The Ciaglia Percutaneous Tracheostomy Introducer Set is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
The Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
The Ciaglia Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.

Device Description

The Cook Ciaglia percutaneous tracheostomy devices are designed for percutaneous dilational tracheostomy for management of the airway. More specifically, the devices allow for two approaches to the dilation of the stoma: serial dilation (Ciaglia Percutaneous Tracheostomy Introducer Set) or single-stage dilation (Blue Rhino® and Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set). Serial dilation is achieved using numerous progressively larger dilators. Single-stage dilation is achieved with a single rhino-horn-shaped dilator using an in-and-out motion. The Cook Ciaglia percutaneous tracheostomy devices are sold sterile for single use. There are multiple configurations that include various set and tray components (Table 1) associated with the procedure and/or in gaining percutaneous access.

AI/ML Overview

The provided document describes the Cook Ciaglia percutaneous tracheostomy devices and their substantial equivalence to a predicate device, K041348: Portex® Ultraperc® Percutaneous Dilation Tracheostomy kit. The submission focuses on non-clinical testing and a summary of existing clinical literature rather than a new standalone clinical study for this 510(k) submission.

Here's the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests with associated acceptance criteria, but it primarily states that the test article met the predetermined acceptance criteria or was greater than/less than or equal to the acceptance criterion/predicate. Specific numerical acceptance criteria or performance metrics are not explicitly detailed in the tables or text.

Test Category	Acceptance Criteria (Stated)	Reported Device Performance (Stated)
Tracheostomy Tube Fit / Removal Testing	Successfully inserted into intended tube & not fall out; successfully removed.	Test article can successfully be inserted into the intended tracheostomy tube and will not fall out under its own weight, and can be successfully removed.
Tensile Testing	Peak tensile load ≥ acceptance criterion	Peak tensile load of each test article was greater than or equal to the acceptance criterion.
Compression Testing	Withstand axial peak compressive load without kinking.	Test article will withstand the axial peak compressive load without kinking.
Flexibility with Guiding Catheter	Mean force to displace tip of guiding catheter < mean to displace dilator.	Mean force to displace the tip of the guiding catheter was less than the mean to displace the dilator.
Fracture Testing	Met predetermined acceptance criteria	Test article met the predetermined acceptance criteria.
Durability Testing	Met predetermined acceptance criteria	Test article met the predetermined acceptance criteria.
3 Point Bend Testing	Load to deflect dilators ≤ load of predicate	Load to deflect the dilators was less than or equal to the load of the predicate.
Insertion Force Testing	Average insertion load ≤ predicate	Average insertion load of the test article was less than or equal to the predicate.
Performance following Aging	Continue to meet applicable design input requirements.	Subject devices continue to meet applicable design input requirements following aging.
Biocompatibility	Deemed acceptable based on tests.	Cytotoxicity, Sensitization, Intracutaneous Reactivity, and Pyrogenicity tests completed, biocompatibility deemed acceptable.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes (n) used for each individual non-clinical test mentioned (e.g., tensile, compression, fracture). The data provenance for these non-clinical tests is "in-house" by Cook Incorporated.

For the summary of clinical performance, which involved an evaluation of published clinical evidence:

Test Set (Clinical Evidence Review):
- Cook devices: 24 articles incorporating 8,726 patients.
- Predicate device (Portex Ultraperc): 4 articles incorporating 1,036 patients.
Data Provenance: Retrospective literature review of published clinical evidence. The specific countries of origin for the studies included in this review are not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A for the non-clinical tests, as ground truth is based on engineering specifications and direct measurement.

For the clinical evidence review, there is no mention of external experts establishing ground truth for the summarized papers. The review itself constitutes an assessment by the applicant, Cook Incorporated.

4. Adjudication Method for the Test Set

N/A for non-clinical testing. For the clinical evidence review, no specific adjudication method for the included articles is described; it appears to be a summary of findings rather than a formal adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "Clinical tests were not required to demonstrate substantial equivalence of the Cook Ciaglia percutaneous tracheostomy devices as compared to the predicate devices." Instead, a summation of existing clinical literature was performed. Therefore, an MRMC comparative effectiveness study was not conducted as part of this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is a medical device (tracheostomy introducer set), not an AI algorithm. The performance evaluation is based on the physical properties and function of the device itself and its components.

