CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET

K041044 · Cook, Inc. · JOH · Jul 29, 2004 · Anesthesiology

Device Facts

• Record ID: K041044
• Device Name: CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
• Applicant: Cook, Inc.
• Product Code: JOH · Anesthesiology
• Decision Date: Jul 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer is intended for controlled elective subcricoid insertion of a tracheostomy tube.

Device Story

The Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer is a sterile, single-use device designed for elective subcricoid tracheostomy tube insertion. The system comprises an inflatable balloon mounted on a 5 Fr double-lumen coaxial catheter shaft, available in 27 and 28 French sizes. The set includes a catheter access needle, 0.035" wire guide, dilator, and a 20 cc controlled syringe. During the procedure, the clinician uses the needle and wire guide to access the trachea, then uses the balloon catheter to dilate the stoma for tracheostomy tube placement. The device features a 21.5 cm shaft length and a rated burst pressure of 6 atm. It is intended for use by healthcare professionals in a clinical setting to facilitate airway management, potentially reducing trauma during the insertion process compared to traditional methods.

Clinical Evidence

Bench testing only. Testing included biocompatibility, tensile strength, fatigue, air and liquid leakage, burst pressure, and inflation/deflation time.

Technological Characteristics

Inflatable balloon on 5 Fr double-lumen coaxial catheter shaft; 21.5 cm length; 27 and 28 French sizes; 6 atm rated burst pressure. Includes Luer ports for inflation and wire guide. Supplied sterile for single-use.

Indications for Use

Indicated for controlled elective subcricoid insertion of a tracheostomy tube in patients requiring tracheostomy.

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

• Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer (Class I Exempt)
• Portex Percutaneous Dilatational Tracheostomy Kit (K022212)

Submission Summary (Full Text)

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# JUL 2 9 2004

COOK®

Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489 Phone: [phone] www.cookgroup.com

# 510(k) SUMMARY

| Submitted By: | COOK INCORPORATED<br>750 Daniels Way, P.O. Box 489<br>Bloomington, IN 47402-0489 |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Contact: | Jennifer Bosley, MBA, RAC<br>Regulatory Affairs Coordinator<br>Tel: [phone] Fax: [phone] |
| Date Prepared: | July 27, 2004 |
| 510(k) #: | K041044 |
| Device: | |
| Trade Name: | Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer |
| Common/Usual Name: | Tracheostomy Tube Introducer |
| Classification Name: | Tracheostomy Tube and Tube Cuff, 21 CFR § 868.5800 |
| Class: | Class II |
| Product/Panel Code: | JOH—Anesthesiology Device Panel |

### Intended Use:

The Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer is intended for controlled elective subcricoid insertion of a tracheostomy tube.

### Substantial Equivalence:

The subject device is similar with respect to intended use and/or design features to the predicate I he subject device is smiller with substantial equivalence. The subject device is safe and effective and is substantially equivalent to the predicate devices.

| Manufacturer | Device | 510(k) # |
|-------------------|----------------------------------------------------------|----------------|
| Cook Incorporated | Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer | Class I Exempt |
| Portex Ltd. | Portex Percutaneous Dilatational Tracheostomy Kit | K022212 |

## Device Description:

Device Desertiption.
The Ciaglia Blue Dolphin™ Balloon Percutancous Tracheostomy Introducer consists of an inflatable balloon on a double lumen 5 Fr inner coaxial catheter shaft; the loading section of the milalable Danbon on a double fullien 9 1 1 11.12 106. 27 and 28 French sizes. The length of the catheter shaft is 21.5 cm with a Luer port for inflation and a Luer port for the wire guide. The calleter shall is 21,5 on with a rated burst pressure of 6 atm. The set components include the balloon catheter, catheter access needle, 0.035" wire guide, dilator, 20 cc controlled syringe and balloon catherer, battleter doods insertion. The set is supplied sterile and intended for one-time use.

#### Test Data:

I esting includes biocompatibility testing, tensile strength, fatigue, air and liquid leakage; burst pressure and inflation/deflation time.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2004

Ms. Jennifer Bosley Regulatory Affairs Coordinator Cook, Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402-0489

Re: K041044

Trade/Device Name: Ciaglia Cheetah Percutaneous Tracheostomy Introducer Set Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: June 28, 2004 Received: June 29, 2004

Dear Ms. Bosley: ﺮ ﺍﻟﻤﺮﺍﺟﻊ

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 -Ms. Bosley

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. or the Free of any 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 and houng (21 ce ready in the quality systems (QS) regulation (21 CFR Part 820); and if requireme as leverronic 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 premiumer hotellers and the 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), rr you dontact 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/dsma/dsmamain.html

Sincerely yours,

Clus

*Tricia Lynn, Ph.D.*

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 Statement

510(k) Number (if known): K041044

Ciaglia Cheetah™ Percutaneous Tracheostomy Introducer Set Device Name:

## Indications for Use:

The Ciaglia Cheetah™ Percutaneous Tracheostomy Introducer Set is intended for controlled elective subcricoid insertion of a tracheostomy tube.

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

Over-The-Counter Use (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)

Aury Solem

Division Sian-Off Division of Anesthesiology, General Hospital, Infection Control. Den

510(k) Number.***_***_

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