRH, Office of Device Evaluation

Cinta Lima

- 82 m-Cit) stan of Anesthesiology, General Hospital, luston Control. Dental Devices

1 10:1.; Number ______________________________________________________________________________________________________________________________________________________________

510(K) NOTIFICATION- TRACOE VARIO TRACHEOSTOMY TUBES