7. The Type of Ground Truth Used

Non-Clinical Testing: Engineering specifications, design requirements, and direct physical measurements (e.g., load, force, kinking absence, fit). For some tests (e.g., 3 Point Bend, Insertion Force), the predicate device's performance also served as a comparative "ground truth" or benchmark.
Summary of Clinical Performance: Published clinical evidence (peer-reviewed articles) on the safety and effectiveness of the subject and predicate devices, which would have their own established ground truths (e.g., clinical outcomes, complication rates from patient data).

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device. There is no "training set" in the context of this device submission.

9. How the Ground Truth for the Training Set Was Established

N/A. Not applicable as there is no training set for an AI/ML device.

Summary

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COOK
INCORPORATED.
750 DANIELS WAY, P.O. BOX-489
BLOOMINGTON, IN 47402-0489 U.S.A.
NONE 812.339.2235 TOLL FREE: 800.457.4500-
WWW.COOKMEDICAL.COM

Image /page/0/Picture/1 description: The image shows information about the Ciaglia Percutaneous Tracheostomy Introducer Set. It also mentions the Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray and the Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray. The image includes the reference 21 CFR §807.92 and states that the date prepared was April 15, 2014, with an additional date of APR 18 2014.

Submitted Bv:

Applicant: Contact: Applicant Address:

Contact Phone Number: Contact Fax Number:

Device Information:

Trade names:

Ciaglia Percutaneous Tracheostomy Introducer Set Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Set/Tray Ciaglia Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray

Common name:	Tracheostomy Introducers
Classification Name:	Tracheostomy tube and tube cuff
Regulation:	21 CFR §868.5800
Product Code:	JOH

Cook Incorporated

Sean Spence, RAC

Cook Incorporated 750 Daniels Way

(812) 332-0281

Bloomington, IN 47404

(812) 335-3575 x105127

Predicate Device:

K041348: Portex® Ultraperc® Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra Tracheostomy Tube and Introducer

Device Description:

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Image /page/1/Picture/0 description: The image shows the logo for Cook Medical. The logo is white text on a black background. The word "COOK" is on the top line, and the word "MEDICAL" is on the bottom line.

The Cook Ciaglia percutaneous tracheostomy devices are sold sterile for single use. There are multiple configurations that include various set and tray components (Table 1) associated with the procedure and/or in gaining percutaneous access.

Components
Loading dilators	Gauze sponges	Endotracheal tube accessory
Guiding catheter	Introducer needles	Suture & needle
Access dilators	Catheter needles	Tracheostomy tube holder
Wire guide	Needle holder cup	Drape
Scalpels	Clamp	Split dressing
Syringes	Infiltration needles	Antiseptic skin prep
Lubricated jelly	Filter straw	Local anesthetic
Ointment

Table 1: Set/Tray Components

Indications for Use:

The Ciaglia Percutaneous Tracheostomy Introducer Set is intended for percutaneous a. dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
b. The Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only.

Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.

The Ciaglia Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer C. Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only.
Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.

Substantial Equivalence:

The Cook Ciaglia percutaneous tracheostomy devices are substantially equivalent in indications for use to the predicate. Both state their purpose as percutaneous dilational tracheostomy for management of the airway. The predicate specifically lists components used (e.g., wire guide, dilator) but those are implied whenever referencing percutaneous access. These differences do not raise new concerns and support a conclusion of substantial equivalence.

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Image /page/2/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. Below "COOK" is the word "MEDICAL" in smaller, white letters.

Table 2: Substantial Equivalence Comparison - Ciaglia and Serial Dilator Predicate

