PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES

K050803 · Vitaid, Ltd. · BTR · Jun 30, 2005 · Anesthesiology

Device Facts

• Record ID: K050803
• Device Name: PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES
• Applicant: Vitaid, Ltd.
• Product Code: BTR · Anesthesiology
• Decision Date: Jun 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Vitaid ET Tubes are designed for oral / nasal intubation and are indicated for airway management. The Vitaid ET tubes have an ultra thin inflatable cuff.

Device Story

Vitaid ET tubes are endotracheal tubes used for airway management in hospital, sub-acute, and pre-hospital emergency settings. The device consists of a PVC tube and an ultra-thin polyurethane 'MicroCuff' for sealing the airway. Available in sizes 3.0 mm to 10.0 mm, with options for cuffed, uncuffed, and Murphy eye configurations. The device is inserted by clinicians to maintain a patent airway in patients requiring intubation. The ultra-thin cuff design is intended to provide an effective seal. The device is supplied sterile and is intended for single use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and design characteristics.

Technological Characteristics

Tube material: PVC. Cuff material: Polyurethane. Sizes: 3.0 mm to 10.0 mm. Configurations: Cuffed, uncuffed, pre-formed, with/without Murphy eye. Sterilization: Supplied sterile. Energy source: None (mechanical device).

Indications for Use

Indicated for airway management via oral or nasal intubation in patients requiring intubation. Contraindicated for use in procedures involving laser beams or electrosurgical active electrodes in the immediate area of the device due to combustion risk.

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

• Unomedical Standard ET Tubes (K951696)
• Unomedical Pediatric ET Tubes (K951967)
• Sheridan Sheridan CF (K822982)
• Mallinckrodt Brandt Hi-contour (K852025)

Submission Summary (Full Text)

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K050803

Premarket Notification 510(k) Section 3 - Certifications and Summaries - Revised 20-June-05 Vitaid ET Tubes

#### Summary of Safety and Effectiveness 3.1

# Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 20-June-05

| 300 International Dr.<br>Suite 100<br>Williamsville, NY 14221 | Tel: | [phone] |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| | Fax: | [phone] |
| Official Contact: | Will Stewart, President | |
| Proprietary or Trade Name: | Vitaid ET tubes | |
| Common/Usual Name: | Endotracheal tubes | |
| Classification Name: | Tracheal Tubes with and without connectors | |
| Predicate Devices: | Unomedical -- Standard ET Tubes K951696<br>Unomedical -- Pediatric ET Tubes K951967<br>Sheridan -- K822982 -- Sheridan CF<br>Mallinckrodt -- K852025 -- Brandt Hi-contour | |

### Device Description:

The Vitaid endotracheal tubes are available in sizes 3.0 mm in increments of 0.5 mm. They are available cuffed, uncuffed and with Murphy eye. Some are pre-formed, they are made with a ultra thin urethane cuff, referred to as the MicroCuff.

#### Indications:

Vitaid Ltd.

| Indications for Use -- | The Vitaid ET Tubes are designed for oral I nasal<br>intubation and are indicated for airway management. The Vitaid<br>ET tubes have an ultra thin inflatable cuff. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population -- | Patients requiring intubation |
| Environment of Use -- | Institutional -- Hospitals. Sub-acute<br>Pre-hospital - emergency services |

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# Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2

20-June-05

### Comparison to Predicate Devices:

| | Vitaid ET Tubes | Predicates |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attributes | | |
| Indications for use | The Vitaid ET Tubes are designed for oral /<br>nasal intubation and are indicated for airway<br>management. | Unomedical - K951696 -<br>Standard ET Tubes<br>Unomedical - K951967 -<br>Pediatric ET Tubes<br>Sheridan - K822982 -<br>Sheridan CF<br>Mallinckrodt - K852025 -<br>Brandt Hi-contour |
| Environments of use | Institutional - Hospital, Sub-acute<br>Pre-hospital - emergency services | Same |
| Patient Population | Patients requiring intubation | Same |
| Contraindications | Use of endotracheal tubes in procedures which<br>involve the use of laser beams or<br>electrosurgical active electrodes in the<br>immediate area of the device is contraindicated.<br>Contact of the endotracheal tub with a laser<br>beam or electrosurgical active electrode<br>especially in the presence of oxygen-enriched<br>mixtures could result in rapid combustion of<br>the endotracheal tube with harmful thermal<br>effects and with emission of corrosive and<br>toxic products including hydrochloric acid<br>(HCl). | Same |
| Technology | | |
| Material | Tube - PVC<br>Cuff - Polyurethane | Tube - PVC<br>Cuff -- PVC |
| Sizes - 3.0 mm to<br>10.0 mm | Yes | Yes |
| Cuffed and uncuffed.<br>pre-formed with and<br>without Murphy eye | Yes | Yes |
| Supplied Sterile | Yes | Yes |

# Differences Between Other Legally Marketed Predicate Devices

There are no significant differences between the proposed device. Vitaid ET Tubes, and the identified predicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

JUN 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Viataid, Ltd. C/o Mr. Paul E. Dryden ProMedic Incorporated Regulatory Consultant for Vitaid Ltd. 6329 W. Waterview Court McCordsville, Indiana 46055-9501

Re: K050803

Trade/Device Name: Vitaid ET Tubes Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal tube Regulatory Class: II Product Code: BTR Dated: June 22, 2005 Received: June 23, 2005

Dear Mr. Dryden:

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. Paul E. Dryden

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 (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 [phone]. 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 [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 Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use - Revised 3.3

(To be assigned) 510(k) Number: K050803 Vitaid ET Tubes Device Name: The Vitaid ET Tubes are designed for oral / nasal Indications for Use: intubation and are indicated for airway management. The Vitaid ET tubes have an ultra thin inflatable cuff.

Prescription Use XX (Per CFR 801.109)

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Over-the-counter use __

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cuxnduen
(Division Sign-Off)

Division of Anesthesiology, General Hospital. Infection Control, Deni 510(k) Number:

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