ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH

K100480 · Vitaltec Corporation · BTO · Jun 11, 2010 · Anesthesiology

Device Facts

• Record ID: K100480
• Device Name: ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
• Applicant: Vitaltec Corporation
• Product Code: BTO · Anesthesiology
• Decision Date: Jun 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

Tracheostomy Tubes are intended for use in providing direct tracheal access for airway management. CAUTION: U.S. Federal law restricts the use of this device to licensed professionals.

Device Story

VITALTEC Rota-Trach Tracheostomy Tube provides direct tracheal access for airway management. Device consists of tube, connector, and air cuff. Used by licensed professionals in clinical settings. Tube inserted into trachea to maintain patent airway. Connector conforms to ISO 5356-1 for compatibility with respiratory equipment. Cuff provides seal within trachea. Device manufactured from silicone with biocompatible properties. Sterilized via moist heat. Output is physical airway access; assists clinicians in managing patient ventilation and airway patency.

Clinical Evidence

Bench testing only. Conformance to ISO 5356-1 (connectors) and ISO 17665-1 (sterilization validation) demonstrated. Biocompatibility testing performed per ISO 10993-1, ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation and sensitization).

Technological Characteristics

Silicone construction; 15mm O.D. connector per ISO 5356-1; pediatric (5.0mm, 6.0mm) and adult (7.0mm-10.0mm) sizes; air cuff; moist heat sterilization.

Indications for Use

Indicated for patients requiring direct tracheal access for airway management. Suitable for pediatric and adult populations.

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

• Medical Tracheostomy Tubes (K031553)

Submission Summary (Full Text)

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#### VITALTEC CORPORATION

No.12, Lane 4-30, Chyuan Zhou Rd., Hou Li Hsiang, Taichung, 42142, Taiwan, ROC Tel: [phone] Fax: [phone] Email: [e-mail]

# 5. 510(K) SUMMARY (as required by 807.92(c))

JUN 11 2010

## K100480

DATE OF SUBMISSION: SUBMITTER:

January 27, 2010 president, Mr. Joseph Chang VITALTEC CORPORATION No. 12, Lane 4-30, Chyuan Zhou Rd., Hou Li Hsiang, Taichung, 42142, Taiwan TEL: [phone] FAX: [phone]

ESTABLISHMENT 3003851906 REGISTRATION NO:

OFFICIAL CONTACT: Dr. JEN, KE-MIN ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY No 58, Fu Chiun Street. Hsin Chu City, 30067, Taiwan TEL: [phone] FAX:[phone]

VITALTEC Rota-Trach Tracheostomy Tube TRADE NAME:

Tracheostomy Tube COMMON/USUAL

Tube, Tracheostomy (W/Wo connector)

CLASSIFICATION NAME:

NAME:

CLASSIFICATION PANEL:

BTO, Class II, 868.5800

PREDICATED DEVICE: INTENDED USE:

NON-CLINIC DATA:

- ISO 5356-1: Anaesthetic and respiratory equipment -. Conical connectors: Part 1: Cones and sockets. 2004.
Tracheostomy Tubes are intended for use in providing direct

Medical Tracheostomy Tubes; 510K No. ( K031553 )

tracheal access for airway management.

- ISO 10993-1: Biological Evaluation of medical ● devices, part 1: Evaluation and testing, 2003.
- 10993-5: Biological Evaluation of medical ● ISO devices, part 5: Tests for in vitro cytotoxicity, 1999.
- ISO 10993-10: Biological Evaluation of medical ● devices, part 10: Tests for irritation and sensitization, 2002.

િર

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## VITALTEC CORPORATION

No.12, Lane 4-30, Chyuan Zhou Rd., Hou Li Hsiang, Taichung, 42142, Taiwan, ROC Tel: [phone] Fax: [phone] Email: [e-mail]

- ISO 17665-1: Sterilization of health care products, part . 1: validation and control of sterilization process for medical devices, 2006.
## DEVICE DESCRIPTION:

The VITALTEC Rota-Trach Tracheostomy Tubes are made from the raw material of The VITALIEC Kota Track Track Tracksonsyland of connector and valve. The the seeff with Sincolle for medical ass, while the components of the propriate hardness, the cuff with tubes have such good perfectionsment tube and excellent biocompatibility.

| ITEM | PREDICATE DEVICE | SUBJECT DEVICE |
|-------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Name | Medical Tracheostomy Tubes<br>( K031553 ) | VITALTEC Rota-Trach<br>Tracheostomy Tubes |
| Intended Use | Tracheostomy Tubes are intended<br>for use in providing direct tracheal<br>access for airway management. | Same |
| Material | Silicone | Same |
| Connector | 15 O.D. per ISO 5356-1 | Same |
| Sterilization<br>Method | ETO | Moist Heat |
| Specification | Various sizes for Pediatric and Adult | Pediatric I.D.: 5.0mm, 6.0mm<br>Adult I.D.:7.0mm, 8.0mm,<br>9.0mm, 10.0mm |
| Cuff Style | Various types for Pediatric and Adult | Each one type of Air Cuff to<br>match with each one size of<br>Tracheostomy Tube |

## COMPARISON WITH PREDICATE DEVICE:

### PERFORMANCE DATA

The dimension, design, material, sterility and packaging of VITALTEC Rota-Trach Tracheostomy Tubes are conformed to ISO 5356-1 and ISO 17665-1.

#### CONCLUSION

In accordance with the FDA 21 CFR 807 and based on the information provided in this areas In accordance with the I DVD DEC Rota-Trach Tracheostomy Tubes have the same
Premarket notification, VITALTEC Rota-Trach Tracheostomy Tubes worlding intended use, material, and use the same specification of connector which is complied mich ISO 5356-1; and the different sterilization method was also got the validation. I The with 100 950 1, and 11.
main differences of the two devices are the subject device only has one type of air cuff and simpler specifications.

Thus the two devices are substantial equivalence.

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Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling birds in flight, stacked on top of each other.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Vitaltec Corporation C/O Ms. Jen Ke-Min Roc Chinese-European Industry Research Society No. 58, Fu Chiun Street Hsin Chu City China (Taiwan) 30067

## JUN 1 1 2010

Re: K100480

Trade/Device Name: Rota-Trach Tracheostomy Tube Model Rota-Trach Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: BTO Dated: June 3, 2010 Received: June 10, 2010

Dear Ms. Ke-Min:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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- Ms. Ke-Min

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/CDRHQffices/ucm115809.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,

Susan Runner

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

Enclosure

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#### VITALTEC CORPORATION

No.12, Lane 4-30, Chyuan Zhou Rd., Hou Li Hsiang, Taichung, 42142, Taiwan, ROC Tel: [phone] Fax: [phone] Email: info@@vitaltec.com.tw

## Indications for Use .

510 (K) Number ( If Known ):

Device Name: VITALTEC Rota-Trach Tracheostomy Tube ●

## Indications for Use :

Tracheostomy Tubes are intended for use in providing direct tracheal access for airway management.

CAUTION: U.S. Federal law restricts the use of this device to licensed professionals.

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultin

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

510(k) Number: N 100480