	SUBJECT DEVICES	PREDICATE
	Ciaglia Percutaneous TracheostomyIntroducer Set	Portex® Ultraperc® Percutaneous DilationTracheostomy Kit with Serial Dilators orSingle Stage Dilator, Blue Line UltraTrach. Tube and Introducer
510(k)	Subject of this submission	K041348
Regulation	21 CFR §868.5800, Tracheostomy tubeand tube cuff	Same
Product Code	JOH, tracheostomy tube and tube cuff	BTO, tube, tracheostomy (w/woconnector)
Classification	II	Same
Indications for Use	... is intended for percutaneous dilationaltracheostomy for management of theairway in adults only... should be performed in a controlledsetting...	Indicated to create a percutaneousdilational tracheostomy using guidewiredilators and components of these kits thatallow for tracheal access for airwaymanagement for use in adults only
Recommended Insertion Site	Between the first and second trachealcartilages or between the second and thirdtracheal cartilages	Same
Duration of Use	Limited duration (≤ 24 hours)	Same
Placement	Percutaneous technique	Same
Patient Population	Adult patients requiring prolongedventilatory support	Same
Sterilization	EtO	EtO
Shelf-Life	3 years	UNKNOWN
Packaging	Thermoform tray with a Tyvek® lid	Polymer bag with Tyvek opening
Tracheostomy Tube	Not sold with tracheostomy tube	Sold with tracheostomy tube in primarypackaging
Serial Dilator Overview	18, 21, 24, 28, 32, 36, and 38 FrenchImage: Serial dilator overview	17, 25, 32, and 37 FrenchImage: Serial dilator overview
Material	Vinyl	UNKNOWN
Black Ink Markings	Single skin level mark	Multiple specific depth marks
Tip Configuration	Tapered and curved	Tapered and straight
Tracheostomy Tube Loading	Serial dilators serve as tracheostomy tubeloading dilators for final placement	Separate tracheostomy tube loading dilatorincluded
	SUBJECT DEVICES	PREDICATE
	Ciaglia Blue Rhino, and Ciaglia BlueRhino G2 Advanced PercutaneousTracheostomy Introducer Sets	Portex® Ultraperc® Percutaneous DilationTracheostomy Kit with Serial Dilators orSingle Stage Dilator, Blue Line UltraTrach. Tube and Introducer
510(k)	Subject of this submission	K041348
Regulation	21 CFR §868.5800, Tracheostomy tubeand tube cuff	Same
Product Code	JOH, tracheostomy tube and tube cuff	BTO, tube, tracheostomy (w/woconnector)
Classification	II	Same
Indications for Use	.... is intended for percutaneous dilationaltracheostomy for management of theairway...should be performed in a controlledsetting...	Indicated to create a percutaneousdilational tracheostomy using guidewiredilators and components of these kits thatallow for tracheal access for airwaymanagement for use in adults only
Contraindicated for Pediatrics	Yes	Same
Recommended Insertion Site	Between the first and second trachealcartilages or between the second and thirdtracheal cartilages	Same
Duration of Use	Limited duration (≤ 24 hours)	Same
Placement	Percutaneous technique	Same
Patient Population	Adult patients requiring prolongedventilatory support	Same
Sterilization	EtO	EtO
Shelf-Life	3 years	UNKNOWN
Packaging	Thermoform tray with a Tyvek® lid	Plastic bag with Tyvek® opening
Tracheostomy Tube	Set or Tray sold individually and co-packaged with a tracheostomy tube	Tracheostomy tube present in primarypackaging
Single-Staged DilatorOverview	Image: Blue Rhino Curved Single-Staged Dilator	Image: Sigmoid Curved Single-Staged Dilator
	Blue Rhino
	Blue Rhino G2
Material	Blue radiopaque polyurethane	UNKNOWN
Surface Characteristics	Blue Rhino = SmoothBlue Rhino G2 = Crosshatch Handle andLongitudinally Grooved Distal Portion	Texture Handle Portion and Smooth DistalPortion
Tip Configuration	Tapered and curved	Same
Black Ink Markings	Single skin level mark	Same
Hydrophilic Coating	PVP based Hydrophilic Coating	UNKNOWN base Hydrophilic Coating

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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. Below the word "COOK" is the word "MEDICAL" in smaller, white letters.

Table 3: Substantial Equivalence Comparison – Ciaglia Blue Rhino / Blue Rhino G2 and Portex Single-Stage Predicate

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Image /page/4/Picture/1 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. Below "COOK" is the word "MEDICAL" in smaller, white letters, also on a black background.

As shown in Table 2, differences in the subject serial dilators and the predicate serial dilators are packaging, presence or absence of a tracheostomy tube, range of serial dilators, material, tracheostomy tube loading, curvature at the distal tip, and depth markings. Table 3 shows differences in the subject single-stage dilators and the predicate are packaging, presence or absence of a tracheostomy tube, shape, material and texture. The differences in characteristics do not raise new concerns and support a conclusion of substantial equivalence. This conclusion was derived by comparing the product literature, specifications, and by performance testing.

Summary of Non-Clinical Testing:

The following tests were performed to demonstrate that the Cook Ciaglia tracheostomy devices met applicable design and performance requirements and support a determination of substantial equivalence.

