CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS

K093469 · Cook, Inc. · JOH · Jan 8, 2010 · Anesthesiology

Device Facts

• Record ID: K093469
• Device Name: CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
• Applicant: Cook, Inc.
• Product Code: JOH · Anesthesiology
• Decision Date: Jan 8, 2010
• 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 utilizes a balloon-based mechanism to dilate the stoma site, allowing for the controlled insertion of a tracheostomy tube. It is intended for use by clinicians in a controlled, elective setting. The device is provided as a sterile introducer, with an optional sterile tracheostomy tube included in some sets. By providing a controlled dilation method, the device assists in the surgical procedure of creating an airway, potentially reducing trauma during the insertion process compared to traditional methods.

Clinical Evidence

Bench testing only. Withdrawal force testing and tensile testing were performed to verify that the modified device meets design and performance requirements.

Technological Characteristics

Balloon-based percutaneous tracheostomy introducer. Materials of construction are identical to the predicate device. The device functions via mechanical dilation of the tracheal stoma. It is provided sterile.

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 (K072148)

Submission Summary (Full Text)

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Special 510(k): Device Modification Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer COOK INCORPORATED 05 November 2009

K093 4621-

# 510(k) SUMMARY

| Submitted By: | Susanne Galin, RAC | JAN - 8 2010 |
|---------------|-------------------------------|--------------|
| | Regulatory Affairs Specialist | |
| | Cook Incorporated | |
| | 750 Daniels Way, P.O. Box 489 | |
| | Bloomington, IN 47402 | |
| | [phone] x 2296 | |
| | November 5, 2009 | |

#### 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: | Ciaglia Blue Dolphin™ Balloon Percutaneous<br>Tracheostomy Introducer, 510(k) number K072148 |

# 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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#### Special 510(k): Device Modification Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer COOK INCORPORATED 05 November 2009

### Substantial Equivalence:

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

## Test Data:

Withdrawal Force Testing and Tensile Testing was presented to demonstrate that the Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer meets applicable design and performance requirements. The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

# JAN - 8 2010

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

Re: K093469

Trade/Device Name: Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: December 10, 2009 Received: December 11, 2009

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 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); 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/CDRHOffices/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Nh for

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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Special 510(k): Device Modification Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer COOK INCORPORATED 05 November 2009

#### Indications for Use

| 510(k) Number (if known): | K093469 |
|---------------------------|------------------------------------------------------------------------------|
| Device Name: | Ciaglia Blue DolphinTM Balloon Percutaneous Tracheostomy<br>Introducer |
| Indications for Use: | Used for controlled elective subcricoid insertion of a tracheostomy<br>tube. |

Prescription Use __ XX _______________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR Over-the-Counter Use :

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Concurrence of CDR

L. Shullton

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

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409346 510(k) Number: _______________________________________________________________________________________________________________________________________________________________