CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER

K072148 · Cook, Inc. · JOH · Oct 3, 2007 · Anesthesiology

Device Facts

• Record ID: K072148
• Device Name: CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
• Applicant: Cook, Inc.
• Product Code: JOH · Anesthesiology
• Decision Date: Oct 3, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used for controlled elective subcricoid insertion of a tracheostomy tube.

Device Story

The Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer facilitates percutaneous entry into the trachea for tracheostomy tube placement. The device set includes a balloon-tipped catheter loading dilator assembly, wire guide, introducer needle, needle holder cup, 14 French dilator, gauze, syringe, measuring tape, scalpel, lubricating jelly, and a full-body drape. Used in clinical settings by healthcare professionals to perform controlled elective subcricoid tracheostomy. The balloon-tipped catheter is inserted to dilate the stoma, allowing for the subsequent placement of a tracheostomy tube. This mechanical approach simplifies the procedure, potentially reducing trauma and improving procedural control during airway access.

Clinical Evidence

Bench testing only. Testing included balloon compliance and burst testing, failure load testing, withdrawal force testing, and tensile testing to demonstrate safety and effectiveness.

Technological Characteristics

Balloon-tipped catheter loading dilator assembly; includes wire guide, introducer needle, 14 French dilator, and accessories. Mechanical dilation principle. Non-powered, manual operation. Sterilized device.

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 Dolphin™ Balloon Percutaneous Tracheostomy Introducer (K041044)

Submission Summary (Full Text)

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Special 510(k): Device Modification Ciaglia Blue Dolphin" Balloon Percutaneous Tracheostomy Introducer COOK INCORPORATED 02 August 2007

K072148

## 510(k) SUMMARY

Submitted By:

| Susanne Galin |
|-------------------------------|
| Regulatory Affairs Specialist |

OCT 3 * 2007

Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 [phone] x 2296 02 August 2007

## Device:

| Trade Name: | Ciaglia Blue Dolphin™ Balloon Percutaneous<br>Tracheostomy Introducer | |
|-------------------------------|------------------------------------------------------------------------------|--|
| Proposed Classification Name: | Tracheostomy tube and tube cuff<br>21 CFR §868.5800, Product Code JOH | |
| Indications for Use: | Used for controlled elective subcricoid insertion of a<br>tracheostomy tube. | |

## Predicate Devices:

The Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer is identical in terms of intended use and technological characteristics to the predicate Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer (K041044), and similar in terms of materials of construction.

## Device Description:

The Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer is a device used to facilitate percutaneous entry into the trachea for placement of a tracheostomy tube. A separate, sterile tracheostomy tube is also included in an optional set.

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The set consists of a balloon-tipped catheter loading dilator assembly, wire guide, introducer needle, needle holder cup, 14 French dilator, gauze pads, disposable syringe, measuring tape, disposable scalpel, lubricating jelly, and a large full-body drape with clear plastic window.

# Substantial Equivalence:

The identical indications for use, technological characteristics, and similar materials of construction of the Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer as compared to the predicate device supports a determination of substantial equivalence.

# Test Data:

Testing data are presented to demonstrate that the Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer meets applicable design and performance requirements.

- Balloon compliance and burst testing .
- . Failure load testing
- Withdraw force testing .
- Tensile testing .

The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susanne Galin Regulatory Affairs Specialist Cook, Incorporated 750 Daniels Way Post Office Box 489 Bloomington, Indiana 47402

OCT 3 2007

Re: K072148

Trade/Device Name: Ciaglia Blue Dolphin™ Balloon Percutancous Tracheostomy Introducer Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: August 31, 2007 Received: September 4, 2007

Dear Ms. Galin:

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. Galin

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.

Chris Lipe, P.E.

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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Special 510(k): Device Modification Ciaglia Blue Dolphin" Balloon Percutaneous Tracheostomy Introducer COOK INCORPORATED 02 August 2007

#### Indications for Use

| 510(k) Number (if known): | K072148 |
|---------------------------|------------------------------------------------------------------------------|
| Device Name: | Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy<br>Introducer |
| Indications for Use: | Used for controlled elective subcricoid insertion of a tracheostomy<br>tube. |

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 1

| (Division Sign-Off) | <img alt="Signature" src="signature.png"/> |
|-----------------------------------|-----------------------------------------------------------|
| Division of Anesthesiology | General Hospital, CDRH, Office of Device Evaluation (ODE) |
| Infection Control, Dental Devices | |

4072148 510(k) Number: __ -Company Confidential-