Tracheostomy Tube Fit / Removal Testing showed that the appropriate loading dilator . can successfully be inserted into the intended tracheostomy tube and will not fall out under its own weight, and can be successfully removed
. Tensile - Testing showed that the peak tensile load of each test article was greater than or equal to the acceptance criterion
Compression - Testing showed that the test article will withstand the axial peak compressive load without kinking
B Flexibility with Guiding Catheter - Testing showed the mean force to displace the tip of the guiding catheter was less than the mean to displace the dilator
피 Fracture - Testing showed the test article met the predetermined acceptance criteria
1 Durability - Testing showed the test article met the predetermined acceptance criteria
I 3 Point Bend - Testing showed the load to deflect the dilators was less than or equal to the load of the predicate
I Insertion Force - Testing showed the average insertion load of the test article was less than or equal to the predicate
. Performance following aging - Testing showed the subject devices continue to meet applicable design input requirements following aging
. Biocompatibility - The proposed devices were classified as external communicating devices with Tissue/Bone/Dentin contact for ≤ 24 hours. The following tests were completed and the biocompatibility was deemed acceptable: Cytotoxicity, Sensitization, Intracutaneous Reactivity, and Pyrogenicity.

In addition, human factors hazard analysis and simulated use testing (usability study) were conducted.

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Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on the top line. Below that, the word "MEDICAL" is in smaller, white letters.

COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 LOOMINGTON, IN 47402-0489 U.S.A. 12.389.2235 TOLLERIS BOD.457.4500 WWW.COOKMEDICAL.COM

Summary of Clinical Performance:

Clinical tests were not required to demonstrate substantial equivalence of the Cook Ciaglia percutaneous tracheostomy devices as compared to the predicate devices. However, since the subject devices have a well-established history of clinical use, an evaluation of published clinical evidence was used to substantiate a history of safe and effective use. A total of 24 articles. incorporating 8,726 patients treated with Cook devices, were summarized. Limited clinical evidence on the predicate Portex Ultraperc® Percutaneous Dilation Tracheostomy kit was also found in 4 articles, incorporating 1,036 patients. Overall, the clinical evidence demonstrates that the subject devices are as safe and effective as the predicate device when used in percutaneous dilational tracheostomy for management of the airway.

Conclusion:

Based on the comparison information, non-clinical performance testing, and published clinical evidence, the Cook Ciaglia percutaneous tracheostomy are substantially equivalent to the predicate Portex® Ultraperc® Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra Tracheostomy Tube and Introducer (K041348).

Portex® and Ultraperc® are registered trademarks of Smiths Medical

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 emblem featuring three abstract shapes that resemble a person with outstretched arms.

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

April 18. 2014

Cook Incorporated Mr. Scan Spence, RAC Regulatory Affairs Team Lead Official Correspondent 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402

Re: K133597

Trade/Device Name: Ciaglia Percutaneous Tracheostomy Introducer Set Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Set/Trav Ciaglia Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube

Regulatory Class: Class II Product Code: JOH Dated: March 17th. 2014 Received: March 18th, 2014

Dear Mr. Spence:

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 - Mr. Spence

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Safetv/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Image /page/7/Picture/8 description: The image shows a signature or stamp with the text "Tejashri Purohit-Sheth, M.D., Clinical Deputy Director, DAGRID, FOR". The text is arranged in a stacked format, with the name and title at the top, followed by the department and a label. The signature or stamp appears to be stylized and may be used for official purposes.

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K133597

Device Name

Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Set/Tray

Indications for Use (Describe)

The Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer SetTray is intended for percutaneous dilational tracheostomy for management of the airway in adults only.

Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FDA USE ONLY FALL r, 1+32-2-

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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.17 16:21:45 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{9}------------------------------------------------

Indications for Use

510(k) Number (if known) K133597

Device Name

Ciaglia Percutaneous Tracheostomy Introducer Set

Indications for Use (Describe)

The Ciaglia Percutaneous Tracheostomy Introducer Set is intended for percutaneous dilational tracheostomy for management of the airway in adults only.

Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operaling room) with the assistance of trained personnel.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FOR FOR FOR FOR FOR FOR THE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FO

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{10}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133597

Device Name

Ciaglia Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray

Indications for Use (Describe)

The Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer SetTray is intended for percutaneous dilational tracheostomy for management of the airway in adults only.

Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

IT THE THE FOR FOR FOR FOR FOR FOR THE TO THE

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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.17 16:22:14 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

Regulation Number and Section

§ 868.5800 Tracheostomy tube and tube cuff.

(a)
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.(b)
Classification. Class II.